MYLAN INC.
`
`FORM 10-K
`(Annual Report)
`
`Filed 02/28/13 for the Period Ending 12/31/12
`
`
`Address
`
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`1500 CORPORATE DRIVE
`CANONSBURG, PA 15317
`724-514-1800
`Telephone
`0000069499
`CIK
`Symbol MYL
`SIC Code
`2834 - Pharmaceutical Preparations
`Industry
`Biotechnology & Drugs
`Sector Healthcare
`Fiscal Year
`12/31
`
`http://www.edgar-online.com
`© Copyright 2013, EDGAR Online, Inc. All Rights Reserved.
`Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use.
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`NCI Exhibit 2013
`Page 1 of 137
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`UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington, DC 20549
`FORM 10-K
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`(cid:1)
`
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`Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
`For the Fiscal Year Ended December 31, 2012
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`OR
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`Transition Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
`For the transition period from to .
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`Commission file number 1-9114
`MYLAN INC.
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`(Exact name of registrant as specified in its charter)
`
`25-1211621
`Pennsylvania
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`(State or other jurisdiction of incorporation or organization)
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`(I.R.S. Employer Identification No.)
`1500 Corporate Drive, Canonsburg, Pennsylvania 15317
`(Address of principal executive offices)
`(724) 514-1800
`(Registrant’s telephone number, including area code)
`Securities registered pursuant to Section 12(b) of the Act:
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`
`
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`Name of Each Exchange on Which Registered:
`The NASDAQ Stock Market
`
`Title of Each Class:
`Common Stock, par value $0.50 per share
`Securities registered pursuant to Section 12(g) of the Act: None
`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes (cid:1) No 
`Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes  No (cid:1)
`Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
`during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
`requirements for the past 90 days. Yes (cid:1) No 
`Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File
`required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter
`period that the registrant was required to submit and post such files). Yes (cid:1) No 
`Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein, and
`will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K
`or any amendment to this Form 10-K. (cid:1)
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See
`the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.:
`
`Large accelerated filer
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`Non-accelerated filer
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`(cid:1)
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` (Do not check if a smaller reporting company)
`
` Accelerated filer
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`
`
` Smaller reporting company 
`
`Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes  No (cid:1)
`The aggregate market value of the outstanding common stock, other than shares held by persons who may be deemed affiliates of the registrant, as of
`June 30, 2012 , the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $8,624,667,439 .
`The number of shares outstanding of common stock of the registrant as of February 25, 2013 , was 395,550,874 .
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`INCORPORATED BY REFERENCE
`
`Document
`Proxy Statement for the 2013 Annual Meeting of Shareholders, which will be filed with the Securities and
`Exchange Commission within 120 days after the end of the registrant’s fiscal year ended December 31, 2012.
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`Part of Form 10-K into Which
`Document is Incorporated
`III
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`NCI Exhibit 2013
`Page 2 of 137
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`Table of Contents
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`MYLAN INC.
`INDEX TO FORM 10-K
`For the Year Ended December 31, 2012
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`PART I
`
`ITEM 1.
`ITEM 1A.
`ITEM 1B.
`ITEM 2.
`ITEM 3.
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`ITEM 5.
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`ITEM 6.
`ITEM 7.
`ITEM 7A.
`ITEM 8.
`ITEM 9.
`ITEM 9A.
`ITEM 9B.
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`ITEM 10.
`ITEM 11.
`ITEM 12.
`ITEM 13.
`ITEM 14.
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`ITEM 15.
`Signatures
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`Business
`Risk Factors
`Unresolved Staff Comments
`Properties
`Legal Proceedings
`
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`PART II
`Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
`Securities
`Selected Financial Data
`Management’s Discussion and Analysis of Financial Condition and Results of Operations
`Quantitative and Qualitative Disclosures about Market Risk
`Financial Statements and Supplementary Data
`Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
`Controls and Procedures
`Other Information
`
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`PART III
`Directors, Executive Officers and Corporate Governance
`Executive Compensation
`Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
`Certain Relationships and Related Transactions, and Director Independence
`Principal Accounting Fees and Services
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`PART IV
`Exhibits and Consolidated Financial Statement Schedules
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`2
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`Page
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`3
`21
`39
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`40
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`43
`44
`64
`66
`118
`118
`118
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`119
`119
`119
`119
`119
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`120
`127
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`NCI Exhibit 2013
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`Table of Contents
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`ITEM 1. Business
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`PART I
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`Mylan Inc. along with its subsidiaries (collectively, the “Company,” “Mylan,” “our” or “we”) is a fully integrated global
`pharmaceutical company that develops, licenses, manufactures, markets and distributes generic, branded generic and specialty pharmaceuticals.
`Mylan ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in
`approximately 140 countries and territories. We maintain one of the industry’s broadest and highest quality product portfolios, supported by a
`robust product pipeline and one of the world’s largest vertically integrated active pharmaceutical ingredient (“API”) operations. Additionally, we
`operate a specialty business which is focused on respiratory, allergy and psychiatric therapies. Mylan was incorporated in Pennsylvania in 1970 .
`
`Overview
`
`Throughout its history, Mylan has been recognized as a leader in the United States (“U.S.”) generic pharmaceutical market. Since 2007,
`Mylan has transformed itself and today is one of the largest generic and specialty pharmaceuticals companies in the world in terms of revenue.
`This transformation has taken place through organic growth and external expansion. Our leadership position in the U.S. generic pharmaceutical
`industry is the result of our ability to obtain Abbreviated New Drug Application (“ANDA”) approvals, as well as our reliable and high quality
`supply chain. Through the acquisitions of Mylan Laboratories Limited (formerly known as Matrix Laboratories Limited), Merck KGaA’s
`generics and specialty pharmaceutical business (the “former Merck Generics business”), Bioniche Pharma Holdings Limited (“Bioniche
`Pharma”) and Pfizer Inc.’s (“Pfizer’s”) respiratory delivery platform, we have created a horizontally and vertically integrated platform with
`global scale, augmented our diversified product portfolio and further expanded our range of capabilities, all of which we believe position us well
`for the future.
`
`
`In addition to the U.S., Mylan has a robust worldwide commercial presence in the generic pharmaceutical market, including leadership
`positions in France and Australia and several other key European and Asia Pacific markets, as well as a leading branded specialty
`pharmaceutical business focusing on respiratory, allergy and psychiatric products.
`
`Currently, Mylan markets a global portfolio of approximately 1,100 different products covering a vast array of therapeutic categories.
`We offer an extensive range of dosage forms and delivery systems, including oral solids, topicals, liquids and semi-solids. In addition, we focus
`on those that are difficult to formulate and manufacture and typically have longer product life cycles than traditional generic pharmaceuticals,
`including transdermal patches, high potency formulations, injectables, controlled-release and respiratory products. Mylan also manufactures and
`supplies low cost, high quality API for its own products and pipeline, as well as for third parties.
`
`Mylan also has one of the deepest pipelines and largest number of products pending regulatory approval in our history. Increasing sales
`volumes and continuing leverage of our vertically integrated platform provides substantial operational efficiencies and economies of scale.
`
`
`We believe that the breadth and depth of our business and platform provides certain competitive advantages over many of our
`competitors in major markets in which we operate, including less dependency on any single market or product, and, as a result, we are better able
`to successfully compete on a global basis.
`
`Our Operations
`
`Mylan has two segments, “Generics” and “Specialty.” Our revenues are primarily derived from the sale of generic and branded generic
`pharmaceuticals, specialty pharmaceuticals and API. Our generic pharmaceutical business is conducted primarily in the U.S. and Canada
`(collectively, “North America”); Europe, the Middle East, and Africa (collectively, “EMEA”); and India, Australia, Japan and New Zealand
`(collectively, “Asia Pacific”). Our API business is conducted through Mylan Laboratories Limited (“Mylan India”), which is included within the
`Asia Pacific region in our Generics Segment. Our specialty pharmaceutical business is conducted by Mylan Specialty L.P. (“Mylan Specialty”).
`Refer to Note 13 to Consolidated Financial Statements included in Item 8 in this Form 10-K for additional information related to our segments.
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`NCI Exhibit 2013
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`Table of Contents
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`Generics Segment
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`North America
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`The U.S. generics market is the largest in the world, with generic prescription market sales of $46.0 billion for the twelve months ended
`November 2012 . Mylan holds the number two ranking in the U.S. generics prescription market in terms of both sales and prescriptions
`dispensed. One in every 11 prescriptions dispensed in the U.S. is a Mylan product. Our sales in the U.S. are derived principally through our
`wholly owned subsidiary Mylan Pharmaceuticals Inc. (“MPI”), our primary U.S. pharmaceutical research, development, manufacturing,
`marketing and distribution subsidiary, as well as through our wholly owned subsidiary Mylan Institutional (“MI”). MI supplies pharmaceutical
`products and services to institutional customers, such as group purchasing organizations, hospitals and long-term care facilities.
`
`MPI’s net revenues are derived primarily from the sale of solid oral dosage and transdermal patch products. MI’s net revenues are
`derived from the sale of its unit dose and injectable product offerings. In the U.S., we have one of the largest product portfolios among all
`generic pharmaceutical companies, consisting of approximately 365 products, of which approximately 310 are in capsule or tablet form in an
`aggregate of approximately 880 dosage strengths. Included in these totals are approximately 40 extended-release products in a total of
`approximately 105 dosage strengths.
`
`Also included in our U.S. product portfolio are three transdermal patch products in a total of 15 dosage strengths that are developed and
`manufactured by Mylan Technologies, Inc. (“MTI”), our wholly owned transdermal technology subsidiary, and marketed and distributed by
`MPI. MTI’s fentanyl transdermal system (“fentanyl”) was the first AB-rated generic alternative to Duragesic® on the market and was also the
`first generic class II narcotic transdermal product ever approved. MTI’s fentanyl product currently remains the only AB-rated generic alternative
`approved in all strengths.
`
`Mylan Institutional focuses on providing a differentiated product offering tailored to institutional customers throughout North America,
`including group purchasing organizations, wholesalers, hospitals, surgical services, home infusion service providers, long-term care facilities,
`correctional facilities, specialty pharmacies and retail outlets. MI markets and repackages products, either obtained from MPI or purchased from
`third parties, in unit dose form, and manufactures and sells a diverse portfolio of injectable products across several therapeutic areas, with most
`of the Company’s sales made to customers in the U.S. MI also provides a platform for the commercialization of future biogeneric product
`offerings. MI has, among other product offerings, a diverse portfolio of approximately 40 injectable products (branded and generic) in a total of
`approximately 60 dosage strengths, across several therapeutic areas for the hospital setting, including analgesics/anesthetics, anti-infections,
`cardiology and oncology. In addition to the products we manufacture in the U.S., we also market approximately 50 generic products in a total of
`approximately 75 dosage strengths under supply and distribution agreements with wholesalers.
`
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`We believe that the breadth and quality of our product offerings help us to successfully meet our customers’ needs and to better
`compete in the generic industry over the long term. We also believe that the future growth of our U.S. generics business is partially dependent
`upon continued acceptance of generic products as low cost alternatives to branded pharmaceuticals, a trend which is largely outside of our
`control. However, we believe that we can maximize the profitability of our generic product opportunities by continuing our proven track record
`of bringing to market high quality products that are difficult to formulate or manufacture, or for which the API is difficult to obtain. Over the last
`several years, in addition to fentanyl, we have successfully introduced many generic products with high barriers to entry that continue to be
`meaningful contributors to our business several years after their initial launch. Additionally, we expect to achieve growth in our U.S. business by
`launching new products for which we may attain U.S. Food and Drug Administration (“FDA”) first-to-file status with Paragraph IV certification.
`As described further in the “Product Development and Government Regulation” discussion below, this Paragraph IV certification makes the
`product approval holder eligible for a period of generic marketing and distribution exclusivity.
`
`Our North America revenues also include those generated by our wholly owned subsidiary Mylan Pharmaceuticals ULC (“MPC”),
`which markets generic pharmaceuticals in Canada, the world’s fifth largest generic prescription market by value and the sixth largest generic
`prescription market by volume with sales of $4.4 billion for the twelve months ended November 2012 . MPC offers a portfolio of approximately
`120 products in an aggregate of approximately 300 dosage strengths, and currently ranks fifth in terms of market share in the generic prescription
`market in Canada. As in the U.S., we believe that growth in Canada will be dependent upon acceptance of generic products as low cost
`alternatives to branded pharmaceuticals. Further, we plan to leverage the strength and reliability of the Mylan brand in the U.S. to foster growth
`throughout North America.
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`EMEA
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`Our generic pharmaceutical sales in EMEA are generated primarily by our wholly owned subsidiaries in Europe, through which we
`have operations in 21 countries. The types of markets within Europe vary from country to country; however, when combined, the European
`market is the second largest generic pharmaceutical market in the world. Within Europe, by value, the generic prescription market in Germany is
`the largest, followed by France, the United Kingdom (“U.K.”), Spain and Italy, respectively. Of the top ten generic prescription markets in
`Europe, we hold leadership positions in several company-branded markets, including the number one market share position in France, the
`number two market share position in Italy and a number three market share position in Belgium and Portugal.
`
`The European generic prescription market varies significantly by country in terms of the extent of generic penetration, the key decision
`maker in terms of drug choice, and other important aspects. Some countries, including Germany, the U.K., the Netherlands and Poland, are
`characterized by relatively high generic penetration, ranging between 58% and 69% of total prescription market sales in the twelve months ended
`November 2012 , based on volume. Conversely, other major European markets, including France, Italy and Spain, are characterized by much
`lower generic penetration, ranging between 17% and 33% of total prescription sales in the twelve months ended November 2012 , based on
`volume. However, recent actions taken by governments, particularly in these latter southern European countries, to reduce health care costs
`could encourage further use of generic pharmaceutical products. In each of these under-penetrated markets, in addition to growth from new
`product launches, we expect our future growth to be driven by increased generic utilization and penetration.
`
`The manner in which products are marketed also varies by country. In addition to selling pharmaceuticals under their International
`Nonproprietary Name (“INN”) (i.e., active ingredient), in certain European countries, there is a market for both branded generic products and
`“company-branded” generic products. Branded generic pharmaceutical products are given a unique brand name, as these markets tend to be
`more responsive to the promotion efforts generally used to promote brand products. Company-branded products generally consist of the name of
`the active ingredient with a prefix or suffix of the company’s name, either in whole or in part.
`
`Some countries, such as France and Italy, permit substitution by pharmacists. In other countries, such as the U.K., most prescriptions
`are written using the INN, which allows the pharmacist to dispense his or her preferred generic. However, if the prescription is written for the
`brand, then the brand must be dispensed.
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`France
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`In France, through our subsidiary Mylan S.A.S., we market a portfolio of approximately 305 products in an aggregate of approximately
`645 dosage strengths. In France, we have the highest market share in the company-branded generic prescription market, with a share of
`approximately 28%. Our future growth in the French market is expected to come primarily from new product launches and increased generic
`utilization and penetration through government initiatives.
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`Italy
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`In Italy, we market through our subsidiary Mylan S.p.A. a portfolio of approximately 175 products in an aggregate of approximately
`345 dosage strengths. In Italy, we have the second highest market share in the company-branded generic prescription market. We believe that the
`Italian generic market is under-penetrated, with company-branded generics representing approximately 17% of the Italian pharmaceutical
`market, based on volume. The Italian government has put forth only limited measures aimed at encouraging generic use, and as a result, generic
`substitution is still in its early stages. Our growth in the Italian generics market will be fueled by increasing generic utilization and penetration
`and new product launches.
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`Spain
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`In Spain, we market through our subsidiary Mylan Pharmaceuticals S.L. a portfolio of approximately 110 products in an aggregate of
`approximately 300 dosage strengths. In Spain, we have the seventh highest market share in the company-branded generic prescription market.
`The company-branded generic market comprised approximately 29% of the total Spanish pharmaceutical market by volume for the twelve
`months ended November 2012 . We view further generic utilization and penetration of the Spanish market to be a key driver of our growth in
`that country.
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`Germany
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`In Germany, we market through our subsidiary Mylan dura a portfolio of approximately 160 products in an aggregate of approximately
`360 dosage strengths. A tender system has been implemented in Germany and, as a result, health insurers play
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` major role in this market. Under a tender system, health insurers invite manufacturers to submit bids that establish prices for generic
`pharmaceuticals. Pricing pressures result from an effort to win the tender. As a result of these tenders, our business in Germany has declined, and
`future growth in the German marketplace will depend upon our ability to compete based primarily on price.
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`U.K.
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`In the U.K., we offer a broad product portfolio of approximately 190 products in an aggregate of approximately 405 dosage strengths.
`Mylan is ranked fourth in the U.K. generic prescription market, in terms of value, with an estimated market share of approximately 6%. Mylan is
`well positioned in the U.K. as a preferred supplier to wholesalers and is also focused on areas such as multiple retail pharmacies and hospitals.
`The U.K. generic prescription market is highly competitive, and any growth in the market will stem from new product launches, although we
`expect that the value will continue to be affected by price erosion.
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`Other EMEA Locations
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`We also have a notable presence in several other European company-branded generic prescription markets, including Belgium and
`Portugal, where we hold the third highest market share. We also operate in several other European markets, including the Netherlands, Sweden,
`Poland, Hungary, Slovakia, Slovenia and the Czech Republic. Additionally, we have an export business which is focused on Africa and the
`Middle East.
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`Our balanced geographical position, our leadership standing in many established and growing markets and our vertically integrated
`platform will all be keys to our future growth and success in EMEA.
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`Asia Pacific
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`We market generic pharmaceuticals in Asia Pacific through subsidiaries in Australia, Japan, New Zealand, India and Taiwan.
`Additionally, through Mylan India, we market API to third parties and supply other Mylan subsidiaries. We have the highest market share in
`both the Australian and New Zealand generic pharmaceuticals markets.
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`India
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`Mylan India manufactures and supplies low cost, high quality API for our own products and pipeline, as well as for third parties. Mylan
`India is one of the world’s largest API manufacturers as measured by the number of drug master files (“DMFs”) filed with regulatory agencies
`and is among the leaders in supplying API for the manufacturing of antiretroviral (“ARV”) drugs, which are utilized in the treatment of
`HIV/AIDS. Mylan India also produces a line of finished dosage form (“FDF”) products in the ARV market, which are sold mostly outside of
`India. Additionally, Mylan India manufactures non-ARV FDF products that are marketed and sold to third parties by other Mylan operations
`around the world. Expansion of this portfolio and an increase in product sales within India and other geographies are both key drivers of future
`growth.
`
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`In addition to the sale of FDF products, Asia Pacific revenues are augmented by API sales. We currently have more than 250 APIs in
`the market or under development, and we focus our marketing efforts on regulated markets such as the U.S. and the European Union (the “EU”).
`We produce API for use in the manufacture of our own pharmaceutical products, as well as for use by third parties, in a wide range of categories,
`including anti-bacterials, central nervous system agents, anti-histamine/anti-asthmatics, cardiovasculars, anti-virals, anti-diabetics, anti-fungals,
`proton pump inhibitors and pain management drugs.
`
`Mylan India has nine API and intermediate manufacturing facilities and two FDF facilities. All but one of these facilities are located in
`India, with one in China. Seven of the API facilities and two FDF facilities located in India are FDA approved, which makes Mylan India one of
`the largest companies in India in terms of FDA-approved API manufacturing capacity. From an API standpoint, growth is dependent upon us
`continuing to leverage our research and development capabilities to produce high quality, low cost API, while capitalizing on the greater API
`volumes afforded through our vertically integrated platform.
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`In August 2012, our subsidiary Mylan Pharmaceuticals Private Limited commenced commercial operations in India starting with the
`launch of a comprehensive portfolio of finished dosage form ARV products for the treatment of HIV/AIDS. We expect to enhance our
`commercial portfolio by adding products from additional therapeutic categories and to continue to build out our sales force across India to
`support this ongoing business expansion.
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`Australia
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`The generic pharmaceutical market in Australia had sales of approximately $1.4 billion during the twelve months ended August 2012 .
`Through our wholly owned subsidiary Alphapharm, we have the highest market share in the off-patent market with an estimated 24% market
`share by volume in Australia, and we offer a portfolio of approximately 180 products in an aggregate of approximately 375 dosage strengths.
`The Australian generics market is still underdeveloped and, as a result, the government is increasingly focused on encouraging the use of
`generics in an effort to reduce costs. Maintaining our position of market leadership as the market undergoes further generic utilization and
`penetration and continued pricing pressure will be the key to our future success in Australia.
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`Japan
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`Mylan Seiyaku Ltd. (”Mylan Seiyaku”), our wholly owned Japanese subsidiary, offers a broad portfolio of more than 360 products in
`an aggregate of approximately 500 dosage strengths. We also have a manufacturing and packaging facility located in Japan, which is key to
`serving the Japanese market. Japan is the second largest pharmaceutical market in the world, behind the U.S., and the sixth largest generic
`prescription market worldwide by value, with sales of approximately $3.3 billion during the twelve months ended November 2012 . Currently,
`the market is largely composed of hospitals and clinics, but pharmacies are expected to play a greater role as generic substitution, aided by recent
`pro-generics government action, becomes more prevalent. The Japanese government has stated that it intends to grow generic utilization to 30%
`by the end of March 2013 from approximately 25% at September 30, 2012.
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`During 2012, we and Pfizer Japan Inc. (“Pfizer Japan”) announced a definitive agreement to establish an exclusive long-term strategic
`collaboration to develop, manufacture, distribute and market generic drugs in Japan. Under the agreement, both parties will continue to operate
`separate legal entities in Japan, but will collaborate on current and future generic products, sharing the costs and profits resulting from the
`collaboration. Mylan Seiyaku’s responsibilities primarily consist of managing operations, including research and development, and
`manufacturing. Pfizer Japan’s responsibilities under the agreement primarily consist of the commercialization of the combined generics portfolio
`and managing a combined marketing and sales effort. The collaboration became operational on January 1, 2013.
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`New Zealand
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`In New Zealand, our business operates under the name Mylan New Zealand and is the largest generics company in the country. New
`Zealand is a government tender market where companies submit offers and if accepted can gain exclusivity of up to three years.
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`Specialty Segment
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`Our specialty pharmaceutical business is conducted through Mylan Specialty, which competes primarily in the respiratory, severe
`allergy and psychiatry markets. Mylan Specialty’s portfolio consists of primarily branded specialty injectable, nebulized and transdermal
`products for life-threatening conditions. A significant portion of Mylan Specialty’s revenues are derived through the sale of the EPIPEN® Auto-
`Injector .
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`The EPIPEN® Auto-Injector , which is used in the treatment of severe allergic reactions, is an epinephrine auto-injector that has been
`sold in the U.S. and internationally since the mid-1980s. Mylan Specialty has worldwide rights to the epinephrine auto-injector, which is
`supplied to Mylan Specialty by a wholly owned subsidiary of Pfizer. Anaphylaxis is a severe allergic reaction that is rapid in onset and may
`cause death, either through swelling that shuts off airways or through significant drop in blood pressure. In December 2010, the National
`Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health, introduced the “Guidelines for the Diagnosis and
`Management of Food Allergy in the United States.” These guidelines state that epinephrine is the first line treatment for anaphylaxis. The
`EPIPEN® Auto-Injector is the number one prescribed epinephrine auto-injector. The strength of the EPIPEN® brand name, quality and ease of
`use of the product and the promotional strength of the Mylan Specialty U.S. sales force have enabled us to maintain our market share.
`
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`Perforomist ® Inhalation Solution, Mylan Specialty’s formoterol fumarate inhalation solution, was launched in October 2007.
`Perforomist ® Inhalation Solution is a long-acting beta 2 -adrenergic agonist indicated for long-term, twice-daily
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`administration in the maintenance treatment of bronchoconstriction in chronic obstructive pulmonary disorder (“COPD”) patients, including
`those with chronic bronchitis and emphysema. Mylan Specialty has been issued several U.S. and international patents protecting Perforomist ®
`Inhalation Solution.
`
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`We believe that we can continue to drive the long-term growth of our Specialty Segment by successfully managing our existing product
`portfolio and bringing to market other product opportunities.
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`Product Development and Government Regulation
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`Generics Segment
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`North America
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`Prescription pharmaceutical products in the U.S. are generally marketed as either brand or generic drugs. Brand products are marketed
`under brand names through marketing programs that are designed to generate physician and consumer loyalty. Brand products generally are
`patent protected, which provides a period of market exclusivity during which time they are sold with little or no competition for the compound,
`although there typically are other participants in the therapeutic area. Additionally, brand products may benefit from other periods of non-patent
`market exclusivity. Exclusivity normally provides brand products with the ability to maintain their profitability for relatively long periods of
`time, and brand products typically continue to play a significant role in the market due to physician and consumer loyalties after the end of patent
`protection or other market exclusivities.
`
`Generic pharmaceutical products are the chemical and therapeutic equivalents of reference brand drugs. A reference brand drug is an
`approved drug product listed in the FDA publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations, popularly
`known as the “Orange Book.” The Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”) provides that
`generic drugs may enter the market after the approval of an ANDA, which requires that bioequivalence to a reference brand product be
`demonstrated, and the expiration, invalidation or non-infringement of any patents on the corresponding reference brand drug, or the end of any
`other relevant market exclusivity periods related to