CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`
`
`APPLICATION NUMBER:
`200678Orig1s000
`
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`
`
`
`
`

`

`Department of Health and Human Services
`Food and Drug Administration
`
`Form Approved: OMB No. 0910-0513
`EXpiratiO” Date: 7/31/10
`See OMB Statement on Page 3.
`
`PATENT INFORMATION SUBMITTED UPON AND
`
`AFTER APPROVAL OF AN NDA OR SUPPLEMENT
`
`For Each Patent That Claims a Drug Substance
`(Active Ingredient), Drug Product (Formulation or
`Composition) and/or Method of Use
`
`NAME OF APPLICANT/NDA HOLDER
`Bristol-Myers Squibb Company
`
`
`The following is provided in accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
`TRADE NAME
`
`Kombiglyze XR
`ACTIVE INGREDIENT(S)
`
`saxagliptin/metformin HCI
`
`'
`
`DOSAGE FORM
`
`STRENGTH(S)
`
`2.5 mg saxagliptin/ 1000 mg metformin HCl
`5.0 mg saxagliptin/SOO mg metformin HCI
`5.0 mg saxagliptin/ 1000 mg metformin HCl
`
`APPROVAL DATE OF NDA OR SUPPLEMENT
`
`saxagliptin and metformin HCI extended-release tablet
`
`November 5, 2010
`
`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) within thirty (30) days after
`approval of an NDA or supplement or within thirty (30) days of issuance of a patent as required by 21 CFR 314.53(c)(2)(ii) at the
`address provided in 21 CFR 314.53(d)(4). To expedite review of this patent declaration form, you may submit an additional copy of
`this declaration form to the Center for Drug Evaluation and Research "Orange Book" staff.
`
`If additional space is required for any narrative answer (i.e., one that does
`I For hand-written or typewriter versions of this report:
`not require a "Yes" or "No" response), please attach an additional page referencing the question number.
`
`FDA will not list patent information if you file an incomplete patent declaration or the patent declaration indicates the patent
`is not eligible for listing.
`
`For each patent submitted for the approved NDA or supplement referenced above, you must submit all the information
`described below. If you are not submitting any patents for this NDA or supplement, complete above section and sections 5
`and 6.
`
`I
`a. United States Patent Number
`
`6,395,767
`‘ d. Name of Patent Owner
`
`Bristol-Myers Squibb Company
`
`b. Issue Date of Patent
`
`I
`
`c. Expiration Date of Patent
`
`May 28, 2002
`Address (of Patent Owner)
`
`February 16, 2021
`
`P.O. Box 4000
`
`
`
`
`
`
`9. Name of agent or representative who resides or main—
`tains a place of Busrness Within the United States author-
`ized to receive notice of patent certification under section
`505(b)(3) and (j)(2)(B) of the Federal Food, Drug, and
`Cosmetic Act and 21 CFR 314.52 and 314.95 (if patent
`owner or NDA applicant/holder does not reside or have a
`place of business within the United States)
`
`City/State
`
`Princeton, NJ
`FAX Number (if available)
`ZIP Code
`
`08543
`609-252-4526
`
`E—Mail Address (if available)
`Telephone Number
`patents@bms.com
`609—252-4000
`Address {of agent or representative named in 1.9.)
`
`
`.
`Qty/State
`
`
`FAX Number (if available)
`ZlP Code
`
`
`Telephone Number
`
`E-Mail Address (if available)
`
`.
`
`ls the patent referenced above a patent that has been submitted previously for the
`approved NDA or supplement referenced above?
`
`.
`
`If the patent referenced above has been submitted previously for listing, is the expiration
`date a new expiration date?
`
`FORM FDA 3542 (12/08)
`
`Page 1
`PEG Graphics (301) 4434090
`EF
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`For the patent referenced above, provide the following information on each patent that claims the drug substance, drug
`product, or method of use that is the subject of the approved NDA or supplement. FDA will not list patent information if
`you file an incomplete patent declaration or the patent declaration indicates the patent is not eligible for listing. FDA will
`consider an incomplete patent declaration to be a declaration that does not include a response to all the questions
`contained within each section below applicable to the patent referenced above.
`
`
`
`
`
`
`
` 2. DrugSubStance (Active Ingredient)
`2.1 Does the patent claim the drug substance that'Is the active ingredient'In the drug product
`
`
`describedIn the approved NDA or supplement?
`E Yes
`D No
`
`
`2.2 Does the patent claim a drug substance that is a different polymorph of the active
`ingredient described in the NDA?
`
`
`
`
`2.3 If the answer to question 2.2 is "Yes," do you certify that, as of the date of this declaration, you have test data
`demonstrating that a drug product containing the polymorph will perform the same as the drug product
`described in the NDA? The type of test data required is described at 21 CFR 314.53(b),
`E Yes
`E No
`
`
`
`2.4 Specify the polymorphic form(s) claimed by the patent for which you have the test results described in 2.3.
`
`
`
`
`
`2.5 Does the patent claim only a metabolite of the approved active ingredient? (Complete the information in
`
`section 4 below if the patent claims an approved method of using the approved drug product to administer
`E No
`|:| Yes
`the metabolite.)
`
`2.6 Does the patent claim only an intermediate?
`
`
`2.7 If the patent referenced in 2.1 is a product-by—process patent, is the product claimed in the
`patent novel? (An answer is required only if the patent is a product-by—process patent.)
`
`
`
`
`the answer to 2.3 is "Yes" and there is no response to 2.4. or,
`
`
`° the answer to 2.5 or 2.6 is "Yes."
`° the answer to 2.7 is "No."
`
`
`
`3. Drug Product (ComposmoanormulatIon)
`3.1 Does the patent claim the approved drug product as defined'In 21 CFR 314.3?
`
`
`
`
`‘ FDA will not list the patent in the Orange Book as claiming the drug product if:
`° the answer to question 3.1 is "No," or,
`
`
`° the answer to question 3.2 is "Yes," or,
`
`° the answer to question 3.3 is "No."
`
`4. Method of Use
`
`Sponsors must submit the information in section 4 for each approved method of using the approved drug product claimed by the patent.
`
`For each approved method of use claimed by the patent, provide the following information:
`
`
`
`
`[:1 No
`Use: {Submit indication or method of use information as identified specifically in the approved labeling.)
`
`
`
`KOMBIGLYZE XR is a dipeptidyl peptidase~4 inhibitor and biguanide
`
`combination product indicated as an adjunct to diet and exercise to improve
`
`
`
`glycemic control in adults with type 2 diabetes mellitus when treatment with
`
`
`
`both saxagliptin and metformin is appropriate.
`
`FORM FDA 3542 (12/08)
`Page 2
`
`FDA will not list the patent in the Orange Book as claiming the'drug substance if:
`the answers to 2.1 and 2.2 are "No," or,
`the answer to 2.2 is "Yes" and the answer to 2.3 is "No," or,
`
`3.2 Does the patent claim only an intermediate?
`
`3.3 if the patent referenced in 3.1 is a product—by—process patent, is the product claimed in the
`patent novel? (An answer is required only if the patent is a product—by-process patent.)
`
`E Yes
`
`[:| No
`
`
`4.1 Does the patent claim one or more approved methods of using the approved drug product?
`
`[3 No
`E Yes
`
`
`4.2 Patent Claim Number(s) (as listed in the patent)
`Does (Do) the patent claim(s) referenced in 4.2 claim an
`23 and 24
`approved method of use of the approved drug product?
`4.2a if the answer to 4.2 is
`"Yes," identify the use
`with specific reference to
`the approved labeling for
`the drug product.
`
`E Yes
`
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`4.2b if the answer to 4.2 is
`Use: (Submit the description of the approved indication or method of use that you propose FDA include as
`
`"Yes," also provide the
`the "Use Code" in the Orange Book, using no more than 240 total characters including spaces.)
`
`
`
`
`KOMBIGLYZE XR is a dipeptidyl peptidase—4 inhibitor and biguanide
`i”f9rm?fi0“ 0” the
`.
`.
`.
`.
`.
`.
`.
`.
`Indication or method of
`comblnatton product indicated as an adjunct to diet and exercrse to 1mprove
`use for the Orange B00k
`glycemic control in adults with type 2 diabetes mellitus when treatment with
`"Use Code" description.
`
`both saxagliptin and metformin is appropriate.
`
`
`
`FDA will not list the patent in the Orange Book as claiming the method of use if:
`’ the answer to question 4.1 or 4.2 is "No," or
`
`' if the answer to 4.2 is "Yes" and the information requested in 4.2a and 4.2b is not provided in full.
`
`
`
`
`
`
`
`5 No RelevantPatents > "
`
`For this NDA or supplement, there are no relevant patents that claim the approved drug substance (active
`
`ingredient) or the approved drug product (formulation or composition) or approved method(s) of use with
`respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the
`owner of the patent engaged in the manufacture, use, or sale of the drug product.
`
`
`
`
`
`
`
`
` 6. Declaration Certification
`,
`.
`_
`,
`,
`‘
`.
`,
`/
`6.1 The undersigned declares that this is an accurate and complete submission of patent information for the NDA or
`
`
`supplement approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-sensitive patent
`information is submitted pursuant to 21 CFR 314.53. I attest that I am familiar with 21 CFR 314.53 and this submission
`complies with the requirements of the regulation. I verify under penalty of perjury that the foregoing is true and
`
`correct.
`‘
`
`Warning: A willfully and knowingly false statement is a criminal offense under 18 U.S.C. 1001.
`gm 9‘ W
`illaallo
`
`
`
`
`
`Check applicable box and provide information below.
`
`
`
`6.2 Authorized Signature of NDA Applicant/Holder or Patent Owner (Attorney, Agent, Representative or
`other Authorized Official) {Provide Information below)
`
`Date Signed
`
`
`
`NOTE: Only an NDA applicant/holder may submit this declaration directly to the FDA. A patent owner who is not the NDA applicant] holder
`
`is authorized to sign the declaration but may not submit it directly to FDA. 21 CFR 314.53(c)(4) and (d)(4).
`
`Name
`
`|: NDA Applicant/Holder
`X NDA Applicant's/Holder’s Attorney, Agent (Representative) or other
`Authorized Official
`
`
`
`
`
`
` l: Patent Owner
`[: Patent Owner‘s Attorney, Agent (Representative) or Other Authorized
`Official
`
`
`
`
`Terence J. Bogie
`Address
`City/State
`
`
`
`P.O. Box 4000
`Princeton, NJ
`
`
`
`
`
`ZlP Code
`Telephone Number
`
`
`609-252-63 85
`
`08543
`
`
`E—Mail Address (if available)
`FAX Number (if available)
`
`
`
`609~252~4526
`patents@bms.com
`
`
`
`
`The public reporting burden for this collection of information has been estimated to average 5 hours per response, including the time for reviewing instructions,
`
`searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments
`
`regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
`
`Department of Health and Human Services
`
`Food and Drug Administration
`
`
`Office of Chief Information Officer (HFA~710)
`5600 Fishers Lane
`
`
`Rockville, MD 20857
`
`An agency may not conduct or sponsor, and a person is not required (0 respond to, a collection of
`
`
`information unless it displays a currently valid OMB control number.
`
`
`FORM FDA 3542 (12/08)
`Page 3
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`

`INFORMATION AND INSTRUCTIONS FOR FORM 3542
`
`PATENT INFORMATION SUBMITTED UPON AND AFTER
`
`APPROVAL OF AN NDA OR SUPPLEMENT
`
`General Information
`
`‘ To submit patent information to the agency the appropriate
`patent declaration form must be used. Two forms are available
`for patent submissions. The approval status of your New Drug
`Application will determine which form you should use.
`
`Form 3542a shouldvbe used when submitting patent information
`with original NDA submissions, NDA amendments and NDA
`supplements prior to approval.
`
`Form 3542 should be used after NDA or supplement approval.
`This form is to be submitted within 30 days after approval of an
`application. This form should also be used to submit patent
`information relating to an approved supplement under 21 CFR
`314.53(d) to change the formulation, add a new indication or
`other condition of use, change the strength, or to make any other
`patented change regarding the drug, drug product, or any
`method of use. Fomi 3542 is also to be used for patents issued
`after drug approval. Patents issued after drug approval are
`required to be submitted within 30 days of patent issuance for
`the patent to be considered "timely filed."
`
`2. Drug Substance (Active Ingredient)
`
`Complete all items in this section if the patent claims the drug
`substance that is the subject of the approved NDA or supplement.
`
`2.4) Name the polymorphic form of the drug identified by the
`patent.
`
`2.5) A patent for a metabolite of the approved active ingredient
`may not be listed. If the patent claims an approved method
`of using the approved drug product to administer the
`metabolite, the patent may be listed as a method of use
`patent depending on the responses to section 4 of this form.
`
`2.7) Answer this question only if the patent is a product—hy-
`process patent.
`
`3. Drug Product (Composition/Formulation)
`
`Complete all items in this section if the patent claims the drug
`product that is the subject of the approved NDA or supplement.
`
`3.3) An answer to this question is required only if the referenced
`patent is a product-by-process patent.
`
`' Only information from form 3542 will be used for Orange Book
`publication purposes.
`
`4. Method of Use
`
`describes the authorized signature.
`
`' Forms should be submitted as described in 21 CFR 314.53.
`Sending an additional copy of form 3542 to the Orange Book
`Staff will expedite patent publication in the Orange Book. The
`Orange Book Staff address (as of April 2007) is: Orange Book
`Staff, Office of Generic Drugs OGD/HFD-GlO, 7500 Standish
`Place, Rockville, MD 20855.
`
`' The receipt date is the date that the patent information is date
`stamped in the central document room. Patents are considered
`listed on the date received.
`
`' Additional copies of these forms may be downloaded from the
`Internet at:
`http://wwwfda.gov/opacom/morechoices/fdaforms/
`fdaforms.html.
`
`First Section
`
`Complete all items in this section.
`
`1. General Section
`
`Complete all items in this section with reference to the patent
`itself.
`
`lc) Include patent expiration date, including any Hatch—Waxman
`patent extension already
`granted. Do not
`include any
`applicable pediatric exclusivity. The agency will include
`pediatric exclusivities where applicable upon publication.
`
`1d) Include full address of patent owner. If patent owner resides
`outside the US. indicate the country in the zip code block.
`
`1e) Answer this question if applicable. If patent owner and NDA
`applicant/holder reside in the United States, leave space
`blank.
`
`Complete all items in this section if the patent claims one or more
`methods of use of the drug product that is the subject of the
`approved NDA or supplement.
`
`4.2)
`
`For each approved use of the drug claimed by the patent,
`identity by number the claim(s) in the patent that claim the
`approved use of the drug. An applicant may list together
`multiple patent claim numbers and information for each
`approved method of use, if applicable. However, each
`approved method of use must be separately listed within
`this section of the form.
`
`4.2a) Specify the part of the approved drug labeling that is
`claimed by the patent.
`
`4.2b) The answer to this question will be what FDA uses to create
`a "use—code" for Orange Book publication. The use code
`designates a method of use patent that claims the approved
`indication or use of a drug product. Each approved use
`claimed by the patent should be separately identified in this
`section
`and contain
`adequate
`information
`to assist
`505(b)(2) and ANDA applicants in determining whether a
`listed method of use patent claims a use for which the
`505(b)(2) or ANDA applicant is not seeking approval. Use
`a maximum of 240 characters for each "use code."
`
`5. No Relevant Patents
`
`Complete this section only if applicable.
`
`6. Declaration Certification
`
`Complete all items in this section.
`
`6.2) Authorized signature. Check one of the four boxes that best
`
`FORM FDA 3542 (12/08)
`
`Page 4
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`Form Appi’f’v‘j’di OMB NC" 99194513
`EXP'ratm Date: 7/31lt0
`See OMB Statement on Page 3.
`PATENT INFORMATION SUBMITTED WITH THE FiLiNG NDA NUMBER
`
`Department of Heaith and Human Services
`Food and Drug Administration
`
`OF AN NDA, AMENDMENT, OR SUPPLEMENT
`
`For Each Patent That Claims a Drug Substance
`{Active Ingredient), Drug Product (Formulation and Composition)
`and/or Method of Use
`
`NAME OF APPL'CAN'T’NDA ”050%
`BT‘StUE'MYeiS 3951155 COmPaflY
`
`The following is provided in accordance with Section 505th) and (c) of the Federal Food, Drug, and Cosmetic Act.
`
`ACTIVE INGREDIENNS}
`
`saxagiiptin/metformin HCI
`
`I I
`
`‘
`
`U " "
`
`STRENGTHS)
`
`2.5 mg saxagiiptin/ 1000 mg motformin HCI
`5.0 mg saxagiiptin/ 500 mg metformin HCi
`5.0 mg saxagiiptinl 1000 mg metformin i—ICi
`
`Fixed Dose Tablet saxagliptin immediate release/ metformin HCivoxtended reieaso
`
`This patent deciaration form is required to be submitted to the Food and Drug Administration (FDA) with an NEDA application,
`amendment. or supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 314.53(d)(4).
`Within thirty (30} days after approvat of an NBA or supplement, or within thirty (30) days of issuance of a new patent, a new patent
`declaration must be submitted pursuant to 21 CFR 314.53(c}(2)(ii) with ail of the required information based on the approved NBA or
`supplement. The information submitted in the declaration form submitted upon or after approvai wili be the
`only information relied
`upon by FDA for listing a patent in the Orange Book.
`
`For hand-written or typewriter versions (only) of this report: if additional space is required for any narrative answer (i.e., one that
`does not require a "Yes" or "No" response), piease attach an additional page referencing the question number.
`
`FDA will not list patent information if you submit an incomplete patent declaration or the pa tent declaration indicates the
`patent is not eligible for listing.
`
`For each patent submitted for the pending NBA, amendment, or supplement referenced above, you must submit all the
`information described below. if you are not submitting any patents for this pending NDA, amendment, or supplement,
`complete above section and sections 5 and 6.
`
`
`
`.
`
`nrted States Patent-Number
`
`in. issue Date of Patent
`
`0. Expiration Date of Patent
`
`
`
`it. Name of Patent Owner
`Bristoi-Myers Squibb Company
`
`e. ‘ame o agen or represen a Ne w o rest-es or main sins
`a place of Eusmess WIEfiIn the United States authon'zed to
`receive notice of patent certification under section 505(b)(3)
`and (i)(2)(B) of the Federal irood, Drug, and Cosmetic Act
`and 21 CFR 3i4.52 and 314.95 (if patent owner or NDA
`applicant/holder does not reside or have a place of
`business within the United States)
`
`Address (of Patent Owner)
`P.O. Box 4000
`
`CitylState
`Princeton, NJ
`
`FAX Number (if available)
`609452—4526
`E-Mail Address {if available)
`Telephone stumber
`patents@bms.com
`609-252—4000
`. . uress o egen orrepresen a me name- in .e.
`
`FAX Numer if available)
`
`9 ep one Number
`
`' — at Address (if available)
`
`
`
`.
`
`s t e patent re erence- emit: a paten i at as een Sitar-mite prewous y ort e
`approved NDA or suppiement referenced above?
`g. '
`the patent referenced a-ove as can submitte- prevrousiy or listing, ist e expiration
`date a new expiration date?
`
`E] Yes
`
`No
`
`FORM FDA 35423 (12108)
`
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`For the patent referenced above, provide the following information on the drug substance, drug product and/or method of
`use that is the subject of the pending NDA, amendment, or supplement.
`
`2.1 Does the patent ciaim the drug substance that is the active ingredient in the drug product
`described in the pending NDA, amendment, or supplement?
`
`2.2 Does the patent ciaim a drug substance that is a different polymorph of the active
`ingredient described in the pending NBA, amendment. or supptement?
`
`2.3 if the answer to question 2.2 is "Yes," do you certify that, as of the date of this decimation, you have test
`data demonstrating that a drug product containing the potymorph will perform the same as the drug product
`described in the NBA? The type of test data required is described at 21 CPR 314.5383).
`
`2.4 Specify the polymorphic form(s) claimed by the patent for which you have the test resutts described in 2.3.
`
`
`
`2.5 Does the patent ciaim only a metabotite oi the active ingredient pending in the NDA or supplement?
`{Compiete the information in section 4 below if the patent claims a pending method of using the pending
`drug product to administer the metabolite.)
`
`2.7 It the patent referencedIn 2.1 is a product—by—process patent, is the product otaimedIn the
`patent novel? (An answer is required only if the patent is a product-by—process patent.)
`
`'3.1 Does the patent ctaim the drug product, as defined in 21 CFR 314.3, in the pending NBA, amendment,
`or supplement?
`
`3.2 Does the patent claim oniy an intermediate?
`
`3.3 it the patent referenced in 3.1 is a product-by—process patent. is the product ctaimed in the
`patent novei? (An answer is required only if the patent is a product-by—process patent.)
`
`
`
`
`
`
`Sponsors must submit the information in section 4 for each method of using the pending drug product for which approval is being
`sought that is claimed by the patent. For each pending method of use claimed by the patent, provide the following information:
`
`4.1 Does the patent claim one or more methods of use for which approval is being sought in
`the pending NDA. amendment. or supplement?
`
`4.2 Patent Claim Numberts) (as listed in the patent)
`
`Does (Go) the patent claim(s) referenced in 4.2 claim a
`pending method of use for which approve: is being sought
`in the pending NDA. amendment, or supplement?
`
`Use: (Submit indication or method of use information as identified specifically in the proposed labeling.)
`
`4.2a If the answer to 4.2 is
`"Yes." identity with speci-
`ficity the use with refer-
`ence to the proposed
`labeiing for the drug
`precinct.
`
`For this pending NDA, amendment. or supplement, there are no relevant patents that claim the drug substance (active ingredient),
`drug product (formutation or composition) or method(s) of use, tor which the appticant is seeking apprOVal and with respect to which
`a claim of patent intringement cootd reasonahty be asserted if a person not licensed by the owner of the patent engaged in the
`manufacture, use, or sate of the drug product.
`
`FORM FDA 3542a (12108)
`
`Page 2
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`6.1 The undersigned declares that this is an accurate and complete submission oioatent information ‘for theNDA,
`amendment, or supplement pending under section 505 of the Federal Food, Drug, and Cosmetic Act. This time
`sensitive patent information is submitted pursuant to 21 CFR 314.53. fattest that i am familiar with 21 CFR 314.53 and
`this submission complies with the requirements of the regulation. l verify under penalty of perjury that the foregoing is
`true and correct.
`
`Warning: A willfully and knowingly false statement is a criminal offense under 18 U.S.C. 1001.
`
`d Signature of NBA ApplicantlHolder or Patent Owner (Attorneys Agent, Representative or
`6.2 Authori
`other H horized Official)
`ovide information below)
`
`Date Signed
`
`bimL/K’WMJ
`
`(QM/web 33,230?
`
`NOTE: Only an NBA apprticantlhoider may submit this declaration directly to the FDA. A patent owner who is not the NDA applicantl
`holder is authorized to sign the declaration but may not submit It directly to FDA. 21 CFR 314.53ic)(4) and (d)(4).
`
`Check applicable box and provide information below.
`
`
`
`[3 NBA Applicant/Homer
`
`.
`
`K} NDA Applicant'slHoider's Attorney, Agent (Representative) or other
`Authorized Official
`
`D Patent Owner
`
`Name
`Maureen Gibbons
`
`Address
`PO. Box 4000
`
`P ' ode
`08543
`
`¥AX Number (if available}
`609—252—4526
`
`[3 Patent Owner‘s Attorney, Agent (Representative) or Other Authorized
`Official
`
`
`
`City/Slate
`Princeton, NJ
`
`Te ephone Number
`609—252—3453
`
`
`
`E-Maii Address (if available)
`patents@bm3.com
`
`information unless it. displays a currently valid OMB contra? number.
`
`The public reporting burden for this collection of information has been estimated to average 20 hours per response, inciuding tire time for reviewing
`instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send
`comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing th is burden to:
`
`Department of Health and Human Services
`Food and Drug Administration
`Office of Chief Information Officer (MFA-3’10)
`5600 Fishers Lane
`Rockvillc, ME) 20857
`
`Air: agency may not conduct or sponsor. and a person is not required to respond to, a collection of
`
`FORM FDA 3542a (1208)
`
`Page 3
`
`Approved v1.0
`
`930040860 1.0
`
`930040860
`
`1.0
`
`1.0
`
`Approved
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`v
`
`

`

`INFORMATION AND INSTRUCTIONS FOR FORM 3542a
`
`PATENT lNFORMATlON SUBMITTED WiTi—l THE FiLING
`
`OF AN NBA, AMENDMENT OR SUPPLEMENT
`
`General information
`
`' To submit patent information to the agency the appropriate
`patent deciaration form must be used. Two forms are avaiiable
`for patent submissions. The approval status of your New Drug
`Application wilt determine which form you should use.
`
`Form 3542a should be used when submitting patent information
`with original NDA submissions, NDA amendments and NBA
`supplements prior to approval.
`
`Form 3542 should be used after NDA or supplement approval.
`This form is to be submitted within 30 days after approval of an
`application. This form should also he used to submit patent
`information relating to an approved supplement under 21 CFR
`314.53(d) to change the formulation, add a new indication or
`other condition of use, change the strength, or to make any other
`patented change regarding the drug, drug product, or any
`method of use.
`
`Form 3542 is also to be used for patents issued after drug
`approval. Patents issued afier drug approval are required to be
`submitted within 30 days of patent issuance for the patent to be
`considered "timely filed."
`
`Only information from form 3542 wiil be used for Orange Book
`publication purposes.
`
`Forms should be submitted as described in 21 CFR 314.53.
`Sending an additional copy of form 3542 to the Orange Book
`Staff will expedite patent pubiicatiou in the Orange Book. The
`Orange Book Staff address (as of Aprii 2007) is: Orange Book
`Staff, Office of Generic Drugs OGD/HFD-dio, 7500 Standish
`Place, Rockville, MD 20855.
`
`The receipt date is the date that the patent information is date
`stamped in the central document room. Patents are considered
`listed on the date received.
`
`' Additional copies of these forms may be downloaded from the
`Internet at: http://wwwfda. gov/opacom/morechoices/fdnjbrms/
`fdafirms. html.
`
`First Section
`
`Complete ail items in this section.
`
`1. General Section
`
`Complete all items in this section with reference to the patent
`itself.
`
`to) Include patent expiration date, including any Hateh-Wmnan
`patent extension already
`granted. Do not include any
`appiicabie pediatric exclusivity. The agency will include
`pediatric exciusivities where appiicabie upon publication.
`
`1d) Include full address of patent owner. if patent owner resides
`outside the US. indicate the country in the zip code block.
`
`describes the authorized signature.
`
`le) Answer this question if applicable. If patent owner and NBA
`appiicantlhoider reside in the United States, leave space
`blank.
`
`2. Drug Substance (Active Ingredient)
`
`Compiete all items in this section if the patent claims the drug
`substance that is the subject of the pending NDA, amendment, or
`supplement.
`
`2.4) Name the polymorphic form of the drug identified by the
`patent.
`'
`
`2.5) A patent for a metabolite of the approved active ingredient
`may not be submitted. if the patent ctaiins an approved
`method of using the approved drug product to administer the
`metabolite, the patent may be submitted as a method of use
`patent depending on the responses to section It of this form.
`
`Answer this question oniy if the patent is a product—by—
`process patent.
`
`3. Drug Product {Composition/Formulation)
`
`Complete ali items in this section if the patent claims the drug
`product that is the subject of the pending NBA, amendment, or
`supplement.
`
`3.3) An answer to this question is required only ifthe referenced
`patent is a product-by-process patent.
`
`4. Method of Use
`
`Complete all items in this section if the patent claims a method of
`use of the drug product that is the subject of the pending NDA,
`amendment, or supplement (pending method of use).
`
`4.2)
`
`For each pending method of use claimed by the patent,
`identify by number the ciairn(s) in the patent that claim the
`pending use ofthe drug. An applicant may list together
`multipie patent claim numbers and information for each
`pending method of use, if applicable. However, each
`pending method of use must be separately listed within this
`section of the form.
`
`4.2a) Specify the part of the proposed drug iabeling that is
`claimed by the patent.
`
`5. No Relevant Patents
`
`Complete this section only if applicable.
`
`6. Dectaration Certification
`
`Complete all items in this section.
`
`6.2) Authorized signature. Check one of the four boxes that best
`
`FORM FDA 35423 (12108)
`
`Page 4
`
`Approved v 1 . 0
`
`930040860 1.0
`
`930040860
`
`1.0
`
`1.0
`
`Approved
`
`v
`
`

`

`Form A9903"? OMB “0- 091043513
`ammo” Date: 7131110
`See OMB Statement on Page 3.
`PATENT INFORMATION SUBMITTED WITH THE FILING NDA NUMBER
`
`Department of Health and Human Services
`Food and Drug Administration
`
`OF AN NDA, AMENDMENT, 0R SUPPLEMENT
`
`For Each Patent That Claims a Drug Substance
`{Active Ingredient), Drug Product (Formulation and Composition)
`and/or Method of Use
`
`meme OF APPL'CANT’NGA HOLDER
`Bilsml‘Ml’eFS Squibb (30‘3“me
`
`The following is provided in accordance with Section 505(1)) and (c) of the Federal Food, Drug, and Cosmetic Act.
`)
`
`“r emaaososso TRADE NAME
`
`W W“
`
`
`
`ACTIVE |NG§EI§EENW$
`saxagliptinlmetfonnin HCl
`
`STRENGTHS)
`2.5 mg saxagliptinl 1000 mg metformin HCI
`5.0 mg saxagliptin/ 500 mg metfonnin HCl
`5.0 mg sexagtiptin/ 1000 mg metformln HCE
`
`Fixed dose tablet saxagliptin immediate~roieasel mctformin HCI extended—release
`
`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) with an NBA application.
`amendment, or supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 314.53(d){4).
`Within thirty (30) days after approve: of an NBA or supplement, or within thirty (30) days of issuance of a new patent, a new patent
`declaration must be submitted pursuant to 21 CPR 314.53(c}(2)(ii) with all of the required information based on the approved MBA or
`supplement. The information submitted in the declaration form submitted upon or after approval will be the
`only information relied
`upon by FDA for listing a patent in the Orange Book.
`
`For hand-written or typewriter versions (only) of this report: if additional space is required for any narrative answer (is. one that
`does not require a "Yes“ or ”No" response). please attach an additional page referencing the question number.
`
`FDA will not list patent information if you submit an incomplete patent declaration or the patent declaration indicates the
`patent is not eligible for listing.
`
`For each patent submitted for the pending NDA, amendment, or supplement referenced above, you must submit all the
`information described below. if you are not submitting any patents for this pending NDA, amendment, or supplement,
`complete above section and sections 5 and 6.
`
`
`a. me
`
`a as aten Number
`
`:
`
`I
`
`d. Name of Patent Owner
`Bristol-Myers Squibb Company
`
`V
`
`0
`
`0 H b. issue Date of Patent
`December 9, 2003
`Address {of Patent Owner)
`PO. Box 4000
`
`c. Expiration Date of Patent
`March 19, 2018
`
`e. ‘ameo agen orrepresen a Ne w o resres or main ains
`a place of Eustness Within the United States authorized to
`receive notice of patent codification under section 505(b)(3}
`and (j)(2)(B) of the Federal Food. Drug. and Cosmetic Act
`and 21 CFR 314.52 and 314.95 (if patent owner or MBA
`applicantlholder does not reside or have a place of
`business within the United States)
`
`CitylState
`Princeton, NJ
`FAX Number (if available)
`ZIP Code
`6092524526
`08543
`E—Mail Address (if available)
`Telephone Number
`patents@ioms.com
`6019—2524000
`. . «ass 0 open or represen a we name- in .e.
`
`.
`City/State
`
`" "
`
`IV“ " umber (ifavallable
`
`Telephone Number
`
`E~Mai| Address if available)
`
`. st e patent re erence- a-ove a pa