CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`APPLICATION NUMBER:
`
`22-341
`
`ADMINISTRATIVE and CORRESPONDENCE
`
`DOCUMENTS
`
`

`

`F°rm APF’FOVB“2 OMB NO- 0910'0513
`Department of Health and Human Services
`Expiration Date: 04/30/10
`Fo
`.
`.
`.
`See OMB Statement on Page 3.
`0d and Drug Administration
`NDA NUMBER
`PATENT INFORMATION SUBMITTED WITH THE ——_—_—
`
`FILING 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
`
`22-341
`NAME OF APPL'CANT/ NDA HOLDER
`NOW Norm-91‘1““
`
`The following is provided in accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
`TRADE NAME (OR PROPOSED TRADE NAME)
`Victoza (proposed trade name)
`
`ACTIVE INGREDIENT(S)
`liraglutjde
`
`DOSAGE FORM
`subcutaneous injection
`
`STRENGTH(S)
`6.0 mg/ml
`
`required to be submitted to the Food and Drug Administration (FDA) with an NDA application,
`This patent declaration form is
`amendment, or supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 3t4.53(d)(4).
`Within thirty (30) days after approval of an NDA 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 all of the required information based on the approved NDA
`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 (i.e., one
`that does not require a "Yes" or "No" response), please attach an additional page referencing the question number.
`FDA will not'Iist 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 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,
`
`com . lete above section and sections 5 and 6.
`1. GENERAL '
`
`
`
`a. United States Patent Number
`6,268,343
`
`d. Name of Patent Owner
`Novo Nordisk A/S
`
`b.
`
`c. Expiration Date of Patent
`issue Date of Patent
`8/22/2017
`7/31/2001
`
`
`Address (of Patent Owner)
`Novo Alle
`
`
`City/State
`2880 Bagsvaerd Denmark
`
`ZIP Code
`
`FAX Number (if available)
`
`
`
`
`E—Mail Address (if available)
`'
`Telephone Number
`(454)444-8888
`
`
`e. Name of agent or representative who resides or maintains
`a place of business within the United States authorized 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)
`(7..
`
`Address (of agent or representative named in 1a)
`
`
`
`City/State
`
`ZIP Code
`
`FAX Number (if available)
`
`
`Telephone Number
`
`E-Mail Address (if available)
`
`
`f.
`
`9.
`
`is 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 3542a (7/07)
`
`'
`
`[:1 Yes
`
`No
`
`C] Yes
`
`[I No
`
`Page 1
`FSC Graphics: (301)4434090
`EF
`
`

`

`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. Drug Substance (Active Ingredient)
`2.1 Does the patent claim the drug substance that is the active ingredient in the drug product
`
`
`
`described in the pending NDA, amendment, or supplement?
`K4 Yes
`D No
`Does the patent claim a drug substance that is a different polymorph of the active
`
`
`
`1:] Yes
`ingredient described in the pending NDA, amendment, or supplement?
`
`
`2.3 lf 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] No I:] Yes
`
`
`
`
`VA No
`
`
`
`
`
`Specify the polymorphic fonn(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 active ingredient pending in the NDA or supplement?
`
`
`
`(Complete the information in section 4 below if the patent claims a pending method of using the pending
`drug product to administerthe metabolite.)
`E] Yes X No
`
`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—prooess patent.)
`
`
`3. Drug Product (Composition/Fomulation)
`
`
`3.1 Does the patent claim the drug product, as defined in 21 CFR 314.3, in the pending NDA,
`
`amendment, or supplement?
`)3 Yes
`D No
`
`Does the patent claim only an intermediate?
`
`
` 3.3 lithe 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.)
`
`4. Method of Use
`
`
`
`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?
` Does (Do) the patent claim(s) referenced in 4.2 claim a
`4.2 Patent Claim Number(s) (as listed in the patent)
`
`
`39
`pending method of use for which approval is being sought
`
`
`D No
`in the pending NDA, amendment, or supplement?
`Yes
`
`4.2a lithe answerto 4.2 is
`Use: (Submit indication or method of use information as identified specifically in the approved labeling.)
`
`
`
`"Yes," identify with speci-
`ficity the use with refer—
`use as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus
`
`
`ence to the proposed
`
`labeling for the drug
`
`
`product.
`
`
`Yes
`
`D No
`
`5. No RelevantPatents
`
`V
`
`
`
`
`For this pending NDA, amendment, or supplement, there are no relevant patents that claim the drug substance (active ingredient),
`drug product (formulation or composition) or method(s) of use, for which the applicant is seeking approval and with respect to
`
`
`D Yes
`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.
`
`FORM FDA 35423 (7/07)
`Page 2
`
`
`
`
`

`

`6. Declaration Certification
`
`6.1 The undersigned declares that this is an accurate and complete submission ofpatent information for the NDA,
`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. I attest that] 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.
`
`6.2 Authorized Signature of NDA Applicant/Holder or Patent Owner {Attomey, Agent, Representative or
`otherAuthon'zed Official) (Provide Information below)
`Dlgitally signed by MaryAnn McEllithI
`-
`DN: cn=Mary Ann McEII'goll. c=US. o=No a Nord' k,
`M a ry An n M CE I I | g Ott cu=RegulaloryAffairs. elrnail=MAMc@No:oNordissk.
`827;: 2008.05.13 15:25:19 ~04'00'
`
`Date Signed
`5/23/2008
`
`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).
`Check applicable box and provide information below.
`
`[:1 NDA Applicant/Holder
`
`IX NDA Applicant’s/Holder's Attorney. Agent (Representative) or other
`Authorized Official
`
`D Patent Owner
`
`I] Patent Owner's Attorney. Agent (Representative) or Other Authorized
`Official
`
`Name
`Mary Ann McElligott, PhD.
`Address
`City/State
`100 College Road West
`Princeton/NJ
`
`information unless i! displays a currently valid OMB control number.
`
`ZIP Code
`08540
`
`Telephone Number
`(609)987-5831
`
`FAX Number (if available)
`(609)987-3916 _
`
`E-Mail Address (if available)
`mamc@novonordisk.com
`
`The public reporting burden for this collection of information has been estimated to average 20 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:
`Food and Drug Administration
`CDER (HFD-OO7)
`5600 Fishers Lane
`Rockville, MD 20857
`
`An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
`
`FORM FDA 3542a (7/07)
`
`Page 3
`
`

`

`INFORMATION AND INSTRUCTIONS FOR FORM 3542a
`
`PATENT INFORMATION SUBMITTED WITH THE FILING
`
`OF AN NDA, AMENDMENT OR SUPPLEMENT
`
`le) Answer this question if applicable. If patent ovme'r and NDA
`applicant/holder reside in the United States,
`leave space
`blank.
`
`2. Drug Substance (Active Ingredient)
`
`items in this section if the patent claims the drug
`Complete all
`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 claims 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 4 ofthis form.
`
`2.7) Answer this question only if the patent
`prooess patent.
`
`is a product-by-
`
`3. Drug Product (Composition/Formulation)
`
`items in this section if the patent claims the drug
`Complete all
`product that is the subject of the pending NDA, amendment, or
`supplement.
`
`3.3) An answer to this question is required only if the 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 elaim(s) in the patent that claim the pending use of
`the drug. An applicant may list together multiple 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 ofthe form.
`
`4.2a) Specify the part of the proposed drug labeling that
`claimed by the patent.
`
`is
`
`5. No Relevant Patents
`
`Complete this section only if applicable.
`
`6. Declaration Certification
`
`Complete all items in this section.
`
`describes the authorized signature.
`
`General Information
`
`information to the agency the appropriate
`.To submit patent
`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.
`
`patent
`submitting
`used when
`be
`should
`a Form 3542a
`information with original NDA submissions, NDA amendments
`and NDA supplements prior to approval.
`
`supplemental
`0 Form 3542 should be used after NDA or
`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 2] 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.
`
`oFonn 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."
`
`-Only information from form 3542 will be used for Orange
`Book publication purposes.
`
`IForms 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/l-lFD-610, 7500 Standish
`Place, Rockville, MD 20855.
`
`oThe 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://www.fda.gov/opacom/morechoices/fdafonns/
`fdaformshtml.
`
`First Section
`
`Complete all items in this section.
`
`1. General Section
`
`Complete all
`itself.
`
`items in this section with reference to the patent
`
`10)
`
`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 firll address of patent owner. If patent owner resides
`outside the US. indicate the country in the zip code block.
`
`6.2) Authorized signature. Check one of the four boxes that best
`
`FORM FDA 3542a (7107)
`
`Page 4
`
`

`

`Department of Health and Human Services
`.
`.
`.
`Food and Drug Administration
`PATENT INFORMATION SUBMITTED WITH THE
`FILING OF AN NDA, AMENDMENT, 0R SUPPLEMENT
`
`Form Appmved: OMB N°- 0910'0513
`Expiration Date: 04/30/10
`See OMB Statementon Page 3,
`NDA NUMBER
`22-341
`
`For Each Patent That Claims 3 Drug Substance
`(Active Ingredient), Drug Product (Formulation and
`Composition) an d/or Method of Use
`
`NAME OF APPUCANT / NDA HOLDER
`N°V° Norms“ 1““-
`
`
`The following is provided in accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
`TRADE NAME (OR PROPOSED TRADE NAME)
`Victoza (proposed trade name)
`
`ACTIVE |NGRED|ENT(S)
`liraglutidc
`
`DOSAGE FORM
`subcutaneous injection
`
`STRENGTH(S)
`6.0 mg/ml
`
`required to be submitted to the Food and Drug Administration (FDA) with an NDA application,
`This patent declaration form is
`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 approval of an NDA 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 all of the required information based on the approved NDA
`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 narrativeranswer (i.e., 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 file 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,
`ilete above section and sections 5 and 6.
`
`1. GENERAL
`issue Date of Patent
`b.
`a. United States Patent Number
`10/1/2002
`6,45 8,924
`_
`
`
`
`
`c. Expiration Date of Patent
`8/22/2017
`
`d. Name of Patent Owner
`Novo Nordisk A/S
`
`Address (of Patent Owner)
`Novo Alle
`
`City/State
`2880 Bagsvaerd‘Dcnmark
`
`
`
`e. Name of agent or representative who resides or maintains
`a place of business within the United States authorized 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)
`(7e
`
`ZIP Code
`
`FAX Number (if available)
`
`Telephone Number
`(454)444-8888
`
`E—Mail Address (if available)
`
`.
`
`Address (of agent or representative named in 1.e.)
`
`City/Siate
`
`ZIP Code
`
`FAX Number (if available)
`
`Telephone Number
`
`E-Mail Address (if available)
`
`f.
`
`9.
`
`Is 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 3542a (7/07)
`
`,
`
`.
`
`Page 1
`PSC Graphics: (30]) 443—1090
`EF
`
`

`

`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. Drug Substance (Active Ingredient)
`
`
` Does the patent claim the drug substance thatIS the active ingredientIn the drug product
`describedIn the pending NDA, amendment, or supplement?
`
`
`Does the patent claim a drug substance thatIs a different polymorph of the active
`
`ingredient described in the pending NDA, amendment, or supplement?
`
` 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 NBA? The type of test data required is described at 21 CFR 314.53(b).
`
`Specify the polymorphic form(s) claimed by the patent for which you have the test results described in 2.3.
`
`
`
`
`
`
`
`
`Does the patent claim only a metabolite of the active ingredlent pending in the NDA or supplement?
`
`(Complete the information in section 4 below if the patent claims a pending method of using the pending
`
`
`drug product to administer the metabolite.) K4 No D Yes
`Does the patent claim only an intermediate?
`
`
`
`
`
`
`
`
` 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.)
`
`
`3. Drug Product (Composition/Fennulation)
`3.1 Does the patent claim the dmg product; as defined in 21 CFR 314.3, in the pending NDA.
`amendment, or supplement?
`3.2 Does the patent claim only an intermediate?
`
`
`
`
`E] No
`
`Yes
`
`
`
`
`
`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)
`D Yes
`[:1 No
`
`
`4. Method of'Use
`
`I
`
`‘
`
`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
`
`
`Yes
`the pending NDA, amendment, or supplement?
`
`
`
`Does (Do) the patent claim(s) referenced in 4.2 claim a
`4.2 Patent Claim Number(s) (as listed in the patent)
`
`
`l9
`pending method of use for which approval is being sought
`
`
`
`in the pending NDA, amendment, or supplement?
`Yes
`D No
`
`
`4.23 If the answer to 4.2 is
`Use: (Submit indication or method of use information as identified specifically in the approved labeling.)
`
`
`
`
`"Yes," identify with speci-
`
`ficity the use with refer-
` use as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus
`
`
`ence to the proposed
`labeling for the drug
`
`product.
`
`
`
`5. No Relevant Patents
`For this pending NDA amendment, or supplement, there are no relevant patents that claim the drug substance (active ingredient),
`drug product (formulation or composition) or method(s) of use, for which the applicantIs seeking approval and 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
`E] Yes
`
`
`the manufacture, use, or sale of the drug product.
`
`
`
`
`FORM FDA 3542a (7107)
`
`Page 2
`
`

`

`6. Declaration Certification
`
`
`
`6.1 The undersigned declares that this is an accurate and complete submission ofpatent information for the NDA,
`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. I attest that! am familiar with 21 CFR 314.53 and
`this submission complies with the requirements 'of the regulation. I verify under penalty ofperjury that the foregoing
`is true and correct.
`
`Warning: A willfully and knowingly false statement is a criminal offense under 18 U.S. C. 1001.
`
`Authorized Signature of NDA Applicant/Holder or Patent Owner (Attorney, Agent, Representative or
`otherAuthorized Official) (Provide Information below)
`Digitally slgned by Mary Ann McEliigolt
`DN: cn=Mary Ann McElligall. e=US_ o=Nwo Nordisk.
`com
`Ma ry An n M CE I I |g Ott ou=Regu|aloiy Affairs, email=MAMc@NovoNordisk.
`Date: 2008.05.13 15:25:41 -D4‘00'
`
`Date Signed
`5/23/2008
`
`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).
`
`Check applicable box and provide information below.
`
`[:1 NDA Applicant/Holder
`
`IX NDA Applicant's/Holder's Attorney. Agent (Representative) or other
`Authorized Official
`
`El Patent Owner
`
`[:1 Patent Owner's Attorney, Agent (Representative) or Other Authorized
`Official
`
`information unless it displays a currently valid OMB control number.
`
`Name
`Mary Ann McElligott, Ph.D.
`
`
`Address
`100 College Road West
`
`ZIP Code
`08540
`
`FAX Number (if available)
`(609)987-3916
`.
`
`
`City/State
`Princeton/NJ
`
`Telephone Number
`(609)987-5831
`
`'
`
`E—Mail Address (if available)
`mamc@novonordisk.com
`
`The public reporting burden for this collection of information has been estimated to average 20 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:
`Food and Drug Administration
`CDER (HFD—OO7)
`5600 Fishers Lane
`Rockville, MD 20857 '
`
`An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
`
`FORM FDA 3542a (7107)
`
`Page 3
`
`

`

`INFORMATION AND INSTRUCTIONS FOR FORM 3542a
`
`PATENT INFORMATION SUBMITTED WITH THE FILING
`OF AN NDA, AMENDMENT OR SUPPLEMENT
`
`16) Answer this question if applicable. If patent owner and NDA
`applicant/holder reside in the United States,
`leave space
`blank
`
`2. Drug Substance (Active Ingredient)
`
`items in this section if the patent claims the drug ‘
`Complete all
`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 claims 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 4 ofthis form.
`
`2.7) Answer this question only if the patent
`process patent.
`
`is a product-by-
`
`3. Drug Product (Composition/Formulation)
`
`items in this section if the patent claims the drug
`Complete all
`product that is the subject of the pending NDA, amendment, or
`supplement.
`
`3.3) An answer to this question is required only if the 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 claim(s) in the patent that claim the pending use of
`the drug. An applicant may list together multiple 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 labeling that
`claimed by the patent.
`
`is
`
`5. No Relevant Patents
`
`Complete this secfion only if applicable.
`
`6. Declaration Certification
`
`Complete all items in this section.
`
`6.2) Authorized signature. Check one of the four boxes that best
`
`describes the authorized signature.
`
`General Information
`
`information to the agency the appropriate
`-To submit patent
`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.
`
`patent
`submitting
`used when
`be
`should
`0Form 3542a
`information with original NDA submissions, NDA amendments
`and NDA supplements prior to approval.
`
`supplemental
`ome 3542 should be used afier NDA or
`approval. This form is to be submitted within 30 days afier
`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.
`
`0Form 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."
`
`oOnly information fi'om form 3542 will be used for Orange
`Book publication purposes.
`
`-Forms should be submitted as described in 2] 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-610, 7500 Standish
`Place, Rockville, MD 20855.
`
`c 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://www.fda.gov/opacom/morechoices/fdaforrns/
`fdaformshtml.
`
`First Section
`
`Complete all items in this section.
`
`1. General Section
`
`Complete all
`itself.
`
`items in this section with reference to the patent
`
`1c)
`
`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.
`
`ld) Include full address of patent owner. If patent owner resides
`outside the US. indicate the country in the zip code block.
`
`FORM FDA 3542a (7/07)
`
`Page 4
`
`

`

`Department of Health and Human Services
`.
`.
`.
`Food and Drug Administration
`PATENT lNFORMATION SUBMITTED WITH THE
`FILING 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
`
`The following is provided in accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
`TRADE NAME (OR PROPOSED TRADE NAME)
`Victoza (proposed trade name)
`
`Fo‘m APPrWEd: OMB No- 0910'0513
`Expiration Date: 04/30/10
`See OMB Statement on Page 3_
`NDANUMBER
`22-34]
`NAME OF APPUCANT/ NDA HOLDER
`MM N0rd‘5k 1““-
`
`ACTIVE INGREDIENT(S)
`liraglutide
`
`DOSAGE FORM
`subcutaneous injection
`
`\
`
`STRENGTH(S)
`6.0 mg/ml
`
`required to be submitted to the Food and Drug Administration (FDA)-with an NDA application,
`This patent declaration form is
`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 approval of an NDA 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 all of the required information based on the approved NDA
`or supplement. The information submitted in the declaration form submitted upon or alter 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 (ie., 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 file 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,
`
`1. GENERAL
`
`a. United States Patent Number
`b.
`Issue Date of Patent
`c. Expiration Date of Patent
`
`7,235,627
`06/26/2007
`8/22/2017
`
`d. Name of Patent Owner
`Novo Nordisk A/S
`
`Address (of Patent Owner)
`Novo Alle
`
`City/State
`2880 Bagsvaerd Denmark
`
`,
`
`
`
`e. Name of agent or representative who resides or maintains
`a place of business within the United States authorized 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)
`c?
`
`-
`
`ZIP Code
`
`FAX Number (if available)
`
`Telephone Number
`(454)444-8888
`
`E-Mail Address (if available)
`
`_
`
`Address (of agent or representative named in 1.e.)
`
`City/State
`
`ZIP Code
`
`FAX Number (if available)
`
`Telephone Number
`
`E—Mail Address (if available)
`
`f.
`
`g.
`
`Is 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?
`
`El Yes
`
`El No
`
`-
`
`FORM FDA 3542a (7/07)
`
`-
`
`Page 1
`Pscompiics;(3oi)m-iow EF
`
`

`

`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. Drug Substance (Active Ingredient)
`2.1 Does the patent claim the drug substance that is the active ingredient in the drug product
`described in the pending NDA, amendment, or supplement?
`
`Does the patent claim a drug substance that is a different polymorph of the active
`ingredient described in the pending NDA, amendment, or supplement?
`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 NBA? The type of test data required is described at 21 CFR 314.53(b).
`
`Specify the polymorphic form(s) claimed by the patent for which you have the test results described in 2.3.
`
`Does the patent claim only a metabolite of the active ingredient pending in the NDA or supplement?
`(Complete the information in section 4 below if the patent claims a pending method of using the pending
`drug product to administer the metabolite.)
`
`Does the patent claim only an intermediate?
`
`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.)
`
`
`3. Drug Product (Composition/Formulation)
`3.1 Does the patent claim the drug product, as defined in 21 CFR 314.3. in the pending NDA,
`
`amendment, or supplement?
`
`Does the patent claim only an intermediate?
`
`
`
`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.)
`
`
`
`4.2 Patent Claim Number(s) (as listed in the patent)
`
`Does (Do) the patent claim(s) referenced in 4.2 claim a
`pending method of use for wh