CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`APPLICATION NUMBER:
`204824Orig1s000
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`Medac Exhibit 2071
`Koios Pharmaceuticals v. Medac
`IPR2016-01370
`Page 00001
`
`

`

`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) with an NDA 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 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.
`
`
`
`M
`
`_
`.
`my’S‘ale
`
`‘aircfidg'"""'—""—“—""'" ----- ‘FAX‘Nu—fib'éfzirgggfimé)—'m_
`
`"' "Emil—Afidfiass (if available}
`
`'
`
`N" '
`
`Page 1
`l'St.‘(hurledJFIill‘lvH-lii‘m [F
`
`Page 00002
`
`Not applicable
`
`’Télepfione Number
`
`.
`
`rence above a patent that has een su mued previoust or the
`s the patent re
`approved NDA or supplement referenced above?
`
`date a new expiration date?
`
`FORM FDA 3542a (10:10)
`
`Department of Health and Human Services
`Food and Drug Administration
`
`Fm“ Appmved: OMB N°- 0910'0513
`Expiration Date: 10(31/2013
`See OMB Statement on Page 3.
`PATENT lNFORMATlON SUBMITTED WITH THE FILING NDA NUMBER
`or AN NDA, AMENDMENT, OR SUPPLEMENT
`
`For Each Patent That Claims 3 Drug Substance
`(Active Ingredient), Drug Product (Formulation and Composition)
`and/or Method of Use
`
`NAME (0 ' ' OF’OSED TRADE NAME)
`
`Otrexup
`ACTIVE INGREDIENT(S)
`Methotrexate
`
`Subcutaneous Injection
`
`STRENGTH(S)
`10 mg/0.4 ml, 15 mg/ 0.4 ml, 20 mg/0.4 ml and 25 tug/0.4 ml
`
`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 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. lf you are not submitting any patents for this pending NDA, amendment, or supplement,
`complete above section and sections 5 and 6.
`1. GENERAL
`3. United States Patent Number
`
`c. Expire on Date of Patent
`
`b. Issue Date of Patent
`
`d, Name at Patent Owner
`Antares Phanna, Inc.
`
`Address (0/ Patent Owner)
`IOO Princeton South Corporate Center, Suite 300
`
`
`
`e. ameo agen 0i" represen a we W 'I YESISS Of main ains
`a p ace ol Business Within the United States authorized to
`receive notice at patent certification under section 505(b)(3)
`and (j)(2)(8) 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)
`
`EityT'State
`Ewing, NJ
`' "FAX—WnEFérl’fil available)
`Z
`ode —_"_"_m'
`609 359 3015
`08628
`m?“ E-MailAddressiifavailabfiaf
`609 359 3020
`kdave@antarespharma.com
`'
`.
`.
`
`"
`
`A
`
`"
`
`Page 00002
`
`

`

`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 NBA, 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 NBA. amendment. or supplement?
`
`2.2 Does the patent claim a drug substance that is a different poiymorph of the active
`ingredient deScribed in the pending NDA. amendment. or supplement?
`
`2.3 If the answer to question 2.2 is "Yes." do you certify that. as of the date of this dectaraticn. 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 314.53tb).
`
`2.4 Specify the polymorphic formls) claimed by the patent for which you have the test results described in 2.3.
`
`L; Yes
`
`
`2.5 Does the patent claim only a melabolite oi 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 mataboiite.)
`
`2.6 Does the patent claim only an intermediate?
`
`
`2.7 If the patent referenced in 2.1 is a product-by-prooess patent, is the product ctaimacl in the
`patent novel? (An answer is required only if the patent is a product—by-process patent.)
`
`
`3. Drug Product {CampositioniFormulation}
`3.1 Does the patent claim the drug product. as defined in 21 CFR 314.3. in the pending NDA. amendment.
`or supplement?
`
`3.2 Does the palant claim only an inlenhediale?
`
`3.3 I|r the patent referenced in 3.1 is a producl-by-prccess patent. is the product claimed in the
`patent novel? (An answer is required only if the patent is a producl-by—pro cess patent.)
`
`4. Method of Use
`
`4.2 Patent Claim Number(s) {as listed in the 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 palant claim one or more melhods of use for which approval is being sought In
`the pending NBA. amendment. or supplement?
`[3 Yes Pg No
`
`Docs (Do) the patent claim(s) referenced in 4.2 claim a
`pending method of use for whlch approval is being sought
`in the pending NDA. amendment. or supplement?
`
`[1 Yes
`
`D No
`
`Use; {Submit indication or method of use inronnaiion as identified specificaliy in the proposed labeling.)
`
`4.2a It the answer to 4.2 is
`"Yes." identify with speci—
`ficity the use with refer-
`ence to the proposed
`labeling for the drug
`product.
`
`5. No Relevant Patents
`
`For this pending NDA. amendment. or supplement. there are no relevant palents that claim the drug substance (active ingredient).
`drug product (lormulation or composition) 0r melhcd(s) of use. for which the applicant is seeking approval and with reaped to which
`a claim of patent infringement oculd reasonably be asserted iia person not licensed by the owner of the patent engaged in the
`manufacture. use. or sale of the drug product.
`
`[1| Yes
`
`FORM FDA 3542a (10i10)
`
`Page 00003
`
`Page 00003
`
`

`

`6. Declaration Certification
`
`Warning: A willfully and knowingly false statement is a criminal offense under 18 as C. 1001.
`
`6.2 Authorized Signature of NDA Applicant/Holder or Patent Owner (Attorney. Agent, Representative or
`other Authorized Official) (Provide Information below)
`
`Date Signed
`
`
`
`Nov 30/ MIL
`"
`‘0,
`NOTE: Only an NBA applicantiholder may submit this declaration directly to the FDA. A patent owner who is not the NDA applicant/
`holder is authorized to slgn the declaratlon but may not submit It directly to FDA. 21 CFR 314.53(c)(4) and (d)(4).
`
`Check applicable box and provide information below.
`
`8 NBA Applicant/Holder
`
`I] NDA Applicant's/Holder's Attorney, Agent (Representative) or other
`Authorized Official
`
`E] Patent Owner
`
`"Na'rne
`
`[3 Patent Owner's Attorney. Agent (Representative) or Other Authorized
`Official
`
`Kaushik J. Dove R.Ph.,Ph.D.,MBA, Executive Vice President Product Development, Antares, Pharma, Inc.
`
`Addie“
`100 Princeton South Corporate Center, Suite 300
`
`'I—Cily/Siaie
`|
`Y Ewing, NJ
`
`—— " “
`
`*
`
`'
`
`‘
`
`6.1 The undersigned declares that this is an accurate and complete submission of patent 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. lattest 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.
`
`
`
`" '
`
`‘Télé‘me"_’—mw'm“""_‘
`{ZIP Code
`609-359-3017 (direct)
`08628
`FKX' N'timbEi‘iif'avai'l‘a—lafifi "“n—‘—_‘_“ "ETHE/EM)“
`
`609-359-3015 1 kdave@antarespharma.com
`
`The public reporting burden for this collection of infomtation has been estimated to average 20 hours per response, including the time for reviewing
`Instrucuons, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send
`comments regarding lh'Ls burden estimate or any other upect ofthis collection of information, including suggestions for reducing this burden to:
`
`Depanment of Health and Human Services
`Food and Drug Administration
`Office ot‘Chict‘ information Officer
`l350 Piccard Drive, Room 400
`Rockvillc. MD 20850
`
`An agency may not conduct or sponsor. and a person is not required to respond lo. a collection of
`irfommlian unless it display: a currently valid OMB control number.
`
`FORM FDA 35423 (10/10)
`
`Page 00004
`
`Page 00004
`
`

`

`INFORMATION AND INSTRUCTIONS FOR FORM 35423
`
`PATENT INFORMATION SUBMITTED WITH THE FILING
`
`OF AN NDA, AMENDMENT 0R SUPPLEMENT
`
`General Information
`
`' To submit patent information to the agency the appropriate
`patent declaration form must he used. ‘l'wo forms are available
`For potent submissions. The approval status ol'your New Drug
`Application will determine which I'orm you should use.
`
`Form 3542:: should be used when submitting patent information
`with original NDA submissions, NBA amendments and NBA
`supplements prior to approval.
`
`Form 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 lbrrn 3542 will he used for Orange Book
`publication purposes.
`
`Forms should be submitted as described in 2| CI’R 3 l4.53.
`Sending an additional copy of Form 3542 to the Orange Book
`StntT will expedite patent publication in the Orange Book. The
`Orange Book Slat'l' address {as of April 200?) is: Orange Book
`Staff. Office ol‘Generic Drugs OGDil-lliD-Gl 0, 7500 Standish
`Placee [{ockyille. MD 20355.
`
`' ‘l'lte 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:
`httprdtwwdeo.gov/apocmndnorcclmicestoformiv’
`fiquormsfitmi.
`
`First Section
`
`Complete all items in this section.
`
`1. General Section
`
`Complete all items in this section with reference to the patent
`ilsell‘.
`
`to} Include patent expiration date, including any l-latch-Waxman
`patent extension already
`granted. Do not include any
`applicable pediatric exclusivity. The agency will include
`pediatric exotnsivitics 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.
`
`Form 3542 should be used after NDA or Supplement approval.
`This form is to he submitted within 30 days alter approval of an
`application. This form should also be used to submit patent
`information relating to an approved supplement under II C FR
`3 ld.S3(d] to change the formulation, add a new indieation 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.
`
`
`
`to) Answer this question if applicable. pratcnt owner and NBA
`applieantfholder reside in the United States. leave space
`blank.
`
`2. Drug Substance (Active Ingredient)
`
`Complete all items in this section il‘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
`patient.
`
`2.5) A patent for a metabolite eitlie approved active ingredient
`may not be submitted. 1f 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 of this farm.
`
`Answer this question only iiitte patent is a pro duct-hy-
`preccss patent.
`
`3. Drug Product (Compositioni'Formulatlon)
`Complete all items in this section ii" the patent claims the drug
`product that is the subject of the pending N DA. amendment, or
`supplement.
`3.3) An answer to this question is required only i l‘ the referenced
`patent is a product-by-pt’occss patent.
`
`4. Method of Use
`
`Complete all items in this section if the patent claims a method ol‘
`use of’the drug product that is the subject ofthe pending NBA.
`amendment, or supplement (pending method of use).
`
`4.2)
`
`For each pending method of‘use claimed by the patentI
`identify by number the claimts) in the patent that claim the
`pending use oflhe drug. An applicant may list together
`multiple patent claim numbers and information for each
`pending method close, if applicable. However, each
`pending method ol'use must be separately listed within this
`section of the foo-n.
`
`4.23} Specify tltc part ofttte proposed drug labeling that is
`claimed by the patent.
`
`S. No Relevant Patents
`
`Complete this section only ifapplicabie.
`
`6. Declaration Certification
`
`Complete all items in this section.
`
`6.2) Authorized signature. Check one ol’ the four boxes that best
`describes the authorized signature.
`
`FORM FDA 35423 {WHO}
`
`Page 00005
`
`Page 00005
`
`

`

`Department of Health and Human Services
`Food and Drug Administration
`
`Form Approved: OMB No. 0910-0513
`Expiration Date: 10/31/2013
`See OMB Statement on Page 3.
`
`PATENT INFORMATION SUBMITTED WITH THE FILING
`OF AN NDA, AMENDMENT. 0R SUPPLEMENT
`For Each Patent That Claims 3 Drug Substance
`(Active Ingredient), Drug Product (Formulation and Composition)
`and/or Method of Use
`
`NAME OF APPLICANT/NDA HOLDER
`Antares Pham‘a' “‘0‘
`
`STRENGTH(S)
`10 mg/OA ml, 15 mg/ 0.4 ml, 20 mg/0.4 ml and 25 mg/OA ml
`
`Subcutaneous Injection
`
`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) with an NDA 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 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 (Led. 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 mustsubmlt 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.
`1. GENERAL
`
`3, United States Patent Number
`
`b. Issue Date of Patent
`
`0. Expiration Data at Patent
`
`d. Name of Patent Owner
`Antares Pharma, Inc.
`
`Address ofPalent Owner)
`100 Princeton South Corporate Center, Suite 300
`
`The following is provided in accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
`
`TRADE NAME (OR PROPOSED—T'WDE NA ’
`Otrcxup
`ACTIVE INGREDIENT(S)
`Methotrexate
`
`
`
`a
`
`ame O agan DI' represen - ve W O l'EsleS 0" main ains
`a place of Busrness 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 (it patent owner or NDA
`applicanl/holder does not reside or have a place of
`business within the United States)
`
`City/5&7?”~ ‘
`Ewing, NJ
`'ZTPTEir-T—“W” “FM—m" FAXNumbéF-(ilavaifiblo)
`
`08628
`609 359 3015
`Emmi“ "
`E-Mali Address (ifavailéblé) "
`609 359 3020
`kdavc@antarespharma.com
`‘ l (SSS 0 agent Of [BPIQSBH HUI/e name In
`.e.
`
`_ 1- we...»
`C'IY’SIaie
`
`ZIP-c566 wgrmm--- ,
`
`.. .
`
`Not applicable
`
`'Té‘erp‘hBhiaWGifi'Sér‘ "w"—
`
`EWEIT’AHG’rSs‘s‘Wi’EEIlfi/Sf _"""'_"'w
`
`i st e patent re erence aove a patent I at has een sumitle prevnous v on 0
`approved NDA or supplement referenced above?
`
`9‘
`
`the patent re erence come as been submtue prevaously orlst ng. ist eexpirauon
`I
`date a new expiration date?
`
`FORM FDA 35423 (10/10)
`
`Page 1
`rM.(Inn-dim.-)tIMl-H-Jiri
`lEl-'
`
`Page 00006
`
`Page 00006
`
`

`

`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 NBA. 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?
`
`2.2 Does the patent claim a drug substance that is a different polymorph oi the active
`ingredient described in the pending NDA. amendment. or supplement?
`
`2.3 lithe 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).
`
`2.4 Specify the polymorphic formis) 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 actlye 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.)
`
`2.6 Does the patent claim only an Intermediate?
`
`2.? It 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.)
`
`
`
`3.1 Does the patent claim the drug product, as defined in 21 CFR 314.3. in the pending NDA. amendment.
`or supplement?
`
`3.2 Does the patent claim only an intermediate?
`
`3.3 It the patent referenced in 3.1 is a product—by—procass 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
`
`No
`
`
`
`4. Method of Use
`
`Sponsors must submit the information in section 4 for each method oi" 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 lot which approval is being sought in
`the pending NBA. amendment. or supplement?
`
`4.2 Patent Claim Numberts) (as listed in the patent)
`
`Does (Do) the patent claimls) referenced in 4.2 claim a
`pending method of use tor which approval is being scught
`in the pending NBA, amendment. or supplement?
`
`a Yes
`
`[3 No
`
`Use: (Submit indication or method of use inionnation as identified specifically in the proposed labeling.)
`
`4.26.
`
`It the answer to 4.2 is
`Wes.“ identify with speci-
`ficity the use with refer-
`ence to the proposed
`labeling lor the drug
`product.
`
`5. No Relevant Patents
`For this pendlng NDA. amendment. or supplement, there are no relevant patents that claim the drug substance (active ingredient).
`i
`drug product (formulation or composition) or method(s) of use. for which the applicant is seeking approval and with respect to which l E yes
`a claim of patent infringement could reasonably be asserted iia person not licensed by the owner of the patent engaged in the
`manulacture. use. or sale of the drug product.
`
`FORM FDA 35423 [10i10]
`
`Page 00007
`
`Page 00007
`
`

`

`6. Declaration Certlflcatlon
`
`Warning: A willfully and knowingly false statement Is a criminal offense under 18 U.$.C. 1001.
`
`6.2 Authorized Signature of NDA Applicant/Holder or Patent Owner (Anomey. Agent, Representative or
`other Authorized Official) (Provide information below)
`
`Date Signed
`
`NOTE: Only an NDA applicantlholder 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 314.53tc)(4) and MW.
`
`Check applicable box and provide information below.
`
`Nov 30/ 20'?—
`
`K] NDA ApplicantlHolder
`
`CI NDA Applicant's/Holder's Attorney. Agent (Representative) or other
`Authorized Official
`
`1
`
`L) Patent Owner
`
`nan? "‘_%'—'_*’
`
`|’_J PatentOwner's Attorney. Agent (Representative)orOlherAuthorized
`
`Official
`
`Kaushik 1. Dave R.Ph.,Ph.D.,MBA, Executive Vice President Product Development, Antares, Pharma, Inc.
`
`Tddress‘""_"
`
`lOO Princeton South Corporate Center, Suite 300
`
`" 'Gtiilé‘t‘afi”
`
`Ewing, NJ
`
`%"ZIP"CBde—'""__W m m "TEiéph’o‘fie—WW—w'n"
`
`08628
`FAX Number (if available)
`609-35 9-3015
`
`609-359-3017 (direct)
`Ermellhddress (if available)
`kdavc@antarcspharma.com
`
`6-1 The undersigned declares that this is an accurate and complete submission of patent 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. Iattest that i am familiar with 21 CFR 314.53 and
`this submission complies with the requirements of the regulation. l verily under penalty of perjury that the foregoing is
`true and correct.
`
`
`
`The public reponing 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 informatlon Send
`comments regarding this burden estimate or any other aspect of this collection of inl’onnation: including suggestions for reducing this burden to:
`
`Department of Health and Human Services
`Food and Drug Administration
`Office ofChicf Information Officer
`1350 Piccard Drive, Room 400
`Rockvillc, MD 20850
`
`An agency may not conduct orxpomor. and a permit is not required to respond to. a collection of
`infurmalion unless it displays a currently valid OMB control number:
`
`FORM FDA 3542a (10/10)
`
`Page 00008
`
`Page 00008
`
`

`

`INFORMATION AND INSTRUCTIONS FOR FORM 3542a
`
`PATENT INFORMATION SUBMITTED WITH THE FILING
`
`OF AN NDA, AMENDMENT OR SUPPLEMENT
`
`General lnt'orntatiOn
`
`' 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 ofyour New Drug
`Application will determine which form you should use.
`
`Form 3542:: should be used when submitting patent information
`with original NDA submissions. NDA amendments and NBA
`supplements prior to approval.
`
`Form 3542 is also to he used for patents issued after drug
`approval. Patents issued allcr drug approval are required to be
`submitted within 30 days of patent issuance {or the patent to be
`considered "timely filed."
`
`Only information from form 3542 will be used for Orange Book
`publication purposes.
`
`Forms should he 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 Stal'f address {as of April 2007} is: Orange Book
`Staff. Office och nerie Drugs ()(iDlHFD-oltl, ~t'500 Standish
`Place, ttockvillo, Ml) 20855.
`
`' ‘I'lre receipt date is the date that the patent information is date
`Stamped in the central document room. Patents are considered
`listed on tlte date received.
`
`' Additional copies ofthese forms may be downloaded from the
`Internet at:
`htrprfl’n’itrwfilo.gow'opocomoiiarccnoiccstfa’qu-msf
`fifajorms. firm}.
`
`First Section
`
`Complete all items in this section.
`
`I. General Section
`
`Complete all items in this section with reference to the patent
`itscll'.
`
`Io} Include patent expiration date, including any Hatch-Waxmatt
`patent extension already
`granted. Do not include arty
`applicable pediatric exclusivity. The agency will include
`pediatric cxclusivities whch applicuhlc upon publication.
`
`ld)
`
`Include full address oi‘palcnt owner. lt'palent owner resides
`outside the US. indicate the country in die zip code block.
`
`Form 3542 should be used tiller NBA or supplement approval.
`'I'his form is to be submitted within 30 days after approval ol‘an
`application. This form should also be used to sulrmit patent
`information relating to an approved supplement under 21 CFR
`314.53th 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.
`
`
`
`to) Answer this question if applicable. lfpatent owner and NBA
`applicantfholdcr reside in the United States, leave space
`blank.
`
`2. Drug Substance (Active Ingredient)
`
`Complete all items in this Section ifthc 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 oftho approved active ingredient
`may not be submitted. If the patent claims on approved
`method of using the approved drug product to administer the
`metabolite, the patent may he submitted as a method of use
`patent depending on the responses to section 4 ot‘this Form.
`
`Ansrvcr this question only if the patent is a product-by—
`proccss patent.
`
`3. Drug Product (Compositioni'Formulation}
`Complete all items in this section iftltc patent claims the drug
`product that is the Subject ofthe pending NDA, amendment. or
`supplement.
`3.3} An answer to this question: is required only it‘thc referenced
`patent is a product~by-proccss 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 ofthc pending NDA,
`amendment. or Supplement (pending method of use).
`
`=32)
`
`For each pending method ofuse claimed by the patent.
`identify by number the claim(s] in the patent that claim the
`pending use ofthc drug. An applicant may list together
`multiple patent claim numbers and information for each
`pending method of use, ifapplicabie. ltowcve r, each
`pending method of use must be separately listed within this
`section of the form.
`
`4.23} Specify the part of' the proposed drug labeling that is
`claimed by the patient.
`
`5. No Relevant Patents
`
`Complete this section only it'applicabic.
`
`6. Declaration Certification
`
`Complete all items in this section.
`
`6.2) Authorized signature. Check one ot‘tltc four boxes that best
`describes the authorized signature.
`
`FORM FDA 3542a (10i'10)
`
`Page 00009
`
`Page 00009
`
`

`

`Department of Health and Human Services
`Food and Drug Administration
`
`Form APPrOVedi OMB No- 091043513
`Expiration Date: 10/31/2013
`See OMB Statement on Page 3.
`PATENT INFORMATION SUBMITTED WITH THE FILING NDA NUMBER
`or AN NDA, AMENDMENT, 0R SUPPLEMENT
`204824
`
`For Each Patent That Claims a Drug Substance
`(Active Ingredient), Drug Product (Formulation and Composition)
`and/or Method of Use
`
`Antares Pharmal Inc‘
`
`The following is provided in accordance with Sect/on 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
`
`Otrcxup
`
`Mcthotrexate
`
`r. I
`
`o ' V
`
`Subcutaneous Injection
`
`STRENGTH(S)
`
`10 rug/0.41711, 15 my 0.4 ml, 20 ngO.4 ml and 25 mg/0.4 ml
`
`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 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.
`
`
`1. GENERAL
`
`a. nite States atent Number
`
`b, issue Dale ot Patent
`
`c. Expiration Date of Patent
`
`d. Name of Patent Owner
`
`Antares Pharma, inc.
`
`Address (oi Patent Owner)
`
`100 Princeton South Corporate Center, Suite 300
`
`8. ame O agen or represon awe W I TESIGS or main atns
`a place oi Eusmess wuihm lfie United States authorized to
`receive notice of patent certification under section 505(b)(3)
`and (j)(2)(B) ol the Federal Food, Drug. and Cosmetic Act
`and 21 CFR 314.52 and 314.95 (ifpatent owner or NDA
`applicant/holder does not reside or have a place of
`business Within the United States)
`
`City/State
`Ewing, NJ
`
`Telephone Wmee’r
`
`,._.. ___._.
`-.
`Guy/Stale
`
`mammogram)
`609-3 59-3015
`"E-N/léil'AEBiES?fifaVaiiébiéTm '
`
`'
`
`"_‘_’_ "
`
`’
`
`" W'
`
`"‘ "" '
`
`" "
`
`’” ‘
`
`Not applicabic
`
`WNU‘TTTW’
`
`_ “"M'"EZMETREEESWEIIfifief
`
`‘ " '
`
`This patent declaration farm is required to be submitted to the Food and Drug Administration (FDA) with an NDA 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 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.
`
`
`
`approved NDA or supplement referenced above?
`
`‘ date a new expiration date?
`FORM FDA 35423 (10/10)
`
`Page 1
`inst:r-.,gmu.mi.i.n.m;
`ifF
`
`Page 00010
`
`Page 00010
`
`

`

`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?
`
`2.2 Does the patent claim a drug substance that is a different polymorph ofthe active
`ingredient described in the pending NDA. amendment. or supplement?
`
`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 NBA? The type of test data required is described at 21 CFR 314.5303).
`
`
`
`2.4 Specify Ihe polymorphic torm(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 it the patent claims a pending method at using the pending
`drug product to administer the metabolite.)
`
`2.6 Does the patent claim only an intermediate?
`
`2.? If the patent referenced in 2.1 is a product-by-procese patent. is the product claimed in the
`palent novel? (An answer is required only if [he patent is a product-by-prooass patent.)
`
`
`
`
`
`3. Drug Product (Composltioanormulaticn]
`
`3.1 Does the patent claim the drug product. as defined in 21 CFR 314.3. in the pending NBA. amendment.
`or supplement?
`
`3.2 Does the patent claim only an intermediate?
`
`3.3 it the patent referenced in 3.1 is a product-by-prooese patent. is the product claimed in the
`patent novel? {An answer is required only if the patent is a product-by-process patent.)
`
`C] Yes
`
`pq No
`
`
`
`4. Method oi 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 ofuse claimed by the patent. provide the following information:
`
`31.1 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 Paienl Claim Number(s) (as listed in the patent)
`
`, Does (Do) the patent claimls] referenced in 4.2 claim a
`g pending method of use for which approval is being sought
`t in the pending NDA, amendment, or supplement?
`l
`
`D Yes
`
`[3 No
`
`Use: (Submit indication or method of use information as identified specifically in the proposed labeling.)
`
`4.23 it the answer to 4.2 is
`"Yes." identify with speci-
`fit:in the use with reler-
`once to the