713112019
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
`
`f §HARE {HITPS:IMW.FACEBOOK.COMI HARERISHARERJ’HP?
`U=H1TPS:IMWW.ACCESSDATA.FDA.GOVISCRIPTSICDERIOBIPATENT |NFO.CFM?PRDDUCT NOMINEAPPL NO=204063EAPPL TYPE=N)_
`
`w! TWEET (HTTPfifln’WIT‘I’ER.COMIINTENTNWEETJ’?TEXT=ORANGE BOOK: APPROVED DRUG PRODUCT§ WITH THERAPEUTlC
`E UNALENCE EVALUATIDNS&URL=HTTPS:IIWWW.ACCESSDATA.FDA.GOVISCRIPTSICDERIOBIPATENT INFO.CFM?
`
`PRODUCT NO=DIJ1&APPL N =204063
`PPL TYPEmN)
`
` +
`
`MJMAILTORSUBJEC'EDRANGE BOOK: APPROVED DRUG PROD TS WITH THERAPEUTIC E
`EVALUATIONS&BDDY=HTTPSHWVWWACCESSDATA.FDA.GDVISCRIPTSICDERIOEIPA'E’ENT INFOCFM?
`PRODUCT NQ=001QPPL NO=204963&APPL TYPE=N)_
`
`IVALENCE
`
`Eh_metrndexcfm°resfileld=1l | BcktoF’roduthafls
`
`Additional Information about Patents
`
`- Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
`
`- Patent listings published prior to August 18, 2003, only identify method-of~use claims. The iisted patents may
`include drug substance and/or drug product claims that are not indicated in the listing.
`
`- As of December 5, 2016, an NBA holder submitting information on a patent that claims both the drug
`substance and the drug product (and is eligible for listing on either basis) is required only to specify that it
`claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book
`patent tisting, regardless of when first published, to determine the range of patent claims that may be
`asserted by an NBA holder or patent owner.
`
`Patent and Exclusivity for: N204063
`
`Product 001
`
`DIMETHYL FUMARATE (TECFIDERA) CAPSULE, DELAYED RELEASE 120MG
`
`Patent Data
`
`Product Patent
`No
`No
`
`Use
`Drug
`Drug
`Patent
`Expiration Substance Product Code
`
`Submission
`Delist
`Requested Date
`
`Patent
`
`httpszh'wwwaccessdata.fda.govlscripts/cder/oblpatent_info.cfm?Product_No=001Mppl_No=204053&Appl_type=N
`
`112
`
`MYLAN PHARMS. INC. EXHIBIT 1071 PAGE 1
`
`MYLAN PHARMS. INC. EXHIBIT 1071 PAGE 1
`
`

`

`7131/2019
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Product Patent
`NO
`No
`
`Patent
`
`_ Expiration
`
`Drug
`Drug
`Substance Product
`
`Patent
`
`Use
`Code
`
`Delist
`
`Requested
`
`Submission
`Date
`
`001
`
`001
`
`001
`
`001
`
`001
`
`6509376
`
`04/01/2019
`
`DP
`
`‘
`
`7320999
`
`10/20/2019
`
`7619001
`
`06/20/2020
`
`7803840
`
`04/01/2019
`
`8399514
`
`02/07/2028
`
`Hfflfij‘:
`
`Hflfifi‘:
`
`.9:..%§§§.
`
`H.:...1.._§.§f’r..
`
`04/24/ 20 13
`
`04/24/ 20 13
`
`04/24/20 13
`
`04/24/20 13
`
`04/ 24/20 1 3
`
`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`There is no unexpired exclusivity for this product in the Orange Book database.
`
`Vlwalltfallmmusul
`
`-
`
`httpsjlmvwaccessdatajda.govlscriptslcderloblpatent_info.cfm?Product_No=001&Appl_No=204053&App|_type=N
`
`2/2
`
`MYLAN PHARMS. INC. EXHIBIT 1071 PAGE 2
`
`MYLAN PHARMS. INC. EXHIBIT 1071 PAGE 2
`
`