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FDA Orange Book · active-ingredient family

Fulvestrant

Fulvestrant is approved as 3 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FASLODEX · NDA 021344

3

Brand (NDA)

15

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
FASLODEXRLD×2ASTRAZENECANDA 021344—Apr 25, 2002
CLIGAVYXAVYXA HOLDINGSNDA 210063—Aug 19, 2019
FULVESTRANTFRESENIUS KABI USANDA 210326AOMay 20, 2019

Generic (ANDA) products (15)

ProductApplicantApplicationTEApproved
FULVESTRANTEUGIA PHARMAANDA 215169—Jun 30, 2023
FULVESTRANTALEMBICANDA 215077AODec 22, 2022
FULVESTRANTJIANGSU HANSOH PHARMANDA 214682AOFeb 10, 2022
FULVESTRANTXIROMEDANDA 213553AOAug 13, 2021
FULVESTRANTZYDUS PHARMSANDA 215234AOJul 29, 2021
FULVESTRANTAPOTEXANDA 211730—Jun 11, 2021
FULVESTRANTACCORD HLTHCAREANDA 211689AONov 17, 2020
FULVESTRANTDR REDDYSANDA 209246AOAug 07, 2020
FULVESTRANTCHIA TAI TIANQINGANDA 211422AOFeb 07, 2020
FULVESTRANTHBT LABS INCANDA 209714AONov 21, 2019
FULVESTRANTGLENMARK PHARMSANDA 207754AOAug 22, 2019
FULVESTRANTSAGENT PHARMS INCANDA 205871AOAug 22, 2019
FULVESTRANTEUGIA PHARMAANDA 208811—Jul 23, 2019
FULVESTRANTSANDOZANDA 205935AOMay 14, 2019
FULVESTRANTAMNEALANDA 210044AOMar 04, 2019

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9833459Feb 14, 2034in 7 yr 9 mo
ProductU-2540
10188663Feb 14, 2034in 7 yr 9 mo
ProductU-2540
9271990May 17, 2034in 8 yr
ProductU-2540

Fulvestrant — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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