FDA Orange Book · active-ingredient family
Fulvestrant
Fulvestrant: 3 brands, 15 generics; first approved Apr 25, 2002; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 15 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
15
Listed patents
3
Next patent expiry
Feb 14, 2034
in 7 yr 5 mo
Brand (NDA) products
Originator applications
- FASLODEXRLDASTRAZENECANDA 02134420022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx AO 125MG/2.5ML (50MG/ML) SOLUTION INTRAMUSCULAR Discontinued - - CLIGAVYXRSAVYXA HOLDINGSNDA 2100632019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx - - FULVESTRANTFRESENIUS KABI USANDA 2103262019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx AO
Generic (ANDA) products (15)
Abbreviated applications
- FULVESTRANTEUGIA PHARMAANDA 2151692023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Discontinued - - FULVESTRANTALEMBICANDA 2150772022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx AO - FULVESTRANTJIANGSU HANSOH PHARMANDA 2146822022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx AO - FULVESTRANTXIROMEDANDA 2135532021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx AO - FULVESTRANTZYDUS PHARMSANDA 2152342021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx AO - FULVESTRANTAPOTEXANDA 2117302021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Discontinued - - FULVESTRANTACCORD HLTHCAREANDA 2116892020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx AO - FULVESTRANTDR REDDYSANDA 2092462020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx AO - FULVESTRANTCHIA TAI TIANQINGANDA 2114222020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx AO - FULVESTRANTHBT LABS INCANDA 2097142019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx AO - FULVESTRANTGLENMARK PHARMSANDA 2077542019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx AO - FULVESTRANTSAGENT PHARMS INCANDA 2058712019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx AO - FULVESTRANTEUGIA PHARMAANDA 2088112019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Discontinued - - FULVESTRANTSANDOZANDA 2059352019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx AO - FULVESTRANTAMNEALANDA 2100442019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML (50MG/ML) SOLUTION INTRAMUSCULAR Rx AO
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9833459 | in 7 yr 5 mo | ProductU-2540 | |
| 10188663 | in 7 yr 5 mo | ProductU-2540 | |
| 9271990 | in 7 yr 8 mo | ProductU-2540 |
Approval history
FDA approval span
First approval
24 yr 10 mo ago
Most recent approval
3 yr 4 mo ago
Approvals span 2002–2023 across 18 FDA applications.
Brand (NDA) 317%
Generic (ANDA) 1583%
Fulvestrant: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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