FDA Orange Book · active-ingredient family
Leuprolide acetate
Leuprolide acetate: 14 brands, 10 generics; first approved Apr 09, 1985; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 10 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
14
Generics (ANDA)
10
Listed patents
5
Next patent expiry
Mar 22, 2028
in 1 yr 6 mo
Brand (NDA) products
Originator applications
- SUN PHARMNDA 2132252026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 28MG/2.8ML (10MG/ML) SOLUTION SUBCUTANEOUS Rx — - TOLMARNDA 2131502020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 45MG POWDER SUBCUTANEOUS Rx — - INVAGEN PHARMSNDA 2050542018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 22.5MG/VIAL FOR SUSPENSION INTRAMUSCULAR Rx — - TOLMARNDA 0217312004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 45MG POWDER SUBCUTANEOUS Rx — - TOLMARNDA 0214882003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG POWDER SUBCUTANEOUS Rx — - TOLMARNDA 0213792002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 22.5MG POWDER SUBCUTANEOUS Rx — - TOLMARNDA 0213432002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG POWDER SUBCUTANEOUS Rx — - ABBVIE ENDOCRINE INCNDA 0207081997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 11.25MG INJECTABLE INJECTION Rx — - LUPRON DEPOTRLDABBVIE ENDOCRINE INCNDA 02051719953 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 22.5MG INJECTABLE INJECTION Rx — 30MG INJECTABLE INJECTION Rx — 45MG INJECTABLE INJECTION Rx — - ABBVIE ENDOCRINE INCNDA 02026319938 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG POWDER INTRAMUSCULAR Rx — 3.75MG,7.5MG POWDER INTRAMUSCULAR Discontinued — 7.5MG,7.5MG POWDER INTRAMUSCULAR Discontinued — 11.25MG POWDER INTRAMUSCULAR Rx — 15MG POWDER INTRAMUSCULAR Rx — 11.25MG POWDER INTRAMUSCULAR Rx — 30MG POWDER INTRAMUSCULAR Rx — 45MG POWDER INTRAMUSCULAR Rx — - LUPRON DEPOTRLDABBVIE ENDOCRINE INCNDA 02001119902 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75MG/VIAL INJECTABLE INJECTION Discontinued — 3.75MG INJECTABLE INJECTION Rx — - ABBVIE ENDOCRINE INCNDA 0197321989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.5MG INJECTABLE INJECTION Rx — - LUPRONRLDABBVIE ENDOCRINE INCNDA 0190101985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 14MG/2.8ML (1MG/0.2ML) SOLUTION SUBCUTANEOUS Discontinued — - ORTHO MCNEIL JANSSENNDA 0210882000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 65MG BASE IMPLANT IMPLANTATION Discontinued —
Generic (ANDA) products (10)
Abbreviated applications
- LEUPROLIDE ACETATEZYDUS PHARMSANDA 2158262025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 14MG/2.8ML (1MG/0.2ML) SOLUTION SUBCUTANEOUS Rx AP - LEUPROLIDE ACETATEPH HEALTHANDA 2174372025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 14MG/2.8ML (1MG/0.2ML) SOLUTION SUBCUTANEOUS Discontinued — - LEUPROLIDE ACETATEUBIANDA 2179572024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 14MG/2.8ML (1MG/0.2ML) SOLUTION SUBCUTANEOUS Rx AP - LEUPROLIDE ACETATEAMNEALANDA 2153362022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 14MG/2.8ML (1MG/0.2ML) SOLUTION SUBCUTANEOUS Rx AP - LEUPROLIDE ACETATEEUGIA PHARMAANDA 2129632022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 14MG/2.8ML (1MG/0.2ML) SOLUTION SUBCUTANEOUS Rx AP - LEUPROLIDE ACETATESOMERSET THERAPS LLCANDA 2138292021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 14MG/2.8ML (1MG/0.2ML) SOLUTION SUBCUTANEOUS Rx AP - LEUPROLIDE ACETATESUN PHARMANDA 0788852009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 14MG/2.8ML (1MG/0.2ML) SOLUTION SUBCUTANEOUS Rx AP - LEUPROLIDE ACETATEGENZYMEANDA 0757212001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 14MG/2.8ML (1MG/0.2ML) SOLUTION SUBCUTANEOUS Discontinued — - LEUPROLIDE ACETATEMEITHEALANDA 0754712000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 14MG/2.8ML (1MG/0.2ML) SOLUTION SUBCUTANEOUS Rx AP - LEUPROLIDE ACETATERSSANDOZANDA 0747281998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 14MG/2.8ML (1MG/0.2ML) SOLUTION SUBCUTANEOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NSNew strength exclusivity (3 years)
5 mo ago
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9617303 | in 1 yr 6 mo | U-4001 | |
| 8921326 | in 4 yr 5 mo | ProductU-1666 | |
| 12397120 | in 15 yr 6 mo | U-4001 | |
| 11931559 | in 15 yr 6 mo | Substance | |
| 11771841 | in 15 yr 6 mo | SubstanceProduct |
Approval history
FDA approval span
First approval
42 yr 1 mo ago
Most recent approval
27 d ago
Approvals span 1985–2026 across 24 FDA applications.
Brand (NDA) 1458%
Generic (ANDA) 1042%
Leuprolide acetate: 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.
