Is there a generic for Leuprolide acetate?

Yes. The FDA Orange Book lists 10 approved generic (ANDA) applications for Leuprolide acetate, referencing the brand FENSOLVI KIT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Leuprolide acetate?

FENSOLVI KIT (NDA 213150, TOLMAR) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Leuprolide acetate?

The Orange Book lists 5 patents against Leuprolide acetate products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Leuprolide acetate have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Leuprolide acetate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Leuprolide acetate are approved?

Leuprolide acetate is approved in the following dosage forms: for suspension, implant, injectable, powder, solution.

FDA Orange Book · active-ingredient family

Leuprolide acetate

Leuprolide acetate: 13 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 Mar 22, 2028Latest exclusivity ends Apr 14, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 22, 2028

in 1 yr 9 mo

Originator applications

Brand (NDA) products

FENSOLVI KITRLDRS

TOLMARNDA 2131502020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
45MG	POWDER	SUBCUTANEOUS	Rx	—

LEUPROLIDE ACETATE FOR DEPOT SUSPENSIONRLDRS

INVAGEN PHARMSNDA 2050542018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
22.5MG/VIAL	FOR SUSPENSION	INTRAMUSCULAR	Rx	—

ELIGARD KITRLDRS

TOLMARNDA 0217312004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
45MG	POWDER	SUBCUTANEOUS	Rx	—

ELIGARD KITRLDRS

TOLMARNDA 0214882003

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG	POWDER	SUBCUTANEOUS	Rx	—

ELIGARD KITRLDRS

TOLMARNDA 0213792002

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
22.5MG	POWDER	SUBCUTANEOUS	Rx	—

ELIGARD KITRLDRS

TOLMARNDA 0213432002

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
7.5MG	POWDER	SUBCUTANEOUS	Rx	—

LUPRON DEPOTRLDRS

ABBVIE ENDOCRINE INCNDA 0207081997

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
11.25MG	INJECTABLE	INJECTION	Rx	—

LUPRON DEPOTRLD

ABBVIE 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	—

LUPRON DEPOT-PED KITRLD

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 Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER	INTRAMUSCULAR	Discontinued	—
7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	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 DEPOTRLD

ABBVIE ENDOCRINE INCNDA 02001119902 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3.75MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
3.75MG	INJECTABLE	INJECTION	Rx	—

LUPRON DEPOTRLDRS

ABBVIE ENDOCRINE INCNDA 0197321989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
7.5MG	INJECTABLE	INJECTION	Rx	—

LUPRONRLD

ABBVIE ENDOCRINE INCNDA 0190101985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION	SUBCUTANEOUS	Discontinued	—

VIADUR

ORTHO MCNEIL JANSSENNDA 0210882000

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 65MG BASE	IMPLANT	IMPLANTATION	Discontinued	—

Abbreviated applications

Generic (ANDA) products (10)

LEUPROLIDE ACETATE

ZYDUS 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 ACETATE

PH HEALTHANDA 2174372025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
14MG/2.8ML (1MG/0.2ML)	SOLUTION	SUBCUTANEOUS	Discontinued	—

LEUPROLIDE ACETATE

UBIANDA 2179572024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
14MG/2.8ML (1MG/0.2ML)	SOLUTION	SUBCUTANEOUS	Rx	AP

LEUPROLIDE ACETATE

AMNEALANDA 2153362022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
14MG/2.8ML (1MG/0.2ML)	SOLUTION	SUBCUTANEOUS	Rx	AP

LEUPROLIDE ACETATE

EUGIA 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 ACETATE

SOMERSET 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 ACETATE

SUN 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 ACETATE

GENZYMEANDA 0757212001

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
14MG/2.8ML (1MG/0.2ML)	SOLUTION	SUBCUTANEOUS	Discontinued	—

LEUPROLIDE ACETATE

MEITHEALANDA 0754712000

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
14MG/2.8ML (1MG/0.2ML)	SOLUTION	SUBCUTANEOUS	Rx	AP

LEUPROLIDE ACETATERS

SANDOZANDA 0747281998

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
14MG/2.8ML (1MG/0.2ML)	SOLUTION	SUBCUTANEOUS	Rx	AP

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (1)

NSNew strength exclusivity (3 years)
Apr 14, 2026
3 mo ago

Orange Book patent file

Listed patents

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9617303	Mar 22, 2028	in 1 yr 9 mo	U-4001
8921326	Feb 05, 2031	in 4 yr 8 mo	ProductU-1666
12397120	Dec 22, 2041	in 15 yr 8 mo	U-4001
11931559	Dec 22, 2041	in 15 yr 8 mo	Substance
11771841	Dec 22, 2041	in 15 yr 8 mo	SubstanceProduct

FDA approval span

Approval history

First approval

Apr 09, 1985

41 yr 10 mo ago

Most recent approval

Nov 13, 2025

8 mo ago

Approvals span 1985–2025 across 23 FDA applications.

Brand (NDA) 1357%

Generic (ANDA) 1043%

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo