Question 1

Is there a generic for Leuprolide acetate?

Accepted Answer

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.

Question 2

What is the reference-listed drug for Leuprolide acetate?

Accepted Answer

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

Question 3

What patents protect Leuprolide acetate?

Accepted Answer

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.

Question 4

Does Leuprolide acetate have FDA marketing exclusivity?

Accepted Answer

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.

Question 5

What dosage forms of Leuprolide acetate are approved?

Accepted Answer

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

Product	Applicant	Application	TE	Approved
FENSOLVI KITRLD	TOLMAR	NDA 213150	—	May 01, 2020
LEUPROLIDE ACETATE FOR DEPOT SUSPENSIONRLD	INVAGEN PHARMS	NDA 205054	—	Aug 28, 2018
ELIGARD KITRLD	TOLMAR	NDA 021731	—	Dec 14, 2004
ELIGARD KITRLD	TOLMAR	NDA 021488	—	Feb 13, 2003
ELIGARD KITRLD	TOLMAR	NDA 021379	—	Jul 24, 2002
ELIGARD KITRLD	TOLMAR	NDA 021343	—	Jan 23, 2002
LUPRON DEPOTRLD	ABBVIE ENDOCRINE INC	NDA 020708	—	Mar 07, 1997
LUPRON DEPOTRLD×3	ABBVIE ENDOCRINE INC	NDA 020517	—	Dec 22, 1995
LUPRON DEPOT-PED KITRLD×8	ABBVIE ENDOCRINE INC	NDA 020263	—	Apr 16, 1993
LUPRON DEPOTRLD×2	ABBVIE ENDOCRINE INC	NDA 020011	—	Oct 22, 1990
LUPRON DEPOTRLD	ABBVIE ENDOCRINE INC	NDA 019732	—	Jan 26, 1989
LUPRONRLD	ABBVIE ENDOCRINE INC	NDA 019010	—	Apr 09, 1985
VIADUR	ORTHO MCNEIL JANSSEN	NDA 021088	—	Mar 03, 2000

Product	Applicant	Application	TE	Approved
LEUPROLIDE ACETATE	ZYDUS PHARMS	ANDA 215826	AP	Nov 13, 2025
LEUPROLIDE ACETATE	PH HEALTH	ANDA 217437	—	Jun 09, 2025
LEUPROLIDE ACETATE	UBI	ANDA 217957	AP	Oct 17, 2024
LEUPROLIDE ACETATE	AMNEAL	ANDA 215336	AP	Oct 28, 2022
LEUPROLIDE ACETATE	EUGIA PHARMA	ANDA 212963	AP	Jun 06, 2022
LEUPROLIDE ACETATE	SOMERSET THERAPS LLC	ANDA 213829	AP	Aug 13, 2021
LEUPROLIDE ACETATE	SUN PHARM	ANDA 078885	AP	Mar 09, 2009
LEUPROLIDE ACETATE	GENZYME	ANDA 075721	—	Nov 29, 2001
LEUPROLIDE ACETATE	MEITHEAL	ANDA 075471	AP	Oct 25, 2000
LEUPROLIDE ACETATE	SANDOZ	ANDA 074728	AP	Aug 04, 1998

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 9 mo	U-4001
11931559	Dec 22, 2041	in 15 yr 9 mo	Substance
11771841	Dec 22, 2041	in 15 yr 9 mo	SubstanceProduct

Leuprolide acetate

Brand (NDA) products · for suspension, implant, injectable, powder, solution

Generic (ANDA) products (10)

Marketing exclusivity (1)

Listed patents (5)

Leuprolide acetate — frequently asked questions

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