Question 1

Is there a generic for Leuprolide mesylate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Leuprolide mesylate. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Leuprolide mesylate?

Accepted Answer

CAMCEVI ETM (NDA 219745, ACCORD) 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 mesylate?

Accepted Answer

The Orange Book lists 5 patents against Leuprolide mesylate products, with the earliest listed expiry in 2027. 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 mesylate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Leuprolide mesylate. 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 mesylate are approved?

Accepted Answer

Leuprolide mesylate is approved in the following dosage form: emulsion.

Product	Applicant	Application	TE	Approved
CAMCEVI ETMRLD	ACCORD	NDA 219745	—	Aug 25, 2025
CAMCEVI KITRLD	ACCORD	NDA 211488	—	May 25, 2021

Patent	Expires	In	Type
9744207	Jan 16, 2027	in 7 mo	Product
10646572	Jan 16, 2027	in 7 mo	Product
9572857	Aug 02, 2029	in 3 yr 2 mo	Product
12133878	Dec 18, 2037	in 11 yr 8 mo	Product
11717555	Jan 01, 2039	in 12 yr 9 mo	Product

Leuprolide mesylate

Brand (NDA) products · emulsion

Marketing exclusivity (1)

Listed patents (5)

Leuprolide mesylate — frequently asked questions

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