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CAMCEVI KIT Drug Patent Profile

Which patents cover Camcevi Kit, and what generic alternatives are available?

Camcevi Kit is a drug marketed by Accord and is included in one NDA. There are four patents protecting this drug.

This drug has thirty-seven patent family members in eighteen countries.

The generic ingredient in CAMCEVI KIT is leuprolide mesylate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the leuprolide mesylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Camcevi Kit

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 16, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CAMCEVI KIT

International Patents:	37
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	CAMCEVI KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CAMCEVI KIT

NDA:

211488

Dosage:

EMULSION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for CAMCEVI KIT

Drug Class	Gonadotropin Releasing Hormone Receptor Agonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

US Patents and Regulatory Information for CAMCEVI KIT

CAMCEVI KIT is protected by four US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CAMCEVI KIT

FDA Regulatory Exclusivity protecting CAMCEVI KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488-001	May 25, 2021		RX	Yes	Yes			Y
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488-001	May 25, 2021		RX	Yes	Yes			Y
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488-001	May 25, 2021		RX	Yes	Yes			Y
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488-001	May 25, 2021		RX	Yes	Yes			Y
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488-001	May 25, 2021		RX	Yes	Yes

International Patents for CAMCEVI KIT

When does loss-of-exclusivity occur for CAMCEVI KIT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

Japan

Mexico

Russian Federation

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CAMCEVI KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2009523798
South Korea	101728868
European Patent Office	3727421	COMPOSITIONS PHARMACEUTIQUES AYANT UNE DURÉE DE LIBÉRATION CHOISIE (PHARMACEUTICAL COMPOSITIONS HAVING A SELECTED RELEASE DURATION)
Japan	7223021
Taiwan	200831131	Pharmaceutical compositions with enhanced stability