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Leuprolide mesylate - Generic Drug Details

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What are the generic drug sources for leuprolide mesylate and what is the scope of freedom to operate?

Leuprolide mesylate is the generic ingredient in one branded drug marketed by Foresee Pharms and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Leuprolide mesylate has twenty patent family members in fifteen countries.

There are twenty-two drug master file entries for leuprolide mesylate.

Summary for leuprolide mesylate

International Patents:	20
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	22
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	4
Patent Applications:	10
DailyMed Link:	leuprolide mesylate at DailyMed

Recent Clinical Trials for leuprolide mesylate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
QPS-Qualitix	Phase 3
Foresee Pharmaceuticals Co., Ltd.	Phase 3
M.D. Anderson Cancer Center	Phase 2

See all leuprolide mesylate clinical trials

US Patents and Regulatory Information for leuprolide mesylate

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

International Patents for leuprolide mesylate

Country	Patent Number	Estimated Expiration
Russian Federation	2008129201
Taiwan	200831131
Denmark	1984009
Russian Federation	2427383
China	101400363