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Last Updated: September 27, 2021

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LEUPROLIDE MESYLATE - Generic Drug Details

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What are the generic 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: 3
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

SponsorPhase
Foresee Pharmaceuticals Co., Ltd.Phase 3
QPS-QualitixPhase 3
M.D. Anderson Cancer CenterPhase 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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Foresee Pharms CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488-001 May 25, 2021 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Foresee Pharms CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488-001 May 25, 2021 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Foresee Pharms CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488-001 May 25, 2021 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Medtronic
Baxter
Harvard Business School
Mallinckrodt

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