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Last Updated: November 2, 2024

LEUPROLIDE MESYLATE - Generic Drug Details


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What are the generic drug sources for leuprolide mesylate and what is the scope of patent protection?

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

Leuprolide mesylate has thirty-seven patent family members in eighteen countries.

There is one drug master file entry for leuprolide mesylate. One supplier is listed for this compound.

Summary for LEUPROLIDE MESYLATE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LEUPROLIDE MESYLATE
Generic Entry Date for LEUPROLIDE MESYLATE*:
Constraining patent/regulatory exclusivity:
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.

Recent Clinical Trials for LEUPROLIDE MESYLATE

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

SponsorPhase
QPSPhase 3
GeneScience Pharmaceuticals Co., Ltd.Phase 3
Foresee Pharmaceuticals Co., Ltd.Phase 3

See all LEUPROLIDE MESYLATE clinical trials

Pharmacology for LEUPROLIDE MESYLATE

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
Accord CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488-001 May 25, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Accord CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488-001 May 25, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Accord CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488-001 May 25, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Accord CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488-001 May 25, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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