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Last Updated: March 29, 2024

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 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
GeneScience Pharmaceuticals Co., Ltd.Phase 3
QPSPhase 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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Accord CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488-001 May 25, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Accord CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488-001 May 25, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Accord CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488-001 May 25, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488-001 May 25, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for leuprolide mesylate

Country Patent Number Title Estimated Expiration
Japan 2009523798 ⤷  Try a Trial
Mexico 2008009125 COMPOSICIONES FARMACEUTICAS CON ESTABILIDAD MEJORADA. (PHARMACEUTICAL COMPOSITIONS WITH ENHANCED STABILITY.) ⤷  Try a Trial
South Korea 20230054755 선택된 방출 기간을 갖는 약제학적 조성물 (Pharmaceutical Compositions Having a Selected Release Duration) ⤷  Try a Trial
European Patent Office 1984009 COMPOSITIONS PHARMACEUTIQUES A STABILITE AMELIOREE (PHARMACEUTICAL COMPOSITIONS WITH ENHANCED STABILITY) ⤷  Try a Trial
Taiwan I376241 ⤷  Try a Trial
Australia 2007207618 Pharmaceutical compositions with enhanced stability ⤷  Try a Trial
Israel 275448 תכשירים רוקחיים עם משך שחרור נבחר (Pharmaceutical compositions having a selected release duration) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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