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Last Updated: February 3, 2023

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

Summary for leuprolide mesylate
Recent Clinical Trials for leuprolide mesylate

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

SponsorPhase
QPSPhase 3
GeneScience Pharmaceuticals Co., Ltd.Phase 3
QPS-QualitixPhase 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Accord CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488-001 May 25, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Accord CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488-001 May 25, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord CAMCEVI KIT leuprolide mesylate EMULSION;SUBCUTANEOUS 211488-001 May 25, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
South Korea 20080089643 PHARMACEUTICAL COMPOSITIONS WITH ENHANCED STABILITY See Plans and Pricing
Taiwan 200831131 Pharmaceutical compositions with enhanced stability See Plans and Pricing
South Korea 101728868 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2007084460 See Plans and Pricing
Brazil PI0706558 composições farmacêuticas com estabilidade aperfeiçoada See Plans and Pricing
Russian Federation 2008129201 ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ С ПОВЫШЕННОЙ СТАБИЛЬНОСТЬЮ See Plans and Pricing
Australia 2007207618 Pharmaceutical compositions with enhanced stability See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Moodys
Boehringer Ingelheim
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Harvard Business School
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.