LEUPROLIDE MESYLATE - Generic Drug Details
What are the generic drug sources for leuprolide mesylate and what is the scope of patent protection?
Leuprolide mesylate
is the generic ingredient in two branded drugs marketed by Accord and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Two suppliers are listed for this compound.
Summary for LEUPROLIDE MESYLATE
| International Patents: | 40 |
| US Patents: | 5 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 6 |
| DailyMed Link: | LEUPROLIDE MESYLATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LEUPROLIDE MESYLATE
Generic Entry Dates for LEUPROLIDE MESYLATE*:
Constraining patent/regulatory exclusivity:
Dosage:
EMULSION;SUBCUTANEOUS |
Generic Entry Dates 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
| Sponsor | Phase |
|---|---|
| QPS | Phase 3 |
| GeneScience Pharmaceuticals Co., Ltd. | Phase 3 |
| Changchun GeneScience Pharmaceutical Co., Ltd. | PHASE3 |
Pharmacology for LEUPROLIDE MESYLATE
| Drug Class | Gonadotropin Releasing Hormone Receptor Agonist |
| Mechanism of Action | Gonadotropin Releasing Hormone Receptor Agonists |
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 ETM | leuprolide mesylate | EMULSION;SUBCUTANEOUS | 219745-001 | Aug 25, 2025 | RX | Yes | Yes | 12,133,878 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Accord | CAMCEVI KIT | leuprolide mesylate | EMULSION;SUBCUTANEOUS | 211488-001 | May 25, 2021 | RX | Yes | Yes | 11,717,555 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Accord | CAMCEVI KIT | leuprolide mesylate | EMULSION;SUBCUTANEOUS | 211488-001 | May 25, 2021 | RX | Yes | Yes | 9,744,207 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Accord | CAMCEVI KIT | leuprolide mesylate | EMULSION;SUBCUTANEOUS | 211488-001 | May 25, 2021 | RX | Yes | Yes | 10,646,572 | ⤷ Start Trial | Y | ⤷ Start 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 |
|---|---|---|---|
| Australia | 2007207618 | ⤷ Start Trial | |
| Brazil | PI0706558 | ⤷ Start Trial | |
| Canada | 2637569 | ⤷ Start Trial | |
| China | 101400363 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2026 - 2027
NCE-1 Patent Challenge Dates 2026 - 2027
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch