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
| International Patents: | 37 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 5 |
| Patent Applications: | 30 |
| DailyMed Link: | leuprolide mesylate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for leuprolide mesylate
*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 |
| QPS-Qualitix | Phase 3 |
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 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 | ||||
| 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 | |||
| >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 | 7223021 | ⤷ Sign Up | |
| Taiwan | I376241 | ⤷ Sign Up | |
| South Korea | 20230054755 | 선택된 방출 기간을 갖는 약제학적 조성물 (Pharmaceutical Compositions Having a Selected Release Duration) | ⤷ Sign Up |
| Hong Kong | 1126975 | PHARMACEUTICAL COMPOSITIONS WITH ENHANCED STABILITY | ⤷ Sign Up |
| Japan | 2009523798 | ⤷ Sign Up | |
| >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. 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
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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