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
| International Patents: | 20 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 5 |
| Patent Applications: | 26 |
| DailyMed Link: | leuprolide mesylate at DailyMed |
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 | 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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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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