LEUPROLIDE MESYLATE - Generic Drug Details
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What are the generic drug sources for leuprolide mesylate and what is the scope of patent protection?
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
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
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 | 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 |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2019125358 | ⤷ Sign Up | |
South Korea | 102522654 | ⤷ Sign Up | |
Australia | 2007207618 | Pharmaceutical compositions with enhanced stability | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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