NALMEFENE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Nalmefene Hydrochloride, and what generic alternatives are available?
Nalmefene Hydrochloride is a drug marketed by Chengdu Shuode and Purdue Pharma Lp and is included in two NDAs.
The generic ingredient in NALMEFENE HYDROCHLORIDE is nalmefene hydrochloride. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nalmefene hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nalmefene Hydrochloride
A generic version of NALMEFENE HYDROCHLORIDE was approved as nalmefene hydrochloride by PURDUE PHARMA LP on February 8th, 2022.
Summary for NALMEFENE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 31 |
| Clinical Trials: | 30 |
| Patent Applications: | 165 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | NALMEFENE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for NALMEFENE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Purdue Pharma LP | Phase 4 |
| Nantes University Hospital | Phase 3 |
| First Affiliated Hospital of Guangxi Medical University | Phase 4 |
Pharmacology for NALMEFENE HYDROCHLORIDE
| Drug Class | Opioid Antagonist |
| Mechanism of Action | Opioid Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for NALMEFENE HYDROCHLORIDE
US Patents and Regulatory Information for NALMEFENE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chengdu Shuode | NALMEFENE HYDROCHLORIDE | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 216007-001 | Nov 15, 2023 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Chengdu Shuode | NALMEFENE HYDROCHLORIDE | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 216007-002 | Nov 15, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Purdue Pharma Lp | NALMEFENE HYDROCHLORIDE | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 212955-001 | Feb 8, 2022 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
