Nalmefene hydrochloride - Generic Drug Details
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What are the generic sources for nalmefene hydrochloride and what is the scope of freedom to operate?
Nalmefene hydrochloride
is the generic ingredient in three branded drugs marketed by Chengdu Shuode, Purdue Pharma Lp, Hikma, and Indivior, and is included in four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Nalmefene hydrochloride has twelve patent family members in eight countries.
There are four drug master file entries for nalmefene hydrochloride. Three suppliers are listed for this compound.
Summary for nalmefene hydrochloride
International Patents: | 12 |
US Patents: | 1 |
Tradenames: | 3 |
Applicants: | 4 |
NDAs: | 4 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 31 |
Clinical Trials: | 31 |
Patent Applications: | 263 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in nalmefene hydrochloride? | nalmefene hydrochloride excipients list |
DailyMed Link: | nalmefene hydrochloride at DailyMed |
Recent Clinical Trials for nalmefene hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Tharimmune Inc | Phase 1 |
Purdue Pharma LP | Phase 4 |
Nantes University Hospital | Phase 3 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | REVEX | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 020459-002 | Apr 17, 1995 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Chengdu Shuode | NALMEFENE HYDROCHLORIDE | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 216007-002 | Nov 15, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Purdue Pharma Lp | NALMEFENE HYDROCHLORIDE | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 212955-001 | Feb 8, 2022 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Indivior | OPVEE | nalmefene hydrochloride | SPRAY;NASAL | 217470-001 | May 22, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Indivior | OPVEE | nalmefene hydrochloride | SPRAY;NASAL | 217470-001 | May 22, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Chengdu Shuode | NALMEFENE HYDROCHLORIDE | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 216007-001 | Nov 15, 2023 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hikma | REVEX | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 020459-001 | Apr 17, 1995 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 nalmefene hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Russian Federation | 2769397 | КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ПЕРЕДОЗИРОВКИ ОПИОИДАМИ (COMPOSITIONS AND METHODS OF TREATING OPIOID OVERDOSE) | ⤷ Sign Up |
China | 110139651 | 用于治疗阿片样物质过量的组合物和方法 (COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE) | ⤷ Sign Up |
Japan | 2019534315 | オピオイド過剰摂取を処置するための組成物および方法 | ⤷ Sign Up |
Australia | 2024201047 | Compositions and methods for the treatment of opioid overdose | ⤷ Sign Up |
Russian Federation | 2019118465 | КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ПЕРЕДОЗИРОВКИ ОПИОИДАМИ | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2018093666 | ⤷ Sign Up | |
European Patent Office | 3541386 | COMPOSITIONS ET MÉTHODES DE TRAITEMENT D'UNE PRISE EXCESSIVE D'OPIOÏDES (COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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