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 four branded drugs marketed by Chengdu Shuode, Purdue Pharma Lp, Hikma, and Indivior, and is included in five NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Nalmefene hydrochloride has eighty patent family members in fifteen countries.
There are four drug master file entries for nalmefene hydrochloride. Three suppliers are listed for this compound.
Summary for nalmefene hydrochloride
| International Patents: | 80 |
| US Patents: | 22 |
| Tradenames: | 4 |
| Applicants: | 4 |
| NDAs: | 5 |
| Drug Master File Entries: | 4 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 31 |
| Clinical Trials: | 31 |
| Patent Applications: | 263 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for nalmefene hydrochloride |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Purdue Pharma Lp | ZURNAI (AUTOINJECTOR) | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 218590-001 | Aug 7, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Purdue Pharma Lp | ZURNAI (AUTOINJECTOR) | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 218590-001 | Aug 7, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Purdue Pharma Lp | ZURNAI (AUTOINJECTOR) | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 218590-001 | Aug 7, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Purdue Pharma Lp | ZURNAI (AUTOINJECTOR) | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 218590-001 | Aug 7, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | ZURNAI (AUTOINJECTOR) | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 218590-001 | Aug 7, 2024 | 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 nalmefene hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2024201047 | Compositions and methods for the treatment of opioid overdose | ⤷ Sign Up |
| Japan | 2017523858 | 注射装置で使用するためのシリンジ緩衝器 | ⤷ Sign Up |
| Japan | 2019150661 | 注射装置で使用するためのシリンジ緩衝器 (SYRINGE SHOCK ABSORBER FOR USE IN INJECTION DEVICE) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2014124464 | ⤷ Sign Up | |
| China | 101132820 | Prefilled needle assisted jet injector | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2014124427 | ⤷ Sign Up | |
| >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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