Naltrexone - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for naltrexone and what is the scope of freedom to operate?
Naltrexone
is the generic ingredient in five branded drugs marketed by Teva Pharms Usa Inc, Alkermes, Accord Hlthcare, Barr, Chartwell, Elite Labs, Fosun Pharma, Specgx Llc, Sun Pharm, Teva Womens, and Pfizer, and is included in eleven NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Naltrexone has eighteen patent family members in eleven countries.
There are nineteen drug master file entries for naltrexone. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for naltrexone
| International Patents: | 18 |
| US Patents: | 3 |
| Tradenames: | 5 |
| Applicants: | 11 |
| NDAs: | 11 |
| Drug Master File Entries: | 19 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 46 |
| Clinical Trials: | 475 |
| Patent Applications: | 7,017 |
| Drug Prices: | Drug price trends for naltrexone |
| Drug Sales Revenues: | Drug sales revenues for naltrexone |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for naltrexone |
| What excipients (inactive ingredients) are in naltrexone? | naltrexone excipients list |
| DailyMed Link: | naltrexone at DailyMed |
Recent Clinical Trials for naltrexone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Brigham and Women's Hospital | Phase 1 |
| University of Utah | Phase 1 |
| National Institute of Mental Health (NIMH) | Phase 2 |
Generic filers with tentative approvals for NALTREXONE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Medical Subject Heading (MeSH) Categories for naltrexone
Anatomical Therapeutic Chemical (ATC) Classes for naltrexone
Paragraph IV (Patent) Challenges for NALTREXONE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VIVITROL | Extended-release Injectable Suspension | naltrexone | 380 mg/vial | 021897 | 1 | 2020-06-18 |
US Patents and Regulatory Information for naltrexone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specgx Llc | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 076264-002 | Mar 22, 2002 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Specgx Llc | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 076264-001 | Mar 22, 2002 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 207905-001 | Jul 21, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fosun Pharma | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 075434-001 | Mar 8, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-003 | Aug 19, 2016 | DISCN | No | No | ⤷ 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 |
Expired US Patents for naltrexone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for naltrexone
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2386269 | Formulation de naltrexone à action prolongée et procédés d'utilisation (Naltrexone long acting formulations and methods of use) | ⤷ Sign Up |
| China | 1946353 | Naltrexone long acting formulations and methods of use | ⤷ Sign Up |
| European Patent Office | 1740120 | COMPOSITIONS DE NALTREXONE, À ACTION LONGUE DURÉE ET MÉTHODE D'UTILISATION (NALTREXONE LONG ACTING FORMULATIONS AND METHODS OF USE) | ⤷ Sign Up |
| New Zealand | 549976 | Naltrexone long acting formulations and methods of use | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2005107753 | ⤷ Sign Up | |
| Canada | 2563086 | PROCEDE ET SYSTEME D'INVESTIGATION ANONYME ETENDUE BASEE SURDES FAITS ET D'ETABLISSEMENT DE RAPPORTS A BASE DE FAITS ET D'ACCES SELECTIF AUX RESULTATS ET RAPPORTS (NALTREXONE LONG ACTING FORMULATIONS AND METHODS OF USE) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for naltrexone
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2316456 | 132017000142109 | Italy | ⤷ Sign Up | PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330 |
| 2316456 | 2017C/064 | Belgium | ⤷ Sign Up | PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330 |
| 2316456 | 1790064-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330 |
| 2316456 | 17C1058 | France | ⤷ Sign Up | PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330 |
| 2316456 | LUC00054 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330 |
| 2316456 | SPC/GB17/078 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
