NALTREXONE - Generic Drug Details
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Womens | REVIA | naltrexone hydrochloride | TABLET;ORAL | 018932-001 | Nov 20, 1984 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-005 | Aug 19, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Sun Pharm | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 090356-001 | Feb 24, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-001 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NALTREXONE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| United Kingdom | 2398895 | Real time trading involving financial instruments | ⤷ Sign Up |
| United Kingdom | 0304637 | ⤷ Sign Up | |
| Japan | 2011225600 | NALTREXONE LONG ACTING FORMULATION AND METHOD OF USE | ⤷ Sign Up |
| Japan | 5426094 | ⤷ 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 | 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 |
| 2316456 | 2017/059 | Ireland | ⤷ 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; REGISTRATION NO/DATE: EU/1/14/988 20150326 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
