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: | 7,165 |
Formulation / Manufacturing: | see details |
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 |
---|---|
University of Utah | Phase 1 |
Brigham and Women's Hospital | Phase 1 |
National Institute of Mental Health (NIMH) | Phase 2 |
Generic filers with tentative approvals for NALTREXONE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 8MG/90MG | TABLET, EXTENDED RELEASE; ORAL |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Specgx Llc | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 076264-003 | Mar 22, 2002 | RX | No | No | ⤷ 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 | ⤷ Sign Up | ||||
Elite Labs | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 075274-001 | May 26, 1999 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Barr | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 074918-001 | May 8, 1998 | AB | RX | No | 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 |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NALTREXONE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20090050111 | NALTREXONE LONG ACTING FORMULATIONS AND METHODS OF USE | ⤷ Sign Up |
China | 103251597 | Naltrexone long acting formulations and methods of use | ⤷ Sign Up |
New Zealand | 549976 | Naltrexone long acting formulations and methods of use | ⤷ Sign Up |
China | 1946353 | Naltrexone long acting formulations and methods of use | ⤷ Sign Up |
Australia | 2005239989 | 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 | 2017C/064 | Belgium | ⤷ Sign Up | PRODUCT NAME: NALTREXONE/BUPROPION; 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 | 132017000142109 | Italy | ⤷ Sign Up | PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |