NALTREXONE HYDROCHLORIDE Drug Patent Profile
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When do Naltrexone Hydrochloride patents expire, and when can generic versions of Naltrexone Hydrochloride launch?
Naltrexone Hydrochloride is a drug marketed by Accord Hlthcare, Barr, Chartwell, Elite Labs, Fosun Pharma, Specgx Llc, and Sun Pharm. and is included in seven NDAs.
The generic ingredient in NALTREXONE HYDROCHLORIDE is naltrexone hydrochloride. There are nineteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Naltrexone Hydrochloride
A generic version of NALTREXONE HYDROCHLORIDE was approved as naltrexone hydrochloride by BARR on May 8th, 1998.
Summary for NALTREXONE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 14 |
| Raw Ingredient (Bulk) Api Vendors: | 71 |
| Clinical Trials: | 468 |
| Patent Applications: | 5,180 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | NALTREXONE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for NALTREXONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Inventage Lab., Inc. | Phase 1 |
| BioXcel Therapeutics Inc | Phase 1/Phase 2 |
| Bicycle Health | Phase 4 |
Pharmacology for NALTREXONE HYDROCHLORIDE
| Drug Class | Opioid Antagonist |
| Mechanism of Action | Opioid Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for NALTREXONE HYDROCHLORIDE
US Patents and Regulatory Information for NALTREXONE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 091205-001 | Aug 17, 2011 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Specgx Llc | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 076264-002 | Mar 22, 2002 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Elite Labs | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 075274-001 | May 26, 1999 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Specgx Llc | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride | TABLET;ORAL | 076264-003 | Mar 22, 2002 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
