Naltrexone hydrochloride - Generic Drug Details

What are the generic sources for naltrexone hydrochloride and what is the scope of freedom to operate?

Naltrexone hydrochloride is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Barr, Chartwell, Elite Labs, Fosun Pharma, Specgx Llc, Sun Pharm, Teva Womens, and Pfizer, and is included in nine NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for naltrexone hydrochloride. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for naltrexone hydrochloride

US Patents:	2
Tradenames:	3
Applicants:	9
NDAs:	9
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	468
Patent Applications:	7,804
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in naltrexone hydrochloride?	naltrexone hydrochloride excipients list
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

See all naltrexone hydrochloride clinical trials

Generic filers with tentative approvals for NALTREXONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		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.

Pharmacology for naltrexone hydrochloride

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for naltrexone hydrochloride

N07BB	Drugs used in alcohol dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-005	Aug 19, 2016		DISCN	No	No
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-002	Aug 19, 2016		DISCN	No	No
Barr	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	074918-001	May 8, 1998	AB	RX	No	No
Elite Labs	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	075274-001	May 26, 1999	AB	RX	No	No
Teva Womens	REVIA	naltrexone hydrochloride	TABLET;ORAL	018932-001	Nov 20, 1984		DISCN	Yes	No
Fosun Pharma	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	075434-001	Mar 8, 2000		DISCN	No	No