NALTREXONE Drug Patent Profile

When do Naltrexone patents expire, and when can generic versions of Naltrexone launch?

Naltrexone is a drug marketed by Teva Pharms Usa Inc, Accord Hlthcare, Barr, Chartwell, Elite Labs, Fosun Pharma, Specgx Llc, and Sun Pharm. and is included in eight NDAs.

The generic ingredient in NALTREXONE 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

A generic version of NALTREXONE was approved as naltrexone hydrochloride by BARR on May 8^th, 1998.

Summary for NALTREXONE

US Patents:	0
Applicants:	8
NDAs:	8
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	468
Patent Applications:	5,497
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NALTREXONE
Drug Sales Revenues:	Drug sales revenues for NALTREXONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NALTREXONE
DailyMed Link:	NALTREXONE at DailyMed

See drug prices for NALTREXONE

See drug sales revenues for NALTREXONE

Recent Clinical Trials for NALTREXONE

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 clinical trials

Medical Subject Heading (MeSH) Categories for NALTREXONE

Narcotic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for NALTREXONE

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

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 Pharms Usa Inc	NALTREXONE	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	213195-001	Jul 6, 2023		DISCN	No	No
Specgx Llc	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	076264-001	Mar 22, 2002		RX	No	No
Chartwell	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	207905-001	Jul 21, 2017	AB	RX	No	No
Specgx Llc	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	076264-002	Mar 22, 2002	AB	RX	No	Yes
Accord Hlthcare	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	091205-001	Aug 17, 2011	AB	RX	No	No
Barr	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	074918-001	May 8, 1998	AB	RX	No	No