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NALTREXONE

ANDA

NALTREXONE | A213195 | TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ALKERMES, INC. et al v. TEVA PHARMACEUTICAL INDUSTRIES USA,INC 2:2020cv12470 1 patentANDA 213195naltrexone	D.N.J.	2020-09-09	Terminated 2023-08-30	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain6 active DMFs5 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

SPECGX LLCNALTREXONE HCL

DMF 62651986

SPECGX LLCNALTREXONE BASE

DMF 95721992

NORAMCO LLCNALTREXONE DRUG SUBSTANCE

DMF 229922009

CHONGQING LAND TOWER PHARMACEUTICAL CO LTDNALTREXONE

DMF 296192015

SANECA PHARMACEUTICALS ASNALTREXONE

DMF 316912017

SIEGFRIED AGNALTREXONE

DMF 404142024

MALLINCKRODT CHEMICAL INCInactiveNALTREXONE METHOBROMIDE

DMF 89481991

TASMANIAN ALKALOIDS PTY LTDInactiveNALTREXONE BENZOATE

DMF 123491997

DIOSYNTH BVInactiveNALTREXONE

DMF 152212001

SPECGX LLCInactiveNALTREXONE METHOBROMIDE

DMF 158372002

NV ORGANONInactiveNALTREXONE

DMF 175632004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 21, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 380MG/VIAL

0 patents0 exclusivities▴

FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Approved: Jul 6, 2023

No patent or exclusivity listings for this strength.