Viewing data from:

METHYLNALTREXONE BROMIDE

ANDA

METHYLNALTREXONE BROMIDE | A208592 | MYLAN LABORATORIES LTD

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
VALEANT PHARMACEUTICALS INTERNATIONAL, INC. et al v. MYLAN PHARAMACEUTICALS, INC. et al 2:2017cv06714 7 patentsANDA 208592, 208594methylnaltrexone bromide	D.N.J.	2017-09-01	Terminated 2018-06-04	—

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

API Supply Chain4 active DMFs

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

NORAMCO LLCMETHYLNALTREXONE BROMIDE

DMF 265282012

CHONGQING LAND TOWER PHARMACEUTICAL CO LTDMETHYLNALTREXONE BROMIDE

DMF 301732016

SIEGFRIED GRAFTON INCMETHYLNALTREXONE BROMIDE

DMF 318032020

SUN PHARMACEUTICAL INDUSTRIES LTDMETHYLNALTREXONE BROMIDE USP

DMF 427822025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 6, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 12MG/0.6ML (12MG/0.6ML)

0 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: May 28, 2025

No patent or exclusivity listings for this strength.