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DIMETHYL FUMARATE

ANDA

DIMETHYL FUMARATE | A210531 | MYLAN PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Biogen International GMBH et al v. Mylan Pharmaceuticals Inc. 1:2017cv00116 6 patentsANDA 210531dimethyl fumarate	WVND	2017-06-30	Terminated 2020-06-22	—

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

API Supply Chain29 active DMFs2 inactive

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

ALIVUS LIFE SCIENCES LTDDIMETHYL FUMARATE

DMF 278662014

AREVIPHARMA GMBHDIMETHYL FUMARATE

DMF 285612014

YABAO PHARMACEUTICAL GROUP CO LTDDIMETHYL FUMARATE

DMF 287002014

MATRIX PHARMACORP PRIVATE LTDDIMETHYL FUMARATE USP

DMF 288312014

MSN ORGANICS PRIVATE LTDDIMETHYL FUMARATE [ROUTE CODE "DV"]

DMF 288692015

BIOPHORE INDIA PHARMACEUTICALS PVT LTDDIMETHYL FUMARATE

DMF 289552015

DR REDDYS LABORATORIES LTDDIMETHYL FUMARATE

DMF 291262015

HONOUR LAB LTDDIMETHYL FUMARATE

DMF 294852015

CHONGQING HUAPONT PHARMACEUTICAL CO LTDDIMETHYL FUMARATE

DMF 294872015

OPTIMUS DRUGS PRIVATE LTDDIMETHYL FUMARATE

DMF 296322015

SHILPA PHARMA LIFESCIENCES LTDDIMETHYL FUMARATE

DMF 296552015

TAPI NL BVDIMETHYL FUMARATE

DMF 299132016

RAKS PHARMA PVT LTDDIMETHYL FUMARATE USP

DMF 300852015

MACLEODS PHARMACEUTICALS LTDDIMETHYL FUMARATE

DMF 302832016

UNICHEM LABORATORIES LTDDIMETHYL FUMARATE

DMF 303842016

ALKEM LABORATORIES LTDDIMETHYL FUMARATE

DMF 306222016

ZYDUS LIFESCIENCES LTDDIMETHYL FUMARATE

DMF 306292016

TORRENT PHARMACEUTICALS LTDDIMETHYL FUMARATE USP

DMF 308232016

MICRO LABS LTDDIMETHYL FUMARATE

DMF 308632016

APITORIA PHARMA PRIVATE LTDDIMETHYL FUMARATE

DMF 309282016

TAPI NL BVDIMETHYL FUMARATE

DMF 309362016

GRANULES INDIA LTDDIMETHYL FUMARATE

DMF 309382016

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDDIMETHYL FUMARATE USP (PROCESS II)

DMF 309442016

SUN PHARMACEUTICAL INDUSTRIES LTDDIMETHYL FUMARATE

DMF 310272016

LABORATORIUM OFICHEM BVDIMETHYL FUMARATE

DMF 310532017

INTAS PHARMACEUTICALS LTDDIMETHYL FUMARATE

DMF 312042016

AMOLI ORGANICS PRIVATE LTDDIMETHYL FUMARATE

DMF 340822019

VASUDHA PHARMA CHEM LTDDIMETHYL FUMARATE IH

DMF 342592021

SRI KRISHNA PHARMACEUTICALS LTDDIMETHYL FUMARATE USP

DMF 400052024

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveDIMETHYL FUMARATE

DMF 297422015

NATCO PHARMA LTDInactiveDIMETHYL FUMARATE

DMF 310042016

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 18, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 120MG

0 patents0 exclusivities▴

CAPSULE, DELAYED RELEASE;ORAL | Approved: Aug 17, 2020

No patent or exclusivity listings for this strength.

#002 — 240MG

0 patents0 exclusivities▾

CAPSULE, DELAYED RELEASE;ORAL | Approved: Aug 17, 2020