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TERIFLUNOMIDE

ANDA

TERIFLUNOMIDE | A209677 | SOLA PHARMACEUTICALS

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: AUBAGIO(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Sanofi-Aventis U.S. LLC et al v. IMPAX Laboratories, Inc. 1:2017cv00004 2 patentsANDA 209677teriflunomide	D. Del.	2017-01-03	Terminated 2017-04-21	—

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

API Supply Chain20 active DMFs

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

MSN LABORATORIES PRIVATE LTDTERIFLUNOMIDE [ROUTE CODE "TO"]

DMF 278602014

ALEMBIC PHARMACEUTICALS LTDTERIFLUNOMIDE

DMF 288982016

ALIVUS LIFE SCIENCES LTDTERIFLUNOMIDE

DMF 289912015

HONOUR LAB LTDTERIFLUNOMIDE

DMF 297012015

UNICHEM LABORATORIES LTDTERIFLUNOMIDE

DMF 297052015

MEGAFINE PHARMA P LTDTERIFLUNOMIDE DRUG SUBSTANCE

DMF 298022015

RAKS PHARMA PVT LTDTERIFLUNOMIDE

DMF 298512015

FORMOSA LABORATORIES INCTERIFLUNOMIDE

DMF 298622015

PHARMAZELL GMBHTERIFLUNOMIDE

DMF 302202016

BIOCON LTDTERIFLUNOMIDE

DMF 302972016

APITORIA PHARMA PRIVATE LTDTERIFLUNOMIDE

DMF 303402016

OLON SPATERIFLUNOMIDE

DMF 303462016

EMCURE PHARMACEUTICALS LTDTERIFLUNOMIDE

DMF 304142016

ZYDUS LIFESCIENCES LTDTERIFLUNOMIDE

DMF 304262016

INTAS PHARMACEUTICALS LTDTERIFLUNOMIDE

DMF 304912016

NATCO PHARMA LTDTERIFLUNOMIDE

DMF 305062016

TIANJIN WEIJIE PHARMACEUTICAL CO LTDTERIFLUNOMIDE

DMF 309782016

SHILPA PHARMA LIFESCIENCES LTDTERIFLUNOMIDE

DMF 321722017

MAPRIMED SATERIFLUNOMIDE

DMF 366222021

OPTIMUS DRUGS PRIVATE LTDTERIFLUNOMIDE

DMF 366532021

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 8, 2023	ORIG -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 14MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 17, 2020

No patent or exclusivity listings for this strength.

#002 — 7MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 28, 2023