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KHEDEZLA

NDA

DESVENLAFAXINE | N204683 | OSMOTICA PHARMACEUTICAL CORP

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs2 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TAPI NL BVDESVENLAFAXINE BASE

DMF 263572012

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)DESVENLAFAXINE USP

DMF 433542025

CADILA HEALTHCARE LTDInactiveDESVENLAFAXINE BASE

DMF 253482011

LUPIN MANUFACTURING SOLUTIONS LTDInactiveDESVENLAFAXINE BENZOATE

DMF 257272012

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

Approval Letters

8 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 10, 2013

No patent or exclusivity listings for this strength.

#002 — 100MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 10, 2013