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AMERGE

NDA

NARATRIPTAN HYDROCHLORIDE | N020763 | GLAXOSMITHKLINE LLC

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 Chain4 active DMFs2 inactive

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

DR REDDYS LABORATORIES LTDNARATRIPTAN HYDROCHLORIDE

DMF 176482004

ORBION PHARMACEUTICALS PRIVATE LTDNARATRIPTAN HYDROCHLORIDE (NON-STERILE BULK API)

DMF 221312008

SUN PHARMACEUTICAL INDUSTRIES LTDNARATRIPTAN HYDROCHLORIDE USP

DMF 227292009

USV PRIVATE LTDNARATRIPTAN HYDROCHLORIDE USP

DMF 229532009

IND SWIFT LABORATORIES LTDInactiveNARATRIPTAN HYDROCHLORIDE USP

DMF 224222008

APOTEX PHARMACHEM INDIA PVT LTDInactiveNARATRIPTAN HYDROCHLORIDE USP

DMF 226212009

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

Approval Letters

9 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 10, 1998

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 10, 1998