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ZOMIG

NDA

ZOLMITRIPTAN | N021450 | AMNEAL PHARMACEUTICALS 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Impax Laboratories Inc. et al v. Lannett Holdings Inc. et al 1:2014cv00999 2 patentsANDA 206350zolmitriptan	D. Del.	2014-07-30	Terminated 2017-04-17	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain17 active DMFs3 inactive

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

SMS PHARMACEUTICALS LTDZOLMITRIPTAN

DMF 201102007

MATRIX PHARMACORP PRIVATE LTDZOLMITRIPTAN USP

DMF 206392007

NATCO PHARMA LTDZOLMITRIPTAN

DMF 213082008

TAPI NL BVZOLMITRIPTAN

DMF 222052008

ALIVUS LIFE SCIENCES LTDZOLMITRIPTAN USP

DMF 222372008

SUVEN LIFE SCIENCES LTDZOLMITRIPTAN

DMF 232072009

JUBILANT BIOSYS LTDZOLMITRIPTAN USP

DMF 236272010

INKE SAZOLMITRIPTAN

DMF 246492011

MACLEODS PHARMACEUTICALS LTDZOLMITRIPTAN

DMF 248692011

SUN PHARMACEUTICAL INDUSTRIES LTDZOLMITRIPTAN

DMF 250782011

ORBION PHARMACEUTICALS PRIVATE LTDZOLMITRIPTAN

DMF 252362011

HETERO DRUGS LTDZOLMITRIPTAN

DMF 252972011

ALEMBIC PHARMACEUTICALS LTDZOLMITRIPTAN USP

DMF 255032011

DR REDDYS LABORATORIES LTDZOLMITRIPTAN (PROCESS-II)

DMF 257342012

EMCURE PHARMACEUTICALS LTDZOLMITRIPTAN

DMF 261052012

APITORIA PHARMA PRIVATE LTDZOLMITRIPTAN

DMF 275022013

SYN-TECH CHEM AND PHARM CO LTDZOLMITRIPTAN

DMF 278182013

DR REDDYS LABORATORIES LTDInactiveZOLMITRIPTAN

DMF 201942007

APOTEX PHARMACHEM INDIA PVT LTDInactiveZOLMITRIPTAN

DMF 238962010

UNICHEM LABORATORIES LTDInactiveZOLMITRIPTAN USP

DMF 247562011

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Dec 31, 2018	SUPPL -10	View Letter (PDF)
Jun 16, 2015	SUPPL -8	View Letter (PDF)
Sep 17, 2013	SUPPL -7	View Letter (PDF)
Oct 21, 2008	SUPPL -5	View Letter (PDF)
Jul 6, 2004	SUPPL -1	View Letter (PDF)
Sep 30, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#003 — 2.5MG/SPRAY

RLDAB

0 patents0 exclusivities▴

SPRAY;NASAL | Approved: Sep 16, 2013

No patent or exclusivity listings for this strength.

#004 — 5MG/SPRAY

RLDAB

0 patents0 exclusivities▾

SPRAY;NASAL | Approved: Sep 30, 2003