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NDA

ZALEPLON | N020859 | PFIZER INC

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 DMFs8 inactive

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

TAPI NL BVZALEPLON

DMF 175652004

APITORIA PHARMA PRIVATE LTDZALEPLON USP

DMF 193982006

ORBION PHARMACEUTICALS PRIVATE LTDZALEPLON

DMF 208772007

CENTAUR PHARMACEUTICALS PVT LTDZALEPLON USP

DMF 275682013

ZACH SYSTEM SPAInactiveZALEPLON

DMF 117471995

AMINO CHEMICALS LTDInactiveZALEPLON

DMF 167852003

MEDICHEM SAInactiveZALEPLON

DMF 172302004

CIPLA LTDInactiveZALEPLON

DMF 180222005

GADOR SAInactiveZALEPLON

DMF 190152005

MEDICHEM MANUFACTURING (MALTA) LTDInactiveZALEPLON (MED - 201970)

DMF 194632006

CADILA HEALTHCARE LTDInactiveZALEPLON

DMF 214822008

APOTEX PHARMACHEM INCInactiveZALEPLON

DMF 225722009

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Aug 20, 2019	SUPPL -16	View Letter (PDF)
Feb 14, 2019	SUPPL -15	View Letter (PDF)
Apr 24, 2013	SUPPL -13	View Letter (PDF)
Jan 9, 2008	SUPPL -11	View Letter (PDF)
Jan 9, 2008	SUPPL -9	View Letter (PDF)
Jun 8, 2003	SUPPL -4	View Letter (PDF)
Jun 8, 2003	SUPPL -5	View Letter (PDF)
Jun 3, 2002	SUPPL -2	View Letter (PDF)
May 31, 2002	SUPPL -3	View Letter (PDF)
Feb 22, 2001	SUPPL -1	View Letter (PDF)
Aug 13, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 13, 1999

No patent or exclusivity listings for this strength.

#002 — 10MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 13, 1999