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ANZEMET

NDA

DOLASETRON MESYLATE | N020624 | VALIDUS PHARMACEUTICALS LLC

3 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 DMFs3 inactive

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

EMCURE PHARMACEUTICALS LTDDOLASETRON MESYLATE USP

DMF 247942011

USV PRIVATE LTDDOLASETRON MESYLATE USP

DMF 332112018

ROLABO OUTSOURCING SLInactiveDOLASETRON MESYLATE

DMF 218522008

USV LTDInactiveDOLASETRON MESYLATE USP

DMF 241452010

APOTEX PHARMACHEM INDIA PVT LTDInactiveDOLASETRON MESYLATE MONOHYDRATE USP

DMF 245312011

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

Approval Letters

10 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 100MG/5ML (20MG/ML)

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 11, 1997

No patent or exclusivity listings for this strength.

#002 — 12.5MG/0.625ML (20MG/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 11, 1997

#003 — 500MG/25ML (20MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 11, 2001