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PERMAX

NDA

PERGOLIDE MESYLATE | N019385 | VALEANT PHARMACEUTICALS INTERNATIONAL

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

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 Chain1 active DMF3 inactive

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

OLON SPAPERGOLIDE MESYLATE

DMF 179822005

BACHEM SAInactivePERGOLIDE MESYLATE

DMF 150132000

GALENA ASInactivePERGOLIDE MESYLATE

DMF 151802000

TEVA PHARMACEUTICAL INDUSTRIES LTDInactivePERGOLIDE MESYLATE

DMF 243232010

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Oct 9, 2003	SUPPL -31	View Letter (PDF)
Oct 9, 2003	SUPPL -30	View Letter (PDF)
Oct 9, 2003	SUPPL -35	View Letter (PDF)
Aug 29, 2002	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 0.05MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 30, 1988

No patent or exclusivity listings for this strength.

#002 — EQ 0.25MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 30, 1988

#003 — EQ 1MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 30, 1988