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TRENTAL

NDA

PENTOXIFYLLINE | N018631 | VALIDUS PHARMACEUTICALS LLC

1 strength0 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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
The PENTO Protocol in Medication-related Osteonecrosis of the Jaw NCT05795647	Phase 2	Recruiting	University Hospital, Limoges	17	2024-02-29 → 2028-04-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain5 active DMFs8 inactive

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

TAPI NL BVPENTOXIFYLLINE USP

DMF 125621997

HIKAL LTDPENTOXIFYLLINE USP

DMF 141821999

SUN PHARMACEUTICAL INDUSTRIES LTDPENTOXIFYLLINE USP

DMF 149872000

ZAKLADY FARMACEUTYCZNE POLPHARMA SAPENTOXIFYLLINE

DMF 209762007

CSPC INNOVATION PHARM CO LTDPENTOXIFYLLINE

DMF 258992012

LABOCHIMInactivePENTOXIFYLLINE

DMF 64851986

DINAMITE DIPHARMA SPAInactivePENTOXIFYLLINE

DMF 76391988

ORION CORP LTDInactivePENTOXIFYLLINE

DMF 77031988

POLI INDUSTRIA CHIMICA SPAInactivePENTOXIFYLLINE

DMF 83241989

ZENTIVA ASInactivePENTOXIFYLLINE

DMF 103741993

PLANTEX LTDInactivePENTOXIFYLLINE

DMF 115491995

IPCA LABORATORIES LTDInactivePENTOXIFYLLINE

DMF 173452004

AUROBINDO PHARMA LTDInactivePENTOXIFYLLINE USP

DMF 182492005

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jan 20, 2016	SUPPL -41	View Letter (PDF)
Feb 17, 2015	SUPPL -40	View Letter (PDF)
Apr 18, 2014	SUPPL -36	View Letter (PDF)
Jul 9, 2012	SUPPL -39	View Letter (PDF)
Apr 12, 2005	SUPPL -34	View Letter (PDF)
Oct 9, 2003	SUPPL -33	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 30, 1984

No patent or exclusivity listings for this strength.