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OCUSERT PILO-20

NDA

PILOCARPINE | N017431 | EPIC PHARMA 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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain0 active DMFs6 inactive

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

PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKSInactivePILOCARPINE (SOLUTION IN ACETONE)

DMF 47751982

LINNEA PHYTOCHEMICALSInactivePILOCARPINE NITRATE

DMF 77091988

VEGEFLORA EXTRACOES DO NORDESTE LTDAInactivePILOCARPINE NITRATE

DMF 92251991

PVP SOCIEDADE ANONIMAInactivePILOCARPINE NITRATE

DMF 110291994

VEGEFLORA EXTRACOES DO NORDESTE LTDAInactivePILOCARPINE USP

DMF 126291997

STERLING WISCONSIN LLCInactivePILOCARPINE (FP-039)

DMF 169362003

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

Products (1)

#001 — 5MG

0 patents0 exclusivities▴

INSERT, EXTENDED RELEASE;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.