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NALFON

NDA

FENOPROFEN CALCIUM | N017710 | DISTA PRODUCTS CO DIV ELI LILLY AND CO

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

3 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Barr Laboratories, Inc. FDA-1987-P-0132 Barr Laboratories, Inc. filed this citizen petition under Section 505(j)(2)(c) requesting permission to submit Abbreviated New Drug Applications for Fenoprofen Calcium 200 mg and 300 mg tablets for prescription use, with formulations identical to the listed drug Nalfon currently marketed by Dista in	Other	2023-10-19	Granted	Barr Laboratories
Attachment 2 Fenoprofen Calcium re Suitability Petition from Pharmobedient Co... FDA-2023-P-4417 Pharmobedient Consulting LLC filed a petition regarding the suitability of fenoprofen calcium, requesting that the FDA establish or clarify regulatory pathways and standards for this active pharmaceutical ingredient to facilitate the development and approval of generic or new drug formulations conta	Suitability	2023-10-06	Open	Pharmobedient Consulting LLC
Attachment 3 Fenoprofen Calcium Draft re Suitability Petition from Pharmobedi... FDA-2023-P-4417 Pharmobedient Consulting LLC filed a suitability petition regarding fenoprofen calcium, requesting that the FDA determine the suitability of the drug substance for use in pharmaceutical formulations and establish appropriate regulatory pathways for its development and approval.	Suitability	2023-10-06	Open	Pharmobedient Consulting LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs6 inactive

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

SUVEN PHARMACEUTICALS LTDFENOPROFEN CALCIUM USP

DMF 204982007

BIOPHORE INDIA PHARMACEUTICALS PVT LTDFENOPROFEN CALCIUM

DMF 344122020

BLASCHIM SPAInactiveFENOPROFEN CALCIUM

DMF 69041987

CAMBREX PROFARMACO MILANO SRLInactiveFENOPROFEN CALCIUM

DMF 69321987

FARMOS GROUP LTD MEDIPOLARInactiveFENOPROFEN CALCIUM

DMF 70411987

ISOCHEM SAInactiveFENOPROFEN CALCIUM USP

DMF 71201987

FRANCIS SPAInactiveFENOPROFEN CALCIUM

DMF 71521987

EMCURE PHARMACEUTICALS LTDInactiveFENOPROFEN CALCIUM USP

DMF 221052008

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

Products (1)

#001 — EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.