Viewing data from:

CLOMID

NDA

CLOMIPHENE CITRATE | N016131 | SANOFI AVENTIS US 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Appco Pharma LLC FDA-2026-P-3444 Appco Pharma LLC filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an ANDA for Clomiphene Citrate Tablets in 25 mg and 100 mg strengths, which differ from the reference listed drug CLOMID 50 mg approved to Sanofi Aven	Suitability	2026-03-31	Open	Appco Pharma LLC

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Clomid (2023)

Total Spending

$564K

Total Claims

3,291

Beneficiaries

1,005

Avg Cost/Unit

$4.83

Spending Trend

$25K(2022)→$564K(2023)

YoY Change:+97.3%

5yr CAGR:+97.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs4 inactive

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

TAPI NL BVCLOMIPHENE CITRATE

DMF 39571980

FIS FABBRICA ITALIANA SINTETICI SPACLOMIPHENE CITRATE

DMF 56741984

MENADIONA SLCLOMIPHENE CITRATE

DMF 75901988

PCASCLOMIPHENE CITRATE

DMF 289472015

VIYASH LIFE SCIENCES PRIVATE LTDCLOMIPHENE CITRATE USP

DMF 401112024

UNICHEM LABORATORIES LTDInactiveCLOMIPHENE CITRATE

DMF 63361985

EGIS PHARMACEUTICALS PRIVATE LTDInactiveCLOMIPHENE CITRATE USP

DMF 65681986

EGIS PHARMACEUTICALS PRIVATE LTDInactiveCLOMIPHENE CITRATE TABLETS

DMF 86721989

PCASInactiveCLOMIPHENE CITRATE

DMF 147282000

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 27, 2017	SUPPL -28	View Letter (PDF)
Oct 24, 2012	SUPPL -26	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.