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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

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Appco Pharma LLC FDA-2026-P-3444 · 8 docket documents 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
Terence J. Mix, Esq. - Citizen Petition FDA-2007-P-0234 · 19 docket documents Terence J. Mix, Esq. filed this citizen petition requesting that the FDA Commissioner order post-market labeling changes to CLOMID (clomiphene citrate) NDA 16-131 and its generic versions to include warnings about teratogenic risks, oversee risk evaluation and mitigation strategies to determine whet	Other	2008-05-10	Denied	—

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

Clinical Trials

109 trials from ClinicalTrials.gov — 1 recruiting, 61 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome NCT03059173	Phase 3	Recruiting	University Hospital, Lille	276	2023-09-12 → 2027-12
Mild Stimulation Protocol Versus Microdose Gonadotropin-releasing Hormone Agonist Flare up Protocol in Poor Responders NCT01213147	Phase 4	Completed	Yazd Medical University	159	2009-04 → 2010-05
Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate NCT03674385	Phase 2	Completed	Ain Shams University	60	2018-07-19 → 2019-03-30
The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene NCT02663830	Phase 2	Completed	Ain Shams University	210	2016-01-10 → 2017-03-12
Treatment of Anovulatory Infertility in PCOS Patients NCT00471523	Phase 4	Completed	University Magna Graecia	80	2006-05 → 2007-03
Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch Compared to Oral Treatment With Clomiphene or Placebo in Infertile Females NCT00796289	Phase 2	Completed	Ferring Pharmaceuticals	350	2009-02 → 2010-01
Short-term Structured Exercise Training Program Plus Diet Intervention in Patients With Polycystic Ovary Syndrome (PCOS)NCT01004068	Phase 4	Completed	University Magna Graecia	96	2008-02 → 2009-10
Letrozole or Combined Clomiphene Citrate Metformin as a First Line Treatment in Women With Polycystic Ovarian Syndrome NCT01679574	N/A	Completed	Assiut University	200	2009-01 → 2012-01
Administration of Clomiphene: Short and Long Term Metabolism in an Anti-Doping Setting NCT03028532	Phase 1	Completed	Stuart Willick	12	2017-03-13 → 2018-10-15
Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility NCT00610077	Phase 3	Completed	Sun Pharmaceutical Industries Limited	55	2004-12 → 2006-07

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

Medicare Part D Spending

CMS annual spending data for Clomid (2024)

Total Spending

$927K

Total Claims

4,273

Beneficiaries

1,280

Avg Cost/Unit

$6.40

Spending Trend

$25K(2022)→$564K(2023)→$927K(2024)

YoY Change:+32.3%

5yr CAGR:+61.6%

Source: CMS Medicare Part D Spending by Drug (2024). 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.