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GYNOREST

NDA

DYDROGESTERONE | N017388 | SOLVAY PHARMACEUTICALS

2 strengths0 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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Foley & Lardner LLP FDA-2016-P-2675 · 6 docket documents Foley & Lardner LLP, on behalf of an unnamed client seeking to file an ANDA, petitioned the FDA under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act to determine whether the listed reference drug Gynorest (dydrogesterone tablets, NDA N017388, held by Solvay Pharmaceuticals) was vol	505(q)	2016-09-09	Granted	Foley & Lardner LLP

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

Clinical Trials

35 trials from ClinicalTrials.gov — 1 recruiting, 20 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Oral Dydrogesterone as Luteal Phase Support in Natural Cycle FET NCT03859921	Phase 3	Recruiting	The University of Hong Kong	716	2021-07-01 → 2026-11-30
Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women NCT00145522	Phase 4	Completed	Solvay Pharmaceuticals	135	2005-11 → 2009-03
Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination NCT00160316	Phase 3	Completed	Solvay Pharmaceuticals	454	2005-04 → 2007-12
Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination NCT00251082	Phase 3	Completed	Solvay Pharmaceuticals	391	2005-12 → 2007-10
Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Threatened Miscarriage NCT02128685	Phase 3	Completed	The University of Hong Kong	406	2016-03 → 2018-05-31
Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor NCT02262481	N/A	Completed	Chulalongkorn University	48	2014-08 → 2015-06
The Effect of Different Types of Progestin on Sleeping of Menopausal Women NCT02086032	N/A	Completed	Chiang Mai University	100	2014-01 → 2015-07
The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis NCT04287205	N/A	Completed	Kanuni Sultan Suleyman Training and Research Hospital	79	2019-04-20 → 2020-03-03
A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization NCT01850030	Phase 3	Completed	Abbott	1,070	2013-08 → 2016-03
MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia NCT03675139	Phase 3	Completed	Xiaojun Chen	471	2019-02-26 → 2022-05-15

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

API Supply Chain3 active DMFs1 inactive

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

XIAN GUOKANG RUIJIN PHARMACEUTICAL CO LTDDYDROGESTERONE

DMF 362712022

YANGZHOU AURISCO PHARMACEUTICAL CO LTDDYDROGESTERONE

DMF 365692022

ARESKO LIFE SCIENCES PRIVATE LTDDYDROGESTERONE USP

DMF 431482026

DUPHAR BVInactiveDYDROGESTERONE (FORMERLY ISOPREGNENONE)

DMF 4271961

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

Products (2)

Sort:

#001 — 5MG **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.

#002 — 10MG **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