Dydrogesterone - Generic Drug Details

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What are the generic sources for dydrogesterone and what is the scope of patent protection?

Dydrogesterone is the generic ingredient in one branded drug marketed by Solvay and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for dydrogesterone.

Summary for dydrogesterone

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	51
Patent Applications:	2,862
DailyMed Link:	dydrogesterone at DailyMed

Recent Clinical Trials for dydrogesterone

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bezmialem Vakif University	N/A
Zagazig University	N/A
El Shatby University Hospital for Obstetrics and Gynecology	Phase 2/Phase 3

See all dydrogesterone clinical trials

Medical Subject Heading (MeSH) Categories for dydrogesterone

Progestins

Anatomical Therapeutic Chemical (ATC) Classes for dydrogesterone

G03DB	Pregnadien derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for dydrogesterone

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Solvay	GYNOREST	dydrogesterone	TABLET;ORAL	017388-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Solvay	GYNOREST	dydrogesterone	TABLET;ORAL	017388-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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