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Progesterone - Generic Drug Details

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

Progesterone is the generic ingredient in six branded drugs marketed by Amneal Pharms Ny, Bionpharma Inc, Dr Reddys, Eugia Pharma, Sofgen Pharms, Teva Pharms, Xiromed, Virtus Pharms, Allergan, Actavis Labs Ut Inc, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Lilly, Alza, Ferring, and Ferring Pharms Inc, and is included in eighteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Progesterone has fifty-three patent family members in twenty-five countries.

There are fifty-seven drug master file entries for progesterone. Seventeen suppliers are listed for this compound.

Summary for progesterone

International Patents:	53
US Patents:	3
Tradenames:	6
Applicants:	17
NDAs:	18
Drug Master File Entries:	57
Suppliers / Packagers:	17
Bulk Api Vendors:	99
Clinical Trials:	931
Patent Applications:	6,752
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for progesterone
Drug Sales Revenues:	Drug sales revenues for progesterone
DailyMed Link:	progesterone at DailyMed

See drug prices for progesterone

See drug sales revenues for progesterone

Recent Clinical Trials for progesterone

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

Sponsor	Phase
VA Office of Research and Development	Phase 2
Boston University	Phase 2
University of California, San Diego	Phase 4

See all progesterone clinical trials

Pharmacology for progesterone

Drug Class

Progesterone

Medical Subject Heading (MeSH) Categories for progesterone

Progestins

US Patents and Regulatory Information for progesterone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Virtus Pharms	PROMETRIUM	progesterone	CAPSULE;ORAL	019781-001	May 14, 1998	AB	RX	Yes	No
Xiromed	PROGESTERONE	progesterone	CAPSULE;ORAL	205229-001	Oct 20, 2017	AB	RX	No	No
Ferring Pharms Inc	MILPROSA	progesterone	SYSTEM;VAGINAL	201110-001	Apr 29, 2020		RX	Yes	Yes
Dr Reddys	PROGESTERONE	progesterone	CAPSULE;ORAL	208801-001	Feb 28, 2017	AB	RX	No	No

Expired US Patents for progesterone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007
Allergan	CRINONE	progesterone	GEL;VAGINAL	020701-001	Jul 31, 1997
Allergan	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997
Allergan	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997

International Patents for progesterone

Country	Patent Number	Estimated Expiration
New Zealand	611268
South Korea	101730517
Eurasian Patent Organization	021615
Denmark	2249757

Supplementary Protection Certificates for progesterone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0113964	97C0037	Belgium		PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826