PROGESTERONE - Generic Drug Details

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, Dr Reddys, Eugia Pharma, Sofgen Pharms, Teva Pharms, Xiromed, Virtus, Allergan, Accord Hlthcare, Actavis Labs Ut Inc, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Lilly, Alza, Ferring, and Ferring Pharms Inc, and is included in twenty 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. Twenty-five suppliers are listed for this compound.

Summary for PROGESTERONE

International Patents:	53
US Patents:	3
Tradenames:	6
Applicants:	18
NDAs:	20
Drug Master File Entries:	57
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	1,115
Patent Applications:	7,265
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for PROGESTERONE
Drug Sales Revenues:	Drug sales revenues for PROGESTERONE
What excipients (inactive ingredients) are in PROGESTERONE?	PROGESTERONE excipients list
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
Fundación Santiago Dexeus Font	Phase 3
Fayoum University	N/A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	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
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007		RX	Yes	Yes
Lilly	PROGESTERONE	progesterone	INJECTABLE;INJECTION	009238-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bionpharma	PROGESTERONE	progesterone	CAPSULE;ORAL	200900-001	Aug 16, 2013	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	020701-002	Jul 31, 1997
Allergan	CRINONE	progesterone	GEL;VAGINAL	020701-001	Jul 31, 1997

International Patents for PROGESTERONE

Country	Patent Number	Title	Estimated Expiration
Israel	207376	MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USING THE SAME
Spain	2648640
Slovenia	2359807

Supplementary Protection Certificates for PROGESTERONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2782584	2021C/558	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
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
2782584	LUC00245	Luxembourg		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701