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 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 nineteen 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-two suppliers are listed for this compound.

Summary for progesterone

International Patents:	53
US Patents:	3
Tradenames:	6
Applicants:	17
NDAs:	19
Drug Master File Entries:	57
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	1,094
Patent Applications:	7,313
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
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 3
First People's Hospital of Foshan	Phase 3
Shenzhen People's Hospital	Phase 3

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
Eugia Pharma	PROGESTERONE	progesterone	INJECTABLE;INJECTION	210965-001	Dec 6, 2018	AO	RX	No	No
Teva Pharms	PROGESTERONE	progesterone	CAPSULE;ORAL	202121-002	Feb 29, 2012		DISCN	No	No
Virtus Pharms	PROMETRIUM	progesterone	CAPSULE;ORAL	019781-002	Oct 15, 1999	AB	RX	Yes	Yes
Sofgen Pharms	PROGESTERONE	progesterone	CAPSULE;ORAL	200456-002	Sep 28, 2012	BX	RX	No	No
Amneal Pharms Ny	PROGESTERONE	progesterone	CAPSULE;ORAL	207724-001	Sep 7, 2017	AB	RX	No	No
Am Regent	PROGESTERONE	progesterone	INJECTABLE;INJECTION	090845-001	Jun 22, 2009		DISCN	No	No
Xiromed	PROGESTERONE	progesterone	INJECTABLE;INJECTION	215634-001	Jan 5, 2022	AO	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
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
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007

International Patents for progesterone

Country	Patent Number	Title	Estimated Expiration
Mexico	2010008545	ANILLOS INTRAVAGINALES MONOLITICOS QUE COMPRENDEN PROGESTERONA Y METODOS DE MANUFACTURA Y USO DE LOS MISMOS. (MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF.)
Japan	6124411
Denmark	2359807
World Intellectual Property Organization (WIPO)	2009099586
Slovenia	2359807
Chile	2009000242	Anillo monolitico intravaginal para tratar un defecto en la fase lutea, que comprende progesterona, un elastomero de polisiloxano y un aceite mineral, estando la progesterona dispersa homogeneamente en el elastomero de polisiloxano y procedimiento para fabricarlo.
Taiwan	201526898	Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof

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
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
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
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