Progesterone - Generic Drug Details

What are the generic drug 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:	1,134
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
Instituto Valenciano de Infertilidad, IVI VALENCIA	N/A
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 3
Lauren Whitehurst	Phase 3

See all progesterone clinical trials

Pharmacology for progesterone

Drug Class

Progesterone

Medical Subject Heading (MeSH) Categories for progesterone

Progestins

Anatomical Therapeutic Chemical (ATC) Classes for progesterone

G03DA	Pregnen (4) 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 progesterone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sofgen Pharms	PROGESTERONE	progesterone	CAPSULE;ORAL	200456-002	Sep 28, 2012	AB	RX	No	No
Teva Pharms	PROGESTERONE	progesterone	CAPSULE;ORAL	202121-001	Feb 29, 2012		DISCN	No	No
Virtus	PROMETRIUM	progesterone	CAPSULE;ORAL	019781-003	Oct 15, 1999		DISCN	No	No
Eugia Pharma	PROGESTERONE	progesterone	INJECTABLE;INJECTION	210965-001	Dec 6, 2018	AO	RX	No	Yes
Fresenius Kabi Usa	PROGESTERONE	progesterone	INJECTABLE;INJECTION	075906-001	Apr 25, 2001	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
Allergan	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007
Allergan	CRINONE	progesterone	GEL;VAGINAL	020701-002	Jul 31, 1997

International Patents for progesterone

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009099586
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	200938204	Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof
China	102098991	Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof
Japan	5507467

Supplementary Protection Certificates for progesterone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2861072	2024C/512	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL, EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS SOUS FORME HEMIHYDRATEE) ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
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