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
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
Lauren Whitehurst	Phase 3
Ohio State University	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
Fresenius Kabi Usa	PROGESTERONE	progesterone	INJECTABLE;INJECTION	075906-001	Apr 25, 2001	AO	RX	No	No
Xiromed	PROGESTERONE	progesterone	CAPSULE;ORAL	205229-001	Oct 20, 2017	AB	RX	No	No
Xiromed	PROGESTERONE	progesterone	CAPSULE;ORAL	205229-002	Oct 20, 2017	AB	RX	No	No
Eugia Pharma	PROGESTERONE	progesterone	CAPSULE;ORAL	211285-001	Oct 26, 2018	AB	RX	No	No
Virtus	PROMETRIUM	progesterone	CAPSULE;ORAL	019781-003	Oct 15, 1999		DISCN	No	No
Amneal Pharms Ny	PROGESTERONE	progesterone	CAPSULE;ORAL	207724-001	Sep 7, 2017	AB	RX	No	No
Actavis Labs Ut Inc	PROGESTERONE	progesterone	INJECTABLE;INJECTION	017362-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for progesterone

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

International Patents for progesterone

Country	Patent Number	Title	Estimated Expiration
South Korea	20100133969	MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USE THEREOF
Taiwan	I599359
Portugal	2249757
European Patent Office	2359807	ANNEAUX INTRAVAGINAUX MONOLITHIQUES COMPRENANT DE LA PROGESTÉRONE; PROCÉDÉS DE FABRICATION ET UTILISATIONS (MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF)
South Africa	201307321	MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF
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.)
China	104146948	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
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
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	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
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	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	21C1058	France		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406