Progesterone - Generic Drug Details

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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

Drug Sales Revenue Trends 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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xiromed	PROGESTERONE	progesterone	CAPSULE;ORAL	205229-002	Oct 20, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Virtus	PROMETRIUM	progesterone	CAPSULE;ORAL	019781-002	Oct 15, 1999	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ferring Pharms Inc	MILPROSA	progesterone	SYSTEM;VAGINAL	201110-001	Apr 29, 2020		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Eugia Pharma	PROGESTERONE	progesterone	INJECTABLE;INJECTION	210965-001	Dec 6, 2018	AO	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for progesterone

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

International Patents for progesterone

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Country	Patent Number	Title	Estimated Expiration
Denmark	2359807		⤷ Sign Up
Japan	2014167001	MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE, AND MANUFACTURING METHODS AND USES THEREOF	⤷ Sign Up
South Korea	20100133969	MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USE THEREOF	⤷ Sign Up
Lithuania	2249757		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for progesterone

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2782584	301153	Netherlands	⤷ Sign Up	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	⤷ Sign Up	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
2861072	2024C/512	Belgium	⤷ Sign Up	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	2021C/558	Belgium	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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