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Last Updated: February 2, 2023

Progesterone - Generic Drug Details


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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.

Drug Prices for progesterone

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

SponsorPhase
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 3
First People's Hospital of FoshanPhase 3
Shenzhen People's HospitalPhase 3

See all progesterone clinical trials

Pharmacology for progesterone
Drug Class Progesterone
Medical Subject Heading (MeSH) Categories for progesterone

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms PROGESTERONE progesterone CAPSULE;ORAL 202121-002 Feb 29, 2012 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Virtus Pharms PROMETRIUM progesterone CAPSULE;ORAL 019781-002 Oct 15, 1999 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sofgen Pharms PROGESTERONE progesterone CAPSULE;ORAL 200456-002 Sep 28, 2012 BX RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms Ny PROGESTERONE progesterone CAPSULE;ORAL 207724-001 Sep 7, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Am Regent PROGESTERONE progesterone INJECTABLE;INJECTION 090845-001 Jun 22, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Xiromed PROGESTERONE progesterone INJECTABLE;INJECTION 215634-001 Jan 5, 2022 AO RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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

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.) See Plans and Pricing
Japan 6124411 See Plans and Pricing
Denmark 2359807 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009099586 See Plans and Pricing
Slovenia 2359807 See Plans and Pricing
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. See Plans and Pricing
Taiwan 201526898 Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for progesterone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0113964 97C0037 Belgium See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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