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Last Updated: June 21, 2024

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.

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
Aga Khan UniversityPhase 1
Pakistan Science FoundationPhase 1
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 4

See all progesterone clinical trials

Pharmacology for progesterone
Drug ClassProgesterone
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
Am Regent PROGESTERONE progesterone INJECTABLE;INJECTION 090845-001 Jun 22, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sofgen Pharms PROGESTERONE progesterone CAPSULE;ORAL 200456-002 Sep 28, 2012 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
Eugia Pharma PROGESTERONE progesterone CAPSULE;ORAL 211285-002 Oct 26, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bionpharma PROGESTERONE progesterone CAPSULE;ORAL 200900-001 Aug 16, 2013 AB RX No No ⤷  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

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
Ferring ENDOMETRIN progesterone INSERT;VAGINAL 022057-001 Jun 21, 2007 ⤷  Sign Up ⤷  Sign Up
Ferring ENDOMETRIN progesterone INSERT;VAGINAL 022057-001 Jun 21, 2007 ⤷  Sign Up ⤷  Sign Up
Allergan CRINONE progesterone GEL;VAGINAL 020701-001 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

Country Patent Number Title Estimated Expiration
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. ⤷  Sign Up
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.) ⤷  Sign Up
Denmark 2359807 ⤷  Sign Up
South Korea 20100133969 MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USE THEREOF ⤷  Sign Up
South Africa 201307320 MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEROF ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for progesterone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0113964 97C0037 Belgium ⤷  Sign Up PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
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 132021000000197 Italy ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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