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Last Updated: November 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.

Summary for progesterone
Drug Prices for progesterone

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Drug Sales Revenue Trends for progesterone

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Recent Clinical Trials for progesterone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Instituto Valenciano de Infertilidad, IVI VALENCIAN/A
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 3
Lauren WhitehurstPhase 3

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
Sofgen Pharms PROGESTERONE progesterone CAPSULE;ORAL 200456-002 Sep 28, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sofgen Pharms PROGESTERONE progesterone CAPSULE;ORAL 200456-001 Sep 28, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys PROGESTERONE progesterone CAPSULE;ORAL 208801-002 Feb 28, 2017 AB RX No No ⤷  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
>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 020701-001 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
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
New Zealand 587758 MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF ⤷  Sign Up
Mexico 337634 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
Taiwan 200938204 Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof ⤷  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 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
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 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
2782584 LUC00245 Luxembourg ⤷  Sign Up 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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