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Last Updated: March 29, 2024

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, 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-four suppliers are listed for this compound.

Drug Prices for PROGESTERONE

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Drug Sales Revenue Trends for PROGESTERONE

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Recent Clinical Trials for PROGESTERONE

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SponsorPhase
Fayoum UniversityN/A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 4
Fundación Santiago Dexeus FontPhase 3

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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
Xiromed PROGESTERONE progesterone CAPSULE;ORAL 205229-002 Oct 20, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ferring Pharms Inc MILPROSA progesterone SYSTEM;VAGINAL 201110-001 Apr 29, 2020 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Allergan CRINONE progesterone GEL;VAGINAL 020701-002 Jul 31, 1997 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lilly PROGESTERONE progesterone INJECTABLE;INJECTION 009238-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Ferring ENDOMETRIN progesterone INSERT;VAGINAL 022057-001 Jun 21, 2007 ⤷  Try a Trial ⤷  Try a Trial
Allergan CRINONE progesterone GEL;VAGINAL 020701-001 Jul 31, 1997 ⤷  Try a Trial ⤷  Try a Trial
Ferring ENDOMETRIN progesterone INSERT;VAGINAL 022057-001 Jun 21, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PROGESTERONE

Country Patent Number Title Estimated Expiration
Japan 2014167001 MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE, AND MANUFACTURING METHODS AND USES THEREOF ⤷  Try a Trial
Eurasian Patent Organization 201070919 ЦЕЛЬНЫЕ ИНТРАВАГИНАЛЬНЫЕ КОЛЬЦА, СОДЕРЖАЩИЕ ПРОГЕСТЕРОН, И СПОСОБЫ ИЗГОТОВЛЕНИЯ И ПРИМЕНЕНИЯ ТАКИХ КОЛЕЦ ⤷  Try a Trial
Spain 2648640 ⤷  Try a Trial
China 102098991 Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof ⤷  Try a Trial
>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 ⤷  Try a Trial 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 ⤷  Try a Trial 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 LUC00245 Luxembourg ⤷  Try a Trial 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 301153 Netherlands ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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