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Last Updated: March 28, 2024

Progesterone - Generic Drug Details


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What are the generic sources for progesterone and what is the scope of freedom to operate?

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

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

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

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
Ferring ENDOMETRIN progesterone INSERT;VAGINAL 022057-001 Jun 21, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lilly PROGESTERONE progesterone INJECTABLE;INJECTION 009238-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Xiromed PROGESTERONE progesterone INJECTABLE;INJECTION 215634-001 Jan 5, 2022 AO RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare PROGESTERONE progesterone INJECTABLE;INJECTION 217707-001 Nov 21, 2023 AO RX 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

Supplementary Protection Certificates for progesterone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 2021C/558 Belgium ⤷  Try a Trial 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 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
2782584 132021000000197 Italy ⤷  Try a Trial 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.