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Last Updated: January 26, 2022

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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 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 eighteen 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-one 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
University of California, San DiegoPhase 4
AHS Cancer Control AlbertaPhase 2
Laniado HospitalN/A

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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
Allergan CRINONE progesterone GEL;VAGINAL 020701-001 Jul 31, 1997 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Eugia Pharma PROGESTERONE progesterone CAPSULE;ORAL 211285-002 Oct 26, 2018 AB RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Lilly PROGESTERONE progesterone INJECTABLE;INJECTION 009238-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Sofgen Pharms PROGESTERONE progesterone CAPSULE;ORAL 200456-001 Sep 28, 2012 BX RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Eugia Pharma PROGESTERONE progesterone CAPSULE;ORAL 211285-001 Oct 26, 2018 AB RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free 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

International Patents for progesterone

Country Patent Number Estimated Expiration
Mexico 337634 ⤷  Sign up for a Free Trial
World Intellectual Property Organization (WIPO) 2009099586 ⤷  Sign up for a Free Trial
Eurasian Patent Organization 031017 ⤷  Sign up for a Free Trial
Japan 2014167001 ⤷  Sign up for a Free Trial
South Korea 20140048321 ⤷  Sign up for a Free Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for progesterone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0113964 97C0037 Belgium ⤷  Sign up for a Free Trial PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
2782584 301153 Netherlands ⤷  Sign up for a Free 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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
McKinsey
Mallinckrodt
Express Scripts
Baxter

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