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Last Updated: August 10, 2020

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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 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. Seventeen 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
University of California, San DiegoPhase 4
James J. Peters Veterans Affairs Medical CenterPhase 2
Wake Forest University Health SciencesPhase 2

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
Dr Reddys PROGESTERONE progesterone CAPSULE;ORAL 208801-001 Feb 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Ferring ENDOMETRIN progesterone INSERT;VAGINAL 022057-001 Jun 21, 2007 RX Yes Yes   Start Trial   Start Trial   Start Trial
Xiromed PROGESTERONE progesterone CAPSULE;ORAL 205229-001 Oct 20, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Eugia Pharma PROGESTERONE progesterone CAPSULE;ORAL 211285-001 Oct 26, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa PROGESTERONE progesterone INJECTABLE;INJECTION 075906-001 Apr 25, 2001 AO RX No No   Start Trial   Start Trial   Start Trial
Virtus Pharms PROMETRIUM progesterone CAPSULE;ORAL 019781-003 Oct 15, 1999 DISCN No No   Start Trial   Start Trial   Start 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
Ferring ENDOMETRIN progesterone INSERT;VAGINAL 022057-001 Jun 21, 2007   Start Trial   Start Trial
Allergan CRINONE progesterone GEL;VAGINAL 020701-001 Jul 31, 1997   Start Trial   Start Trial
Ferring ENDOMETRIN progesterone INSERT;VAGINAL 022057-001 Jun 21, 2007   Start Trial   Start Trial
Allergan CRINONE progesterone GEL;VAGINAL 020701-002 Jul 31, 1997   Start Trial   Start Trial
Allergan CRINONE progesterone GEL;VAGINAL 020701-001 Jul 31, 1997   Start Trial   Start Trial
Allergan CRINONE progesterone GEL;VAGINAL 020701-002 Jul 31, 1997   Start Trial   Start 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
0113964 97C0037 Belgium   Start Trial PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Harvard Business School
Merck
AstraZeneca
McKinsey

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