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Last Updated: August 10, 2020

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PROMETRIUM Drug Profile

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When do Prometrium patents expire, and what generic alternatives are available?

Prometrium is a drug marketed by Virtus Pharms and is included in one NDA.

The generic ingredient in PROMETRIUM is progesterone. There are fifty-seven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the progesterone profile page.

US ANDA Litigation and Generic Entry Outlook for Prometrium

A generic version of PROMETRIUM was approved as progesterone by FRESENIUS KABI USA on April 25th, 2001.

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Drug patent expirations by year for PROMETRIUM
Drug Prices for PROMETRIUM

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Recent Clinical Trials for PROMETRIUM

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SponsorPhase
National Institute of Mental Health (NIMH)Phase 2
University of North Carolina, Chapel HillPhase 2
University of California, DavisPhase 1/Phase 2

See all PROMETRIUM clinical trials

Pharmacology for PROMETRIUM
Drug ClassProgesterone

US Patents and Regulatory Information for PROMETRIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Virtus Pharms PROMETRIUM progesterone CAPSULE;ORAL 019781-001 May 14, 1998 AB RX Yes No   Start Trial   Start Trial   Start Trial
Virtus Pharms PROMETRIUM progesterone CAPSULE;ORAL 019781-002 Oct 15, 1999 AB RX Yes Yes   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

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Medtronic
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McKinsey

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