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Last Updated: August 12, 2020

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CYTOTEC Drug Profile

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Which patents cover Cytotec, and what generic alternatives are available?

Cytotec is a drug marketed by Gd Searle Llc and is included in one NDA.

The generic ingredient in CYTOTEC is misoprostol. There are fourteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the misoprostol profile page.

US ANDA Litigation and Generic Entry Outlook for Cytotec

A generic version of CYTOTEC was approved as misoprostol by NOVEL LABS INC on July 25th, 2012.

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Drug patent expirations by year for CYTOTEC
Drug Prices for CYTOTEC

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Recent Clinical Trials for CYTOTEC

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

SponsorPhase
sammour.ramiN/A
University of MarylandN/A
Christiana Care Health ServicesEarly Phase 1

See all CYTOTEC clinical trials

Pharmacology for CYTOTEC

US Patents and Regulatory Information for CYTOTEC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-003 Sep 21, 1990 AB RX Yes No   Start Trial   Start Trial   Start Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988 AB RX Yes Yes   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 CYTOTEC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-003 Sep 21, 1990   Start Trial   Start Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988   Start Trial   Start Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988   Start Trial   Start Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988   Start Trial   Start Trial
Gd Searle Llc CYTOTEC misoprostol TABLET;ORAL 019268-001 Dec 27, 1988   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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