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Last Updated: August 9, 2020

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Megestrol acetate - Generic Drug Details

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What are the generic drug sources for megestrol acetate and what is the scope of freedom to operate?

Megestrol acetate is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Endo Pharms Inc, Breckenridge, Hi Tech, Hikma, Par Pharm, Pharm Assoc, Teva Pharms, Twi Pharms, Wockhardt Bio Ag, Barr, Teva, and Usl Pharma, and is included in eighteen NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Megestrol acetate has one hundred and ninety-eight patent family members in twenty-eight countries.

There are eighteen drug master file entries for megestrol acetate. Sixteen suppliers are listed for this compound.

Drug Prices for megestrol acetate

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Recent Clinical Trials for megestrol acetate

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

SponsorPhase
Zagazig UniversityPhase 2/Phase 3
Children's Hospital of Fudan UniversityPhase 4
University of Kansas Medical CenterPhase 4

See all megestrol acetate clinical trials

Pharmacology for megestrol acetate
Drug ClassProgestin
Medical Subject Heading (MeSH) Categories for megestrol acetate
Paragraph IV (Patent) Challenges for MEGESTROL ACETATE
Tradename Dosage Ingredient NDA Submissiondate
MEGACE ES SUSPENSION;ORAL megestrol acetate 021778 2011-04-27
MEGACE SUSPENSION;ORAL megestrol acetate 020264

US Patents and Regulatory Information for megestrol acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Hikma MEGESTROL ACETATE megestrol acetate TABLET;ORAL 074458-002 Sep 29, 1995 AB RX No No   Start Trial   Start Trial   Start Trial
Usl Pharma MEGESTROL ACETATE megestrol acetate TABLET;ORAL 070647-001 Oct 2, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Barr MEGESTROL ACETATE megestrol acetate TABLET;ORAL 074621-001 Nov 30, 1995 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 075681-001 May 5, 2003 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 megestrol acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb MEGACE megestrol acetate SUSPENSION;ORAL 020264-001 Sep 10, 1993   Start Trial   Start Trial
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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