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Last Updated: March 29, 2024

Megestrol acetate - Generic Drug Details


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What are the generic 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, Bionpharma, Hikma, Novitium Pharma, Strides Pharma, Teva Pharms, Twi Pharms, Xttrium Labs Inc, Barr, Teva, and Usl Pharma, and is included in eighteen NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Megestrol acetate has thirty-six patent family members in nineteen countries.

There are seventeen drug master file entries for megestrol acetate. Fourteen 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
National Cancer Institute (NCI)Phase 1/Phase 2
Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshPhase 2
Ontario Institute for Cancer ResearchPhase 1

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 Strength NDA ANDAs Submitted Submissiondate
MEGACE ES Oral Suspension megestrol acetate 125 mg/mL 021778 1 2011-04-27

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
Xttrium Labs Inc MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 076721-001 Nov 1, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma MEGESTROL ACETATE megestrol acetate TABLET;ORAL 074458-001 Sep 29, 1995 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 075671-001 Jul 25, 2001 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 203960-001 Jun 9, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for megestrol acetate

Country Patent Number Title Estimated Expiration
European Patent Office 1494649 PREPARATIONS DE MEGESTROL NANOPARTICULAIRES (NANOPARTICULATE MEGESTROL FORMULATIONS) ⤷  Try a Trial
Mexico 2008000396 FORMULACIONES DE MEGESTROL EN NANOPARTICULA. (NANOPARTICULATE MEGESTROL FORMULATIONS.) ⤷  Try a Trial
European Patent Office 2263650 Formulations de mégestrol nanoparticulaire (Nanoparticulate megestrol formulations) ⤷  Try a Trial
Japan 2008546796 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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