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Last Updated: January 27, 2023

Megestrol acetate - Generic Drug Details


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What are the generic drug sources for megestrol acetate and what is the scope of patent protection?

Megestrol acetate is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Endo Pharms Inc, Akorn, Breckenridge, Hikma, Pharm Assoc, Strides Pharma, Teva Pharms, Twi Pharms, Wockhardt Bio Ag, 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
Sunnybrook Health Sciences CentrePhase 1

See all megestrol acetate clinical trials

Pharmacology for megestrol acetate
Drug Class Progestin
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
Teva Pharms MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 075681-001 May 5, 2003 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Usl Pharma MEGESTROL ACETATE megestrol acetate TABLET;ORAL 070646-001 Oct 2, 1987 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb MEGACE megestrol acetate TABLET;ORAL 016979-001 Approved Prior to Jan 1, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Strides Pharma MEGESTROL ACETATE megestrol acetate TABLET;ORAL 072423-001 Aug 8, 1988 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 See Plans and Pricing See Plans and Pricing
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for megestrol acetate

Country Patent Number Title Estimated Expiration
Japan 2008546796 See Plans and Pricing
Mexico 2008000396 FORMULACIONES DE MEGESTROL EN NANOPARTICULA. (NANOPARTICULATE MEGESTROL FORMULATIONS.) See Plans and Pricing
Denmark 1494649 See Plans and Pricing
Israel 188322 See Plans and Pricing
Canada 2481390 PREPARATIONS DE MEGESTROL NANOPARTICULAIRES (NANOPARTICULATE MEGESTROL FORMULATIONS) See Plans and Pricing
Australia 2003230885 NANOPARTICULATE MEGESTROL FORMULATIONS See Plans and Pricing
Slovenia 1494649 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.