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Last Updated: November 21, 2024

MEGESTROL ACETATE Drug Patent Profile


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

Megestrol Acetate is a drug marketed by Chartwell, Hikma, Novitium Pharma, Strides Pharma, Teva Pharms, Twi Pharms, Xttrium Labs Inc, Barr, Teva, and Usl Pharma. and is included in fifteen NDAs.

The generic ingredient in MEGESTROL ACETATE is megestrol acetate. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Megestrol Acetate

A generic version of MEGESTROL ACETATE was approved as megestrol acetate by STRIDES PHARMA on August 8th, 1988.

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Drug patent expirations by year 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
Chartwell MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 204688-001 Dec 1, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Twi Pharms MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 203139-001 Aug 27, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novitium Pharma MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 077404-001 Feb 16, 2006 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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