➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKesson
Merck
Baxter
Mallinckrodt
AstraZeneca
Express Scripts

Last Updated: October 23, 2021

DrugPatentWatch Database Preview

Megestrol acetate - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

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 Pharms, Par Pharm, Pharm Assoc, 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 eighteen drug master file entries for megestrol acetate. Fifteen suppliers are listed for this compound.

Drug Prices for megestrol acetate

See drug prices for megestrol acetate

Recent Clinical Trials for megestrol acetate

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

SponsorPhase
Wake Forest University Health SciencesPhase 3
University Health Network, TorontoPhase 1
Huashan HospitalPhase 2/Phase 3

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
Par Pharm MEGESTROL ACETATE megestrol acetate TABLET;ORAL 072423-001 Aug 8, 1988 AB RX No Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Usl Pharma MEGESTROL ACETATE megestrol acetate TABLET;ORAL 070647-001 Oct 2, 1987 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Akorn MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 203960-001 Jun 9, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Par Pharm MEGESTROL ACETATE megestrol acetate TABLET;ORAL 072422-001 Aug 8, 1988 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 it Free ⤷  Try it Free
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 ⤷  Try it Free ⤷  Try it Free
Endo Pharms Inc MEGACE ES megestrol acetate SUSPENSION;ORAL 021778-001 Jul 5, 2005 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Merck
Baxter
Mallinckrodt
AstraZeneca
Express Scripts

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.