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 Bionpharma, 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. Thirteen 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.
Summary for MEGESTROL ACETATE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 15 |
| Finished Product Suppliers / Packagers: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 90 |
| Clinical Trials: | 73 |
| Patent Applications: | 4,515 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MEGESTROL ACETATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MEGESTROL ACETATE |
| What excipients (inactive ingredients) are in MEGESTROL ACETATE? | MEGESTROL ACETATE excipients list |
| DailyMed Link: | MEGESTROL ACETATE at DailyMed |
Recent Clinical Trials for MEGESTROL ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 1/Phase 2 |
| Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Phase 2 |
| Sunnybrook Health Sciences Centre | Phase 1 |
Pharmacology for MEGESTROL ACETATE
| Drug Class | Progestin |
Medical Subject Heading (MeSH) Categories for MEGESTROL ACETATE
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bionpharma | MEGESTROL ACETATE | megestrol acetate | SUSPENSION;ORAL | 204688-001 | Dec 1, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Twi Pharms | MEGESTROL ACETATE | megestrol acetate | SUSPENSION;ORAL | 203139-001 | Aug 27, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novitium Pharma | MEGESTROL ACETATE | megestrol acetate | SUSPENSION;ORAL | 077404-001 | Feb 16, 2006 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hikma | MEGESTROL ACETATE | megestrol acetate | TABLET;ORAL | 074458-002 | Sep 29, 1995 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| 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 | ||||
| Usl Pharma | MEGESTROL ACETATE | megestrol acetate | TABLET;ORAL | 070646-001 | Oct 2, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Strides Pharma | MEGESTROL ACETATE | megestrol acetate | TABLET;ORAL | 072423-001 | Aug 8, 1988 | AB | RX | No | Yes | ⤷ 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 |
