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, 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. Thirteen suppliers are listed for this compound.
Summary for megestrol acetate
| International Patents: | 36 |
| US Patents: | 5 |
| Tradenames: | 3 |
| Applicants: | 12 |
| NDAs: | 18 |
| Drug Master File Entries: | 17 |
| Finished Product Suppliers / Packagers: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 90 |
| Clinical Trials: | 73 |
| Patent Applications: | 7,364 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends 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
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| Teva | MEGESTROL ACETATE | megestrol acetate | TABLET;ORAL | 074745-001 | Feb 27, 1998 | 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 | |||
| 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 | ||||
| Endo Pharms Inc | MEGACE ES | megestrol acetate | SUSPENSION;ORAL | 021778-001 | Jul 5, 2005 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms | MEGESTROL ACETATE | megestrol acetate | SUSPENSION;ORAL | 075681-001 | May 5, 2003 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol Myers Squibb | MEGACE | megestrol acetate | SUSPENSION;ORAL | 020264-001 | Sep 10, 1993 | DISCN | Yes | 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 |
|---|---|---|---|---|---|---|---|
| Endo Pharms Inc | MEGACE ES | megestrol acetate | SUSPENSION;ORAL | 021778-001 | Jul 5, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for megestrol acetate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Cyprus | 1113036 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2004050059 | ⤷ Try a Trial | |
| Japan | 4838514 | ⤷ Try a Trial | |
| Spain | 2380318 | ⤷ Try a Trial | |
| Japan | 4865990 | ⤷ Try a Trial | |
| Israel | 188322 | ⤷ Try a Trial | |
| Japan | 2006510726 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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