AVANDAMET Drug Patent Profile
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When do Avandamet patents expire, and when can generic versions of Avandamet launch?
Avandamet is a drug marketed by Sb Pharmco and is included in one NDA.
The generic ingredient in AVANDAMET is metformin hydrochloride; rosiglitazone maleate. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.
Summary for AVANDAMET
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 127 |
| Clinical Trials: | 14 |
| Patent Applications: | 2,652 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AVANDAMET |
| What excipients (inactive ingredients) are in AVANDAMET? | AVANDAMET excipients list |
| DailyMed Link: | AVANDAMET at DailyMed |
Recent Clinical Trials for AVANDAMET
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlaxoSmithKline | Phase 1 |
| Susan G. Komen Breast Cancer Foundation | Phase 1 |
| M.D. Anderson Cancer Center | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for AVANDAMET
Paragraph IV (Patent) Challenges for AVANDAMET
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AVANDAMET | Tablets | metformin hydrochloride; rosiglitazone maleate | 1 mg/ 500 mg, 2 mg/ 500mg 4 mg/ 500 mg 2 mg/ 1000 mg 4 mg/ 1000 mg | 021410 | 1 | 2004-10-22 |
US Patents and Regulatory Information for AVANDAMET
Expired US Patents for AVANDAMET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-003 | Oct 10, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-003 | Oct 10, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-001 | Oct 10, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-005 | Aug 25, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sb Pharmco | AVANDAMET | metformin hydrochloride; rosiglitazone maleate | TABLET;ORAL | 021410-004 | Aug 25, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AVANDAMET
See the table below for patents covering AVANDAMET around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Uruguay | 26119 | NUEVO PRODUCTO FARMACÉUTICO | ⤷ Try a Trial |
| Czech Republic | 287473 | Salt of maleic acid and a 5-[4-[2-(N-methyl-N-(2-pyridyl)amino)ethoxy]benzyl]thiazolidine-2,4-dione, process of its preparation, pharmaceutical preparation in which this compound is comprised as well as use thereof | ⤷ Try a Trial |
| Australia | 4307200 | ⤷ Try a Trial | |
| Austria | 182147 | ⤷ Try a Trial | |
| Japan | 2007191494 | MEDICINE | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AVANDAMET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2498758 | PA2020003 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: METFORMINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
| 1174135 | 437 | Finland | ⤷ Try a Trial | |
| 2498758 | 2090013-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113 |
| 1532149 | PA2012022 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720 |
| 1506211 | CR 2014 00037 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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.
ISSN: 2162-2639
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