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Generated: August 22, 2017
What is the patent landscape for Actoplus Met, and what generic Actoplus Met alternatives are available?
Actoplus Met is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are thirteen patents protecting this drug and two Paragraph IV challenges.| Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 4 |
| Clinical Trials: see list | 1,292 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | ACTOPLUS MET at DailyMed |
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-002 | Aug 29, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-002 | Aug 29, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-001 | Aug 29, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-001 | Aug 29, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Takeda Pharms Usa | ACTOPLUS MET | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 021842-002 | Aug 29, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| pioglitazone hydrochloride and metformin hydrochloride | Extended-release Tablets | 15 mg/1000 mg and 30 mg/1000 mg | Actoplus Met XR | 9/23/2011 |
| pioglitazone hydrochloride and metformin hydrochloride | Tablets | 15 mg/500 mg and 15 mg/850 mg | Actoplus Met | 3/6/2008 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Portugal | 1561472 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2008208141 | ► Subscribe | |||||||||||||||||||||||||||
| Costa Rica | 7797 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | PA05003668 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2003271103 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2008013 | Lithuania | ► Subscribe | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716 | ||||||||||||||||||||||||||
| 2014 00037 | Denmark | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 2014 00037 | Denmark | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 2012022 | Lithuania | ► Subscribe | PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720 | ||||||||||||||||||||||||||
| 128 | Luxembourg | ► Subscribe | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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