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Generated: June 23, 2017
Which patents cover Janumet, and when can generic versions of Janumet launch?
Janumet is a drug marketed by Merck Sharp Dohme and is included in two NDAs. There are ten patents protecting this drug and three Paragraph IV challenges.| Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 51 |
| Clinical Trials: see list | 12 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | JANUMET at DailyMed |
| Ingredient-type | Biguanides |
| Drug Class | Dipeptidyl Peptidase 4 Inhibitor Biguanide |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Merck Sharp Dohme | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-002 | Mar 30, 2007 | 6,303,661 | ► Subscribe | ||||||||||||||||||||||
Merck Sharp Dohme | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-001 | Mar 30, 2007 | 6,303,661 | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| sitagliptin phosphate and metformin hydrochloride | Extended-release Tablets | 100 mg/1000 mg | Janumet XR | 10/22/2012 |
| sitagliptin phosphate and metformin hydrochloride | Extended-release Capsules | 50 mg/500 mg and 50 mg/1000 mg | Janumet XR | 3/16/2012 |
| sitagliptin phosphate and metformin hydrochloride | Tablets | 50 mg/500 mg and 50 mg/1000 mg | Janumet | 10/18/2010 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,157,429 | Method of regulating glucose metabolism, and reagents related thereto | ► Subscribe | |||||||||||||||||||||||||||
| 8,318,669 | Method of regulating glucose metabolism, and reagents related thereto | ► Subscribe | |||||||||||||||||||||||||||
| 8,513,190 | Method of regulating glucose metabolism, and reagents related thereto | ► Subscribe | |||||||||||||||||||||||||||
| 8,168,637 | Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes | ► Subscribe | |||||||||||||||||||||||||||
| 7,829,530 | Method of regulating glucose metabolism, and reagents related thereto | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2010248253 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2013047260 | ► Subscribe | |||||||||||||||||||||||||||
| Jordan | 2230 | ► Subscribe | |||||||||||||||||||||||||||
| Jordan | 2625 | ► Subscribe | |||||||||||||||||||||||||||
| Dominican Republic | P2004000941 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014 00062 | Denmark | ► Subscribe | PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001 | ||||||||||||||||||||||||||
| 0677 | Netherlands | ► Subscribe | PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121 | ||||||||||||||||||||||||||
| C0041 | France | ► Subscribe | PRODUCT NAME: SITAGLIPTINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET EN PARTICULIER LE PHOSPHATE DE SITAGLIPTINE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/07/383/001 20070323 | ||||||||||||||||||||||||||
| 2014 00065 | Denmark | ► Subscribe | PRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110824 | ||||||||||||||||||||||||||
| 2013 00001 | Denmark | ► 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 ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720 | ||||||||||||||||||||||||||
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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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