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Generated: October 21, 2017
What are the generic drug sources for sitagliptin phosphate and what is the scope of sitagliptin phosphate patent protection?
Sitagliptin phosphate is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 26 |
| Suppliers / Packagers: see list | 4 |
| Bulk Api Vendors: see list | 132 |
| Clinical Trials: see list | 1,140 |
| Patent Applications: see list | 5,401 |
| Therapeutic Class: | Blood Glucose Regulators |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | sitagliptin phosphate at DailyMed |
| Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
| Applicant | Application No. | Strength | Dosage Form |
| u | ► Subscribe | 25MG | TABLET;ORAL |
| u | ► Subscribe | 100MG | TABLET;ORAL |
| u | ► Subscribe | 50MG | TABLET;ORAL |
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-001 | Oct 16, 2006 | ► Subscribe | ► Subscribe | ||||||||
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-003 | Oct 16, 2006 | ► Subscribe | ► Subscribe | ||||||||
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-002 | Oct 16, 2006 | ► Subscribe | ► Subscribe | ||||||||
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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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,513,190 | Method of regulating glucose metabolism, and reagents related thereto | ► Subscribe | |||||||||||||
| 7,829,530 | 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 | |||||||||||||
| 8,318,669 | Method of regulating glucose metabolism, and reagents related thereto | ► Subscribe | |||||||||||||
| 9,044,424 | Methods of regulating glucose metabolism, and reagents related thereto | ► Subscribe | |||||||||||||
| 7,157,429 | Method of regulating glucose metabolism, and reagents related thereto | ► Subscribe | |||||||||||||
| 8,440,668 | Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of type 2 diabetes | ► Subscribe | |||||||||||||
| 6,803,357 | 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Poland | 196278 | ► Subscribe | |||||||||||||
| Denmark | 1654263 | ► Subscribe | |||||||||||||
| Germany | 122008000046 | ► Subscribe | |||||||||||||
| South Korea | 20060026061 | ► Subscribe | |||||||||||||
| Malaysia | 127961 | ► Subscribe | |||||||||||||
| Eurasian Patent Organization | 200501805 | ► Subscribe | |||||||||||||
| Eurasian Patent Organization | 006845 | ► Subscribe | |||||||||||||
| New Zealand | 544026 | ► Subscribe | |||||||||||||
| Australia | 721477 | ► Subscribe | |||||||||||||
| South Africa | 200309294 | ► 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2007000056 | Germany | ► Subscribe | PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE FUER SITAGLIPTINPHOSPHAT-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321 | ||||||||||||
| 2014044 | Lithuania | ► Subscribe | PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824 | ||||||||||||
| C/GB07/046 | United Kingdom | ► Subscribe | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/046 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT SITAGLIPTIN PHOSPHATE MONOHYDRATE, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6212 DATED 11/06/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22/03/2022. | ||||||||||||
| C/GB14/086 | United Kingdom | ► Subscribe | PRODUCT NAME: VILDAGLIPTIN; REGISTERED: UK EU/1/07/414/001-017 20070928 | ||||||||||||
| 0070004 00113 | Estonia | ► Subscribe | PRODUCT NAME: SITAGLIPTIIN;REG NO/DATE: K(2007)1362 23.03.2007 | ||||||||||||
| 3 | Finland | ► Subscribe | |||||||||||||
| 2014 00063 | Denmark | ► Subscribe | PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070321 | ||||||||||||
| 00709 | Netherlands | ► Subscribe | PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919 | ||||||||||||
| 2007 00061 | Denmark | ► Subscribe | |||||||||||||
| 2008013 | Lithuania | ► Subscribe | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716 | ||||||||||||
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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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