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Generated: August 20, 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.| Tradenames: | 1 |
| Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 26 |
| Suppliers / Packagers: see list | 5 |
| Bulk Api Vendors: see list | 132 |
| Clinical Trials: see list | 1,131 |
| Patent Applications: see list | 4,874 |
| 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 |
| ► Subscribe | ► Subscribe | 25MG | TABLET;ORAL |
| ► Subscribe | ► Subscribe | 100MG | TABLET;ORAL |
| ► Subscribe | ► Subscribe | 50MG | TABLET;ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-001 | Oct 16, 2006 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-002 | Oct 16, 2006 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-002 | Oct 16, 2006 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-002 | Oct 16, 2006 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-003 | Oct 16, 2006 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,044,424 | Methods of regulating glucose metabolism, and reagents related thereto | ► Subscribe | |||||||||||||||||||||||||||
| 8,168,637 | Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes | ► Subscribe | |||||||||||||||||||||||||||
| 6,803,357 | 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 | |||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Russian Federation | 2305553 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1625847 | ► Subscribe | |||||||||||||||||||||||||||
| Croatia | P20031098 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2226324 | ► Subscribe | |||||||||||||||||||||||||||
| Luxembourg | 91382 | ► 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 00064 | Denmark | ► Subscribe | PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070928 | ||||||||||||||||||||||||||
| 2014043 | Lithuania | ► Subscribe | PRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001 | ||||||||||||||||||||||||||
| 2007 00030 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 2008013,C1412357 | Lithuania | ► Subscribe | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716 | ||||||||||||||||||||||||||
| 6 4-2007 | Slovakia | ► Subscribe | PRODUCT NAME: SITAGLIPTIN; NAT. REGISTRATION NO/DATE: EU/1/07/383/001 - EU/1/07/383/018 20070321; FIRST REGISTRATION: EU EU/1/07/383/001 - EU/1/07/383/018 | ||||||||||||||||||||||||||
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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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