DrugPatentWatch Database Preview
JANUMET XR Drug Profile
When do Janumet Xr patents expire, and what generic alternatives are available?
This drug has one hundred and forty-one patent family members in forty-five countries.
The generic ingredient in JANUMET XR is metformin hydrochloride; sitagliptin phosphate. There are forty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.
Summary for JANUMET XR
| International Patents: | 141 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 12 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | JANUMET XR at DailyMed |
Pharmacology for JANUMET XR
| Ingredient-type | Biguanides |
| Drug Class | Dipeptidyl Peptidase 4 Inhibitor Biguanide |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
US Patents and Regulatory Information for JANUMET XR
| 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 | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-002 | Feb 2, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Merck Sharp Dohme | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-001 | Feb 2, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Merck Sharp Dohme | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-003 | Feb 2, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Merck Sharp Dohme | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-002 | Feb 2, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Expired US Patents for JANUMET XR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-002 | Feb 2, 2012 | ➤ Sign Up | ➤ Sign Up |
| Merck Sharp Dohme | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-003 | Feb 2, 2012 | ➤ Sign Up | ➤ Sign Up |
| Merck Sharp Dohme | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-001 | Feb 2, 2012 | ➤ Sign Up | ➤ Sign Up |
| Merck Sharp Dohme | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-002 | Feb 2, 2012 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for JANUMET XR
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Tablets | 100 mg/1000 mg | ➤ Subscribe | 2012-10-22 |
| ➤ Subscribe | Extended-release Capsules | 50 mg/500 mg and 50 mg/1000 mg | ➤ Subscribe | 2012-03-16 |
Non-Orange Book US Patents for JANUMET XR
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 |
|---|---|---|
| 6,803,357 | Method of regulating glucose metabolism, and reagents related thereto | ➤ Sign Up |
| 7,157,429 | Method of regulating glucose metabolism, and reagents related thereto | ➤ Sign Up |
| 7,829,530 | Method of regulating glucose metabolism, and reagents related thereto | ➤ Sign Up |
| 8,168,637 | Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for JANUMET XR
| Country | Document Number | Estimated Expiration |
|---|---|---|
| China | 1524082 | ➤ Sign Up |
| Mexico | PA04000018 | ➤ Sign Up |
| Japan | 2014144986 | ➤ Sign Up |
| Taiwan | 200524610 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for JANUMET XR
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2008013,C1412357 | Lithuania | ➤ Sign Up | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716 |
| 00524 | Netherlands | ➤ Sign Up | PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION: |
| 2013 00001 | Denmark | ➤ Sign Up | 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 |
| 2007006,C1412357 | Lithuania | ➤ Sign Up | PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-EU/1/07/383/018 20070321 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
