DrugPatentWatch Database Preview
JANUMET XR Drug Profile
When do Janumet Xr patents expire, and what generic alternatives are available?
Janumet Xr is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are six patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and forty-three patent family members in forty-five countries.
The generic ingredient in JANUMET XR is metformin hydrochloride; sitagliptin phosphate. There are forty-nine 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: | 143 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 12 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for JANUMET XR |
| Drug Sales Revenues: | Drug sales revenues for JANUMET XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JANUMET XR |
| DailyMed Link: | JANUMET XR at DailyMed |
See drug prices for JANUMET XR
Recent Clinical Trials for JANUMET XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Population Health Research Institute | Phase 3 |
| University Medical Centre Ljubljana | Phase 4 |
| Woman's | Phase 4 |
Recent Litigation for JANUMET XR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc. | 2019-05-02 |
| Merck Sharp & Dohme Corp. v. Anchen Pharmaceuticals, Inc. | 2019-02-13 |
| Merck Sharp & Dohme Corp. v. Sandoz Inc. | 2019-02-13 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Endo Pharmaceutical Inc. | 2014-04-17 |
| Purdue Pharma L.P. | 2014-01-24 |
Pharmacology for JANUMET XR
| 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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Merck Sharp Dohme | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-001 | Feb 2, 2012 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Merck Sharp Dohme | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-003 | Feb 2, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >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 | 202270-001 | Feb 2, 2012 | Start Trial | Start Trial |
| Merck Sharp Dohme | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-001 | Feb 2, 2012 | Start Trial | Start Trial |
| Merck Sharp Dohme | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-002 | Feb 2, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for JANUMET XR
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Tablets | 100 mg/1000 mg | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Extended-release Capsules | 50 mg/500 mg and 50 mg/1000 mg | ➤ Subscribe | Start Trial |
International Patents for JANUMET XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2226324 | Start Trial |
| South Korea | 101016569 | Start Trial |
| Hong Kong | 1095144 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for JANUMET XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1506211 | PA2014026 | Lithuania | Start Trial | PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
| 1532149 | 92128 | Luxembourg | Start Trial | 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 |
| 1412357 | PA2008013,C1412357 | Lithuania | Start Trial | PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
