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JANUMET Drug Profile
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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 seven patents protecting this drug and three Paragraph IV challenges.
This drug has one hundred and fifty patent family members in forty-five countries.
The generic ingredient in JANUMET 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
| International Patents: | 150 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 72 |
| Clinical Trials: | 12 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for JANUMET |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JANUMET |
| DailyMed Link: | JANUMET at DailyMed |
Generic Entry Opportunity Date for JANUMET
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for JANUMET
| Ingredient-type | Biguanides |
| Drug Class | Dipeptidyl Peptidase 4 Inhibitor Biguanide |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Synonyms for JANUMET
| (1R)-3-oxo-3-[3-(trifluoroethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorobenzyl)propylamine |
| (2r)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a] pyrazin-7(8h)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine |
| (2R)-4-OXO-4-[3-(TRIFLUOROMETHYL)-5,6-DIHYDRO[1,2,4]TRIAZOLO[4,3-A]PYRAZIN-7(8H)-YL]-1-(2,4,5-TRIFLUOROPHENYL)BUTAN-2-AMINE |
| (2R)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-alpha]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine |
| (3R)-3-AMINO-1-(3-(TRIFLUOROMETHYL)-5,6,7,8-TETRAHYDRO-1,2,4-TRIAZOLO(4,3-A)PYRAZIN-7-YL)-4-(2,4,5-TRIFLUOROPHENYL)BUTAN-1-ONE |
| (3R)-3-AMINO-1-[3-(TRIFLUOROMETHYL)-5,6-DIHYDRO[1,2,4]TRIAZOLO[4,3-A]PYRAZIN-7(8H)-YL]-4-(2,4,5-TRIFLUOROPHENYL)-1-BUTANONE |
| (3R)-3-amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one |
| (3R)-3-Amino-1-[3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one |
| (3R)-3-amino-1-[3-(trifluoromethyl)-5H,6H,7H,8H-[1,2,4]triazolo[3,4-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one hydrochloride |
| (3R)-3-AMINO-1-[3-(TRIFLUOROMETHYL)-5H,6H,7H,8H-[1,2,4]TRIAZOLO[4,3-A]PYRAZIN-7-YL]-4-(2,4,5-TRIFLUOROPHENYL)BUTAN-1-ONE |
| (3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[3,4-c]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one |
| (3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one |
| (R)-3-AMINO-1-(3-(TRIFLUOROMETHYL)-5,6-DIHYDRO-[1,2,4]TRIAZOLO[4,3-A]PYRAZIN-7(8H)-YL)-4-(2,4,5-TRIFLUOROPHENYL)BUTAN-1-ONE |
| (R)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine |
| 1,2,4-Triazolo(4,3-a)pyrazine, 7-((3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl)-5,6,7,8-tetrahydor-3-(trifluoromethyl)- |
| 1x70 |
| 486460-32-6 |
| 7-((3R)-3-Amino-1-oxo-4-(2,4,5-trifluorophenyl)buyl)-5,6,7,8-tetrahydro-3-trifluoromethyl)-1,4-triazolo(4,3-a) |
| 7-[(3r)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine |
| 790712-60-6 |
| A25516 |
| AB0006583 |
| AB01563393_01 |
| AB1004599 |
| ABP000233 |
| AC1N9ZYR |
| ACT02665 |
| AJ-26333 |
| AK172047 |
| AKOS015888724 |
| AMX10120 |
| AN-404 |
| AS-19118 |
| BDBM11162 |
| BRD-K19416115-001-01-2 |
| BSPBio_002262 |
| C16H15F6N5O |
| CHEBI:40237 |
| CHEMBL1422 |
| CS-2914 |
| D08516 |
| D0P0HH |
| D0U2JP |
| DB01261 |
| DTXSID70197572 |
| EC 690-730-1 |
| FT-0650740 |
| FT-0693933 |
| GTPL6286 |
| HMS2093F20 |
| HSDB 7516 |
| HY-13749 |
| Januvia |
| Januvia (merck & Co.) |
| Januvia (TN) |
| KB-60462 |
| LEZ 763 |
| LEZ763 |
| LS-187389 |
| MCULE-2101761133 |
| MFCD09838015 |
| MFFMDFFZMYYVKS-SECBINFHSA-N |
| MK-0431 |
| MLS006011959 |
| MolPort-003-666-756 |
| NCGC00178734-03 |
| PB17676 |
| PubChem18268 |
| Q-101366 |
| Q-1665 |
| Q-201711 |
| QFP0P1DV7Z |
| ristaben |
| RL03803 |
| SBI-0206871.P001 |
| SC-19743 |
| SCHEMBL17783 |
| Sitagliptan |
| Sitagliptin |
| Sitagliptin (13) |
| Sitagliptin (Metformin,MK-0431) |
| Sitagliptin (Prop.INN) |
| Sitagliptin [INN:BAN] |
| sitagliptin monophosphate monohydrate |
| Sitagliptin phosphate |
| sitagliptin phosphate anhydrous |
| Sitagliptin/ |
| Sitagliptin/atovastatin |
| sitagliptina |
| sitagliptine |
| sitagliptinum |
| SMR002546724 |
| Stotigliptin |
| Tesavel |
| Triazolopiperazine Analogue 1 |
| Tube110 |
| UNII-QFP0P1DV7Z |
| X4663 |
| Xelevia |
| Z1541638523 |
| ZINC1489478 |
US Patents and Regulatory Information for JANUMET
| 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 | 202270-001 | Feb 2, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ 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 | ➤ 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 | Y | Y | ➤ 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 | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Expired US Patents for JANUMET
| 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 | ➤ Sign Up | ➤ Sign Up |
| Merck Sharp Dohme | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-001 | Mar 30, 2007 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for JANUMET
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Tablets | 100 mg/1000 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Extended-release Capsules | 50 mg/500 mg and 50 mg/1000 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Tablets | 50 mg/500 mg and 50 mg/1000 mg | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for JANUMET
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 |
|---|---|---|
| 8,318,669 | 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 |
| 8,513,190 | Method of regulating glucose metabolism, and reagents related thereto | ➤ Sign Up |
| 6,803,357 | Method of regulating glucose metabolism, and reagents related thereto | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for JANUMET
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Georgia, Republic of | P20084489 | ➤ Sign Up |
| Spain | 2344846 | ➤ Sign Up |
| European Patent Office | 1962827 | ➤ Sign Up |
| Mexico | PA05013931 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for JANUMET
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2014000071 | Germany | ➤ Sign Up | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
| 2014026 | Lithuania | ➤ Sign Up | PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
| /2007 | Austria | ➤ Sign Up | PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001-018 (MITTEILUNG) 20070323 |
| 77; 5006-2008 | Slovakia | ➤ Sign Up | PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
