DrugPatentWatch Database Preview
JANUMET XR Drug Profile
» See Plans and Pricing
Which patents cover Janumet Xr, and when can generic versions of Janumet Xr launch?
Janumet Xr is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and twenty-seven patent family members in forty-six countries.
The generic ingredient in JANUMET XR is metformin hydrochloride; sitagliptin phosphate. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.
US ANDA Litigation and Generic Entry Outlook for Janumet Xr
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 24, 2027. This may change due to patent challenges or generic licensing.
Annual sales in 2018 were $1.1bn, indicating a strong incentive for generic entry.
There have been eighteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (metformin hydrochloride; sitagliptin phosphate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for JANUMET XR
| International Patents: | 127 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 14 |
| 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
Generic Entry Opportunity Date for JANUMET XR
Generic Entry Date for JANUMET XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
*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.
Recent Clinical Trials for JANUMET XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shahid Beheshti University of Medical Sciences | Phase 1/Phase 2 |
| University of Dundee | N/A |
| Population Health Research Institute | Phase 3 |
Pharmacology for JANUMET XR
| Drug Class | Dipeptidyl Peptidase 4 Inhibitor Biguanide |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Paragraph IV (Patent) Challenges for JANUMET XR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| JANUMET XR | TABLET, EXTENDED RELEASE;ORAL | metformin hydrochloride; sitagliptin phosphate | 202270 | 2012-10-22 |
| JANUMET XR | TABLET, EXTENDED RELEASE;ORAL | metformin hydrochloride; sitagliptin phosphate | 202270 | 2012-03-16 |
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 | 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 | Start Trial | |||
| 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 | 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 | 202270-003 | 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 |
| Merck Sharp Dohme | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-003 | Feb 2, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for JANUMET XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 03004498 | Start Trial |
| Netherlands | 300308 | Start Trial |
| Spain | 2259713 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for JANUMET XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1084705 | CA 2014 00066 | Denmark | Start Trial | PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130919 |
| 1412357 | DO 77; 5006-2008 | Slovakia | Start Trial | PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 |
| 1084705 | PA2014042 | Lithuania | Start Trial | PRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
