JANUMET XR Drug Patent Profile
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Which patents cover Janumet Xr, and when can generic versions of Janumet Xr launch?
Janumet Xr is a drug marketed by Msd Sub Merck and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.
This drug has fifty-two patent family members in forty countries.
The generic ingredient in JANUMET XR is metformin hydrochloride; sitagliptin phosphate. There are forty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.
DrugPatentWatch® 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 2021 were $734mm indicating the motivation for generic entry (peak sales were $1.1bn in 2018).
There have been twenty-six 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
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Questions you can ask:
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Summary for JANUMET XR
| International Patents: | 52 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 5 |
| Clinical Trials: | 20 |
| Patent Applications: | 48 |
| 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 |
| What excipients (inactive ingredients) are in JANUMET XR? | JANUMET XR excipients list |
| DailyMed Link: | JANUMET XR at DailyMed |
See drug prices for JANUMET XR
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for JANUMET XR
*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 |
|---|---|
| Galenicum Health | Phase 1 |
| Eva Pharma | Phase 1 |
| Genuine Research Center, Egypt | Phase 1 |
Pharmacology for JANUMET XR
| Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Paragraph IV (Patent) Challenges for JANUMET XR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| JANUMET XR | Extended-release Tablets | metformin hydrochloride; sitagliptin phosphate | 100 mg/1000 mg | 202270 | 1 | 2012-10-22 |
| JANUMET XR | Extended-release Tablets | metformin hydrochloride; sitagliptin phosphate | 50 mg/500 mg and 50 mg/1000 mg | 202270 | 1 | 2012-03-16 |
US Patents and Regulatory Information for JANUMET XR
JANUMET XR is protected by one US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of JANUMET XR is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting JANUMET XR
Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting JANUMET XR
ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-002 | Feb 2, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Msd Sub Merck | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-001 | Feb 2, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msd Sub Merck | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-003 | Feb 2, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Msd Sub Merck | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-002 | Feb 2, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msd Sub Merck | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-002 | Feb 2, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msd Sub Merck | JANUMET XR | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270-001 | Feb 2, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msd Sub Merck | 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 | |||
| >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
International Patents for JANUMET XR
See the table below for patents covering JANUMET XR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 4083818 | ⤷ Sign Up | |
| China | 1832949 | Phosphoric acid salt of a dipeptidyl peptidase-iv inhibitor | ⤷ Sign Up |
| European Patent Office | 0998271 | FORMES DE DOSAGE DE MEDICAMENTS ADMINISTRES PAR VOIE ORALE A RETENTION GASTRIQUE POUR LIBERATION LENTE DE MEDICAMENTS HAUTEMENT SOLUBLES (GASTRIC-RETENTIVE ORAL DRUG DOSAGE FORMS FOR CONTROLLED RELEASE OF HIGHLY SOLUBLE DRUGS) | ⤷ Sign Up |
| Israel | 172563 | PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR | ⤷ Sign Up |
| Canada | 2755452 | PROCEDE DE REGULATION DU METABOLISME DU GLUCOSE ET REACTIFS AFFERENTS (METHOD OF REGULATING GLUCOSE METABOLISM, AND REAGENTS RELATED THERETO) | ⤷ Sign Up |
| Eurasian Patent Organization | 200600095 | СОЛЬ ФОСФОРНОЙ КИСЛОТЫ ИНГИБИТОРА ДИПЕПТИДИЛПЕПТИДАЗЫ-IV | ⤷ Sign Up |
| Iceland | 7062 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JANUMET XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1084705 | CR 2014 00065 | Denmark | ⤷ Sign Up | PRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110830 |
| 1730131 | C01730131/02 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015 |
| 1084705 | SPC/GB14/082 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323 |
| 1412357 | 91360 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN; AUTHORISATION NUMBER AND DATE: EU/1/07/383/001-018 20070323 |
| 1412357 | PA2008013,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 |
| 1084705 | C300707 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001 |
| 0896538 | 91334 | Luxembourg | ⤷ Sign Up | CERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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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