JUVISYNC Drug Patent Profile
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When do Juvisync patents expire, and when can generic versions of Juvisync launch?
Juvisync is a drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this drug.
This drug has fifty-two patent family members in forty countries.
The generic ingredient in JUVISYNC is simvastatin; sitagliptin phosphate. There are forty drug master file entries for this compound. Additional details are available on the simvastatin; sitagliptin phosphate profile page.
DrugPatentWatch® Generic Entry Outlook for Juvisync
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 11, 2026. This may change due to patent challenges or generic licensing.
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.
Indicators of Generic Entry
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for JUVISYNC?
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Summary for JUVISYNC
| International Patents: | 52 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JUVISYNC |
| DailyMed Link: | JUVISYNC at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for JUVISYNC
*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.
US Patents and Regulatory Information for JUVISYNC
JUVISYNC is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of JUVISYNC 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 JUVISYNC
Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Patent Number: ⤷ Sign Up
Patent 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-004 | Sep 18, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-002 | Oct 7, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-001 | Oct 7, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-005 | Sep 18, 2012 | DISCN | 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 JUVISYNC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-005 | Sep 18, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-002 | Oct 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-003 | Oct 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-004 | Sep 18, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for JUVISYNC
See the table below for patents covering JUVISYNC around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 100606871 | ⤷ Sign Up | |
| Netherlands | 300280 | ⤷ Sign Up | |
| Australia | 3023397 | ⤷ Sign Up | |
| Ukraine | 74912 | BETA-AMINOTETRAHYDROIMIDAZO-(1,2-A)-PYRAZINES AND TETRATRIAZOLO-(4,3-A)-PYRAZINES AS INHIBITORS OF DIPEPTYLPEPTIDASE FOR THE TREATMENT OR PREVENTION OF DIABETES | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JUVISYNC
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1084705 | C01084705/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007 |
| 1412357 | SPC/GB07/046 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN PHOSPHATE MONOHYDRATE; REGISTERED: UK EU/1/07/383/001 20070323; UK EU/1/07/383/002 20070323; UK EU/1/07/383/003 20070323; UK EU/1/07/383/004 20070323; UK EU/1/07/383/005 20070323; UK EU/1/07/383/006 20070323; UK EU/1/07/383/007 20070323; UK EU/1/07/383/008 20070323; UK EU/1/07/383/009 20070323; UK EU/1/07/383/010 20070323; UK EU/1/07/383/011 20070323; UK EU/1/07/383/012 20070323; UK EU/1/07/383/013 20070323; UK EU/1/07/383/014 20070323; UK EU/1/07/383/015 20070323; UK EU/1/07/383/016 20070323; UK EU/1/07/383/017 20070323; UK EU/1/07/383/018 20070323 |
| 0896538 | 08C0008 | France | ⤷ Sign Up | PRODUCT NAME: VILDAGLIPTINE OU UN DE SES SELS PHARMACETIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/414/001 DU 20070926; REGISTRATION NO/DATE AT EEC: EU/1/07/414/001-017 DU 20070926 |
| 1412357 | 91360 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN; AUTHORISATION NUMBER AND DATE: EU/1/07/383/001-018 20070323 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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