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
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
Generic Entry Date for JUVISYNC*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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.
Anatomical Therapeutic Chemical (ATC) Classes for JUVISYNC
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-002 | Oct 7, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-001 | Oct 7, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-005 | Sep 18, 2012 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 JUVISYNC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-001 | Oct 7, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-006 | Sep 18, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-003 | Oct 7, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-004 | Sep 18, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 Africa | 200309294 | Beta-amino tetrahydroimidazo (1,2-A) pyrazines and tetrahydrotrioazolo (4, 3-A) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes. | ⤷ Try a Trial |
Norway | 20031574 | ⤷ Try a Trial | |
European Patent Office | 2433623 | ⤷ Try a Trial | |
Poland | 367279 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JUVISYNC
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1412357 | 42/2007 | Austria | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001-018 (MITTEILUNG) 20070323 |
1412357 | 343 | Finland | ⤷ Try a Trial | |
0720599 | SPC/GB05/010 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411 |
1412357 | PA2007006,C1412357 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-EU/1/07/383/018 20070321 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |