You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 202343


✉ Email this page to a colleague

« Back to Dashboard


NDA 202343 describes JUVISYNC, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the JUVISYNC profile page.

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.
Summary for 202343
Tradename:JUVISYNC
Applicant:Merck Sharp Dohme
Ingredient:simvastatin; sitagliptin phosphate
Patents:1
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202343
Generic Entry Date for 202343*:
Constraining patent/regulatory exclusivity:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 7, 2011TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Oct 11, 2026Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 7, 2011TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Oct 11, 2026Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 7, 2011TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Oct 11, 2026Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 202343

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-002 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 202343-005 Sep 18, 2012 ⤷  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

Complete Access Available with Subscription

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.