Juvisync is a drug owned by Merck Sharp And Dohme Corp. It is protected by 11 US drug patents filed from 2013 to 2021. Out of these, 2 drug patents are active and 9 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 11, 2026. Details of Juvisync's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7326708 | Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor |
Apr, 2026
(1 year, 3 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7326708 (Pediatric) | Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor |
Oct, 2026
(1 year, 9 months from now) | Active |
|
US6699871 (Pediatric) | Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes |
Jan, 2023
(1 year, 10 months ago) |
Expired
|
|
US7125873 (Pediatric) | Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes |
Jan, 2023
(1 year, 10 months ago) |
Expired
|
| US7125873 | Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes |
Jul, 2022
(2 years ago) |
Expired
|
| US6699871 | Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes |
Jul, 2022
(2 years ago) |
Expired
|
| US8168637 | Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes |
Jun, 2022
(2 years ago) |
Expired
|
| US7078381 | Method of regulating glucose metabolism, and reagents related thereto |
Feb, 2019
(5 years ago) |
Expired
|
| US7459428 | Method of regulating glucose metabolism, and reagents related thereto |
Feb, 2019
(5 years ago) |
Expired
|
| US6890898 | Method of regulating glucose metabolism, and reagents related thereto |
Feb, 2019
(5 years ago) |
Expired
|
| US6303661 | Use of dipeptidyl peptidase IV effectors for lowering the blood glucose level in mammals |
Apr, 2017
(7 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Juvisync's patents.
Latest Legal Activities on Juvisync's Patents
Given below is the list of recent legal activities going on the following patents of Juvisync.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 03 Jun, 2024 | US8168637 |
| Court Processing Terminated | 17 Apr, 2024 | US7326708 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 18 Dec, 2023 | US8168637 |
| Review Certificate Mailed | 19 Sep, 2023 | US7326708 (Litigated) |
| Review Certificate | 06 Sep, 2023 | US7326708 (Litigated) |
| Decision in Civil Action - Affirmed | 29 Sep, 2022 | US7326708 (Litigated) |
| Case Docketed to Examiner in GAU Critical | 03 Jan, 2022 | US7326708 (Litigated) |
| Termination or Final Written Decision | 10 May, 2021 | US7326708 (Litigated) |
| Termination or Final Written Decision | 07 May, 2021 | US7326708 (Litigated) |
| Mail Certificate of Correction Memo | 22 Jan, 2021 | US7326708 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Juvisync and ongoing litigations to help you estimate the early arrival of Juvisync generic.
Juvisync's Litigations
Juvisync been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 10, 2020, against patent number US7326708. The petitioner Teva Pharmaceuticals USA, Inc., challenged the validity of this patent, with Merck Sharp & Dohme Corp. as the respondent. Click below to track the latest information on how companies are challenging Juvisync's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7326708 | June, 2020 |
Final Written Decision
(10 May, 2021) | Merck Sharp & Dohme Corp. et al. | Dr. Reddy's Laboratories, Inc. et al. |
| US7326708 | June, 2020 |
Final Written Decision
(10 May, 2021) | Merck Sharp & Dohme Corp. et al. | Sun Pharmaceutical Industries Ltd. et al. |
| US7326708 | October, 2019 |
Final Written Decision
(07 May, 2021) | Merck Sharp & Dohme Corp. et al. | Mylan Pharmaceuticals, Inc. |
| US7326708 | June, 2020 |
Terminated-Settled
(08 Dec, 2020) | Merck Sharp & Dohme Corp. | Teva Pharmaceuticals USA, Inc. |
Several oppositions have been filed on Juvisync's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Juvisync's generic, the next section provides detailed information on ongoing and past EP oppositions related to Juvisync patents.
Juvisync's Oppositions Filed in EPO
Juvisync has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 11, 2008, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP04755691A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP05077584A | Mar, 2011 | APOTEX INC. | Revoked |
| EP04755691A | Jun, 2008 | Teva Pharmaceutical Industries Ltd. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Juvisync is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Juvisync's family patents as well as insights into ongoing legal events on those patents.
Juvisync's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Juvisync's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 11, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Juvisync Generics:
There are no approved generic versions for Juvisync as of now.
About Juvisync
Juvisync is a drug owned by Merck Sharp And Dohme Corp. It is used for managing type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate. Juvisync uses Simvastatin; Sitagliptin Phosphate as an active ingredient. Juvisync was launched by Merck Sharp Dohme in 2012.
Approval Date:
Juvisync was approved by FDA for market use on 18 September, 2012.
Active Ingredient:
Juvisync uses Simvastatin; Sitagliptin Phosphate as the active ingredient. Check out other Drugs and Companies using Simvastatin; Sitagliptin Phosphate ingredient
Treatment:
Juvisync is used for managing type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate.
Dosage:
Juvisync is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |