Janumet Xr is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is protected by 12 US drug patents filed from 2013 to 2021. Out of these, 2 drug patents are active and 10 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 24, 2027. Details of Janumet Xr'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 |
Nov, 2026
(1 year, 6 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 |
May, 2027
(2 years from now) | Active |
|
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
(2 years ago) |
Expired
|
|
US6699871 (Pediatric) | Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes |
Jan, 2023
(2 years 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
|
| US7078381 | Method of regulating glucose metabolism, and reagents related thereto |
Feb, 2019
(6 years ago) |
Expired
|
| US6890898 | Method of regulating glucose metabolism, and reagents related thereto |
Feb, 2019
(6 years ago) |
Expired
|
| US7459428 | Method of regulating glucose metabolism, and reagents related thereto |
Feb, 2019
(6 years ago) |
Expired
|
| US6303661 | Use of dipeptidyl peptidase IV effectors for lowering the blood glucose level in mammals |
Apr, 2017
(8 years ago) |
Expired
|
| US6635280 | Extending the duration of drug release within the stomach during the fed mode |
Sep, 2016
(8 years ago) |
Expired
|
| US6340475 | Extending the duration of drug release within the stomach during the fed mode |
Sep, 2016
(8 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 Janumet Xr's patents.
Latest Legal Activities on Janumet Xr's Patents
Given below is the list of recent legal activities going on the following patents of Janumet Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Court Processing Terminated | 17 Apr, 2024 | US7326708 (Litigated) |
| 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) |
| Post Issue Communication - Certificate of Correction | 19 Jan, 2021 | US7326708 (Litigated) |
| Certificate of Correction Memo | 18 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 Janumet Xr and ongoing litigations to help you estimate the early arrival of Janumet Xr generic.
Janumet Xr's Litigations
Janumet Xr been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 17, 2014, against patent number US6635280. The petitioner Endo Pharmaceutical Inc. et al., challenged the validity of this patent, with Depomed, Inc. as the respondent. Click below to track the latest information on how companies are challenging Janumet Xr'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. |
| US6340475 | April, 2014 |
Final Written Decision
(21 Sep, 2015) | Depomed, Inc. | Endo Pharmaceutical Inc. et al. |
| US6635280 | April, 2014 |
Final Written Decision
(21 Sep, 2015) | Depomed, Inc. | Endo Pharmaceutical Inc. et al. |
| US6340475 | January, 2014 |
FWD Entered
(08 Jul, 2015) | Depomed, Inc. | Purdue Pharma L.P. |
| US6635280 | January, 2014 |
FWD Entered
(08 Jul, 2015) | DepoMed, Inc. | Purdue Pharma L.P. |
| US6340475 | April, 2014 |
Institution Denied
(29 Sep, 2014) | Depomed, Inc. | Endo Pharmaceutical Inc. et al. |
| US6635280 | April, 2014 |
Institution Denied
(29 Sep, 2014) | Depomed, Inc. | Endo Pharmaceutical Inc. et al. |
FDA has granted some exclusivities to Janumet Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Janumet Xr, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Janumet Xr.
Exclusivity Information
Janumet Xr holds 3 exclusivities. All of its exclusivities have expired in 2024. Details of Janumet Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-244) | Aug 12, 2022 |
| Pediatric Exclusivity(PED) | Jun 04, 2024 |
| M(M-187) | Dec 04, 2023 |
Several oppositions have been filed on Janumet Xr'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 Janumet Xr's generic, the next section provides detailed information on ongoing and past EP oppositions related to Janumet Xr patents.
Janumet Xr's Oppositions Filed in EPO
Janumet Xr 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 Janumet Xr 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 Janumet Xr's family patents as well as insights into ongoing legal events on those patents.
Janumet Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Janumet Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 24, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Janumet Xr Generics:
There are no approved generic versions for Janumet Xr as of now.
How can I launch a generic of Janumet Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Janumet Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Janumet Xr's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Janumet Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg/500 mg and 50 mg/1000 mg | 16 Mar, 2012 | 1 | 24 Nov, 2026 | ||
| 100 mg/1000 mg | 22 Oct, 2012 | 1 | 24 Nov, 2026 |
Alternative Brands for Janumet Xr
Janumet Xr which is used for managing type 2 diabetes mellitus with the combination of sitagliptin and metformin HCl extended release, either alone or with insulin., has several other brand drugs using the same active ingredient (Metformin Hydrochloride; Sitagliptin Phosphate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Msd Sub Merck |
|
About Janumet Xr
Janumet Xr is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is used for managing type 2 diabetes mellitus with the combination of sitagliptin and metformin HCl extended release, either alone or with insulin. Janumet Xr uses Metformin Hydrochloride; Sitagliptin Phosphate as an active ingredient. Janumet Xr was launched by Msd Sub Merck in 2012.
Approval Date:
Janumet Xr was approved by FDA for market use on 02 February, 2012.
Active Ingredient:
Janumet Xr uses Metformin Hydrochloride; Sitagliptin Phosphate as the active ingredient. Check out other Drugs and Companies using Metformin Hydrochloride; Sitagliptin Phosphate ingredient
Treatment:
Janumet Xr is used for managing type 2 diabetes mellitus with the combination of sitagliptin and metformin HCl extended release, either alone or with insulin.
Dosage:
Janumet Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM;EQ 50MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 500MG;EQ 50MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 1GM;EQ 100MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |