Januvia is a drug owned by Merck Sharp And Dohme Corp. It is protected by 10 US drug patents filed from 2013 to 2021. Out of these, 2 drug patents are active and 8 have expired. Januvia's patents have been open to challenges since 05 June, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be May 24, 2027. Details of Januvia'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, 11 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
(1 year, 10 months ago) |
Expired
|
|
US6699871 (Pediatric) | Beta-amino heterocyclic 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
|
| 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 Januvia's patents.
Latest Legal Activities on Januvia's Patents
Given below is the list of recent legal activities going on the following patents of Januvia.
| 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 Januvia and ongoing litigations to help you estimate the early arrival of Januvia generic.
Januvia's Litigations
Januvia 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 Januvia'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. |
FDA has granted some exclusivities to Januvia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Januvia, 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 Januvia.
Exclusivity Information
Januvia holds 4 exclusivities. All of its exclusivities have expired in 2024. Details of Januvia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 16, 2011 |
| M(M-244) | Aug 12, 2022 |
| M(M-187) | Dec 04, 2023 |
| Pediatric Exclusivity(PED) | Jun 04, 2024 |
Several oppositions have been filed on Januvia'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 Januvia's generic, the next section provides detailed information on ongoing and past EP oppositions related to Januvia patents.
Januvia's Oppositions Filed in EPO
Januvia 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 Januvia 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 Januvia's family patents as well as insights into ongoing legal events on those patents.
Januvia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Januvia'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)
Januvia Generics:
There are no approved generic versions for Januvia as of now.
How can I launch a generic of Januvia before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Januvia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Januvia'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 Januvia -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg, 50 mg and 100 mg | 18 Oct, 2010 | 6 | 24 Nov, 2026 | ||
| 100 mg/10 mg and 100 mg/40 mg | 19 Jun, 2012 | 1 | 11 Apr, 2026 | Extinguished | |
| 100 mg/20 mg | 25 Jun, 2012 | 1 | 11 Apr, 2026 | Extinguished | |
| 50 mg/10 mg 50 mg/20 mg 50 mg/40 mg | 06 Nov, 2012 | 1 | 11 Apr, 2026 | Extinguished |
Alternative Brands for Januvia
Januvia which is used for managing glycemic control in adults with type 2 diabetes mellitus, often in combination with other medications like metformin or insulin., has several other brand drugs in the same treatment category and using the same active ingredient (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 | Treatment Area | ||||||
|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim |
| |||||||
| Msd Sub Merck |
| |||||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Sitagliptin Phosphate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Merck Sharp Dohme |
| ||
| Msd Sub Merck |
|
About Januvia
Januvia is a drug owned by Merck Sharp And Dohme Corp. It is used for managing glycemic control in adults with type 2 diabetes mellitus, often in combination with other medications like metformin or insulin. Januvia uses Sitagliptin Phosphate as an active ingredient. Januvia was launched by Merck Sharp Dohme in 2006.
Approval Date:
Januvia was approved by FDA for market use on 16 October, 2006.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Januvia is 16 October, 2006, its NCE-1 date is estimated to be 05 June, 2023.
Active Ingredient:
Januvia uses Sitagliptin Phosphate as the active ingredient. Check out other Drugs and Companies using Sitagliptin Phosphate ingredient
Treatment:
Januvia is used for managing glycemic control in adults with type 2 diabetes mellitus, often in combination with other medications like metformin or insulin.
Dosage:
Januvia is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE | TABLET | Prescription | ORAL |
| EQ 25MG BASE | TABLET | Prescription | ORAL |
| EQ 100MG BASE | TABLET | Prescription | ORAL |