Nesina is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 12 US drug patents filed from 2013 to 2014. Out of these, 4 drug patents are active and 8 have expired. Nesina's patents have been open to challenges since 25 January, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 16, 2029. Details of Nesina'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. | |||
| US7807689 | Dipeptidyl peptidase inhibitors |
Jun, 2028
(3 years from now) | Active |
| US8288539 | Dipeptidyl peptidase inhibitors |
Mar, 2025
(4 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). | |||
| US8697125 | Tablet preparation without causing a tableting trouble |
Jun, 2029
(4 years from now) | Active |
| US8173663 | Dipeptidyl peptidase inhibitors |
Dec, 2025
(1 year, 1 month from now) | Active |
| US6890898 | Method of regulating glucose metabolism, and reagents related thereto |
Feb, 2019
(5 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
|
| US6303661 | Use of dipeptidyl peptidase IV effectors for lowering the blood glucose level in mammals |
Apr, 2017
(7 years ago) |
Expired
|
| US6303640 | Pharmaceutical composition |
Aug, 2016
(8 years ago) |
Expired
|
| US6329404 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
| US6211205 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
| US6150383 | Pharmaceutical composition |
Jun, 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 Nesina's patents.
Latest Legal Activities on Nesina's Patents
Given below is the list of recent legal activities going on the following patents of Nesina.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Mar, 2024 | US8288539 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Oct, 2023 | US8173663 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Mar, 2022 | US7807689 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Sep, 2021 | US8697125 |
| Expire Patent Critical | 04 Jan, 2021 | US7459428 |
| Maintenance Fee Reminder Mailed Critical | 20 Jul, 2020 | US7459428 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Apr, 2020 | US8288539 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Nov, 2019 | US8173663 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Apr, 2018 | US7807689 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Jan, 2018 | US7078381 |
FDA has granted several exclusivities to Nesina. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nesina, 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 Nesina.
Exclusivity Information
Nesina holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Nesina's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 25, 2018 |
| M(M-177) | Apr 05, 2019 |
| M(M-300) | Jul 27, 2026 |
US patents provide insights into the exclusivity only within the United States, but Nesina 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 Nesina's family patents as well as insights into ongoing legal events on those patents.
Nesina's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nesina's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 16, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nesina Generics:
There are no approved generic versions for Nesina as of now.
How can I launch a generic of Nesina before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nesina's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nesina'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 Nesina -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 6.25 mg, 12.5 mg and 25 mg | 25 Jan, 2017 | 5 | 16 Jun, 2029 |
Alternative Brands for Nesina
Nesina which is used for treating diabetes and associated disorders such as lipid and glucose metabolism issues., has several other brand drugs in the same treatment category and using the same active ingredient (Alogliptin Benzoate). 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.
About Nesina
Nesina is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating diabetes and associated disorders such as lipid and glucose metabolism issues. Nesina uses Alogliptin Benzoate as an active ingredient. Nesina was launched by Takeda Pharms Usa in 2013.
Can you believe Nesina received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Nesina was approved by FDA for market use on 25 January, 2013.
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 Nesina is 25 January, 2013, its NCE-1 date is estimated to be 25 January, 2017.
Active Ingredient:
Nesina uses Alogliptin Benzoate as the active ingredient. Check out other Drugs and Companies using Alogliptin Benzoate ingredient
Treatment:
Nesina is used for treating diabetes and associated disorders such as lipid and glucose metabolism issues.
Dosage:
Nesina is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 12.5MG BASE | TABLET | Prescription | ORAL |
| EQ 25MG BASE | TABLET | Prescription | ORAL |
| EQ 6.25MG BASE | TABLET | Prescription | ORAL |