Nerlynx is a drug owned by Puma Biotechnology Inc. It is protected by 11 US drug patents filed from 2017 to 2021. Out of these, 10 drug patents are active and 1 has expired. Nerlynx's patents have been open to challenges since 17 July, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 18, 2031. Details of Nerlynx'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. | |||
| US7399865 | Protein tyrosine kinase enzyme inhibitors |
Dec, 2030
(6 years from now) | Active |
| US6288082 | Substituted 3-cyanoquinolines |
Sep, 2019
(5 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8669273 | Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine |
Jul, 2031
(6 years from now) | Active |
| US8518446 | Coated tablet formulations and uses thereof |
Nov, 2030
(6 years from now) | Active |
| US8790708 | Coated tablet formulations and uses thereof |
Nov, 2030
(5 years from now) | Active |
| US9211291 | Treatment regimen utilizing neratinib for breast cancer |
Mar, 2030
(5 years from now) | Active |
| US9265784 | Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine |
Aug, 2029
(4 years from now) | Active |
| US9630946 | Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof |
Oct, 2028
(3 years from now) | Active |
| US10035788 | Maleate salts of (E)-N-{4[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof |
Oct, 2028
(3 years from now) | Active |
| US9139558 | Maleate salts of (E)-N-{4-[3-Chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof |
Oct, 2028
(3 years from now) | Active |
| US7982043 | Protein tyrosine kinase enzyme inhibitors |
Oct, 2025
(10 months from now) | Active |
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 Nerlynx's patents.
Latest Legal Activities on Nerlynx's Patents
Given below is the list of recent legal activities going on the following patents of Nerlynx.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Aug, 2023 | US9265784 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 31 May, 2023 | US9211291 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Mar, 2023 | US9139558 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Jan, 2023 | US7982043 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Jan, 2022 | US10035788 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Jan, 2022 | US8790708 |
| Patent Term Extension Certificate Critical | 19 Nov, 2021 | US7399865 |
| Email Notification Critical | 04 Oct, 2021 | US7399865 |
| Change in Power of Attorney (May Include Associate POA) Critical | 04 Oct, 2021 | US7399865 |
| Correspondence Address Change Critical | 03 Oct, 2021 | US7399865 |
FDA has granted several exclusivities to Nerlynx. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nerlynx, 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 Nerlynx.
Exclusivity Information
Nerlynx holds 3 exclusivities. All of its exclusivities have expired in 2024. Details of Nerlynx's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 17, 2022 |
| New Indication(I-823) | Feb 25, 2023 |
| New Dosing Schedule(D-182) | Jun 28, 2024 |
Several oppositions have been filed on Nerlynx'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 Nerlynx's generic, the next section provides detailed information on ongoing and past EP oppositions related to Nerlynx patents.
Nerlynx's Oppositions Filed in EPO
Nerlynx has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 03, 2016, by Hexal Ag. This opposition was filed on patent number EP10722215A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10779339A | May, 2020 | Cooke, Richard | Patent maintained as amended |
| EP09791127A | Oct, 2017 | Hexal AG | Granted and Under Opposition |
| EP10722215A | Aug, 2016 | Hexal AG | Revoked |
US patents provide insights into the exclusivity only within the United States, but Nerlynx 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 Nerlynx's family patents as well as insights into ongoing legal events on those patents.
Nerlynx's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nerlynx's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 18, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nerlynx Generics:
There are no approved generic versions for Nerlynx as of now.
How can I launch a generic of Nerlynx before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nerlynx's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nerlynx'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 Nerlynx -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg | 19 Jul, 2021 | 1 | 29 Dec, 2025 |
About Nerlynx
Nerlynx is a drug owned by Puma Biotechnology Inc. It is used for treating early-stage and advanced HER2-positive breast cancer. Nerlynx uses Neratinib Maleate as an active ingredient. Nerlynx was launched by Puma Biotech in 2017.
Approval Date:
Nerlynx was approved by FDA for market use on 17 July, 2017.
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 Nerlynx is 17 July, 2017, its NCE-1 date is estimated to be 17 July, 2021.
Active Ingredient:
Nerlynx uses Neratinib Maleate as the active ingredient. Check out other Drugs and Companies using Neratinib Maleate ingredient
Treatment:
Nerlynx is used for treating early-stage and advanced HER2-positive breast cancer.
Dosage:
Nerlynx is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 40MG BASE | TABLET | Prescription | ORAL |