Tykerb is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 7 US drug patents filed from 2013 to 2014. Out of these, 1 drug patents are active and 6 have expired. Tykerb's patents have been open to challenges since 14 March, 2011. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 18, 2029. Details of Tykerb'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. | |||
| US8821927 | Pharmaceutical composition |
Sep, 2029
(4 years from now) | Active |
| US8513262 | Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors |
Jan, 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). | |||
| US7157466 | Quinazoline ditosylate salt compounds |
Nov, 2021
(3 years ago) |
Expired
|
| US6713485 | Heterocyclic compounds |
Sep, 2020
(4 years ago) |
Expired
|
| US6727256 | Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors |
Jan, 2019
(5 years ago) |
Expired
|
| US6391874 | Fused heterocyclic compounds as protein tyrosine kinase inhibitors |
Jul, 2017
(7 years ago) |
Expired
|
| US6828320 | Heterocyclic compounds |
Jul, 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 Tykerb's patents.
Latest Legal Activities on Tykerb's Patents
Given below is the list of recent legal activities going on the following patents of Tykerb.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Feb, 2022 | US8821927 |
| Expire Patent Critical | 27 Sep, 2021 | US8513262 |
| Maintenance Fee Reminder Mailed Critical | 12 Apr, 2021 | US8513262 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Jun, 2018 | US7157466 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Feb, 2018 | US8821927 |
| Post Issue Communication - Certificate of Correction | 28 Jul, 2015 | US8821927 |
| Change in Power of Attorney (May Include Associate POA) Critical | 05 Jun, 2015 | US8821927 |
| Email Notification Critical | 05 Jun, 2015 | US8821927 |
| Email Notification Critical | 05 Jun, 2015 | US8513262 |
| Change in Power of Attorney (May Include Associate POA) Critical | 04 Jun, 2015 | US8513262 |
FDA has granted several exclusivities to Tykerb. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tykerb, 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 Tykerb.
Exclusivity Information
Tykerb holds 3 exclusivities. All of its exclusivities have expired in 2021. Details of Tykerb's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 13, 2012 |
| New Indication(I-620) | Jan 29, 2013 |
| M(M-235) | Dec 06, 2021 |
US patents provide insights into the exclusivity only within the United States, but Tykerb 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 Tykerb's family patents as well as insights into ongoing legal events on those patents.
Tykerb's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tykerb's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 18, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tykerb Generic API suppliers:
Lapatinib Ditosylate is the generic name for the brand Tykerb. 2 different companies have already filed for the generic of Tykerb, with Natco Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tykerb's generic
How can I launch a generic of Tykerb before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tykerb's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tykerb'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 Tykerb -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 250 mg | 14 Mar, 2011 | 1 | 29 Sep, 2020 | 19 Nov, 2021 | Deferred |
About Tykerb
Tykerb is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating advanced or metastatic breast cancer with HER2 overexpression that has not responded to prior treatments. Tykerb uses Lapatinib Ditosylate as an active ingredient. Tykerb was launched by Novartis in 2007.
Approval Date:
Tykerb was approved by FDA for market use on 13 March, 2007.
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 Tykerb is 13 March, 2007, its NCE-1 date is estimated to be 14 March, 2011.
Active Ingredient:
Tykerb uses Lapatinib Ditosylate as the active ingredient. Check out other Drugs and Companies using Lapatinib Ditosylate ingredient
Treatment:
Tykerb is used for treating advanced or metastatic breast cancer with HER2 overexpression that has not responded to prior treatments.
Dosage:
Tykerb is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 250MG BASE | TABLET | Prescription | ORAL |