Lapatinib Ditosylate Patent Expiration
Lapatinib Ditosylate is Used for treating advanced or metastatic breast cancer with HER2 overexpression that has not responded to prior treatments. It was first introduced by Novartis Pharmaceuticals Corp
Lapatinib Ditosylate Patents
Given below is the list of patents protecting Lapatinib Ditosylate, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Tykerb | US8821927 | Pharmaceutical composition | Sep 18, 2029 | Novartis |
| Tykerb | US7157466 | Quinazoline ditosylate salt compounds |
Nov 19, 2021
(Expired) | Novartis |
| Tykerb | US6713485 | Heterocyclic compounds |
Sep 29, 2020
(Expired) | Novartis |
| Tykerb | US6727256 | Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors |
Jan 08, 2019
(Expired) | Novartis |
| Tykerb | US8513262 | Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors |
Jan 08, 2019
(Expired) | Novartis |
| Tykerb | US6391874 | Fused heterocyclic compounds as protein tyrosine kinase inhibitors |
Jul 11, 2017
(Expired) | Novartis |
| Tykerb | US6828320 | Heterocyclic compounds |
Jul 11, 2017
(Expired) | Novartis |
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 Lapatinib Ditosylate's patents.
Latest Legal Activities on Lapatinib Ditosylate's Patents
Given below is the list recent legal activities going on the following patents of Lapatinib Ditosylate.
| 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 |
Lapatinib Ditosylate's Family Patents
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Lapatinib Ditosylate Generic API Manufacturers
Several generic applications have been filed for Lapatinib Ditosylate. The first generic version for Lapatinib Ditosylate was by Natco Pharma Ltd and was approved on Sep 29, 2020. And the latest generic version is by Teva Pharmaceuticals Usa Inc and was approved on Aug 16, 2024.
Given below is the list of companies who have filed for Lapatinib Ditosylate generic, along with the locations of their manufacturing plants worldwide.
1. NATCO PHARMA LTD
Natco Pharma Ltd has filed for 1 generic for Lapatinib Ditosylate. Given below are the details of the strengths of this generic introduced by Natco Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 250MG BASE | tablet | Prescription | ORAL | AB | Sep 29, 2020 |
Manufacturing Plant Locations New
Natco Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Natco Pharma Ltd as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| India |
| |||||
2. TEVA PHARMS USA INC
Teva Pharmaceuticals Usa Inc has filed for 1 generic for Lapatinib Ditosylate. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 250MG BASE | tablet | Prescription | ORAL | AB | Aug 16, 2024 |