Tyzeka is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 7 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 11, 2023. Details of Tyzeka's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6395716 | β-L-2′-deoxy-nucleosides for the treatment of hepatitis B |
Aug, 2019
(4 years ago) |
Expired
|
| US7795238 | β-L-2′-deoxy-nucleosides for the treatment of hepatitis B |
Aug, 2019
(4 years ago) |
Expired
|
| US6566344 | β-L-2′-deoxy-nucleosides for the treatment of hepatitis B |
Aug, 2019
(4 years ago) |
Expired
|
| US6444652 | β-L-2'-deoxy-nucleosides for the treatment of hepatitis B |
Aug, 2019
(4 years ago) |
Expired
|
| US6569837 | β-L-2′-deoxy pyrimidine nucleosides for the treatment of hepatitis B |
Oct, 2020
(3 years ago) |
Expired
|
| US7858594 | Crystalline and amorphous forms of beta-L-2′-deoxythymidine |
Sep, 2023
(10 months ago) |
Expired
|
| US7589079 | Crystalline and amorphous forms of beta-L-2′-deoxythymidine |
Sep, 2023
(10 months 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 Tyzeka's patents.
Latest Legal Activities on Tyzeka's Patents
Given below is the list of recent legal activities going on the following patents of Tyzeka.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 17 Oct, 2022 | US7795238 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Jun, 2022 | US7858594 |
| Maintenance Fee Reminder Mailed | 02 May, 2022 | US7795238 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Mar, 2021 | US7589079 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Jun, 2018 | US7858594 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Mar, 2018 | US7795238 |
| Post Issue Communication - Certificate of Correction | 04 Aug, 2011 | US7589079 |
| Post Issue Communication - Certificate of Correction | 18 Jul, 2011 | US7589079 |
| Patent Issue Date Used in PTA Calculation | 28 Dec, 2010 | US7858594 |
| Recordation of Patent Grant Mailed | 28 Dec, 2010 | US7858594 |
FDA has granted several exclusivities to Tyzeka. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tyzeka, 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 Tyzeka.
Exclusivity Information
Tyzeka holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Tyzeka's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 25, 2011 |
| M(M-124) | Jan 28, 2016 |
US patents provide insights into the exclusivity only within the United States, but Tyzeka 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 Tyzeka's family patents as well as insights into ongoing legal events on those patents.
Tyzeka's family patents
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Generic Launch
Generic Release Date:
Tyzeka's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 11, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tyzeka Generics:
There are no approved generic versions for Tyzeka as of now.
About Tyzeka
Tyzeka is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating chronic hepatitis B in adult patients with evidence of viral replication and either elevated serum aminotransferases or active histological disease. Tyzeka uses Telbivudine as an active ingredient. Tyzeka was launched by Novartis in 2006.
Market Authorisation Date:
Tyzeka was approved by FDA for market use on 25 October, 2006.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Tyzeka is 25 October, 2006, its NCE-1 date is estimated to be 25 October, 2010
Active Ingredient:
Tyzeka uses Telbivudine as the active ingredient. Check out other Drugs and Companies using Telbivudine ingredient
Treatment:
Tyzeka is used for treating chronic hepatitis B in adult patients with evidence of viral replication and either elevated serum aminotransferases or active histological disease.
Dosage:
Tyzeka is available in the following dosage forms - solution form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 600MG | TABLET | Discontinued | ORAL |
| 100MG/5ML | SOLUTION | Discontinued | ORAL |