Talicia is a drug owned by Redhill Biopharma Ltd. It is protected by 7 US drug patents filed from 2019 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 27, 2042. Details of Talicia'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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11878011 | Method for eradicating Helicobacter pylori infection in patients regardless of body mass index |
May, 2042
(17 years from now) | Active |
| US9498445 | Pharmaceutical compositions for the treatment of Helicobacter pylori |
Feb, 2034
(9 years from now) | Active |
| US9050263 | Pharmaceutical compositions for the treatment of Helicobacter pylori |
Feb, 2034
(9 years from now) | Active |
| US9603806 | Pharmaceutical compositions for the treatment of Helicobacter pylori |
Feb, 2034
(9 years from now) | Active |
| US11135172 | Rifabutin-based compositions and methods for treating Helicobacter pylori infection |
Feb, 2034
(9 years from now) | Active |
| US11931463 | All-in-one fixed-dose combination for treating Helicobacter pylori infection |
Feb, 2034
(9 years from now) | Active |
| US10238606 | Pharmaceutical compositions for the treatment of Helicobacter pylori |
Feb, 2034
(9 years 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 Talicia's patents.
Latest Legal Activities on Talicia's Patents
Given below is the list of recent legal activities going on the following patents of Talicia.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 08 May, 2024 | US9498445 |
| Recordation of Patent eGrant | 19 Mar, 2024 | US11931463 |
| Recordation of Patent Grant Mailed Critical | 19 Mar, 2024 | US11931463 |
| Email Notification Critical | 19 Mar, 2024 | US11931463 |
| Mail Patent eGrant Notification | 19 Mar, 2024 | US11931463 |
| Patent eGrant Notification | 19 Mar, 2024 | US11931463 |
| Patent Issue Date Used in PTA Calculation Critical | 19 Mar, 2024 | US11931463 |
| Email Notification Critical | 29 Feb, 2024 | US11931463 |
| Issue Notification Mailed Critical | 28 Feb, 2024 | US11931463 |
| Application Is Considered Ready for Issue Critical | 09 Feb, 2024 | US11931463 |
FDA has granted several exclusivities to Talicia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Talicia, 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 Talicia.
Exclusivity Information
Talicia holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Talicia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 01, 2022 |
| Generating Antibiotic Incentives Now(GAIN) | Nov 01, 2027 |
US patents provide insights into the exclusivity only within the United States, but Talicia 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 Talicia's family patents as well as insights into ongoing legal events on those patents.
Talicia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Talicia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 27, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Talicia Generics:
There are no approved generic versions for Talicia as of now.
About Talicia
Talicia is a drug owned by Redhill Biopharma Ltd. It is used for treating Helicobacter pylori infection in adults. Talicia uses Amoxicillin; Omeprazole Magnesium; Rifabutin as an active ingredient. Talicia was launched by Redhill in 2019.
Approval Date:
Talicia was approved by FDA for market use on 01 November, 2019.
Active Ingredient:
Talicia uses Amoxicillin; Omeprazole Magnesium; Rifabutin as the active ingredient. Check out other Drugs and Companies using Amoxicillin; Omeprazole Magnesium; Rifabutin ingredient
Treatment:
Talicia is used for treating Helicobacter pylori infection in adults.
Dosage:
Talicia is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG;EQ 10MG BASE;12.5MG | CAPSULE, DELAYED RELEASE | Prescription | ORAL |