Tiglutik Kit is a drug owned by Italfarmaco Sa. It is protected by 1 US drug patent filed in 2018 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 12, 2029. Details of Tiglutik Kit'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). | |||
| US8765150 | Riluzole aqueous suspensions |
Mar, 2029
(3 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 Tiglutik Kit's patents.
Latest Legal Activities on Tiglutik Kit's Patents
Given below is the list of recent legal activities going on the following patents of Tiglutik Kit.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Jan, 2022 | US8765150 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Jan, 2018 | US8765150 |
| Recordation of Patent Grant Mailed Critical | 01 Jul, 2014 | US8765150 |
| Patent Issue Date Used in PTA Calculation Critical | 01 Jul, 2014 | US8765150 |
| Email Notification Critical | 12 Jun, 2014 | US8765150 |
| Issue Notification Mailed Critical | 11 Jun, 2014 | US8765150 |
| Dispatch to FDC | 29 May, 2014 | US8765150 |
| Mail Miscellaneous Communication to Applicant | 27 May, 2014 | US8765150 |
| Printer Rush- No mailing | 27 May, 2014 | US8765150 |
| Email Notification Critical | 27 May, 2014 | US8765150 |
US patents provide insights into the exclusivity only within the United States, but Tiglutik Kit 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 Tiglutik Kit's family patents as well as insights into ongoing legal events on those patents.
Tiglutik Kit's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tiglutik Kit's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 12, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tiglutik Kit Generic API suppliers:
Riluzole is the generic name for the brand Tiglutik Kit. 8 different companies have already filed for the generic of Tiglutik Kit, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tiglutik Kit's generic
How can I launch a generic of Tiglutik Kit before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tiglutik Kit's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tiglutik Kit'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 Tiglutik Kit -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg/10 mL | 12 Mar, 2021 | 1 | 12 Mar, 2029 |
Alternative Brands for Tiglutik Kit
Tiglutik Kit which is used for treating amyotrophic lateral sclerosis in patients., has several other brand drugs using the same active ingredient (Riluzole). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Riluzole, Tiglutik Kit's active ingredient. Check the complete list of approved generic manufacturers for Tiglutik Kit
About Tiglutik Kit
Tiglutik Kit is a drug owned by Italfarmaco Sa. It is used for treating amyotrophic lateral sclerosis in patients. Tiglutik Kit uses Riluzole as an active ingredient. Tiglutik Kit was launched by Italfarmaco Sa in 2018.
Approval Date:
Tiglutik Kit was approved by FDA for market use on 05 September, 2018.
Active Ingredient:
Tiglutik Kit uses Riluzole as the active ingredient. Check out other Drugs and Companies using Riluzole ingredient
Treatment:
Tiglutik Kit is used for treating amyotrophic lateral sclerosis in patients.
Dosage:
Tiglutik Kit is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG/10ML | SUSPENSION | Prescription | ORAL |