Tibsovo is a drug owned by Servier Pharmaceuticals Llc. It is protected by 10 US drug patents filed from 2018 to 2023 out of which none have expired yet. Tibsovo's patents have been open to challenges since 20 July, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 07, 2039. Details of Tibsovo'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. | |||
| US9474779 | Therapeutically active compositions and their methods of use |
Aug, 2033
(8 years from now) | Active |
| US9850277 | Therapeutically active compositions and their methods of use |
Jan, 2033
(8 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10980788 | Therapy for treating malignancies |
Jun, 2039
(14 years from now) | Active |
| US10653710 | Combination therapy for treating malignancies |
Oct, 2036
(11 years from now) | Active |
| US10799490 | Pharmaceutical compositions of therapeutically active compounds |
Mar, 2035
(10 years from now) | Active |
| US9968595 | Pharmaceutical compositions of therapeutically active compounds |
Mar, 2035
(10 years from now) | Active |
| US10449184 | Pharmaceutical compositions of therapeutically active compounds |
Mar, 2035
(10 years from now) | Active |
| US11667673 | Therapeutically active compounds and their methods of use |
Jan, 2033
(8 years from now) | Active |
| US10717764 | Therapeutically active compounds and their methods of use |
Jan, 2033
(8 years from now) | Active |
| US10610125 | Methods and compositions for cell-proliferation-related disorders |
Jun, 2030
(5 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 Tibsovo's patents.
Latest Legal Activities on Tibsovo's Patents
Given below is the list of recent legal activities going on the following patents of Tibsovo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Apr, 2024 | US9474779 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Jan, 2024 | US10717764 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Nov, 2023 | US10653710 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Jun, 2023 | US11667673 |
| Mail Patent eGrant Notification | 06 Jun, 2023 | US11667673 |
| Email Notification Critical | 06 Jun, 2023 | US11667673 |
| Recordation of Patent eGrant | 06 Jun, 2023 | US11667673 |
| Patent eGrant Notification | 06 Jun, 2023 | US11667673 |
| Electronic Review Critical | 06 Jun, 2023 | US11667673 |
| Recordation of Patent Grant Mailed Critical | 06 Jun, 2023 | US11667673 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Tibsovo and ongoing litigations to help you estimate the early arrival of Tibsovo generic.
Tibsovo's Litigations
Tibsovo been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 15, 2022, against patent number US10610125. The petitioner Rigel Pharmaceuticals, Inc., challenged the validity of this patent, with Servier Pharmaceuticals LLC et al. as the respondent. Click below to track the latest information on how companies are challenging Tibsovo's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10610125 | August, 2022 |
Terminated-Settled
(06 Jan, 2023) | Servier Pharmaceuticals LLC et al. | Rigel Pharmaceuticals, Inc. |
FDA has granted some exclusivities to Tibsovo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tibsovo, 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 Tibsovo.
Exclusivity Information
Tibsovo holds 9 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Tibsovo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-816) | May 02, 2022 |
| New Chemical Entity Exclusivity(NCE) | Jul 20, 2023 |
| New Indication(I-875) | Aug 25, 2024 |
| New Indication(I-893) | May 25, 2025 |
| Orphan Drug Exclusivity(ODE-203) | Jul 20, 2025 |
| Orphan Drug Exclusivity(ODE-242) | May 02, 2026 |
| New Indication(I-924) | Oct 24, 2026 |
| Orphan Drug Exclusivity(ODE-368) | Aug 25, 2028 |
| Orphan Drug Exclusivity(ODE-447) | Oct 24, 2030 |
US patents provide insights into the exclusivity only within the United States, but Tibsovo 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 Tibsovo's family patents as well as insights into ongoing legal events on those patents.
Tibsovo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tibsovo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 07, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tibsovo Generics:
There are no approved generic versions for Tibsovo as of now.
How can I launch a generic of Tibsovo before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tibsovo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tibsovo'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 Tibsovo -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 250 mg | 20 Jul, 2022 | 1 | 07 Jun, 2039 |
About Tibsovo
Tibsovo is a drug owned by Servier Pharmaceuticals Llc. It is used for treating AML, cholangiocarcinoma, and myelodysplastic syndromes with IDH1 mutations. Tibsovo uses Ivosidenib as an active ingredient. Tibsovo was launched by Servier in 2018.
Can you believe Tibsovo received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Tibsovo was approved by FDA for market use on 20 July, 2018.
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 Tibsovo is 20 July, 2018, its NCE-1 date is estimated to be 20 July, 2022.
Active Ingredient:
Tibsovo uses Ivosidenib as the active ingredient. Check out other Drugs and Companies using Ivosidenib ingredient
Treatment:
Tibsovo is used for treating AML, cholangiocarcinoma, and myelodysplastic syndromes with IDH1 mutations.
Dosage:
Tibsovo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG | TABLET | Prescription | ORAL |