Tavalisse is a drug owned by Rigel Pharmaceuticals Inc. It is protected by 15 US drug patents filed from 2018 to 2022 out of which none have expired yet. Tavalisse's patents have been open to challenges since 17 April, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 27, 2032. Details of Tavalisse'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. | |||
| US7449458 | Prodrugs of 2,4-pyrimidinediamine compounds and their uses |
Sep, 2031
(6 years from now) | Active |
| US8163902 | Prodrugs of 2,4-pyrimidinediamine compounds and their uses |
Jun, 2026
(1 year, 5 months from now) | Active |
| US7989448 | Prodrugs of 2,4-pyrimidinediamine compounds and their uses |
Jun, 2026
(1 year, 5 months from now) | Active |
| US7538108 | Prodrugs of 2,4-pyrimidinediamine compounds and their uses |
Mar, 2026
(1 year, 3 months from now) | Active |
| US8211889 | Prodrugs of 2,4-pyrimidinediamine compounds and their uses |
Jan, 2026
(1 year, 27 days from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8771648 | (Trimethoxyphenylamino) pyrimidinyl formulations |
Jul, 2032
(7 years from now) | Active |
| US8951504 | (trimethoxyphenylamino) pyrimidinyl formulations |
Jul, 2032
(7 years from now) | Active |
| US8263122 | Wet granulation using a water sequestering agent |
Nov, 2030
(5 years from now) | Active |
| US8652492 | Wet granulation using a water sequestering agent |
Nov, 2028
(3 years from now) | Active |
| US9283238 | Prodrugs of 2,4-pyrimidinediamine compounds and their uses |
Jun, 2026
(1 year, 5 months from now) | Active |
| US8912170 | Prodrugs of 2,4-pyrimidinediamine compounds and their uses |
Jun, 2026
(1 year, 5 months from now) | Active |
| US8445485 | Prodrugs of 2,4-pyrimidinediamine compounds and their uses |
Jun, 2026
(1 year, 5 months from now) | Active |
| US9737554 | Prodrugs of 2,4-pyrimidinediamine compounds and their uses |
Jan, 2026
(1 year, 27 days from now) | Active |
| US9266912 | Prodrugs of 2,4-pyrimidinediamine compounds and their uses |
Jan, 2026
(1 year, 27 days from now) | Active |
| USRE48898 | Prodrugs of 2,4-pyrimidinediamine compounds and their uses |
Jan, 2026
(1 year, 27 days 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 Tavalisse's patents.
Latest Legal Activities on Tavalisse's Patents
Given below is the list of recent legal activities going on the following patents of Tavalisse.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Petition Decision - Accept Late Payment of Maintenance Fees - Granted Critical | 07 May, 2024 | US9283238 |
| Mail-Petition Decision - Accept Late Payment of Maintenance Fees - Granted Critical | 07 May, 2024 | US9283238 |
| Petition to Accept Late Payment of Maintenance Fee Payment Filed Critical | 07 May, 2024 | US9283238 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 07 May, 2024 | US9283238 |
| Surcharge, Petition to Accept Pymt After Exp, Unintentional. | 07 May, 2024 | US9283238 |
| Expire Patent Critical | 22 Apr, 2024 | US9283238 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 11 Mar, 2024 | US8263122 |
| Change in Power of Attorney (May Include Associate POA) Critical | 28 Feb, 2024 | US8771648 |
| Email Notification Critical | 28 Feb, 2024 | US8652492 |
| Email Notification Critical | 28 Feb, 2024 | US8771648 |
FDA has granted several exclusivities to Tavalisse. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tavalisse, 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 Tavalisse.
Exclusivity Information
Tavalisse holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Tavalisse's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 17, 2023 |
| Orphan Drug Exclusivity(ODE-174) | Apr 17, 2025 |
Several oppositions have been filed on Tavalisse's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tavalisse's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tavalisse patents.
Tavalisse's Oppositions Filed in EPO
Tavalisse has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 07, 2019, by Teva Pharmaceutical Industries, Ltd.. This opposition was filed on patent number EP12759802A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP12759802A | Aug, 2019 | TEVA PHARMACEUTICAL INDUSTRIES, LTD. | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Tavalisse 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 Tavalisse's family patents as well as insights into ongoing legal events on those patents.
Tavalisse's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tavalisse's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 27, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tavalisse Generics:
There are no approved generic versions for Tavalisse as of now.
How can I launch a generic of Tavalisse before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tavalisse's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tavalisse'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 Tavalisse -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg and 150 mg | 18 Apr, 2022 | 1 | 27 Jul, 2032 |
About Tavalisse
Tavalisse is a drug owned by Rigel Pharmaceuticals Inc. It is used for treating thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who had an insufficient response to previous treatment. Tavalisse uses Fostamatinib Disodium as an active ingredient. Tavalisse was launched by Rigel Pharms in 2018.
Approval Date:
Tavalisse was approved by FDA for market use on 17 April, 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 Tavalisse is 17 April, 2018, its NCE-1 date is estimated to be 17 April, 2022.
Active Ingredient:
Tavalisse uses Fostamatinib Disodium as the active ingredient. Check out other Drugs and Companies using Fostamatinib Disodium ingredient
Treatment:
Tavalisse is used for treating thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who had an insufficient response to previous treatment.
Dosage:
Tavalisse is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 100MG BASE | TABLET | Prescription | ORAL |
| EQ 150MG BASE | TABLET | Prescription | ORAL |