Sprycel is a drug owned by Bristol Myers Squibb Co. It is protected by 10 US drug patents filed from 2013 to 2018. Out of these, 4 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 28, 2026. Details of Sprycel's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US7491725 | Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors |
Mar, 2026
(1 year, 7 months from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7125875 | Cyclic protein tyrosine kinase inhibitors |
Apr, 2020
(4 years ago) |
Expired
|
| US7153856 | Cyclic protein tyrosine kinase inhibitors |
Apr, 2020
(4 years ago) |
Expired
|
| US6596746 | Cyclic protein tyrosine kinase inhibitors |
Jun, 2020
(4 years ago) |
Expired
|
|
US7125875 (Pediatric) | Cyclic protein tyrosine kinase inhibitors |
Oct, 2020
(3 years ago) |
Expired
|
|
US7153856 (Pediatric) | Cyclic protein tyrosine kinase inhibitors |
Oct, 2020
(3 years ago) |
Expired
|
|
US6596746 (Pediatric) | Cyclic protein tyrosine kinase inhibitors |
Dec, 2020
(3 years ago) |
Expired
|
| US8680103 | Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors |
Feb, 2025
(6 months from now) | Active |
|
US8680103 (Pediatric) | Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors |
Aug, 2025
(1 year, 7 days from now) | Active |
|
US7491725 (Pediatric) | Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors |
Sep, 2026
(2 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 Sprycel's patents.
Latest Legal Activities on Sprycel's Patents
Given below is the list of recent legal activities going on the following patents of Sprycel.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Aug, 2020 | US7491725 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Jun, 2018 | US7153856 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Apr, 2018 | US7125875 |
| Post Issue Communication - Certificate of Correction | 22 Nov, 2011 | US7491725 |
| Email Notification | 03 Aug, 2010 | US7491725 |
| Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Allowance | 28 Jul, 2010 | US7491725 |
| Record a Petition Decision of Granted for Patent Term Adjustment after Allowance | 27 Jul, 2010 | US7491725 |
| Adjustment of PTA Calculation by PTO | 27 Jul, 2010 | US7491725 |
| Court Processing Terminated | 23 Jun, 2010 | US7491725 |
| Decision in Civil Action - Dismissed by Court | 23 Jun, 2010 | US7491725 |
FDA has granted several exclusivities to Sprycel. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sprycel, 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 Sprycel.
Exclusivity Information
Sprycel holds 8 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Sprycel's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-120) | May 21, 2012 |
| Orphan Drug Exclusivity(ODE) | Jun 28, 2013 |
| M(M-94) | Oct 28, 2013 |
| New Patient Population(NPP) | Nov 09, 2020 |
| New Indication(I-791) | Dec 21, 2021 |
| Orphan Drug Exclusivity(ODE-164) | Nov 09, 2024 |
| Orphan Drug Exclusivity(ODE-225) | Dec 21, 2025 |
| Pediatric Exclusivity(PED) | Jun 21, 2026 |
Several oppositions have been filed on Sprycel'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 Sprycel's generic, the next section provides detailed information on ongoing and past EP oppositions related to Sprycel patents.
Sprycel's oppositions filed in EPO
Sprycel has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 29, 2010, by Apotex Inc.. This opposition was filed on patent number EP05722772A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP05722772A | Sep, 2010 | Gallafent, Antony Xavier | Patent maintained as amended |
| EP05722772A | Sep, 2010 | APOTEX INC. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Sprycel 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 Sprycel's family patents as well as insights into ongoing legal events on those patents.
Sprycel's family patents
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Generic Launch
Generic Release Date:
Sprycel's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 28, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sprycel Generics:
Dasatinib is the generic name for the brand Sprycel. 1 company has already filed for the generic of Sprycel. Check out the entire list of companies who have already received approval for Sprycel's generic
How can I launch a generic of Sprycel before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Sprycel's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sprycel'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 Sprycel -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 80 mg and 140 mg | 17 Jun, 2011 | 1 | 23 Nov, 2021 | 28 Mar, 2026 | Non-Forfeiture |
| 20 mg, 50 mg, 70 mg and 100 mg | 28 Jun, 2010 | 1 | 10 Jun, 2016 | 28 Mar, 2026 | Non-Forfeiture Deferred |
About Sprycel
Sprycel is a drug owned by Bristol Myers Squibb Co. It is used for treating protein tyrosine kinase-associated disorders and various types of cancer, including chronic myelogenous leukemia. Sprycel uses Dasatinib as an active ingredient. Sprycel was launched by Bristol Myers Squibb in 2006.
Market Authorisation Date:
Sprycel was approved by FDA for market use on 28 June, 2006.
Active Ingredient:
Sprycel uses Dasatinib as the active ingredient. Check out other Drugs and Companies using Dasatinib ingredient
Treatment:
Sprycel is used for treating protein tyrosine kinase-associated disorders and various types of cancer, including chronic myelogenous leukemia.
Dosage:
Sprycel is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET | Prescription | ORAL |
| 70MG | TABLET | Prescription | ORAL |
| 80MG | TABLET | Prescription | ORAL |
| 50MG | TABLET | Prescription | ORAL |
| 20MG | TABLET | Prescription | ORAL |
| 140MG | TABLET | Prescription | ORAL |