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 which all 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7491725 | Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors |
Mar, 2026
(6 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7491725 (Pediatric) | Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors |
Sep, 2026
(8 days ago) |
Expired
|
|
US8680103 (Pediatric) | Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors |
Aug, 2025
(1 year, 2 months ago) |
Expired
|
| US8680103 | Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors |
Feb, 2025
(1 year, 8 months ago) |
Expired
|
|
US6596746 (Pediatric) | Cyclic protein tyrosine kinase inhibitors |
Dec, 2020
(5 years ago) |
Expired
|
|
US7153856 (Pediatric) | Cyclic protein tyrosine kinase inhibitors |
Oct, 2020
(5 years ago) |
Expired
|
|
US7125875 (Pediatric) | Cyclic protein tyrosine kinase inhibitors |
Oct, 2020
(5 years ago) |
Expired
|
| US6596746 | Cyclic protein tyrosine kinase inhibitors |
Jun, 2020
(6 years ago) |
Expired
|
| US7153856 | Cyclic protein tyrosine kinase inhibitors |
Apr, 2020
(6 years ago) |
Expired
|
| US7125875 | Cyclic protein tyrosine kinase inhibitors |
Apr, 2020
(6 years ago) |
Expired
|
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.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed | 10 Nov, 2025 | US8680103 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Sep, 2021 | US8680103 |
| 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 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Sep, 2017 | US8680103 |
| Recordation of Patent Grant Mailed | 25 Mar, 2014 | US8680103 |
| Patent Issue Date Used in PTA Calculation | 25 Mar, 2014 | US8680103 |
| Email Notification | 06 Mar, 2014 | US8680103 |
| Issue Notification Mailed | 05 Mar, 2014 | US8680103 |
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. All of its exclusivities have expired 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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Sprycel:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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 Generic API suppliers:
Dasatinib is the generic name for the brand Sprycel. 8 different companies have already filed for the generic of Sprycel, with Alembic having the maximum number of approved applications. 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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 17 Jun, 2011 | 28 Mar, 2026 | Non-Forfeiture | 23 Nov, 2021 | Less | |
| 28 Jun, 2010 | 28 Mar, 2026 | Non-Forfeiture Deferred | 10 Jun, 2016 | Less |
Alternative Brands for Sprycel
Sprycel which is used for treating protein tyrosine kinase-associated disorders and various types of cancer, including chronic myelogenous leukemia., has several other brand drugs using the same active ingredient (Dasatinib). 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.
| Drug Owner | Drug Name | |
|---|---|---|
| Handa Therap |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Dasatinib, Sprycel's active ingredient. Check the complete list of approved generic manufacturers for Sprycel
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 in 2006.
Approval 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 |
|---|---|---|---|
| 70MG | TABLET | Prescription | ORAL |
| 100MG | TABLET | Prescription | ORAL |
| 80MG | TABLET | Prescription | ORAL |
| 140MG | TABLET | Prescription | ORAL |
| 20MG | TABLET | Prescription | ORAL |
| 50MG | TABLET | Prescription | ORAL |