Viewing data from:

SPRYCEL

NDA

DASATINIB | N021986 | BRISTOL MYERS SQUIBB CO

6 strengths1 unique patent2 unique exclusivities

Patent Timeline

1 unique patent, 1 exclusivity by expiration date

Expired (1)TodayPED (+6 mo)Exclusivity

2026

Today

7491725

Sep. 28, 2026

ODE-225

Jun. 21, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
BRISTOL-MYERS SQUIBB COMPANY v. XSPRAY PHARMA AB 1:2022cv00964 2 patentsdasatinib	D.N.J.	2022-02-23	Terminated 2023-09-19	—
BRISTOL-MYERS SQUIBB CO. v. TEVA PHARMACEUTICALS USA, INC. 3:2020cv03229 1 patentANDA 211094dasatinib	D.N.J.	2020-03-25	Terminated 2020-08-27	—
BRISTOL-MYERS SQUIBB COMPANY v. APOTEX, INC. et al 3:2010cv05810 4 patentsANDA 202103Dasatinib	D.N.J.	2010-11-08	Terminated 2013-09-12	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Sprycel (2023)

Total Spending

$510.2M

Total Claims

37,783

Beneficiaries

5,120

Avg Cost/Unit

$444.79

Spending Trend

$378.9M(2019)→$418.7M(2020)→$450.2M(2021)→$500.5M(2022)→$510.2M(2023)

YoY Change:+6.5%

5yr CAGR:+5.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain30 active DMFs2 inactive

20 active API suppliers hold Drug Master Files for this ingredient.

HUBEI HAOSUN PHARMACEUTICAL CO LTDDASATINIB

DMF 237632010

ALP PHARM BEIJING CO LTDDASATINIB

DMF 295052015

HIKMA PHARMACEUTICALS LLCDASATINIB MONOHYDRATE

DMF 301652015

MSN LABORATORIES PRIVATE LTDDASATINIB PROPYLENE GLYCOL [ROUTE CODE DB]

DMF 302192016

RELIANCE LIFE SCIENCES PVT LTDDASATINIB

DMF 311692017

ALEMBIC PHARMACEUTICALS LTDDASATINIB

DMF 312822017

TAPI NL BVDASATINIB MONOHYDRATE

DMF 316052017

HETERO LABS LTDDASATINIB ANHYDROUS

DMF 322782017

DR REDDYS LABORATORIES LTDDASATINIB (S)-PROPYLENE GLYCOL

DMF 324002018

TAPI NL BVDASATINIB ANHYDROUS

DMF 324072018

MSN LABORATORIES PRIVATE LTDDASATINIB

DMF 325432018

MSN LABORATORIES PRIVATE LTDDASATINIB MONOHYDRATE

DMF 325552018

SUN PHARMACEUTICAL INDUSTRIES LTDDASATINIB

DMF 331082019

CIPLA LTDDASATINIB

DMF 335892019

BIOCARE PHARMACEUTICAL LTDDASATINIB

DMF 336442019

DR REDDYS LABORATORIES LTDDASATINIB MONOHYDRATE

DMF 346762020

HUBEI HAOSUN PHARMACEUTICAL CO LTDDASATINIB ANHYDROUS

DMF 348752020

APITORIA PHARMA PRIVATE LTDDASATINIB

DMF 348922020

CIPLA LTDDASATINIB (A)

DMF 352192020

GRANULES INDIA LTDDASATINIB

DMF 352702020

INTAS PHARMACEUTICALS LTDDASATINIB

DMF 353822020

CDYMAX (INDIA) PHARMA PRIVATE LTDDASATINIB [DRUG SUBSTANCE (NON-STERILE)]

DMF 359902021

BIOCON LTDDASATINIB MONOHYDRATE

DMF 361852021

CDYMAX (INDIA) PHARMA PRIVATE LTDDASATINIB

DMF 379422023

GRANULES INDIA LTDDASATINIB MONOHYDRATE

DMF 380652023

DEVA HOLDING ASDASATINIB

DMF 391112024

CIPLA LTDDASATINIB MONOHYDRATE

DMF 391332023

SICHUAN ELIXIR PHARMACEUTICAL CO LTDDASATINIB

DMF 396462024

HETERO LABS LTDDASATINIB MONOHYDRATE

DMF 415752025

SHILPA PHARMA LIFESCIENCES LTDDASATINIB

DMF 418342025

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveDASATINIB

DMF 264942012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveDASATINIB

DMF 283422014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Aug 2, 2024	SUPPL -28	View Letter (PDF)
Feb 9, 2023	SUPPL -27	View Letter (PDF)
Jun 30, 2021	SUPPL -25	View Letter (PDF)
Dec 30, 2018	SUPPL -21	View Letter (PDF)
Dec 7, 2018	SUPPL -23	View Letter (PDF)
Nov 15, 2017	SUPPL -20	View Letter (PDF)
Aug 15, 2017	SUPPL -19	View Letter (PDF)
Sep 30, 2016	SUPPL -18	View Letter (PDF)
Aug 14, 2015	SUPPL -16	View Letter (PDF)
Aug 14, 2015	SUPPL -17	View Letter (PDF)
Apr 14, 2014	SUPPL -14	View Letter (PDF)
Jun 18, 2013	SUPPL -13	View Letter (PDF)
Oct 13, 2011	SUPPL -9	View Letter (PDF)
Oct 13, 2011	SUPPL -10	View Letter (PDF)
Nov 3, 2010	SUPPL -8	View Letter (PDF)
Nov 3, 2010	SUPPL -7	View Letter (PDF)
Aug 9, 2010	SUPPL -5	View Letter (PDF)
May 29, 2009	SUPPL -4	View Letter (PDF)
Jun 3, 2008	SUPPL -3	View Letter (PDF)
Nov 19, 2007	SUPPL -2	View Letter (PDF)
Nov 19, 2007	SUPPL -1	View Letter (PDF)
Jul 3, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 20MG

RLDAB

1 patent2 exclusivities▴

TABLET;ORAL | Approved: Jun 28, 2006

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7491725	Mar 28, 2026PED: Sep 28, 2026	PED	Yes	Yes	—	—

Exclusivities (2)

Code	Date	Status
ODE-225	Dec 21, 2025	Expired
PED	Jun 21, 2026	Expired

#002 — 50MG

RLDAB

1 patent2 exclusivities▾

TABLET;ORAL | Approved: Jun 28, 2006

#003 — 70MG

RLDAB

1 patent2 exclusivities▾

TABLET;ORAL | Approved: Jun 28, 2006

#004 — 100MG

RLDAB

1 patent2 exclusivities▾

TABLET;ORAL | Approved: May 30, 2008

#005 — 80MG

RLDAB

1 patent2 exclusivities▾

TABLET;ORAL | Approved: Oct 28, 2010

#006 — 140MG

RLDAB

1 patent2 exclusivities▾

TABLET;ORAL | Approved: Oct 28, 2010