Viewing data from:

DASATINIB

ANDA

DASATINIB | A202103 | APOTEX INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SPRYCEL(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
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).

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

1 letter from Drugs@FDA

Date	Submission	Document
Jun 14, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 20MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 10, 2016

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 10, 2016

#003 — 70MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 10, 2016

#004 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 10, 2016