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REGADENOSON

ANDA

REGADENOSON | A207604 | APOTEX INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: LEXISCAN(TE code: AP)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Astellas US LLC et al v. Hospira, Inc. 1:2018cv01675 3 patentsANDA 207604regadenoson	D. Del.	2018-10-25	Terminated 2022-06-01	—
Apotex Inc. v. Gilead Sciences, Inc. et al 3:2018cv06475 2 patentsANDA 207604regadenoson	N.D. Cal.	2018-10-23	Terminated 2019-01-31	—

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

API Supply Chain12 active DMFs1 inactive

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

GLAND PHARMA LTDREGADENOSON

DMF 279722014

SCINOPHARM TAIWAN LTDREGADENOSON

DMF 289392014

WOCKHARDT BIO AGREGADENOSON (AMORPHOUS)

DMF 291852015

USV PRIVATE LTDREGADENOSON

DMF 293152015

CURIA MISSOURI INCREGADENOSON

DMF 305422016

BIOPHORE INDIA PHARMACEUTICALS PVT LTDREGADENOSON

DMF 308342016

SUN PHARMACEUTICAL INDUSTRIES LTDREGADENOSON

DMF 315392017

MATRIX PHARMACORP PRIVATE LTDREGADENOSON

DMF 323392018

FARMAK ASREGADENOSON

DMF 354332021

MSN LIFE SCIENCES PRIVATE LTDREGADENOSON

DMF 363382021

NANJING HERON PHARMACEUTICAL CO LTDREGADENOSON

DMF 366792022

GLAND PHARMA LTDREGADENOSON (PROCESS – II)

DMF 372262022

FARMAK ASInactiveREGADENOSON MONOHYDRATE

DMF 259392012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 26, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.4MG/5ML (0.08MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Apr 11, 2022

No patent or exclusivity listings for this strength.