Viewing data from:

LUBIPROSTONE

ANDA

LUBIPROSTONE | A209450 | AMNEAL PHARMACEUTICALS LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: AMITIZA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
SUCAMPO PHARMA, LLC et al v. AMNEAL PHARMACEUTICALS LLC 3:2017cv02577 5 patentsANDA 209450lubiprostone	D.N.J.	2017-04-13	Terminated 2018-07-02	—

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

API Supply Chain8 active DMFs3 inactive

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

SUCAMPO PHARMA AMERICAS LLCLUBIPROSTONE (RU-0211)

DMF 180912005

EVERLIGHT CHEMICAL INDUSTRIAL CORPLUBIPROSTONE

DMF 233832009

DR REDDYS LABORATORIES LTDLUBIPROSTONE

DMF 247052011

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDLUBIPROSTONE

DMF 308022016

APOTEX PHARMACHEM INDIA PVT LTDLUBIPROSTONE

DMF 312752017

SUN PHARMACEUTICAL INDUSTRIES LTDLUBIPROSTONE

DMF 324722018

MSN LABORATORIES PRIVATE LTDLUBIPROSTONE

DMF 344162019

YS LIFE SCIENCE CO LTDLUBIPROSTONE

DMF 372812022

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveLUBIPROSTONE

DMF 234022009

APOTEX PHARMACHEM INCInactiveLUBIPROSTONE

DMF 234902010

FIS FABBRICA ITALIANA SINTETICI SPAInactiveLUBIPROSTONE

DMF 242862010

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 20, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 8MCG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Nov 30, 2021

No patent or exclusivity listings for this strength.

#002 — 24MCG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 30, 2021