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ALOSETRON HYDROCHLORIDE

ANDA

ALOSETRON HYDROCHLORIDE | A200652 | HIKMA PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
PROMETHEUS LABORATORIES INC. v. ROXANE LABORATORIES, INC. 2:2011cv01241 1 patentANDA 200652alosetron hydrochloride	D.N.J.	2011-03-04	Terminated 2014-06-03	—
PROMETHEUS LABORATORIES INC. v. ROXANE LABORATORIES, INC. 2:2011cv00230 1 patentANDA 200652Alosetron Hydrochloride	D.N.J.	2011-01-14	Terminated 2014-06-03	—

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Prometheus Laboratories Inc. - Citizen Petition FDA-2013-P-0572 · 3 docket documents Prometheus Laboratories Inc. filed this citizen petition on May 10, 2013, requesting that the FDA establish notice-and-comment rulemaking to create standards and processes for single shared Risk Evaluation and Mitigation Strategies (REMS) for Lotronex (alosetron hydrochloride), and that Prometheus r	505(q)	2013-05-28	Partially Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain3 active DMFs

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

CIPLA LTDALOSETRON HYDROCHLORIDE USP

DMF 221252009

NURAY CHEMICALS PVT LTDALOSETRON HYDROCHLORIDE

DMF 273782013

BIOPHORE INDIA PHARMACEUTICALS PVT LTDALOSETRON HYDROCHLORIDE

DMF 274702013

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

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 0.5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 4, 2015

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 4, 2015