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LOTRONEX

NDA

ALOSETRON HYDROCHLORIDE | N021107 | LEGACY PHARMA INC

2 strengths0 unique patents0 unique exclusivities

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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.

Clinical Trials

3 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy NCT00067457	Phase 3	Completed	GlaxoSmithKline	700	2003-06 → 2005-12
Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy NCT00067561	Phase 3	Completed	GlaxoSmithKline	702	2003-06 → 2005-01
Study to Assess the Effect Of Alosetron On Mucosal Blood Flow NCT00370032	Phase 4	Completed	GlaxoSmithKline	49	2006-12 → 2007-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (4 FSS, 2 Big4)

Lowest Price

$16.63

Highest Price

$1669.26

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
54766-0895-03LOTRONEX 1MG TAB	$1669.26	FSS	Legacy Pharma USA, Inc.	09/14/2028
45963-0479-03ALOSETRON HCL 0.5MG TAB	$87.32	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
45963-0479-03ALOSETRON HCL 0.5MG TAB	$16.63	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
45963-0480-03ALOSETRON HCL 1MG TAB	$174.63	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
45963-0480-03ALOSETRON HCL 1MG TAB	$21.85	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
54766-0894-03LOTRONEX 0.5MG TAB	$856.64	FSS	Legacy Pharma USA, Inc.	09/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Lotronex (2024)

Total Spending

$1.3M

Total Claims

226

Beneficiaries

Avg Cost/Unit

$66.24

Spending Trend

$1.6M(2019)→$1.8M(2020)→$1.3M(2021)→$1.3M(2022)→$1.3M(2023)→$1.3M(2024)

YoY Change:+0.5%

5yr CAGR:+2.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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

16 letters from Drugs@FDA

Date	Submission	Document
Sep 11, 2023	SUPPL -30	View Letter (PDF)
Apr 4, 2019	SUPPL -29	View Letter (PDF)
Jan 11, 2016	SUPPL -27	View Letter (PDF)
Jan 11, 2016	SUPPL -26	View Letter (PDF)
Jul 27, 2015	SUPPL -25	View Letter (PDF)
May 12, 2014	SUPPL -24	View Letter (PDF)
Sep 7, 2010	SUPPL -14	View Letter (PDF)
Sep 7, 2010	SUPPL -16	View Letter (PDF)
Apr 9, 2008	SUPPL -13	View Letter (PDF)
Mar 23, 2006	SUPPL -12	View Letter (PDF)
Feb 23, 2005	SUPPL -11	View Letter (PDF)
Feb 8, 2005	SUPPL -10	View Letter (PDF)
Dec 24, 2003	SUPPL -8	View Letter (PDF)
Mar 26, 2003	SUPPL -7	View Letter (PDF)
Jun 7, 2002	SUPPL -5	View Letter (PDF)
Feb 9, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 1MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 9, 2000

No patent or exclusivity listings for this strength.

#002 — EQ 0.5MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 23, 2003