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Last Updated: March 28, 2024

ALOSETRON HYDROCHLORIDE Drug Patent Profile


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When do Alosetron Hydrochloride patents expire, and what generic alternatives are available?

Alosetron Hydrochloride is a drug marketed by Amneal Pharms, Eywa Pharma, Hikma, Mankind Pharma, Par Pharm Inc, and Rising. and is included in six NDAs.

The generic ingredient in ALOSETRON HYDROCHLORIDE is alosetron hydrochloride. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the alosetron hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Alosetron Hydrochloride

A generic version of ALOSETRON HYDROCHLORIDE was approved as alosetron hydrochloride by AMNEAL PHARMS on December 22nd, 2016.

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Drug patent expirations by year for ALOSETRON HYDROCHLORIDE
Recent Clinical Trials for ALOSETRON HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
GlaxoSmithKlinePhase 4
Hadassah Medical OrganizationPhase 1
GlaxoSmithKlinePhase 2

See all ALOSETRON HYDROCHLORIDE clinical trials

Pharmacology for ALOSETRON HYDROCHLORIDE
Paragraph IV (Patent) Challenges for ALOSETRON HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LOTRONEX Tablets alosetron hydrochloride 0.5 mg and 1 mg 021107 1 2010-12-02

US Patents and Regulatory Information for ALOSETRON HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms ALOSETRON HYDROCHLORIDE alosetron hydrochloride TABLET;ORAL 206647-001 Dec 22, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mankind Pharma ALOSETRON HYDROCHLORIDE alosetron hydrochloride TABLET;ORAL 213614-001 Sep 9, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eywa Pharma ALOSETRON HYDROCHLORIDE alosetron hydrochloride TABLET;ORAL 211621-002 Sep 16, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising ALOSETRON HYDROCHLORIDE alosetron hydrochloride TABLET;ORAL 209180-002 Jan 14, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mankind Pharma ALOSETRON HYDROCHLORIDE alosetron hydrochloride TABLET;ORAL 213614-002 Sep 9, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms ALOSETRON HYDROCHLORIDE alosetron hydrochloride TABLET;ORAL 206647-002 Dec 22, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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