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Last Updated: August 13, 2020

DrugPatentWatch Database Preview

LURASIDONE HYDROCHLORIDE Drug Profile

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Which patents cover Lurasidone Hydrochloride, and what generic alternatives are available?

Lurasidone Hydrochloride is a drug marketed by Accord Hlthcare, Amneal Pharms Co, Emcure Pharms Ltd, Invagen Pharms, Lupin Ltd, Sun Pharm, Teva Pharms Usa, Torrent, and Zydus Pharms. and is included in nine NDAs.

The generic ingredient in LURASIDONE HYDROCHLORIDE is lurasidone hydrochloride. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Lurasidone Hydrochloride

A generic version of LURASIDONE HYDROCHLORIDE was approved as lurasidone hydrochloride by ACCORD HLTHCARE on January 3rd, 2019.

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

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

SponsorPhase
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.Phase 3
Columbia UniversityPhase 4
New York State Psychiatric InstitutePhase 4

See all LURASIDONE HYDROCHLORIDE clinical trials

Paragraph IV (Patent) Challenges for LURASIDONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
LATUDA TABLET;ORAL lurasidone hydrochloride 200603 2014-10-28

US Patents and Regulatory Information for LURASIDONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208052-003 Mar 19, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208060-003 May 17, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208066-004 Jan 4, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208060-004 May 17, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208066-005 Jan 4, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208049-001 Jan 3, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Invagen Pharms LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208028-004 Jan 3, 2019 DISCN No No   Start Trial   Start Trial   Start 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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Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
McKinsey
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Baxter
Johnson and Johnson

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