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Last Updated: August 2, 2021

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ZALEPLON Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Zaleplon

A generic version of ZALEPLON was approved as zaleplon by AUROBINDO PHARMA on June 6th, 2008.

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Drug patent expirations by year for ZALEPLON
Drug Prices for ZALEPLON

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Recent Clinical Trials for ZALEPLON

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SponsorPhase
Saint-Joseph UniversityPhase 3
Chang Gung Memorial HospitalPhase 2/Phase 3
Taipei City HospitalPhase 2/Phase 3

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Pharmacology for ZALEPLON
Paragraph IV (Patent) Challenges for ZALEPLON
Tradename Dosage Ingredient NDA Submissiondate
SONATA CAPSULE;ORAL zaleplon 020859 2005-06-21

US Patents and Regulatory Information for ZALEPLON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma ZALEPLON zaleplon CAPSULE;ORAL 078829-001 Jun 6, 2008 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Upsher Smith Labs ZALEPLON zaleplon CAPSULE;ORAL 078706-001 Jun 6, 2008 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hikma Pharms ZALEPLON zaleplon CAPSULE;ORAL 078147-001 Nov 25, 2008 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Cipla Ltd ZALEPLON zaleplon CAPSULE;ORAL 077505-002 Jun 20, 2008 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Orchid Hlthcare ZALEPLON zaleplon CAPSULE;ORAL 090374-002 Sep 17, 2009 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Upsher Smith Labs ZALEPLON zaleplon CAPSULE;ORAL 078706-002 Jun 6, 2008 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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:

Boehringer Ingelheim
Harvard Business School
Express Scripts
McKesson
Baxter
Dow

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