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Last Updated: September 20, 2020

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ACARBOSE Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Acarbose

A generic version of ACARBOSE was approved as acarbose by HIKMA on May 7th, 2008.

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Drug patent expirations by year for ACARBOSE
Drug Prices for ACARBOSE

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Recent Clinical Trials for ACARBOSE

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SponsorPhase
Empros Pharma ABPhase 1/Phase 2
Clinical Trial Consultants ABPhase 1/Phase 2
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolN/A

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Pharmacology for ACARBOSE
Medical Subject Heading (MeSH) Categories for ACARBOSE
Paragraph IV (Patent) Challenges for ACARBOSE
Tradename Dosage Ingredient NDA Submissiondate
PRECOSE TABLET;ORAL acarbose 020482 2005-03-22

US Patents and Regulatory Information for ACARBOSE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Emcure Pharms Ltd ACARBOSE acarbose TABLET;ORAL 202271-001 Feb 7, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Virtus Pharm ACARBOSE acarbose TABLET;ORAL 091343-003 Oct 17, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Impax Labs ACARBOSE acarbose TABLET;ORAL 078441-001 May 14, 2009 AB RX 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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