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Last Updated: April 14, 2021

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ALPRAZOLAM Drug Profile

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Which patents cover Alprazolam, and when can generic versions of Alprazolam launch?

Alprazolam is a drug marketed by Hikma, Roxane, Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Anchen Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Heritage Pharms Inc, Impax Labs, Impax Labs Inc, Mylan, Sandoz Inc, Vintage Pharms, Par Pharm, Breckenridge, Ivax Sub Teva Pharms, Mylan Pharms Inc, Natco Pharma Ltd, Novitium Pharma, Oxford Pharms, Sandoz, Sun Pharm, and Watson Labs. and is included in thirty-six NDAs.

The generic ingredient in ALPRAZOLAM is alprazolam. There are fifteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the alprazolam profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Alprazolam

A generic version of ALPRAZOLAM was approved as alprazolam by HIKMA on October 31st, 1993.

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Drug patent expirations by year for ALPRAZOLAM
Drug Prices for ALPRAZOLAM

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Drug Sales Revenue Trends for ALPRAZOLAM

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Recent Clinical Trials for ALPRAZOLAM

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SponsorPhase
Sohaib AshrafPhase 1/Phase 2
Ehab Tarek FahmyPhase 1
Istanbul Medeniyet UniversityPhase 4

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Pharmacology for ALPRAZOLAM
Drug ClassBenzodiazepine
Medical Subject Heading (MeSH) Categories for ALPRAZOLAM
Paragraph IV (Patent) Challenges for ALPRAZOLAM
Tradename Dosage Ingredient NDA Submissiondate
NIRAVAM TABLET, ORALLY DISINTEGRATING;ORAL alprazolam 021726 2005-12-27
XANAX TABLET;ORAL alprazolam 018276

US Patents and Regulatory Information for ALPRAZOLAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms Inc ALPRAZOLAM alprazolam TABLET;ORAL 074085-002 Feb 16, 1994 DISCN No No   Start Trial   Start Trial   Start Trial
Natco Pharma Ltd ALPRAZOLAM alprazolam TABLET;ORAL 200739-003 Apr 15, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Impax Labs ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 077968-002 May 24, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 090871-002 Jun 7, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Breckenridge ALPRAZOLAM alprazolam TABLET;ORAL 207507-004 Jul 9, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz ALPRAZOLAM alprazolam TABLET;ORAL 074112-001 Dec 29, 1995 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 077391-004 Jan 26, 2006 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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