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Last Updated: August 15, 2020

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ALPRAZOLAM - Generic Drug Details

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What are the generic drug sources for alprazolam and what is the scope of freedom to operate?

Alprazolam is the generic ingredient in four branded drugs 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, Upjohn, Par Pharm, Ucb Inc, Breckenridge, Dava Intl Inc, Ivax Sub Teva Pharms, Mylan Pharms Inc, Natco Pharma Ltd, Oxford Pharms, Sandoz, Sun Pharm, and Watson Labs, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for alprazolam. Thirty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

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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Istanbul Medeniyet UniversityPhase 4
University of Illinois at ChicagoPhase 1
Oregon State UniversityPhase 1

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Generic filers with tentative approvals for ALPRAZOLAM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1MGTABLET;ORAL
  Start Trial  Start Trial0.5MGTABLET;ORAL
  Start Trial  Start Trial0.25MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ALPRAZOLAM
Drug ClassBenzodiazepine
Medical Subject Heading (MeSH) Categories for ALPRAZOLAM
Paragraph IV (Patent) Challenges for ALPRAZOLAM
Tradename Dosage Ingredient NDA Submissiondate
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
Mylan Pharms Inc ALPRAZOLAM alprazolam TABLET;ORAL 074046-002 Oct 19, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm ALPRAZOLAM alprazolam TABLET;ORAL 090082-001 Jun 17, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharms Inc ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078489-002 Oct 17, 2008 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

Expired US Patents for ALPRAZOLAM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc NIRAVAM alprazolam TABLET, ORALLY DISINTEGRATING;ORAL 021726-001 Jan 19, 2005   Start Trial   Start Trial
Upjohn XANAX alprazolam TABLET;ORAL 018276-004 Nov 27, 1985   Start Trial   Start Trial
Upjohn XANAX alprazolam TABLET;ORAL 018276-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.