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Last Updated: August 10, 2020

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Alprazolam - Generic Drug Details

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What are the generic sources for alprazolam and what is the scope of patent protection?

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

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

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

See all alprazolam clinical trials

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
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
Actavis Elizabeth ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078056-003 Feb 13, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-004 Jan 17, 2003 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Sandoz Inc ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 077777-002 Jun 30, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Vintage Pharms ALPRAZOLAM alprazolam TABLET;ORAL 090248-002 Sep 17, 2010 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

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
Upjohn XANAX alprazolam TABLET;ORAL 018276-001 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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