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Last Updated: May 16, 2021

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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, 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-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for alprazolam. Forty-one 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
UCB Biopharma SRLPhase 1
Sohaib AshrafPhase 1/Phase 2
Ehab Tarek FahmyPhase 1

See all alprazolam clinical trials

Generic filers with tentative approvals for ALPRAZOLAM
Applicant Application No. Strength Dosage Form
  Get Started for $10  Get Started for $100.5MGTABLET;ORAL
  Get Started for $10  Get Started for $100.25MGTABLET;ORAL
  Get Started for $10  Get Started for $101MGTABLET;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
Amneal Pharms Ny ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078387-003 May 30, 2008 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Par Pharm ALPRAZOLAM alprazolam TABLET, ORALLY DISINTEGRATING;ORAL 078088-001 Jan 9, 2009 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Actavis Elizabeth ALPRAZOLAM alprazolam TABLET;ORAL 074342-003 Oct 31, 1993 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
>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 021726-002 Jan 19, 2005   Get Started for $10   Get Started for $10
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-003 Jan 17, 2003   Get Started for $10   Get Started for $10
Upjohn XANAX alprazolam TABLET;ORAL 018276-003 Approved Prior to Jan 1, 1982   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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