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Last Updated: March 5, 2021

DrugPatentWatch Database Preview

Alprazolam - Generic Drug Details

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What are the generic drug 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-two 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
Sohaib AshrafPhase 1/Phase 2
Ehab Tarek FahmyPhase 1
Istanbul Medeniyet UniversityPhase 4

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
Sun Pharm ALPRAZOLAM alprazolam TABLET;ORAL 090082-002 Jun 17, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc ALPRAZOLAM alprazolam TABLET;ORAL 074085-004 Feb 26, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz ALPRAZOLAM alprazolam TABLET;ORAL 074112-003 Dec 29, 1995 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth ALPRAZOLAM alprazolam TABLET;ORAL 074342-002 Oct 31, 1993 AB RX No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 077979-002 Feb 28, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan ALPRAZOLAM alprazolam TABLET;ORAL 074215-001 Jan 27, 1994 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharms Inc ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078489-003 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
Upjohn XANAX alprazolam TABLET;ORAL 018276-004 Nov 27, 1985   Start Trial   Start Trial
Upjohn XANAX alprazolam TABLET;ORAL 018276-002 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
Ucb Inc NIRAVAM alprazolam TABLET, ORALLY DISINTEGRATING;ORAL 021726-002 Jan 19, 2005   Start Trial   Start Trial
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-001 Jan 17, 2003   Start Trial   Start Trial
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-004 Jan 17, 2003   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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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Moodys
Express Scripts
Dow
Medtronic

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