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Last Updated: November 2, 2024

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, Ani Pharms, Apotex Inc, Aurobindo Pharma, Endo Operations, Heritage Pharms Inc, Impax Labs, Impax Labs Inc, Norvium Bioscience, Sandoz Inc, Upjohn, Ucb Inc, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Natco, Novitium Pharma, Oxford Pharms, Sandoz, Strides Pharma, 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-six 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
Centre Hospitalier Universitaire Saint PierreN/A
TakedaPhase 1
UCB Biopharma SRLPhase 3

See all alprazolam clinical trials

Generic filers with tentative approvals for ALPRAZOLAM
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up1MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up0.5MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up0.25MGTABLET;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
Anatomical Therapeutic Chemical (ATC) Classes for alprazolam
Paragraph IV (Patent) Challenges for ALPRAZOLAM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NIRAVAM Orally Disintegrating Tablets alprazolam 0.25 mg, 0.5 mg, 1 mg and 2 mg 021726 1 2005-12-27

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
Sandoz ALPRAZOLAM alprazolam TABLET;ORAL 074112-002 Dec 29, 1995 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Elizabeth ALPRAZOLAM alprazolam TABLET;ORAL 074342-004 Oct 31, 1993 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Upjohn XANAX alprazolam TABLET;ORAL 018276-004 Nov 27, 1985 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma ALPRAZOLAM alprazolam TABLET;ORAL 090248-003 Sep 17, 2010 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal Pharms Ny ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078387-004 May 30, 2008 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-004 Jan 17, 2003 ⤷  Sign Up ⤷  Sign Up
Ucb Inc NIRAVAM alprazolam TABLET, ORALLY DISINTEGRATING;ORAL 021726-004 Jan 19, 2005 ⤷  Sign Up ⤷  Sign Up
Upjohn XANAX alprazolam TABLET;ORAL 018276-003 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-001 Jan 17, 2003 ⤷  Sign Up ⤷  Sign Up
Upjohn XANAX alprazolam TABLET;ORAL 018276-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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