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Last Updated: February 22, 2024

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, Apotex Inc, Aurobindo Pharma, 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, 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 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
⤷  Try a Trial⤷  Try a Trial1MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial0.5MGTABLET;ORAL
⤷  Try a Trial⤷  Try a 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 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
Aurobindo Pharma ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 090871-002 Jun 7, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Impax Labs ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 077968-001 May 24, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Elizabeth ALPRAZOLAM alprazolam TABLET;ORAL 074342-003 Oct 31, 1993 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 018276-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Upjohn XANAX alprazolam TABLET;ORAL 018276-002 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-001 Jan 17, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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