Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
Colorcon
Boehringer Ingelheim
Johnson and Johnson
Express Scripts

Last Updated: December 7, 2022

Alprazolam - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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-three suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for alprazolam

See drug prices for alprazolam

Drug Sales Revenue Trends for alprazolam

See drug sales revenues for alprazolam

Recent Clinical Trials for alprazolam

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

SponsorPhase
TakedaPhase 1
UCB Biopharma SRLPhase 3
Wayne State UniversityPhase 2

See all alprazolam clinical trials

Generic filers with tentative approvals for ALPRAZOLAM
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing1MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing0.5MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing0.25MGTABLET;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
Breckenridge ALPRAZOLAM alprazolam TABLET;ORAL 207507-004 Jul 9, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actavis Elizabeth ALPRAZOLAM alprazolam TABLET;ORAL 074342-004 Oct 31, 1993 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Upjohn XANAX alprazolam TABLET;ORAL 018276-001 Approved Prior to Jan 1, 1982 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sandoz Inc ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 077777-002 Jun 30, 2006 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sandoz Inc ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 077777-003 Jun 30, 2006 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sandoz Inc ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 077777-001 Jun 30, 2006 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Ucb Inc NIRAVAM alprazolam TABLET, ORALLY DISINTEGRATING;ORAL 021726-004 Jan 19, 2005 See Plans and Pricing See Plans and Pricing
Upjohn XANAX alprazolam TABLET;ORAL 018276-004 Nov 27, 1985 See Plans and Pricing See Plans and Pricing
Upjohn XANAX alprazolam TABLET;ORAL 018276-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Upjohn XANAX XR alprazolam TABLET, EXTENDED RELEASE;ORAL 021434-001 Jan 17, 2003 See Plans and Pricing See Plans and Pricing
Ucb Inc NIRAVAM alprazolam TABLET, ORALLY DISINTEGRATING;ORAL 021726-001 Jan 19, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Moodys
Express Scripts
Dow
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.