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Last Updated: June 2, 2024

ALPRAZOLAM - Generic Drug Details

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What are the generic drug sources for alprazolam and what is the scope of freedom to operate?

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, Chartwell Rx, 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.

Summary for ALPRAZOLAM

US Patents:	0
Tradenames:	4
Applicants:	28
NDAs:	39
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	96
Patent Applications:	6,391
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ALPRAZOLAM
Drug Sales Revenues:	Drug sales revenues for ALPRAZOLAM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALPRAZOLAM
What excipients (inactive ingredients) are in ALPRAZOLAM?	ALPRAZOLAM excipients list
DailyMed Link:	ALPRAZOLAM at DailyMed

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

Sponsor	Phase
Centre Hospitalier Universitaire Saint Pierre	N/A
Takeda	Phase 1
UCB Biopharma SRL	Phase 3

See all ALPRAZOLAM clinical trials

Generic filers with tentative approvals for ALPRAZOLAM

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	1MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	0.5MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	0.25MG	TABLET;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 Class	Benzodiazepine

Medical Subject Heading (MeSH) Categories for ALPRAZOLAM

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex Inc	ALPRAZOLAM	alprazolam	TABLET, EXTENDED RELEASE;ORAL	078449-003	Nov 12, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heritage Pharms Inc	ALPRAZOLAM	alprazolam	TABLET, EXTENDED RELEASE;ORAL	078489-001	Oct 17, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs	ALPRAZOLAM	alprazolam	TABLET, EXTENDED RELEASE;ORAL	077968-002	May 24, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Roxane	ALPRAZOLAM	alprazolam	TABLET;ORAL	074199-003	Oct 19, 1993		DISCN	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	XANAX	alprazolam	TABLET;ORAL	018276-004	Nov 27, 1985	⤷ Sign Up	⤷ Sign Up
Ucb Inc	NIRAVAM	alprazolam	TABLET, ORALLY DISINTEGRATING;ORAL	021726-004	Jan 19, 2005	⤷ Sign Up	⤷ Sign Up
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-003	Jan 17, 2003	⤷ Sign Up	⤷ Sign Up
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-001	Jan 17, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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.