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Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Farmers Insurance
Chinese Patent Office
Julphar
Deloitte
Johnson and Johnson
UBS
Express Scripts
McKesson

Generated: October 16, 2017

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 alprazolam freedom to operate?

Alprazolam
is the generic ingredient in four branded drugs marketed by Sandoz, West-ward Pharms Int, Roxane, Mylan, Ani Pharms Inc, Ucb Inc, Pharmacia And Upjohn, Natco Pharma Ltd, Apotex Inc, Vintage Pharms, Actavis Elizabeth, Aurobindo Pharma Ltd, Mylan Pharms Inc, Watson Labs, Impax Labs, Anchen Pharms, Dava Intl Inc, Sandoz Inc, Sun Pharma Global, Amneal Pharms Ny, Par Pharm, Heritage Pharms Inc, Vintage, Ivax Sub Teva Pharms, Impax Labs Inc, and Actavis Labs Fl Inc, and is included in thirty-eight NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alprazolam has fifteen patent family members in nine countries.

There are fifteen drug master file entries for alprazolam. Fifty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: alprazolam

US Patents:2
Tradenames:4
Applicants:26
NDAs:38
Drug Master File Entries: see list15
Suppliers / Packagers: see list55
Bulk Api Vendors: see list34
Clinical Trials: see list67
Patent Applications: see list8,813
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:alprazolam at DailyMed

Pharmacology for Ingredient: alprazolam

Ingredient-typeBenzodiazepines
Drug ClassBenzodiazepine

Tentative approvals for ALPRAZOLAM

Applicant Application No. Strength Dosage Form
u► Subscribe0.25MGTABLET;ORAL
u► Subscribe1MGTABLET;ORAL
u► Subscribe0.5MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
ALPRAZOLAM
alprazolam
TABLET;ORAL074456-001Aug 31, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan
ALPRAZOLAM
alprazolam
TABLET, EXTENDED RELEASE;ORAL077391-001Jan 26, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs
ALPRAZOLAM
alprazolam
TABLET, EXTENDED RELEASE;ORAL077968-004May 24, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Sandoz Inc
ALPRAZOLAM
alprazolam
TABLET, EXTENDED RELEASE;ORAL077777-002Jun 30, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan
ALPRAZOLAM
alprazolam
TABLET, EXTENDED RELEASE;ORAL077391-002Jan 26, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
ALPRAZOLAM
alprazolam
TABLET;ORAL074456-002Aug 31, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Fl Inc
ALPRAZOLAM
alprazolam
TABLET, EXTENDED RELEASE;ORAL077198-003May 13, 2010DISCNNoNo► Subscribe► Subscribe► Subscribe
Impax Labs
ALPRAZOLAM
alprazolam
TABLET, EXTENDED RELEASE;ORAL077968-002May 24, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Natco Pharma Ltd
ALPRAZOLAM
alprazolam
TABLET;ORAL200739-002Apr 15, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Elizabeth
ALPRAZOLAM
alprazolam
TABLET;ORAL074342-002Oct 31, 1993ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: alprazolam

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
XANAX
alprazolam
TABLET;ORAL018276-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Pharmacia And Upjohn
XANAX
alprazolam
TABLET;ORAL018276-004Nov 27, 1985► Subscribe► Subscribe
Pharmacia And Upjohn
XANAX
alprazolam
TABLET;ORAL018276-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Pharmacia And Upjohn
XANAX XR
alprazolam
TABLET, EXTENDED RELEASE;ORAL021434-001Jan 17, 2003► Subscribe► Subscribe
Pharmacia And Upjohn
XANAX
alprazolam
TABLET;ORAL018276-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Pharmacia And Upjohn
XANAX
alprazolam
TABLET;ORAL018276-004Nov 27, 1985► Subscribe► Subscribe
Pharmacia And Upjohn
XANAX
alprazolam
TABLET;ORAL018276-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Pharmacia And Upjohn
XANAX XR
alprazolam
TABLET, EXTENDED RELEASE;ORAL021434-003Jan 17, 2003► Subscribe► Subscribe
Pharmacia And Upjohn
XANAX
alprazolam
TABLET;ORAL018276-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Pharmacia And Upjohn
XANAX XR
alprazolam
TABLET, EXTENDED RELEASE;ORAL021434-004Jan 17, 2003► Subscribe► Subscribe
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International Patent Family for Ingredient: alprazolam

Country Document Number Estimated Expiration
Canada2284663► Subscribe
Hong Kong1137654► Subscribe
Japan2001524956► Subscribe
Spain2525720► Subscribe
Australia6896998► Subscribe
Denmark2147669► Subscribe
Japan2012162558► Subscribe
European Patent Office2147669► Subscribe
European Patent Office0975336► Subscribe
Japan2008001726► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
McKinsey
Merck
Express Scripts
Farmers Insurance
Fuji
Dow
Boehringer Ingelheim
US Department of Justice

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 verifification 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.

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