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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Medtronic
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Generated: December 12, 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 West-ward Pharms Int, Roxane, Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Anchen Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Heritage Pharms Inc, Impax Labs, Impax Labs Inc, Mylan, Sandoz Inc, Vintage Pharms, Pharmacia And Upjohn, Par Pharm, Ucb Inc, Dava Intl Inc, Ivax Sub Teva Pharms, Mylan Pharms Inc, Natco Pharma Ltd, Sandoz, Sun Pharma Global, Vintage, and Watson Labs, 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 sixteen patent family members in nine countries.

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

Pharmacology for alprazolam

Ingredient-typeBenzodiazepines
Drug ClassBenzodiazepine

Medical Subject Heading (MeSH) Categories for alprazolam

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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Watson LabsALPRAZOLAMalprazolamTABLET;ORAL074456-003Aug 31, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sandoz IncALPRAZOLAMalprazolamTABLET, EXTENDED RELEASE;ORAL077777-001Jun 30, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dava Intl IncALPRAZOLAMalprazolamTABLET;ORAL074174-002Oct 19, 1993ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson LabsALPRAZOLAMalprazolamTABLET;ORAL074456-002Aug 31, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis ElizabethALPRAZOLAMalprazolamTABLET, EXTENDED RELEASE;ORAL078056-004Feb 13, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncALPRAZOLAMalprazolamTABLET;ORAL074046-001Oct 19, 1993ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharma GlobalALPRAZOLAMalprazolamTABLET;ORAL090082-001Jun 17, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Pharmacia And UpjohnXANAXalprazolamTABLET;ORAL018276-003Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Ani Pharms IncALPRAZOLAMalprazolamTABLET, EXTENDED RELEASE;ORAL077725-004Jul 31, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Impax Labs IncALPRAZOLAMalprazolamTABLET, EXTENDED RELEASE;ORAL077996-004Jan 31, 2007DISCNNoNo► Subscribe► 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 UpjohnXANAXalprazolamTABLET;ORAL018276-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Pharmacia And UpjohnXANAXalprazolamTABLET;ORAL018276-004Nov 27, 1985► Subscribe► Subscribe
Pharmacia And UpjohnXANAXalprazolamTABLET;ORAL018276-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Pharmacia And UpjohnXANAX XRalprazolamTABLET, EXTENDED RELEASE;ORAL021434-001Jan 17, 2003► Subscribe► Subscribe
Pharmacia And UpjohnXANAXalprazolamTABLET;ORAL018276-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Pharmacia And UpjohnXANAXalprazolamTABLET;ORAL018276-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Pharmacia And UpjohnXANAXalprazolamTABLET;ORAL018276-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Pharmacia And UpjohnXANAXalprazolamTABLET;ORAL018276-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Pharmacia And UpjohnXANAX XRalprazolamTABLET, EXTENDED RELEASE;ORAL021434-004Jan 17, 2003► Subscribe► Subscribe
Pharmacia And UpjohnXANAXalprazolamTABLET;ORAL018276-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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International Patent Family for Ingredient: alprazolam

Country Document Number Estimated Expiration
Denmark2266538► Subscribe
Australia726336► Subscribe
European Patent Office2147669► Subscribe
Canada2284663► Subscribe
World Intellectual Property Organization (WIPO)9846215► Subscribe
European Patent Office2266538► Subscribe
Hong Kong1137654► Subscribe
Australia6896998► Subscribe
Portugal2147669► 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:

Fuji
Merck
McKinsey
Medtronic
Fish and Richardson
McKesson
Accenture
Healthtrust
Deloitte
UBS

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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