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Serving leading biopharmaceutical companies globally:

Argus Health
Queensland Health
Healthtrust
Julphar
Mallinckrodt
Cerilliant
Medtronic
Accenture
Citi
Chubb

Generated: December 12, 2017

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Nizatidine - Generic Drug Details

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What are the generic drug sources for nizatidine and what is the scope of nizatidine patent protection?

Nizatidine
is the generic ingredient in three branded drugs marketed by Smithkline Beecham, Ani Pharms Inc, Apotex Inc, Dr Reddys Labs Ltd, Glenmark Generics, Mylan Pharms Inc, Sandoz, Watson Labs, Braintree, Amneal Pharms, and Pfizer, and is included in thirteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nizatidine has two patent family members in two countries.

There are seven drug master file entries for nizatidine. Nineteen suppliers are listed for this compound.

Pharmacology for nizatidine

Medical Subject Heading (MeSH) Categories for nizatidine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Ani Pharms IncNIZATIDINEnizatidineCAPSULE;ORAL075668-002Sep 12, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
PfizerAXID ARnizatidineTABLET;ORAL020555-001May 9, 1996OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Smithkline BeechamAXIDnizatidineCAPSULE;ORAL019508-002Apr 12, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdNIZATIDINEnizatidineCAPSULE;ORAL077314-001Sep 15, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Ani Pharms IncNIZATIDINEnizatidineCAPSULE;ORAL075461-001Jul 8, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncNIZATIDINEnizatidineCAPSULE;ORAL075806-001Jul 5, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Amneal PharmsNIZATIDINEnizatidineSOLUTION;ORAL090576-001Nov 18, 2009RXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Glenmark GenericsNIZATIDINEnizatidineCAPSULE;ORAL090618-002Jul 15, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncNIZATIDINEnizatidineCAPSULE;ORAL075934-002Jul 9, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Smithkline BeechamAXIDnizatidineCAPSULE;ORAL019508-001Apr 12, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nizatidine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
PfizerAXID ARnizatidineTABLET;ORAL020555-001May 9, 1996► Subscribe► Subscribe
Smithkline BeechamAXIDnizatidineCAPSULE;ORAL019508-001Apr 12, 1988► Subscribe► Subscribe
Smithkline BeechamAXIDnizatidineCAPSULE;ORAL019508-002Apr 12, 1988► Subscribe► Subscribe
Smithkline BeechamAXIDnizatidineCAPSULE;ORAL019508-002Apr 12, 1988► Subscribe► Subscribe
Smithkline BeechamAXIDnizatidineCAPSULE;ORAL019508-002Apr 12, 1988► Subscribe► Subscribe
Smithkline BeechamAXIDnizatidineCAPSULE;ORAL019508-001Apr 12, 1988► Subscribe► Subscribe
Smithkline BeechamAXIDnizatidineCAPSULE;ORAL019508-001Apr 12, 1988► Subscribe► Subscribe
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International Patent Family for Ingredient: nizatidine

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2004009077► Subscribe
Australia2003247769► 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:

Chubb
QuintilesIMS
Merck
US Department of Justice
Medtronic
McKinsey
Fish and Richardson
Boehringer Ingelheim
Cipla
Farmers Insurance

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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