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Nizatidine - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for nizatidine?

Nizatidine is the generic ingredient in three branded drugs marketed by Mylan Pharms Inc, Smithkline Beecham, Dr Reddys Labs Ltd, Watson Labs, Glenmark Generics, Pfizer, Ani Pharms Inc, Amneal Pharms, Sandoz, Apotex Inc, and Braintree, 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.

This ingredient has two patent family members in two countries.

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

Summary for Generic Name: nizatidine

Tradenames:3
Patents:2
Applicants:11
NDAs:13
Drug Master File Entries: see list7
Suppliers / Packagers: see list20
Bulk Api Vendors: see list43
Clinical Trials: see list3
Patent Applications: see list2,735
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:nizatidine at DailyMed

Pharmacology for Ingredient: nizatidine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc
NIZATIDINE
nizatidine
CAPSULE;ORAL076383-001Jan 23, 2003DISCNNoNo► Subscribe► Subscribe
Ani Pharms Inc
NIZATIDINE
nizatidine
CAPSULE;ORAL075668-002Sep 12, 2002RXNoNo► Subscribe► Subscribe
Watson Labs
NIZATIDINE
nizatidine
CAPSULE;ORAL075616-002Jul 9, 2002RXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
NIZATIDINE
nizatidine
CAPSULE;ORAL075806-001Jul 5, 2002RXNoNo► Subscribe► Subscribe
Pfizer
AXID AR
nizatidine
TABLET;ORAL020555-001May 9, 1996OTCYesYes► 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
Pfizer
AXID AR
nizatidine
TABLET;ORAL020555-001May 9, 19964,375,547► Subscribe
Smithkline Beecham
AXID
nizatidine
CAPSULE;ORAL019508-001Apr 12, 19884,760,075► Subscribe
Smithkline Beecham
AXID
nizatidine
CAPSULE;ORAL019508-001Apr 12, 19884,382,090► Subscribe
Smithkline Beecham
AXID
nizatidine
CAPSULE;ORAL019508-001Apr 12, 19884,375,547► Subscribe
Smithkline Beecham
AXID
nizatidine
CAPSULE;ORAL019508-002Apr 12, 19884,375,547► Subscribe
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International Patent Family for Ingredient: nizatidine

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