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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
UBS
Accenture
Johnson and Johnson
Teva
Dow
McKinsey
Chubb
Chinese Patent Office
Deloitte

Generated: February 21, 2018

DrugPatentWatch Database Preview

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. Seventeen suppliers are listed for this compound.
Pharmacology for nizatidine
Medical Subject Heading (MeSH) Categories for nizatidine

US Patents and Regulatory Information for nizatidine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz NIZATIDINE nizatidine CAPSULE;ORAL 076178-002 Jul 5, 2002 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ani Pharms Inc NIZATIDINE nizatidine CAPSULE;ORAL 075668-001 Sep 12, 2002 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc NIZATIDINE nizatidine CAPSULE;ORAL 075934-002 Jul 9, 2002 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ani Pharms Inc NIZATIDINE nizatidine CAPSULE;ORAL 075461-001 Jul 8, 2002 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ani Pharms Inc NIZATIDINE nizatidine CAPSULE;ORAL 075668-002 Sep 12, 2002 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc NIZATIDINE nizatidine CAPSULE;ORAL 076383-001 Jan 23, 2003 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer AXID AR nizatidine TABLET;ORAL 020555-001 May 9, 1996 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-002 Apr 12, 1988 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ani Pharms Inc NIZATIDINE nizatidine CAPSULE;ORAL 075461-002 Jul 8, 2002 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd NIZATIDINE nizatidine CAPSULE;ORAL 077314-002 Sep 15, 2005 AB RX 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

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Expired US Patents for nizatidine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-001 Apr 12, 1988 ➤ Sign Up ➤ Sign Up
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-002 Apr 12, 1988 ➤ Sign Up ➤ Sign Up
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-002 Apr 12, 1988 ➤ Sign Up ➤ Sign Up
Pfizer AXID AR nizatidine TABLET;ORAL 020555-001 May 9, 1996 ➤ Sign Up ➤ Sign Up
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-002 Apr 12, 1988 ➤ Sign Up ➤ Sign Up
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-001 Apr 12, 1988 ➤ Sign Up ➤ Sign Up
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-001 Apr 12, 1988 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
AstraZeneca
Merck
US Department of Justice
Accenture
Healthtrust
Teva
US Army
Medtronic

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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