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Last Updated: March 28, 2024

Nizatidine - Generic Drug Details


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

Nizatidine is the generic ingredient in three branded drugs marketed by Smithkline Beecham, Ani Pharms, Apotex Inc, Dr Reddys Labs Ltd, Epic Pharma Llc, Glenmark Generics, Mylan Pharms Inc, Watson Labs, Braintree, Amneal Pharms, and Haleon Us Holdings, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for nizatidine

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Recent Clinical Trials for nizatidine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Daewoong Pharmaceutical Co. LTD.Phase 4
National Center for Research Resources (NCRR)Phase 1
Adil BharuchaPhase 1

See all nizatidine clinical trials

Pharmacology for nizatidine
Medical Subject Heading (MeSH) Categories for nizatidine
Paragraph IV (Patent) Challenges for NIZATIDINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AXID Oral Solution nizatidine 15 mg/mL 021494 1 2008-05-14

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
Watson Labs NIZATIDINE nizatidine CAPSULE;ORAL 075616-002 Jul 9, 2002 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings AXID AR nizatidine TABLET;ORAL 020555-001 May 9, 1996 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms NIZATIDINE nizatidine CAPSULE;ORAL 075668-002 Sep 12, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Braintree AXID nizatidine SOLUTION;ORAL 021494-001 May 25, 2004 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms NIZATIDINE nizatidine CAPSULE;ORAL 075461-001 Jul 8, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-002 Apr 12, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms NIZATIDINE nizatidine CAPSULE;ORAL 075461-002 Jul 8, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Try a Trial ⤷  Try a Trial
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-002 Apr 12, 1988 ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings AXID AR nizatidine TABLET;ORAL 020555-001 May 9, 1996 ⤷  Try a Trial ⤷  Try a Trial
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-001 Apr 12, 1988 ⤷  Try a Trial ⤷  Try a Trial
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-002 Apr 12, 1988 ⤷  Try a Trial ⤷  Try a Trial
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-002 Apr 12, 1988 ⤷  Try a Trial ⤷  Try a Trial
Smithkline Beecham AXID nizatidine CAPSULE;ORAL 019508-001 Apr 12, 1988 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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