NIZATIDINE Drug Patent Profile
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Which patents cover Nizatidine, and what generic alternatives are available?
Nizatidine is a drug marketed by Ani Pharms, Apotex Inc, Dr Reddys Labs Ltd, Epic Pharma Llc, Glenmark Pharms Inc, Mylan Pharms Inc, Norvium Bioscience, Watson Labs, and Amneal Pharms. and is included in ten NDAs.
The generic ingredient in NIZATIDINE is nizatidine. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nizatidine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nizatidine
A generic version of NIZATIDINE was approved as nizatidine by EPIC PHARMA LLC on July 5th, 2002.
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Questions you can ask:
- What is the 5 year forecast for NIZATIDINE?
- What are the global sales for NIZATIDINE?
- What is Average Wholesale Price for NIZATIDINE?
Summary for NIZATIDINE
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 10 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 82 |
| Clinical Trials: | 9 |
| Patent Applications: | 5,941 |
| Drug Prices: | Drug price information for NIZATIDINE |
| DailyMed Link: | NIZATIDINE at DailyMed |
Recent Clinical Trials for NIZATIDINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Daewoong Pharmaceutical Co. LTD. | Phase 4 |
| National Center for Research Resources (NCRR) | Phase 1 |
| Adil Bharucha | Phase 1 |
Pharmacology for NIZATIDINE
| Drug Class | Histamine-2 Receptor Antagonist |
| Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for NIZATIDINE
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | NIZATIDINE | nizatidine | CAPSULE;ORAL | 075461-001 | Jul 8, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | NIZATIDINE | nizatidine | CAPSULE;ORAL | 075616-002 | Jul 9, 2002 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys Labs Ltd | NIZATIDINE | nizatidine | CAPSULE;ORAL | 077314-001 | Sep 15, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ani Pharms | NIZATIDINE | nizatidine | CAPSULE;ORAL | 075668-002 | Sep 12, 2002 | DISCN | 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 |
