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 Pharms Inc, Mylan Pharms Inc, Norvium Bioscience, 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. Four suppliers are listed for this compound.
Summary for nizatidine
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 12 |
NDAs: | 13 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 82 |
Clinical Trials: | 9 |
Patent Applications: | 7,153 |
Drug Prices: | Drug price trends for nizatidine |
What excipients (inactive ingredients) are in nizatidine? | nizatidine excipients list |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Pharms Inc | NIZATIDINE | nizatidine | CAPSULE;ORAL | 075934-001 | Jul 9, 2002 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Glenmark Pharms Inc | NIZATIDINE | nizatidine | CAPSULE;ORAL | 090618-002 | Jul 15, 2011 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Ani Pharms | NIZATIDINE | nizatidine | CAPSULE;ORAL | 075668-001 | Sep 12, 2002 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Braintree | AXID | nizatidine | SOLUTION;ORAL | 021494-001 | May 25, 2004 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Glenmark Pharms Inc | NIZATIDINE | nizatidine | CAPSULE;ORAL | 090618-001 | Jul 15, 2011 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>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 | 019508-002 | Apr 12, 1988 | 4,382,090 | ⤷ Subscribe |
Smithkline Beecham | AXID | nizatidine | CAPSULE;ORAL | 019508-001 | Apr 12, 1988 | 4,375,547 | ⤷ Subscribe |
Braintree | AXID | nizatidine | SOLUTION;ORAL | 021494-001 | May 25, 2004 | 6,930,119 | ⤷ Subscribe |
Smithkline Beecham | AXID | nizatidine | CAPSULE;ORAL | 019508-002 | Apr 12, 1988 | 4,760,075 | ⤷ Subscribe |
Smithkline Beecham | AXID | nizatidine | CAPSULE;ORAL | 019508-002 | Apr 12, 1988 | 4,375,547 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Nizatidine Market Analysis and Financial Projection Experimental
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