NIZATIDINE - Generic Drug Details

What are the generic drug sources for nizatidine and what is the scope of freedom to operate?

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

See drug prices for NIZATIDINE

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

See all NIZATIDINE clinical trials

Pharmacology for NIZATIDINE

Drug Class	Histamine-2 Receptor Antagonist
Mechanism of Action	Histamine H2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for NIZATIDINE

Anti-Ulcer Agents

Histamine H2 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for NIZATIDINE

A02BA	H2-receptor antagonists
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

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
Glenmark Pharms Inc	NIZATIDINE	nizatidine	CAPSULE;ORAL	090618-002	Jul 15, 2011	AB	RX	No	No
Ani Pharms	NIZATIDINE	nizatidine	CAPSULE;ORAL	075668-001	Sep 12, 2002		DISCN	No	No
Braintree	AXID	nizatidine	SOLUTION;ORAL	021494-001	May 25, 2004		DISCN	Yes	No
Glenmark Pharms Inc	NIZATIDINE	nizatidine	CAPSULE;ORAL	090618-001	Jul 15, 2011	AB	RX	No	No

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
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-001	Apr 12, 1988	4,375,547
Braintree	AXID	nizatidine	SOLUTION;ORAL	021494-001	May 25, 2004	6,930,119
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-002	Apr 12, 1988	4,760,075
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-002	Apr 12, 1988	4,375,547

NIZATIDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nizatidine

Introduction to Nizatidine

Nizatidine is a histamine H2 receptor antagonist, initially developed by Eli Lilly & Co., and is widely used to treat various gastrointestinal disorders such as peptic ulcers, gastric ulcers, duodenal ulcers, and gastroesophageal reflux disease (GERD)[2].

Market Size and Forecast

The global market for nizatidine is experiencing significant growth. As of 2021, the market value was estimated at approximately USD 5.1 billion, and it is projected to reach USD 12.2 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 9% during the 2021-2031 period[1].

Another forecast suggests that the nizatidine market was valued at USD 5.40 billion in 2022 and is expected to reach USD 10.85 billion by 2030, growing at a CAGR of 7.93% from 2023 to 2030[4].

Key Drivers of Market Growth

Rising Prevalence of Gastrointestinal Disorders

The increasing prevalence of gastrointestinal disorders such as peptic ulcers, gastric ulcers, and GERD is a major driver of the nizatidine market. For instance, peptic ulcer disease affects approximately four million people globally each year, with a lifetime prevalence of 5-10% in the general population[4].

Aging Population

The aging population is more susceptible to gastrointestinal disorders, which further fuels the demand for nizatidine. The growing elderly population, particularly in regions like North America, contributes significantly to the market growth[4].

Research and Development

Ongoing research and development activities aimed at improving the formulation and efficacy of nizatidine also drive market growth. For example, nizatidine is being investigated for its anti-inflammatory effects and potential use in developing anti-viral drugs, including those to counter the COVID-19 pandemic[1].

Market Segmentation

By Type

The nizatidine market is segmented into nizatidine capsules, nizatidine tablets, and other types. Nizatidine capsules are expected to witness huge demand, growing at a CAGR of over 10% from 2021 to 2031. This is due to their faster absorption and quicker onset of action compared to tablets[1][4].

By Distribution Channel

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies currently hold the highest share, ensuring accurate dosing, controlled dispensing, and expert pharmacist support. However, sales through retail and online pharmacies are expanding rapidly, with a CAGR of about 14%, due to the convenience and accessibility they offer[1][4].

Geographical Analysis

North America

North America contributes the highest share to the global nizatidine market, driven by the high prevalence of ulcers and GERD, particularly among the aging population. The region's robust healthcare infrastructure and high healthcare expenditure also play a significant role[4].

India

India is another key market, expected to grow at a CAGR of 8.5% by 2031. India is the world's largest provider of generic medications, and the home market is predicted to grow threefold by 2031, with medicine spending expected to increase by more than 9%[1].

United States

In the U.S., the market is driven by the high incidence of digestive diseases, with over 20 million hospitalizations annually. Companies like Amneal Pharmaceuticals Inc. have been given permission to resume sales of their nizatidine oral solutions, indicating potential future growth. The U.S. market is expected to grow at a CAGR of 7.2% until 2031[1].

Competitive Landscape

The nizatidine market is competitive, with several key players including:

• Glenmark Pharmaceuticals
• Dr. Reddy's Laboratories
• Strides Pharma Science
• Mylan
• MedChemExpress
• Weightech (Hunan) Pharmaceutical
• Hengdian Group
• Lilly
• Chongqing Zhien Pharmaceutical
• Changzhou Sailu Industry[4].

These companies are involved in various strategies such as product benchmarking, SWOT analysis, and innovation to maintain their market position.

Distribution and Sales Channels

While hospital pharmacies remain the primary source of nizatidine, sales through retail and online pharmacies are growing rapidly. The convenience and accessibility offered by these channels are making them increasingly popular among consumers[1][4].

Challenges and Opportunities

Regulatory Approvals

Regulatory approvals play a crucial role in the growth of the nizatidine market. Expedited approvals in regions like India are expected to attract more players into the market, driving growth[1].

Generic Medications

The trend towards generic medications is also a significant factor. States are encouraging the use of lower-cost generic drugs, which can impact the market dynamics of branded nizatidine products[3].

Key Takeaways

• The global nizatidine market is projected to grow significantly, driven by the rising prevalence of gastrointestinal disorders and the aging population.
• Nizatidine capsules are expected to dominate the market due to their faster absorption and quicker onset of action.
• North America and India are key regions driving market growth.
• The market is highly competitive, with several major pharmaceutical companies involved.
• Sales through retail and online pharmacies are expanding rapidly due to convenience and accessibility.

FAQs

1. What is the primary use of nizatidine?

Nizatidine is primarily used to treat gastrointestinal disorders such as peptic ulcers, gastric ulcers, duodenal ulcers, and gastroesophageal reflux disease (GERD) by acting as an H2 receptor antagonist to reduce stomach acid production.

2. What is the projected market size of nizatidine by 2031?

The global market for nizatidine is expected to reach approximately USD 12.2 billion by 2031, growing at a CAGR of 9% from 2021 to 2031[1].

3. Which region is expected to grow the most in the nizatidine market?

India is expected to witness high growth, with the market poised to surge at a CAGR of 8.5% by 2031, driven by its status as the world's largest provider of generic medications and increasing medicine spending[1].

4. What are the key distribution channels for nizatidine?

The key distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies. While hospital pharmacies currently hold the highest share, sales through retail and online pharmacies are growing rapidly[1][4].

5. Which companies are major players in the nizatidine market?

Major players include Glenmark Pharmaceuticals, Dr. Reddy's Laboratories, Strides Pharma Science, Mylan, MedChemExpress, and others[4].

Cited Sources:

1. Fact.MR - Nizatidine Market Size, Share, Growth Forecast to 2031
2. Patsnap Synapse - Nizatidine: Drug Targets, Indications, Patents
3. Medicaid.gov - National Medicaid Fee-For-Service Drug Utilization Review
4. Verified Market Research - Nizatidine Market Size, Share, Trends, Opportunities & Forecast