ZEGERID Drug Patent Profile

Which patents cover Zegerid, and when can generic versions of Zegerid launch?

Zegerid is a drug marketed by Salix, Santarus, and Riley Consumer. and is included in five NDAs.

The generic ingredient in ZEGERID is magnesium hydroxide; omeprazole; sodium bicarbonate. There are one hundred and forty-six drug master file entries for this compound. Additional details are available on the magnesium hydroxide; omeprazole; sodium bicarbonate profile page.

Summary for ZEGERID

US Patents:	0
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	225
Clinical Trials:	13
Patent Applications:	3,524
Drug Prices:	Drug price information for ZEGERID
What excipients (inactive ingredients) are in ZEGERID?	ZEGERID excipients list
DailyMed Link:	ZEGERID at DailyMed

See drug prices for ZEGERID

Recent Clinical Trials for ZEGERID

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

Sponsor	Phase
Syndax Pharmaceuticals	Phase 1
Population Health Research Institute	Phase 3
Norgine	Phase 3

See all ZEGERID clinical trials

Pharmacology for ZEGERID

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Alkalinizing Activity Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Paragraph IV (Patent) Challenges for ZEGERID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZEGERID	Powder for Oral Suspension	omeprazole; sodium bicarbonate	20mg/1680mg per packet	021636	1	2007-11-13
ZEGERID	Powder for Oral Suspension	omeprazole; sodium bicarbonate	40 mg/1680 mg per packet	021636	1	2007-08-24
ZEGERID	Capsules	omeprazole; sodium bicarbonate	20 mg/1100 mg and 40 mg/1100 mg	021849	1	2007-04-30

US Patents and Regulatory Information for ZEGERID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004		DISCN	Yes	No
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-001	Feb 27, 2006		DISCN	Yes	No
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009		OTC	Yes	Yes
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	022283-001	Jun 17, 2013		OTC	Yes	Yes

Expired US Patents for ZEGERID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004
Santarus	ZEGERID	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET, CHEWABLE;ORAL	021850-002	Mar 24, 2006
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004

International Patents for ZEGERID

See the table below for patents covering ZEGERID around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2003214858
Eurasian Patent Organization	200400966
European Patent Office	1927354
Norway	20040072

Supplementary Protection Certificates for ZEGERID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1499331	122014000007	Germany		PRODUCT NAME: NATRIUMSULFAT, MAGNESIUMSULFAT UND KALIUMSULFAT; NAT. REGISTRATION NO/DATE: 86203.00.00 20130808; FIRST REGISTRATION: BELGIEN BE434323 20130220
0984957	C300483	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
0984957	CR 2012 00035	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
0124495	SPC/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727

Market Dynamics and Financial Trajectory for Zegerid

Introduction to Zegerid

Zegerid, a brand name for omeprazole, is a proton pump inhibitor (PPI) used to treat various gastrointestinal conditions, including gastroesophageal reflux disease (GERD), duodenal ulcers, and gastric ulcers. Here’s a detailed look at the market dynamics and financial trajectory of Zegerid.

Market Size and Growth

The omeprazole market, which includes Zegerid, is projected to experience significant growth. As of 2023, the omeprazole market size was valued at USD 1.06 billion and is expected to cross USD 2.38 billion by 2036, growing at a CAGR of more than 6.4% during the forecast period of 2024-2036[1].

Growth Drivers

Several factors are driving the growth of the omeprazole market, including:

• Increasing Chronic Diseases: The global rise in chronic diseases such as cancer, diabetes, and respiratory ailments is boosting the demand for omeprazole. By 2050, these diseases are expected to account for 90% of all global fatalities, according to the WHO[1].
• Clinical Trials and Therapeutic Uses: Positive results from clinical trials, such as those for H. pylori elimination therapy, are anticipated to increase the demand for omeprazole. For example, RedHill Biopharma's Talicia capsule, which combines antibiotics and a proton pump inhibitor, has shown promising results[1].
• Changing Lifestyles: Increasing stress levels, excessive intake of alcohol, aerated drinks, and fast food, especially among the younger generation, are contributing to the rising prevalence of gastrointestinal diseases like GERD[3].

Dosage Forms and Preferences

The market is segmented by dosage forms, with capsules expected to dominate the market. The capsule segment is projected to occupy 52% of the market share by 2036 and is expected to cross USD 1.8 billion by the end of 2036. Tablets, although easy to handle and inexpensive, are also a significant part of the market[1].

Regional Market Dynamics

The Asia Pacific region is expected to hold a significant share of the omeprazole market, driven by greater awareness and growing incidences of gastrointestinal diseases. The region's market growth is also fueled by key market players expanding their product portfolios and increasing demand for over-the-counter and generic medications[1].

Competitive Landscape

The GERD drugs and devices market, which includes omeprazole, is competitive with several major players. Companies like AstraZeneca, Bausch Health, and others are actively involved in research and development, as well as strategic acquisitions to enhance their market presence. For instance, AstraZeneca's acquisition of Alexion has significantly impacted their financial performance and growth outlook[5].

Financial Performance

The financial trajectory of Zegerid and similar PPIs is influenced by the overall performance of the pharmaceutical companies that produce them. Here are some key financial insights:

• Revenue Growth: The global GERD drugs and devices market, which includes omeprazole, was valued at USD 5.21 billion in 2020 and is expected to reach USD 6.28 billion by 2028, growing at a CAGR of 2.3% during the forecast period[3].
• Company Performance: Companies like Bausch Health have reported significant revenue growth, with a 10% increase in total revenue from 2020 to 2021. However, the specific financial performance of Zegerid would depend on the sales data of the company that manufactures it[2].

Challenges and Opportunities

Despite the growth potential, there are challenges to consider:

• Generic Competition: The availability of generic versions of omeprazole can impact the sales of branded products like Zegerid.
• Regulatory Environment: Changes in regulatory policies and healthcare reforms can affect the market dynamics.
• Research and Development: Continuous investment in R&D is crucial to stay competitive and address emerging health needs[1][3].

Key Takeaways

• The omeprazole market, including Zegerid, is expected to grow significantly due to increasing chronic diseases and positive clinical trial results.
• The Asia Pacific region is a key growth area driven by increasing awareness and demand for gastrointestinal treatments.
• The market is competitive, with major players investing in R&D and strategic acquisitions.
• Financial performance is influenced by overall market trends and company-specific strategies.

FAQs

What is the projected market size of omeprazole by 2036?

The omeprazole market is expected to cross USD 2.38 billion by the end of 2036[1].

Which region is expected to drive the growth of the omeprazole market?

The Asia Pacific region is expected to hold a significant share and drive market growth due to increasing awareness and demand for gastrointestinal treatments[1].

What are the primary dosage forms of omeprazole?

The primary dosage forms are capsules, tablets, and powder, with capsules expected to dominate the market[1].

What factors are driving the growth of the GERD drugs and devices market?

Key factors include the increasing geriatric population, rising prevalence of gastrointestinal diseases, changing lifestyles, and growing demand for generic and over-the-counter drugs[3].

Which companies are major players in the GERD drugs and devices market?

Major companies include AstraZeneca, Bausch Health, and others involved in research and development and strategic acquisitions[2][5].

Cited Sources:

1. Research Nester: Omeprazole Market Size & Share | Growth Forecasts 2036
2. Bausch Health Companies Inc.: 4Q & FY 2021 - Financial Results
3. Emergen Research: GERD Drugs and Devices Market Size to Reach USD 6.28 Billion in 2028
4. GlobalData: Net Present Value Model: Zegerid
5. AstraZeneca PLC: Full year and Q4 2021 results