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
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	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
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004		DISCN	Yes	No
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	022283-001	Jun 17, 2013		OTC	Yes	Yes
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-002	Feb 27, 2006		DISCN	Yes	No

Expired US Patents for ZEGERID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santarus	ZEGERID	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET, CHEWABLE;ORAL	021850-001	Mar 24, 2006	6,699,885
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-002	Feb 27, 2006	6,699,885
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-001	Feb 27, 2006	6,699,885
Santarus	ZEGERID	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET, CHEWABLE;ORAL	021850-001	Mar 24, 2006	7,399,772
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	7,399,772

International Patents for ZEGERID

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

Country	Patent Number	Title	Estimated Expiration
Israel	150696	PHARMACEUTICAL COMPOSITIONS CONTAINING BENZIMIDAZOLE DERIVATIVES AND PROCESSES FOR THE MANUFACTURE THEREOF
Israel	159725
Mexico	PA04000223	FORMAS DE DOSIS DE BENCIMIDAZOL SUBSTITUIDAS NOVEDOSAS Y METODO PARA USAR LAS MISMAS. (NOVEL SUBSTITUTED BENZIMIDAZOLE DOSAGE FORMS AND METHOD OF USING SAME.)
Spain	2275650
Poland	357144

Supplementary Protection Certificates for ZEGERID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1020461	300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
1499331	122014000007	Germany		PRODUCT NAME: NATRIUMSULFAT, MAGNESIUMSULFAT UND KALIUMSULFAT; NAT. REGISTRATION NO/DATE: 86203.00.00 20130808; FIRST REGISTRATION: BELGIEN BE434323 20130220
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220

ZEGERID: Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

ZEGERID (omeprazole/sodium bicarbonate) is a marketed proton pump inhibitor (PPI) product in the U.S. that competes in a mature, high-generic-share segment for acid suppression. Its market dynamics are driven by patent/market exclusivity expiry effects, payer-driven generic substitution, and franchise competition within PPIs. Financial trajectory indicators in this class are typically tied to unit volume declines after generic entry, ongoing pricing compression, and partial offsets from brand lifecycle actions (labeling, pack/brand extensions, and channel strategy). Public, audited financial metrics by product for ZEGERID itself are not consistently disclosed in accessible sources, so the most reliable market-facing trajectory view is built from (1) U.S. formulary and generic-share behavior patterns for PPIs and (2) the branded-to-generic market transition timeline for omeprazole bicarbonate products.

What drives ZEGERID’s market demand?

1) Core indication concentration and class substitution

ZEGERID is positioned for acid-related gastrointestinal conditions where PPIs are clinically interchangeable at the class level. That structure shifts demand away from molecule-specific brand differentiation toward:

• Plan formularies that steer patients to lowest net cost PPI options
• Automatic substitution to lower-priced generics by pharmacy benefit design
• Switching behavior among prescribers driven by guideline-concordant efficacy within the PPI class

The implication for ZEGERID is stable underlying class demand, but weaker brand retention once low-cost entrants dominate the tiering.

2) Payer economics and net price pressure

In mature PPI markets, brand margins compress as:

• Generic entrants expand across dosage forms
• PBMs negotiate rebates based on net cost benchmarks
• Copay tiers and preferred drug lists push utilization toward generics

For ZEGERID, this typically shows up as declining share at launch-to-follow-on time horizons after generic penetration, followed by stabilization at a reduced branded share.

3) Delivery-form and timing as a tactical differentiation

The sodium bicarbonate component is designed to affect onset characteristics versus delayed-release omeprazole-only products. In practice, that creates a narrower differentiation wedge:

• Used where clinicians or payers view formulation-driven onset as beneficial
• Retained selectively on formularies compared with equivalent generic-only options, when managed-care exceptions are granted

This tends to slow, but not stop, the overall brand share erosion once generic substitution is entrenched.

How does competition shape ZEGERID’s trajectory?

Competition set

ZEGERID competes inside a dense PPI and immediate/rapid-onset acid suppression landscape. The competitive set includes:

• Other branded PPIs with historical claims-based share retention (depending on period)
• Low-cost generics spanning omeprazole and multiple PPIs (e.g., pantoprazole, lansoprazole, esomeprazole)
• Reformulations and brand extensions that attempt to protect managed-care access

Competitive mechanisms

ZEGERID’s market share outcome depends on how often it is:

• Placed on non-preferred tiers
• Excluded from preferred status in response to PBM contracting cycles
• Replaced at pharmacy counter by AB-rated generics

Because PPIs are broadly interchangeable for many indications, the competitive battlefield is pricing and access, not pharmacologic superiority.

What does the market lifecycle imply for ZEGERID’s financial performance?

Expected financial pattern after generic penetration

For PPIs, branded product revenue typically follows a repeatable pattern:

1. Pre-generic or early transition: higher net revenue, rebate-driven managed-care contracts maintain some share
2. Generic entry and expansion: revenue declines as scripts move to generics, with net price falling
3. Late-stage maturity: revenue stabilizes at a lower base if the brand retains any formulary or clinical niche access

For ZEGERID, this lifecycle is consistent with a mature PPI brand profile: market demand exists, but brand monetization declines as unit mix shifts to generics.

Key financial metrics that tend to move

Even without ZEGERID-only audited statements, financial trajectory for PPI brands generally reflects:

• Prescription volume decline after generic substitution
• Net price per unit compression from rebate resets and competitive contracting
• Channel mix shifts (retail vs mail order) as PBMs manage utilization

ZEGERID’s U.S. commercial standing

Public product and regulatory documentation establishes ZEGERID as an approved PPI formulation with active commercial presence in the U.S., including pediatric-related labeling that can influence physician selection and coverage decisions. ZEGERID’s approval and labeling framework is documented in the FDA product labeling record. (See FDA labeling and product listing sources below.)

Market dynamics at a glance (PPI franchise mechanics)

The following mechanics typically govern branded PPI revenue trajectories after generic entry:

Driver	What changes in the market	Likely ZEGERID impact
PBM formulary positioning	Movement to non-preferred tiers	Share loss and lower net revenue
Generic substitution	Pharmacy counter replacement with AB-rated products	Unit volume compression
Net price and rebates	Contract resets based on lowest-cost benchmarks	Margin pressure
Clinical switching	Prescribers switch to preferred PPI generics	Sustained demand shift away from brand
Niche access	Some continued use where formulation timing matters	Partial revenue stabilization vs total collapse

Financial trajectory framework for ZEGERID (investment-use view)

Since ZEGERID’s standalone audited financials are not reliably available from public filings in a product-level form across time, the actionable approach for decision-makers is to map it to observable market outcomes in PPI:

Trajectory stages

• Stage A: High brand access
  Brand revenue linked to protected contracting and brand-preferred positioning.
• Stage B: Generics scale-up
  Revenue declines accelerate; net price drops and rebate intensity often rises.
• Stage C: Mature low-share stability
  Brand revenue plateaus; trend becomes slower and driven by ongoing niche retention and pediatric/label-specific use.

What to watch to infer the trajectory

For ZEGERID, the most decision-useful indicators are:

• Formulary coverage changes by major PBMs
• AB substitution rates for the relevant strength and formulation
• Prescription trends in retail and mail channels for PPI category, especially omeprazole-based products
• Pricing disclosures and pharmacy reimbursement behavior that reflect net price compression

Key implications for strategy and budgeting

For R&D, licensing, or acquisition decisions tied to ZEGERID-like assets, the commercial reality is that:

• Revenue growth is unlikely without differentiated clinical or payer value beyond standard PPI performance.
• Competitive access is the dominant lever post-generic entry.
• Formulation-based onset claims can matter, but the durability of those claims in managed care is limited unless supported by payer economics and outcomes data.

Key Takeaways

• ZEGERID operates in a mature PPI market where branded revenue is structurally exposed to generic substitution and payer-driven tiering.
• The financial trajectory is typically a post-generic decline followed by stabilization at reduced branded share, with net price compression and unit volume loss as the primary mechanisms.
• Formulation and label specificity can slow erosion in niche segments, but they rarely reverse the broader managed-care substitution trend for PPIs.
• The most actionable proxy indicators for ZEGERID’s trajectory are formulary placement, AB substitution behavior, and category prescription trend movement for omeprazole-based PPIs.

FAQs

1) Is ZEGERID’s revenue driven by new clinical differentiation or by managed-care access?

Managed-care access and formulary placement drive the dominant part of revenue outcomes in mature PPI markets; differentiation can influence niche prescribing but typically cannot offset generic substitution at scale.

2) What typically happens to branded PPI prices after generic entry?

Net price compresses through rebate renegotiations and PBM contracting against lowest-cost alternatives, reducing brand revenue per unit even if some share remains.

3) Does pediatric or label-specific use change ZEGERID’s market trajectory?

It can improve retention in targeted prescriber and coverage segments, but it generally supports a slower decline rather than a high-growth profile once generics dominate the formulary.

4) Which market signals best indicate ZEGERID’s direction?

Formulary tiering changes, AB substitution patterns, and PPI category prescription trends tied to omeprazole-based products.

5) Where does competitive pressure come from?

From generic omeprazole and competing PPIs within the managed-care preferred list framework, plus ongoing PBM renegotiations that shift utilization toward the lowest net cost.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). ZEGERID (omeprazole and sodium bicarbonate) prescribing information / label. FDA label and drug database records. https://www.accessdata.fda.gov/