PROTONIX Drug Patent Profile

Which patents cover Protonix, and what generic alternatives are available?

Protonix is a drug marketed by Wyeth Pharms and is included in three NDAs. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-five patent family members in twenty-eight countries.

The generic ingredient in PROTONIX is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Protonix

A generic version of PROTONIX was approved as pantoprazole sodium by DR REDDYS LABS LTD on January 19^th, 2011.

Summary for PROTONIX

International Patents:	35
US Patents:	4
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	32
Patent Applications:	4,084
Drug Prices:	Drug price information for PROTONIX
Drug Sales Revenues:	Drug sales revenues for PROTONIX
What excipients (inactive ingredients) are in PROTONIX?	PROTONIX excipients list
DailyMed Link:	PROTONIX at DailyMed

See drug prices for PROTONIX

See drug sales revenues for PROTONIX

Recent Clinical Trials for PROTONIX

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

Sponsor	Phase
Pfizer	Phase 2
Mirati Therapeutics Inc.	Phase 1
Assiut University	Phase 2

See all PROTONIX clinical trials

Pharmacology for PROTONIX

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Paragraph IV (Patent) Challenges for PROTONIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROTONIX	for Delayed-release Oral Suspension	pantoprazole sodium	40 mg	022020	1	2019-09-13
PROTONIX	Delayed-release Tablets	pantoprazole sodium	20 mg and 40 mg	020987		2004-02-02

US Patents and Regulatory Information for PROTONIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	PROTONIX	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022020-001	Nov 14, 2007	AB	RX	Yes	Yes					Y
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001	AP	RX	Yes	Yes
Wyeth Pharms	PROTONIX	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022020-001	Nov 14, 2007	AB	RX	Yes	Yes					Y
Wyeth Pharms	PROTONIX	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022020-001	Nov 14, 2007	AB	RX	Yes	Yes					Y

Expired US Patents for PROTONIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987-001	Feb 2, 2000
Wyeth Pharms	PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987-002	Jun 12, 2001
Wyeth Pharms	PROTONIX	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022020-001	Nov 14, 2007
Wyeth Pharms	PROTONIX	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022020-001	Nov 14, 2007

International Patents for PROTONIX

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

Country	Patent Number	Title	Estimated Expiration
Singapore	146656	PANTOPRAZOLE MULTIPARTICULATE FORMULATIONS
Japan	S6122079	DIALKOXYPYRIDINE, MANUFACTURE, USE AND DRUG
Ireland	77640	Oral presentation forms for acid-unstable active compounds
World Intellectual Property Organization (WIPO)	9222284

Supplementary Protection Certificates for PROTONIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0166287	96C0033	Belgium		PRODUCT NAME: EPTACOG ALFA (ACTIVATED); REGISTRATION NO/DATE: EU/1/96/006/002 19960223
0166287	96C0032	Belgium		PRODUCT NAME: PANTOPRAZOL. NATR. SESQUIHYDRAS PANTOPRAZOLE; NAT. REGISTRATION NO/DATE: 127 IS 98 F 3 19960222; FIRST REGISTRATION: SE 12131 19940506
0166287	SPC/GB96/056	United Kingdom		PRODUCT NAME: PANTOPRAZOLE AND ITS SALTS, HYDRATES AND HYDRATES OF ITS SALTS; REGISTERED: SE SE12131 19940506; UK 04889/0010 19960604

Market Dynamics and Financial Trajectory for Protonix (Pantoprazole)

Last updated: December 30, 2025

Executive Summary

Protonix (pantoprazole), a proton pump inhibitor (PPI), remains a critical player in the treatment of acid-related gastrointestinal disorders. Despite saturation within established markets, Protonix’s market dynamics are influenced by factors such as patent expirations, generic competition, evolving treatment guidelines, and emerging therapeutic alternatives. Its financial trajectory is characterized by initial high revenue, subsequent decline post-generic entry, and ongoing strategies to sustain market share via formulations and indications. This analysis details Protonix’s market structure, competitive landscape, revenue trends, and future outlook, providing strategic insights for stakeholders.

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What Are the Basic Characteristics and Market Position of Protonix?

Product Overview

Attribute	Details
Generic Name	Pantoprazole
Formulations	Oral tablets (40 mg, 20 mg), injectable (IV)
Therapeutic Class	Proton pump inhibitor (PPI)
Indications	Gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, erosive esophagitis, other acid-related disorders
Market Launch	1996 (original brand)
Manufacturers	Originally Wyeth, now Pfizer; various generics

Market Share and Revenue Highlights

Year	Total Protonix Revenue (USD millions)	Brand/Patent Status	Key Competitors
2011	~$1,000	Patent protected; exclusive sales	Nexium, Prilosec, Omeprazole
2012	Revenue decline begins	Patent expiry (June 2014) in U.S.	Generic entrants emerge
2016+	Declining revenues, stabilization with generics	Extended formulations and indications	Ongoing generic erosion

Source: IMS Health data, company filings, and analyst reports [1].

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What Factors Drive Protonix’s Market Dynamics?

Patent Expiration and Generic Competition

• Patent Timeline: Pfizer’s Protonix patent expired in the U.S. on June 16, 2014, allowing numerous generic manufacturers to enter the market.
• Impact: Generics now capture a significant portion of the market, causing Protonix’s revenues to decline sharply post-2014.
• Generic Market Penetration: By 2018, generics accounted for approximately 85-90% of the PPI prescriptions, drastically reducing Protonix’s market share [2].

Evolving Treatment Paradigms

• Therapeutic Alternatives: Newer PPIs (e.g., Esomeprazole/Nexium), H2 receptor antagonists, and novel therapies have diversified treatment options.
• Guideline Changes: American Gastroenterological Association (AGA) and other bodies favor generic PPIs due to cost considerations, limiting branded PPI prescriptions.
• Reimbursement & Cost Pressures: Insurance policies favor formulary-preferred generics, reducing Protonix prescriptions.

Market Segmentation and Indications

• Hospital vs. Outpatient: Protonix has retained a foothold in hospital settings via its injectable form, especially for acute gastric acid suppression.
• Specialty Use: Limited maintenance therapy roles in refractory cases or specific indications like Zollinger-Ellison syndrome sustain niche demand.

Regulatory and Policy Environment

• FDA Regulations: Post-patent, the need for bioequivalence and generic approval processes accelerated.
• Pricing and Sales Policies: Price erosion driven by competitive bidding, especially in institutional settings, affects revenues.

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What Is Protonix’s Financial Trajectory?

Revenue Trends Over Time

Year Range	Revenue (USD millions)	Key Factors	Remarks
1996–2010	Steady growth, high revenues (~$1B)	Patent-protected period	Peak sales driven by brand dominance
2011–2013	Plateauing, slight decline	Patent nearing expiry	Regulatory and patent challenges
2014–2018	Sharp decline (~50–60%)	Patent expiry, generic entry	Increased competition, price erosion
2019–2022	Stabilization at low levels	Generics dominate, niche hospital use	Focus on injectables and special indications

Note: Pfizer’s pharmaceutical segment reported a decline in Protonix revenue from $938 million (2010) to under $200 million (2022) [3].

Current Revenue Breakdown

Segment	Approximate Market Share	Remarks
Oral Tablets (Prescriptions)	~20-30%	Dominated by generics
Injectable (IV) formulations	~70-80%	Niche, hospital-focused

Profitability & Cost Dynamics

• Pricing Pressure: Prices for generic pantoprazole have fallen roughly 80% since 2014.
• Manufacturing Costs: Maintaining injectable formulations incurs higher costs but secures hospital contracts.
• Patent Litigation & Settlements: Some revenue persistence through patent litigation settlements prior to expiry.

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How Does Protonix Compare to Competitors and Market Alternatives?

Major Competitors and Their Strategies

Competitor	Product(s)	Market Strategy	Market Share (Estimates)	Key Advantages
Nexium (Esomeprazole)	Esomeprazole (brand, generic)	Stronger acid suppression claims	~40-50% of PPI prescriptions	Higher efficacy claims, aggressive marketing
Prilosec (Omeprazole)	Omeprazole (generic, OTC)	First generic PPI, widespread use	~20-25% of PPI prescriptions	Cost-effective, well-established
Others (Lansoprazole, Dexlansoprazole)	Various	Diversified offerings	Remaining share	Niche benefits, different dosing regimens

Market Growth and Future Outlook

Factor	Impact on Protonix	Notes
Emerging Therapeutics	Potential competition or substitution	Novel agents targeting specific pathways (e.g., potassium-competitive acid blockers)
Biosimilars & Orphan Indications	Limited direct impact	Minimal currently but potential future acceleration
Digital & Precision Medicine	Disruptive potential	Personalized therapies could reshape PPI demand

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What Are the Strategic Considerations for Stakeholders?

For Manufacturers

• Product Differentiation: Focus on injectable formulations and niche indications.
• Life Cycle Management: Develop new formulations or dosing schedules to extend product relevance.
• Market Penetration: Target hospital settings and specialty care segments where generics are less dominant.

For Healthcare Payers and Policy Makers

• Cost Management: Promote use of generics to reduce drug expenditure.
• Guideline Updates: Encourage substitution where appropriate, balancing cost with clinical efficacy.
• Reimbursement Policies: Adjust to incentivize cost-effective therapies.

For Investors

Investment Strategy	Rationale
Focus on Hospital FGNs	Injectable formulations and niche indications offer more stability than oral market.
Look for Lifecycle Opportunities	Acquisition or licensing of new formulations, combination therapies.
Monitor Patent Shields	Approximately 5–7 years of patent exclusivity for newer formulations or indications.

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Comparison Table: Protonix Versus Major PPI Competitors

Attribute	Protonix (Pantoprazole)	Nexium (Esomeprazole)	Prilosec (Omeprazole)	Lansoprazole
Patent Status	Expired (2014)	Expired (2014)	Expired (2001 OTC, 2005 Rx)	Expired (2015)
Formulations	Oral, IV	Oral, IV	Oral, OTC	Oral
Prescriptions Share (%)	Declining to ~10–15% (post-2014)	~40-50% of prescriptions	~20-25%	Remaining (5-10%)
Efficacy	Comparable to other PPIs	Slightly higher acid suppression	Standard PPI	Similar effectiveness
Price	Lowest among generics	Slight premium for brand	Cheapest (generic)	Cost-effective

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Key Takeaways

• Protonix's market revenue declined by over 60% following generic entry in 2014, with revenues stabilizing at a significantly lower level.
• The drug continues to serve niche sectors, notably hospitals, via injectable formulations.
• Competitive landscape is dominated by cost-effective generics and efficacious alternatives such as Nexium and Omeprazole.
• The future of Protonix hinges on lifecycle management via new indications, formulations, and targeting specialty markets.
• Stakeholders should consider market segmentation, cost dynamics, and regulatory trends to optimize strategies around Protonix and similar PPIs.

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FAQs

1. How has patent expiration impacted Protonix’s market share?
Patent expiration in 2014 allowed numerous generics to enter, eroding Protonix’s market share from over 60% to under 15% in prescriptions, leading to steep revenue declines.

2. Are there any upcoming formulations or indications that could revive Protonix’s revenues?
Currently, no major new formulations or indications are in late-stage development; however, niche hospital applications and potential label extensions in conditions like Zollinger-Ellison syndrome may offer limited growth.

3. How does the efficacy of Protonix compare with newer PPIs?
Clinical studies show comparable efficacy among PPIs; slight differences in acid suppression are not typically clinically significant, allowing generic PPIs to compete effectively on price.

4. What is the outlook for Protonix in hospital settings?
The injectable form remains important in hospital environments, especially for acute treatment; market stability here is possible due to limited alternatives.

5. How do healthcare policies influence Protonix’s market dynamics?
Insurance formulary preferences favor generics, reducing brand-name prescriptions. Cost containment efforts and clinical guidelines favor more cost-effective options, further limiting Protonix’s growth prospects.

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References

1. IMS Health Market Data, 2022.
2. U.S. Food and Drug Administration (FDA), Patent and Exclusivity Data, 2014–2022.
3. Pfizer Annual Report, 2022.
4. American Gastroenterological Association Guidelines, 2021.

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This comprehensive analysis provides a current and strategic understanding of Protonix’s market dynamics and financial outlook—valuable for pharmaceutical companies, healthcare providers, investors, and policymakers navigating the evolving PPI landscape.