PROTONIX Drug Patent Profile

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

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. Seventy-one 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:	2
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	32
Patent Applications:	3,714
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
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	TABLET, DELAYED RELEASE;ORAL	020987-001	Feb 2, 2000	AB	RX	Yes	Yes

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	020987-002	Jun 12, 2001
Wyeth Pharms	PROTONIX	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022020-001	Nov 14, 2007
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	TABLET, DELAYED RELEASE;ORAL	020987-001	Feb 2, 2000

International Patents for PROTONIX

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

Country	Patent Number	Title	Estimated Expiration
Canada	2524168
Poland	169951
Serbia	20060238	VIŠEČESTIČNE FORMULACIJE PANTOPRAZOLA (PANTOPRAZOLE MULTIPARTICULATE FORMULATIONS)
Malaysia	147180	PANTOPRAZOLE MULTIPARTICULATE FORMULATIONS
Croatia	P920162	FORMS OF PREPARATIONS FOR ACID-INSTABLE ACTIVE SUBSTANCES FOR ORAL USE
Peru	20050960	FORMULACIONES DE MULTIPARTICULAS DE PANTOPRAZOL

Supplementary Protection Certificates for PROTONIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

PROTONIX Market Analysis and Financial Projection Experimental

Proton Pump Inhibitors (PPIs) Market Dynamics and Financial Trajectory: A Focus on PROTONIX

Market Overview

The proton pump inhibitors (PPIs) market, which includes drugs like PROTONIX, is a significant segment within the pharmaceutical industry. Here, we will delve into the market dynamics and financial trajectory of PPIs, with a particular focus on PROTONIX.

Market Size and Growth

The PPIs market is substantial and growing. As of 2024, the market size is estimated to be USD 12.70 billion and is projected to reach USD 16.32 billion by 2029, growing at a Compound Annual Growth Rate (CAGR) of 5.14% during the forecast period[1][3].

Market Drivers

Increasing Burden of Gastroesophageal Reflux Disease (GERD)

One of the primary drivers of the PPIs market is the increasing prevalence of gastroesophageal reflux disease (GERD). GERD affects a significant portion of the population, with approximately 40% of the U.S. population experiencing GERD symptoms, and 10-20% being affected on a weekly basis[1].

Rising Acceptance of Novel Drug Delivery Systems

The market is also driven by the rising acceptance of novel drug delivery systems. Innovations in drug formulations, such as delayed-release capsules, are enhancing the efficacy and patient compliance of PPIs. For instance, the launch of Omeprazole Delayed-Release Capsules by Xiromed LLC in March 2021 has contributed to market growth[1][3].

Shift from Prescription to OTC Drugs

The increasing shift from prescription-only medications to over-the-counter (OTC) availability is another significant driver. This shift has made PPIs more accessible to a broader audience, thereby increasing demand[1][3].

Market Restraints

Increasing Use of Generic Products

Despite the growth drivers, the market faces restraints such as the increasing use of generic products. Generic versions of PPIs, like those launched by Xiromed LLC, offer therapeutic equivalents at lower prices, which can reduce the market share of branded drugs like PROTONIX[1][3].

Side Effects Related to Proton Pump Inhibitors

Another restraint is the side effects associated with PPIs. Research has shown that PPI use can increase the risk of COVID-19 infection and poor outcomes in patients with COVID-19. Additionally, long-term use of PPIs can lead to other side effects, which may deter some patients from using these medications[1][3].

Financial Trajectory

Revenue and Market Share

PROTONIX, a brand of pantoprazole, is one of the key players in the PPIs market. While specific financial data for PROTONIX alone is not provided in the sources, the overall market trends indicate that branded PPIs continue to generate significant revenue. However, the rise of generic alternatives and OTC options may impact the revenue and market share of branded drugs.

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the PPIs market. Patients were advised to reduce or avoid PPI use unless absolutely necessary, which temporarily slowed market growth. However, as the pandemic subsided, the market is expected to return to a favorable growth trajectory[1][3].

Regional Analysis

North America

North America, particularly the United States, dominates the PPIs market. The high incidence of GERD, coupled with advanced healthcare infrastructure and aggressive marketing campaigns, drives the demand for PPIs in this region. PROTONIX, being a widely prescribed drug in the U.S., benefits from this regional dominance[1][4].

Asia Pacific

The Asia Pacific region is the fastest-growing market for PPIs. This growth is driven by increasing awareness of gastrointestinal disorders, improving healthcare infrastructure, and lifestyle changes that contribute to the prevalence of GERD and other gastrointestinal conditions[1][4].

Key Players and Competitive Landscape

The PPIs market is moderately fragmented, with key players such as AstraZeneca, Bayer AG, Pfizer, and Takeda Pharmaceuticals competing for market share. These companies are involved in various strategic initiatives, including research and development of new formulations and partnerships to enhance their market presence[1][3].

Product Launches and Innovations

Product launches and innovations are crucial for sustaining market growth. For example, the launch of generic versions of PPIs, such as Xiromed LLC's Omeprazole Delayed-Release Capsules, has helped in expanding the market. These launches provide therapeutic equivalents to branded drugs, offering patients more affordable options without compromising on efficacy[1][3].

Industry Attractiveness - Porter's Five Forces Analysis

Threat of New Entrants

The threat of new entrants in the PPIs market is relatively low due to high barriers to entry, including stringent regulatory requirements and significant research and development costs.

Bargaining Power of Buyers/Consumers

The bargaining power of buyers is moderate, as patients have a range of options available, including branded and generic PPIs. However, the shift towards OTC availability has increased consumer bargaining power.

Bargaining Power of Suppliers

The bargaining power of suppliers is relatively low, as pharmaceutical companies have multiple suppliers for raw materials and manufacturing services.

Threat of Substitute Products

The threat of substitute products is moderate, with other treatments for GERD and gastrointestinal disorders available, although PPIs remain the gold standard.

Intensity of Competitive Rivalry

The intensity of competitive rivalry is high, with several key players competing for market share through innovative products, strategic partnerships, and aggressive marketing[1][3].

Key Takeaways

• The PPIs market is expected to grow from USD 12.70 billion in 2024 to USD 16.32 billion by 2029, driven by the increasing prevalence of GERD and the rising acceptance of novel drug delivery systems.
• North America dominates the market, while the Asia Pacific region is the fastest-growing.
• The market faces restraints such as the increasing use of generic products and side effects associated with PPIs.
• Key players are focusing on research, development, and strategic initiatives to maintain market share.
• Product launches and innovations are crucial for sustaining market growth.

FAQs

What is the current market size of the Proton Pump Inhibitors (PPIs) market?

The PPIs market size is estimated at USD 12.70 billion in 2024[1][3].

Which region dominates the PPIs market?

North America currently dominates the PPIs market, driven by a high incidence of GERD and advanced healthcare infrastructure[1][4].

What is the fastest-growing region in the PPIs market?

The Asia Pacific region is the fastest-growing market for PPIs, driven by increasing awareness of gastrointestinal disorders and improving healthcare infrastructure[1][4].

What are the major drivers of the PPIs market?

The major drivers include the increasing burden of GERD, the rising acceptance of novel drug delivery systems, and the shift from prescription to OTC drugs[1][3].

Who are the key players in the PPIs market?

Key players include AstraZeneca, Bayer AG, Pfizer, Takeda Pharmaceuticals, and Cadila Pharmaceuticals[1][3].

Sources

1. Mordor Intelligence: Proton Pump Inhibitors Market - Size, Share & Analysis
2. Pfizer: Form 10-Q (2020)
3. Mordor Intelligence: Proton Pump Inhibitors Market Size (2024)
4. Transparency Market Research: Proton Pump Inhibitors (PPIs) Market Size & Growth 2034