PROTONIX IV Drug Patent Profile

When do Protonix Iv patents expire, and what generic alternatives are available?

Protonix Iv is a drug marketed by Wyeth Pharms and is included in one NDA.

The generic ingredient in PROTONIX IV 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 Iv

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

Summary for PROTONIX IV

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	32
Patent Applications:	4,759
Drug Prices:	Drug price information for PROTONIX IV
DailyMed Link:	PROTONIX IV at DailyMed

See drug prices for PROTONIX IV

Recent Clinical Trials for PROTONIX IV

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 IV clinical trials

Pharmacology for PROTONIX IV

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Paragraph IV (Patent) Challenges for PROTONIX IV

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROTONIX IV	For Injection	pantoprazole sodium	40 mg/vial	020988	1	2005-04-07

US Patents and Regulatory Information for PROTONIX IV

PROTONIX IV is protected by zero US patents and one FDA Regulatory Exclusivity.

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 IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001	AP	RX	Yes	Yes

Expired US Patents for PROTONIX IV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001	7,351,723*PED
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001	4,758,579*PED
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001	8,754,108*PED

International Patents for PROTONIX IV

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

Country	Patent Number	Title	Estimated Expiration
Australia	578703
Canada	1254215	DIALKOXYPIRIDINES, ET LEUR PREPARATION (DIALKOXYPYRIDINES AND PROCESS FOR THEIR PREPARATION)
Canada	2428870	PREPARATION LYOPHILISEE DE PANTOPRAZOLE ET INJECTION DE PANTOPRAZOLE (FREEZE-DRIED PANTOPRAZOLE PREPARATION AND PANTOPRAZOLE INJECTION)

Supplementary Protection Certificates for PROTONIX IV

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 IV (Pantoprazole)

Introduction to Protonix IV

Protonix IV, also known as pantoprazole sodium, is a proton pump inhibitor (PPI) used primarily for the treatment of gastroesophageal reflux disease (GERD), erosive esophagitis, and Zollinger-Ellison Syndrome (ZES). Here, we delve into the market dynamics and financial trajectory of this medication.

Market Size and Growth

The global proton pump inhibitors (PPIs) market, which includes Protonix IV, was valued at USD 3.08 billion in 2023 and is anticipated to reach USD 4.04 billion by 2029, growing at a CAGR of 4.72% during the forecast period[3].

Segmentation and Market Share

By Type of Drug

The market for pantoprazole is segmented into generic and branded versions. The generic version of pantoprazole is expected to have a larger market share compared to the branded version, primarily due to its cost-effectiveness and wider availability[1].

By Type of Dosage

Protonix IV is available in various dosages, including 20 mg and 40 mg, with the 40 mg intravenous powder for injection being a common formulation. The availability of different dosages caters to various patient needs, contributing to market growth[1].

By Route of Administration

Protonix IV can be administered both orally (in the form of delayed-release tablets or enteric-coated tablets) and intravenously. The intravenous route is particularly important for patients who cannot take oral medications, such as those in hospital settings[1][5].

By Indication

The primary indications for Protonix IV include GERD, erosive esophagitis, and hypersecretory conditions like Zollinger-Ellison Syndrome. GERD is a highly incident disorder, driving significant demand for PPIs like Protonix IV[1].

Regional Analysis

North America

North America is projected to maintain the largest market share in the global PPIs market, driven by the high prevalence of acid-related disorders such as GERD. The adoption of a Western diet and lifestyle has contributed to the rising incidence of these conditions[3].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment due to the increasing cases of gastroenterology-related diseases and improving healthcare infrastructure[1].

Financial Trajectory

Cost and Pricing

The cost of Protonix IV can vary significantly depending on the dosage and form. For example, the 40 mg intravenous powder for injection can cost around $63 for a supply of 10, while generic versions can be as low as $14.61 for the same quantity[2].

Revenue Projections

The pantoprazole API market is expected to grow at a CAGR of 3.2% from 2020 to 2026. This growth is driven by the increasing demand for PPIs, particularly in regions with rising cases of gastroenterology-related diseases[1].

Competitor Analysis

The global PPIs market is competitive, with several key players. However, the market has seen increased competition from generic manufacturers following the patent expirations of leading PPI brands. This competition has impacted the market revenues of branded PPIs like Protonix IV[3].

Challenges and Opportunities

Patent Expirations

The expiration of patents for branded PPIs has led to increased competition from generic manufacturers, which can impact the market share and revenues of branded products like Protonix IV[3].

Safety Concerns

Prolonged use of PPIs has been associated with certain side effects and health risks, leading to concerns among patients and healthcare providers. This has prompted some to explore alternative treatments, potentially diverting market share away from PPIs[3].

Growing Patient Population

The rising prevalence of GERD and other gastroenterology-related disorders presents a significant opportunity for the PPI market, including Protonix IV. Developing economies, in particular, offer untapped potential as healthcare infrastructure improves and access to these medications increases[3].

Hospital Segment Dominance

Hospitals play a crucial role in the PPIs market, particularly for severe acid-related conditions, gastrointestinal bleeding cases, endoscopic procedures, and surgical care. Hospitals often prefer branded and specialized PPI formulations, contributing significantly to the market share of products like Protonix IV[3].

Patient Assistance Programs

While there are no specific patient assistance programs for Protonix IV, patients may benefit from general drug discount programs and copay cards that can reduce the cost of the medication. These programs are particularly important for individuals with low income or those who are uninsured or under-insured[2].

Key Takeaways

• Market Growth: The PPIs market, including Protonix IV, is expected to grow at a CAGR of 4.72% from 2024 to 2029.
• Segmentation: The market is segmented by type of drug, dosage, route of administration, and indication, with GERD being a major driver.
• Regional Dominance: North America leads the market, while the Asia Pacific region is the fastest-growing segment.
• Financials: The cost of Protonix IV varies, with generic versions being significantly cheaper.
• Challenges: Patent expirations and safety concerns pose challenges, while a growing patient population offers opportunities.

FAQs

Q: What are the primary indications for Protonix IV? A: The primary indications for Protonix IV include GERD, erosive esophagitis, and hypersecretory conditions like Zollinger-Ellison Syndrome[1][5].

Q: How does the cost of Protonix IV compare to its generic version? A: The cost of Protonix IV can be around $63 for a supply of 10, while the generic version can cost as low as $14.61 for the same quantity[2].

Q: Which region is expected to be the fastest-growing segment for the PPIs market? A: The Asia Pacific region is expected to be the fastest-growing segment due to increasing cases of gastroenterology-related diseases and improving healthcare infrastructure[1].

Q: What are the main challenges facing the PPIs market, including Protonix IV? A: The main challenges include patent expirations leading to increased competition from generic manufacturers and safety concerns associated with prolonged PPI use[3].

Q: How significant is the hospital segment in the PPIs market? A: The hospital segment is crucial, as hospitals prioritize the use of PPIs for severe acid-related conditions, contributing significantly to the market share of products like Protonix IV[3].

Cited Sources

1. Global Pantoprazole API Market Analysis | Size & Forecasts - Global Market Estimates
2. Protonix IV Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com
3. Proton Pump Inhibitors Market By Size, Share, and Forecast 2019 - TechSci Research
4. NDA 20988/S-070 Protonix IV (Pantoprazole Sodium) - FDA
5. Pharmacotherapy Update | Intravenous Pantoprazole (Protonix®) - Cleveland Clinic MedEd