PANCREAZE Drug Profile

Summary for Tradename: PANCREAZE

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for PANCREAZE
Recent Clinical Trials:	See clinical trials for PANCREAZE

See drug prices for PANCREAZE

Recent Clinical Trials for PANCREAZE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
VIVUS, Inc.	Phase 2
Andrew Hendifar, MD	Phase 2

See all PANCREAZE clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for PANCREAZE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PANCREAZE Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Vivus Llc	PANCREAZE	pancrelipase	Capsule, Delayed Release	022523		2027-02-20	Company disclosures
Vivus Llc	PANCREAZE	pancrelipase	Capsule, Delayed Release	022523		2027-02-20	Company disclosures
Vivus Llc	PANCREAZE	pancrelipase	Capsule, Delayed Release	022523		2027-02-20	Company disclosures
Vivus Llc	PANCREAZE	pancrelipase	Capsule, Delayed Release	022523		2027-02-20	Company disclosures
Vivus Llc	PANCREAZE	pancrelipase	Capsule, Delayed Release	022523		2027-02-20	Company disclosures

3) Low Certainty: US Patents for PANCREAZE Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Vivus Llc	PANCREAZE	pancrelipase	Capsule, Delayed Release	022523		2024-07-05	Patent claims search
Vivus Llc	PANCREAZE	pancrelipase	Capsule, Delayed Release	022523		2031-06-20	Patent claims search
Vivus Llc	PANCREAZE	pancrelipase	Capsule, Delayed Release	022523		2040-03-30	Patent claims search
Vivus Llc	PANCREAZE	pancrelipase	Capsule, Delayed Release	022523		2034-06-19	Patent claims search
Vivus Llc	PANCREAZE	pancrelipase	Capsule, Delayed Release	022523		2027-02-20	Patent claims search
Vivus Llc	PANCREAZE	pancrelipase	Capsule, Delayed Release	022523		2029-09-04	Patent claims search
Vivus Llc	PANCREAZE	pancrelipase	Capsule, Delayed Release	022523		2034-12-31	Patent claims search

International Patents for PANCREAZE

Country	Patent Number	Estimated Expiration
Spain	2674681
Singapore	186648
Israel	200407
Taiwan	201422233
Spain	2560527
Japan	5966202
Japan	2010519217

Market Dynamics and Financial Trajectory for PANCREAZE

Overview of PANCREAZE

PANCREAZE, a brand of pancrelipase, is a biologic drug indicated for the treatment of exocrine pancreatic insufficiency (EPI) in both adult and pediatric patients. This medication is crucial for patients suffering from conditions such as chronic pancreatitis, cystic fibrosis, and pancreatic cancer, which impair the pancreas's ability to produce digestive enzymes.

Market Size and Growth

The global pancrelipase market, which includes PANCREAZE, was valued at $1.8 billion in 2021 and is projected to reach $2.7 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.3% from 2022 to 2031[1].

Segment Analysis

By Application

The pancrelipase market is segmented into chronic pancreatitis, cystic fibrosis, and other applications. The chronic pancreatitis segment generated the maximum revenue in 2021 and is expected to witness the highest CAGR during the forecast period due to the high incidence of chronic pancreatitis and the increasing prevalence of alcohol consumption[1].

By Age

The market is segmented into children and adult & geriatric categories. The adult & geriatric segment generated the maximum revenue in 2021 and is expected to continue growing, driven by the high incidence of pancreatic cancer in adults and the prevalence of digestive disorders in the geriatric population[1].

By Distribution Channel

The distribution channels include hospital pharmacies, drug store & retail pharmacies, and online pharmacies. Drug store & retail pharmacies dominated the market share in 2021 due to the increased sales of prescription drugs and the rising prevalence of digestive disorders. However, online pharmacies are expected to witness the highest CAGR during the forecast period due to their convenience and cost-effectiveness[1].

Regional Analysis

North America accounted for the majority of the global pancrelipase market share in 2021 and is anticipated to remain dominant during the forecast period. This dominance is attributed to the surge in incidence of chronic pancreatitis, increased awareness about pancrelipase usage, and the robust hospital infrastructure in the region. However, the Asia-Pacific region is expected to witness notable growth due to the rise in incidence of pancreatic cancer, development of healthcare infrastructure, and increased investments in the region[1].

Key Market Players

The major players in the pancrelipase market include AbbVie Inc, Digestive Care, Inc, Nestlé S.A., Organon Canada Inc., Viatris Inc., and Vivus LLC. Among these, AbbVie's Creon is the market leader, approved for the treatment of five EPI medical diagnoses, giving it a competitive advantage over other products like Zenpep and Pertzye[3].

Financial Trajectory

Revenue and Growth

PANCREAZE, as part of the broader pancrelipase market, is expected to contribute significantly to the market's financial growth. With a projected market size of $2.7 billion by 2031, the financial trajectory for PANCREAZE is positive, driven by increasing demand for digestive enzymes and the expanding patient population suffering from EPI[1].

Pricing and Savings Programs

To make PANCREAZE more accessible, Vivus LLC offers various savings and support programs. Patients can save up to $100 per prescription fill for a 30-day supply or $300 for a 90-day supply. Additionally, the PANCREAZE Engage program provides assistance to eligible patients who cannot afford the medication, allowing them to receive it at no cost[2][5].

Market Drivers

Increasing Incidence of Chronic Pancreatitis and Pancreatic Cancer

The rising incidence of chronic pancreatitis and pancreatic cancer is a significant driver for the pancrelipase market. These conditions necessitate the use of pancreatic enzyme replacements, thereby increasing demand for products like PANCREAZE[1].

Awareness and Innovation

Increased awareness about the importance of digestive health and advancements in pancrelipase formulations are driving market growth. Key players are investing in research and development, leading to improved products and higher demand[1].

Market Challenges

High Treatment Costs

One of the major challenges facing the pancrelipase market is the high cost associated with drug development and treatment. This can limit market growth, especially in regions with limited healthcare budgets[1].

Competitive Landscape

The market is highly competitive, with several key players vying for market share. Smaller companies like Vivus LLC and Digestive Care, Inc. face challenges in competing with larger players like AbbVie, which has a broader range of approved indications and stronger bargaining power with insurance companies[3].

Safety and Side Effects

PANCREAZE, like other pancreatic enzyme products, comes with potential side effects such as fibrosing colonopathy, hyperuricemia, and irritation of the oral mucosa. These risks necessitate careful monitoring and adherence to recommended dosages[5].

Key Takeaways

• Market Growth: The pancrelipase market, including PANCREAZE, is expected to grow at a CAGR of 4.3% from 2022 to 2031.
• Segment Dominance: Chronic pancreatitis and the adult & geriatric segments are expected to drive market growth.
• Regional Dominance: North America leads the market, but Asia-Pacific is expected to show significant growth.
• Savings Programs: Various savings and support programs are available to make PANCREAZE more affordable.
• Market Drivers: Increasing incidence of chronic pancreatitis and pancreatic cancer, along with advancements in digestive health awareness, drive market growth.
• Challenges: High treatment costs and a competitive market landscape are key challenges.

FAQs

What is the primary indication for PANCREAZE?

PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients[2][5].

How is the pancrelipase market segmented?

The market is segmented by application (chronic pancreatitis, cystic fibrosis, others), age (children, adult & geriatric), and distribution channel (hospital pharmacies, drug store & retail pharmacies, online pharmacies)[1].

What are the key drivers of the pancrelipase market?

Key drivers include the increasing incidence of chronic pancreatitis and pancreatic cancer, and advancements in digestive health awareness and enzyme formulations[1].

Which region dominates the pancrelipase market?

North America dominates the market, but the Asia-Pacific region is expected to show significant growth[1].

What savings programs are available for PANCREAZE?

Patients can save up to $100 per prescription fill for a 30-day supply or $300 for a 90-day supply through the PANCREAZE Savings Card and other support programs[2][5].

What are the potential side effects of PANCREAZE?

Potential side effects include fibrosing colonopathy, hyperuricemia, and irritation of the oral mucosa[5].

Sources

1. Allied Market Research: Pancrelipase Market Size, Trends | Growth Analysis, 2021-2030
2. PANCREAZE: Co-Pay and Savings Card
3. FTC: Dissenting Statement of Commissioner Rohit Chopra
4. GMI Insights: Exocrine Pancreatic Insufficiency Treatment Market Report, 2032
5. PANCREAZE HCP Site: Savings and Support