Pancrelipase - Biologic Drug Details

Summary for pancrelipase

Tradenames:	6
High Confidence Patents:	14
Applicants:	6
BLAs:	6
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for pancrelipase

Recent Clinical Trials for pancrelipase

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Philipp Schuetz	NA
University of Illinois Chicago	PHASE4
University of Southern California	PHASE4

See all pancrelipase 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. DrugPatentWatch analysis and 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 pancrelipase Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pancrelipase Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Abbvie Inc.	CREON	pancrelipase	Capsule, Delayed Release	020725		2026-08-15	DrugPatentWatch analysis and company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175		2012-06-22	DrugPatentWatch analysis and company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175		2012-06-22	DrugPatentWatch analysis and company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175		2013-08-11	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for pancrelipase 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
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	COTAZYM	pancrelipase	Capsule, Delayed Release	020580		2035-05-08	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	COTAZYM	pancrelipase	Capsule, Delayed Release	020580		2036-11-30	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	COTAZYM	pancrelipase	Capsule, Delayed Release	020580		2029-03-09	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	COTAZYM	pancrelipase	Capsule, Delayed Release	020580		2035-06-19	Patent claims search

International Patents for pancrelipase

Country	Patent Number	Estimated Expiration
South Korea	20060003010
European Patent Office	1409684
Japan	2019069979
Australia	2018214132

Supplementary Protection Certificates for pancrelipase

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C20250016	Finland
CR 2025 00013	Denmark		PRODUCT NAME: ACORAMIDIS, AND/OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY ACORAMIDIS HYDROCHLORIDE; REG. NO/DATE: EU/1/24/1906 20250211
122025000014	Germany		PRODUCT NAME: ACORAMIDIS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ACORAMIDISHYDROCHLORID; REGISTRATION NO/DATE: EU/1/24/1906 20250210
2590011-9	Sweden		PRODUCT NAME: ACORAMIDIS, AND/OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY ACORAMIDIS HYDROCHLORIDE; REG. NO/DATE: EU/1/24/1906 20250211

Market Dynamics and Financial Trajectory for Pancrelipase

Last updated: March 5, 2026

What is the current market size and growth rate for pancrelipase?

The global pancrelipase market was valued at approximately $650 million in 2022. It is projected to reach around $1.1 billion by 2030, growing at a compound annual growth rate (CAGR) of 6.8% from 2023 to 2030. The growth is driven by increasing diagnoses of pancreatic insufficiency, expanding pediatric indications, and rising prevalence of chronic pancreatitis.

What are the key drivers influencing market growth?

• Increasing prevalence of pancreatic-related disorders: Chronic pancreatitis, cystic fibrosis, and pancreatic cancer contribute to higher pancrelipase demand.

• Expanding indications: Patents and approvals have extended use cases, including for pediatric populations and malabsorption conditions.

• Rising awareness and diagnosis: Advances in diagnostic tools lead to earlier detection, increasing eligible patient populations.

• New product launches and formulations: Development of low-dose, sustained-release, and enteric-coated formulations enhances adherence and expands market share.

How does the competitive landscape shape the market?

Company	Major Products	Market Share	R&D Focus
AbbVie	Creon, Ultresa	45%	Extended-release formulations, pediatric studies
Pfizer	Viokace	20%	Dose optimization, alternative delivery systems
Mylan (now part of Viatris)	Zenpep (sold to AbbVie)	10%	Biosimilars, combination therapies
Others	Various regional brands	25%	Cost reduction, generic development

AbbVie's Creon dominates with an estimated 45% market share, followed by Pfizer’s Viokace at 20%. The market exhibits a moderate level of consolidation, with major players investing heavily in formulation improvements and new indications.

What regulatory trends impact the financial outlook?

• FDA and EMA approvals: Recent approvals for pediatric formulations and new delivery methods support revenue growth.

• Patent expirations: Several key patents expired or are nearing expiration, leading to increased generic competition starting around 2024-2025.

• Pricing policies: Payer pressure to lower drug costs influences revenue, especially in the U.S. market where payers scrutinize high-cost biologics.

• Incentives for orphan and rare disease drugs: Pancreatic insufficiency related to cystic fibrosis qualified as a rare disease, benefiting from orphan drug exclusivities.

What are the main challenges affecting future revenues?

• Generic competition: As patents expire, biosimilars and generics threaten pricing power and market share.

• Pricing pressures: Payers' push for cost containment reduces reimbursement levels and profit margins.

• Manufacturing complexities: The biological nature involves high costs and scalability concerns, especially for biosimilars.

• Regional disparities: Emerging markets show growth potential but face regulatory, infrastructural, and affordability hurdles.

How do future R&D trends impact financial projections?

Investment in novel formulations, such as microencapsulation and enzyme engineering, could extend patent life and strengthen market positions. Development of biosimilars and value-added combination products could capture incremental share but require high upfront R&D costs.

What is the projected financial trajectory for key players?

Company	2023 Revenue (Estimated)	2030 Revenue Projection	Key R&D Investments
AbbVie	$290 million	$450 million	Next-generation formulations, pediatric studies
Pfizer	$120 million	$180 million	Dosing accuracy, delivery system improvements
Others	$140 million	$220 million	Biosimilars, regional market development

Revenue growth hinges on maintaining market share amid patent expirations, expanding indications, and advancing formulations.

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Key Takeaways

• The pancrelipase market is expected to grow at 6.8% CAGR from 2023 to 2030, reaching $1.1 billion.
• Dominated by AbbVie and Pfizer, with a combined market share exceeding 65%.
• Patent expirations around 2024-2025 introduce biosimilar competition.
• Growth is driven by rising disease prevalence, expanding indications, and formulation innovations.
• Price and reimbursement pressures pose risks to profit margins.
• R&D focuses on novel formulations, biosimilars, and combination therapies to support revenue stability.

FAQs

1. When are major pancrelipase patents expiring?
   Most key patents expire between 2024 and 2025, opening the market to biosimilar entrants.

2. What are the primary indications for pancrelipase?
   Treatment of pancreatic exocrine insufficiency resulting from conditions like cystic fibrosis, chronic pancreatitis, and pancreatic cancer.

3. What regional markets show the highest growth potential?
   Emerging markets in Asia-Pacific and Latin America exhibit high growth, driven by increasing disease awareness and improving healthcare infrastructure.

4. How do biosimilars impact the market?
   Biosimilars threaten pricing power for branded formulations, potentially reducing revenues by 20-30% post-patent expiry if uptake is rapid.

5. Are there any significant regulatory changes expected?
   Regulatory agencies continue to streamline approval pathways for orphan drugs and biosimilars, which could affect market entry strategies.

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References

[1] MarketWatch. (2022). Global Pancrelipase Market Size, Share & Trends Analysis.
[2] Grand View Research. (2023). Pancrelipase Market Analysis and Forecast.
[3] U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.