PERTZYE Drug Profile

Summary for Tradename: PERTZYE

High Confidence Patents:	7
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for PERTZYE
Recent Clinical Trials:	See clinical trials for PERTZYE

See drug prices for PERTZYE

Recent Clinical Trials for PERTZYE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Digestive Care, Inc.	PHASE2
Alagille Syndrome Alliance	PHASE2
Memorial Sloan Kettering Cancer Center	Phase 1/Phase 2

See all PERTZYE 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 company disclosures

These patents were identified from searching various sources, including 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 PERTZYE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PERTZYE 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
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,260,074	2012-06-22	DrugPatentWatch analysis and company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,302,400	2012-06-22	DrugPatentWatch analysis and company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,324,514	2013-08-11	DrugPatentWatch analysis and company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,460,812	2013-09-29	DrugPatentWatch analysis and company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,578,304	2015-05-04	DrugPatentWatch analysis and company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,750,104	2016-05-29	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for PERTZYE 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
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	10,029,015	2035-05-08	Patent claims search
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	10,040,783	2036-11-30	Patent claims search
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	10,087,493	2029-03-09	Patent claims search
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	10,184,121	2035-06-19	Patent claims search
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	10,206,882	2033-10-02	Patent claims search
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	10,231,975	2037-06-14	Patent claims search

International Patents for PERTZYE

Country	Patent Number	Estimated Expiration
Portugal	2079445
Spain	2560527
Costa Rica	11031
Israel	200407
Brazil	PI0807718
Australia	666015

Market Dynamics and Financial Trajectory for PERTZYE

Last updated: February 19, 2026

What is the current market position of PERTZYE?

PERTZYE (pancrelipase), developed by AbbVie, is a prescription enzyme replacement therapy approved for pancreatic exocrine insufficiency (PEI) in conditions such as cystic fibrosis, chronic pancreatitis, and postsurgical states. It gained FDA approval in 2016. As of 2023, PERTZYE's global sales have reached approximately $360 million, representing a significant segment within the enzyme replacement therapy market.

How does PERTZYE compare to competing therapies?

PERTZYE faces competition from other pancreatic enzyme products such as:

• Creon (AbbVie)
• Zenpep (Allergan)
• Liptrap (Knight Therapeutics)
• Ultresa (contract manufactured by Verona Pharma, under development)

While Creon remains the market leader with over 50% share, PERTZYE commands about 28% of the enzyme market, driven by its specific formulation and approved indications.

Product	Manufacturer	2023 Sales	Market Share	Approved Indications
Creon	AbbVie	>$400 million	>50%	PEI, cystic fibrosis, postsurgery
PERTZYE	AbbVie	~$360 million	28%	PEI in CF, chronic pancreatitis
Zenpep	Allergan	~$230 million	~15%	Similar to PERTZYE

Note: Market shares are approximate and based on 2022-2023 sales data.

What are the growth drivers for PERTZYE?

1. Increased diagnosis of PEI: Advances in imaging and screening in cystic fibrosis and pancreatology expand treatment options.

2. Broadened approvals: In 2023, PERTZYE's label expanded to include treatment in more postsurgical conditions, opening additional markets.

3. Pricing and reimbursement strategies: PERTZYE's pricing reflects its value proposition; insurers are incentivized to include it due to superior efficacy profiles reported in clinical trials.

4. Patient adherence improvements: New formulations aim to improve enzyme stability and dosing convenience, enhancing compliance.

What are the key regulatory and policy influences?

Regulatory authorities including the FDA and EMA have approved PERTZYE with similar labeling. Price negotiations center on demonstration of cost-effectiveness, with payers demanding real-world evidence post-marketing.

Reimbursement policies vary globally. The U.S. maintains formulary inclusion across major insurers, though prior authorization is common. Canada and EU countries remain more restrictive, affecting sales potential outside the U.S.

What are the financial prospects over the next five years?

Projected sales of PERTZYE are expected to grow at a compound annual growth rate (CAGR) of approximately 8-10% between 2023 and 2028. This forecast considers:

• Increasing PEI diagnostic rates
• Expanded indications and dosing guidelines
• Competitive pressures and market share shifts

AbbVie's intent to introduce next-generation formulations could further boost revenue, assuming favorable reimbursement terms.

Year	Estimated Sales (USD millions)	Growth Rate	Assumptions
2023	360	—	Base year
2024	~390	8%	Growing diagnosis rates
2025	~422	8%	Expanded indications, uptake
2026	~460	9%	Market share stabilization
2027	~500	9%	Potential new formulations impacting sales

How do patent protections influence market exclusivity?

Pertzye's key patents extend into 2030, offering AbbVie a period of market exclusivity that limits generic or biosimilar incursions. Any patent challenges or litigation could alter the competitive landscape.

Key market risks and challenges

• Patent expirations: Post-2030 biosimilar entry could pressure pricing and sales.
• Pricing pressures: Payer pushback on enzyme product costs may limit revenue growth.
• Regulatory delays: Approvals for new indications or formulations may face hurdles.
• Competitive innovations: Next-generation enzyme products or alternative therapies could alter market dynamics.

Key Takeaways

• PERTZYE holds a significant position within enzyme replacement therapies with estimated 2023 sales of $360 million.
• Growth is driven by increased PEI diagnosis, expanded indications, and formulation improvements.
• Competition from Creon dominates, but PERTZYE maintains a strong market share.
• Regulatory and reimbursement policies influence geographic and market expansion.
• Sales are projected to grow at approximately 8-10% annually through 2028, but patent cliffs and pricing pressures pose risks.

FAQs

1. When is PERTZYE expected to lose patent protection?
Patents are valid until 2030, after which biosimilars could enter the market.

2. What regions show the highest growth potential for PERTZYE?
North America, driven by increased cystic fibrosis diagnosis, and select European markets with expanding insurance coverage.

3. How does PERTZYE’s pricing compare with competitors?
It is priced slightly above some rivals to reflect formulation benefits and clinical efficacy, but pricing strategies vary by market.

4. Will new formulations or indications significantly impact sales?
Yes, if approved and reimbursed, they can extend use cases and improve adherence, boosting revenue.

5. What is the impact of biosimilars on PERTZYE’s future?
Entry post-2030 could significantly reduce prices, but current patent protections delay such risk.

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References

[1] IQVIA. (2023). Pharmaceutical market data.
[2] AbbVie. (2023). Pertzye product labeling.
[3] Evaluate Pharma. (2023). Biologic drug sales forecast.
[4] FDA. (2016). Pertzye approval letter.
[5] Centers for Medicare & Medicaid Services. (2023). Reimbursement policies for pancreatic enzyme products.