PERTZYE Drug Profile

Summary for Tradename: PERTZYE

High Confidence Patents:	6
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for PERTZYE
Recent Clinical Trials:	See clinical trials for PERTZYE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PERTZYE

See drug prices for PERTZYE

Recent Clinical Trials for PERTZYE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Memorial Sloan Kettering Cancer Center	Phase 1/Phase 2
Massimo Raimondo, M.D.	Phase 1/Phase 2
Digestive Care, Inc.	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. 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 PERTZYE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PERTZYE Derived from 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	2040-03-30	Company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,302,400	2040-03-30	Company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,324,514	2012-06-22	Company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,460,812	2012-06-22	Company disclosures
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	5,578,304	2013-11-26	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	2024-07-05	Patent claims search
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	10,040,783	2031-06-20	Patent claims search
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	10,087,493	2040-03-30	Patent claims search
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	10,184,121	2034-06-19	Patent claims search
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	10,206,882	2027-02-20	Patent claims search

International Patents for PERTZYE

Country	Patent Number	Estimated Expiration
Australia	4132993
Canada	2228389
Australia	666015
Australia	4133193
Canada	2096002

PERTZYE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PERTZYE

Introduction

PERTZYE, a pancreatic enzyme replacement therapy (PERT), is a crucial treatment for Exocrine Pancreatic Insufficiency (EPI) particularly in patients with cystic fibrosis. Here, we delve into the market dynamics and financial trajectory of PERTZYE, exploring its approval, marketing, competition, and future prospects.

FDA Approval and Unique Formulation

PERTZYE was approved by the U.S. Food and Drug Administration (FDA) for the treatment of EPI due to cystic fibrosis and other conditions. It is distinguished by its bicarbonate-buffered, enteric-coated microspheres, designed to optimize the pH environment for enzyme activity and nutrient absorption[1].

Marketing and Distribution

Cornerstone Therapeutics Inc. initiated the marketing and sales efforts for PERTZYE in the U.S. in 2013, after acquiring the exclusive U.S. marketing rights from Digestive Care, Inc. (DCI). DCI continued to focus on other EPI conditions beyond cystic fibrosis[1].

Market Segment and Competition

The global market for EPI diagnostics and therapeutics is projected to reach $8.3 billion by 2031, growing at a CAGR of 8%[4].

• In the therapeutic segment, PERTZYE competes with other PERT products such as Creon, Pancreaze, Ultresa, Viokace, and Zenpep. Creon holds the largest market share in the U.S., followed by Zenpep and Pancreaze[4].

Financial Performance

The financial performance of PERTZYE is tied to the overall performance of its marketing and distribution companies. Here are some key financial insights:

• Revenue Contribution: As part of Cornerstone Therapeutics' portfolio, PERTZYE contributed to the company's revenue. However, specific financial figures for PERTZYE alone are not publicly disclosed. Cornerstone's overall strategy included building a portfolio of cystic fibrosis treatments, which would impact their financial health[1].
• Market Growth: The growing demand for PERTs due to increasing diagnoses and treatments of EPI conditions, including cystic fibrosis, suggests a positive financial trajectory for PERTZYE. The U.S. therapeutic products segment is anticipated to register the fastest growth rate over the forecast period[4].

Competitive Landscape

The competitive landscape for PERTZYE is dynamic, with several other PERTs available in the market:

• Creon: The market leader in PERTs, Creon has a significant market share and is widely prescribed.
• Zenpep and Pancreaze: These products also hold substantial market shares and are competitors to PERTZYE.
• Innovation and Differentiation: PERTZYE's unique formulation with bicarbonate-buffered, enteric-coated microspheres sets it apart from other PERTs, potentially attracting patients and healthcare providers seeking specific benefits[1][4].

Future Prospects

The future prospects for PERTZYE are promising due to several factors:

• Growing Market: The global EPI market is expanding, driven by increasing awareness and better diagnostic techniques.
• Patient Need: Approximately 90% of patients with cystic fibrosis require PERT, ensuring a steady demand for products like PERTZYE[1].
• Regulatory Environment: Continued FDA approval and compliance will be crucial for maintaining market presence.
• Competition and Innovation: The ability to innovate and differentiate PERTZYE from other PERTs will be key to maintaining market share and attracting new patients.

Impact of Regulatory and Market Changes

Regulatory changes and market dynamics can significantly impact the financial trajectory of PERTZYE:

• Mergers and Acquisitions: Changes in ownership or distribution rights, such as the involvement of companies like Chiesi Farmaceutici S.p.A., can affect marketing strategies and financial performance[2].
• Compliance and Approval: Maintaining FDA approval and compliance with regulatory standards is essential for continued market presence.

Key Takeaways

• Unique Formulation: PERTZYE's bicarbonate-buffered, enteric-coated microspheres differentiate it in the PERT market.
• Growing Market: The global EPI market is expanding, driven by increasing demand for PERTs.
• Competition: PERTZYE competes with other established PERTs like Creon, Zenpep, and Pancreaze.
• Financial Performance: Tied to the overall performance of its marketing and distribution companies, with a positive trajectory due to market growth.

FAQs

What is PERTZYE used for?

PERTZYE is used for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis and other conditions. It is a pancreatic enzyme replacement therapy (PERT) designed to help manage nutrient malabsorption.

Who markets PERTZYE in the U.S.?

PERTZYE is marketed in the U.S. by Cornerstone Therapeutics Inc., which acquired the exclusive U.S. marketing rights from Digestive Care, Inc. (DCI)[1].

What makes PERTZYE unique?

PERTZYE is unique due to its bicarbonate-buffered, enteric-coated microspheres, which optimize the pH environment for enzyme activity and nutrient absorption[1].

How does PERTZYE compete in the market?

PERTZYE competes with other PERT products like Creon, Zenpep, and Pancreaze. Its unique formulation and focus on cystic fibrosis patients help it differentiate in the market[4].

What is the projected growth of the EPI market?

The global EPI market is projected to reach $8.3 billion by 2031, growing at a CAGR of 8%[4].

Sources

1. Cornerstone Therapeutics Inc. - "Cornerstone Therapeutics Inc. announced it is now actively marketing PERTZYE in the U.S."
2. FIRST WAVE BIOPHARMA, INC. - "Annual Report on Form 10-K YEAR ENDED DECEMBER 31, 2021"
3. Codexis - "Codexis Annual Report on Form 10-K YEAR ENDED DECEMBER 31, 2022"
4. iHealthcareAnalyst - "Global Exocrine Pancreatic Insufficiency Market $8.3 Billion by 2031"