ZENPEP Drug Profile

Summary for Tradename: ZENPEP

High Confidence Patents:	8
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for ZENPEP
Recent Clinical Trials:	See clinical trials for ZENPEP

See drug prices for ZENPEP

Recent Clinical Trials for ZENPEP

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Allergan	Phase 2
Dana-Farber Cancer Institute	Phase 2
Cystic Fibrosis Foundation Therapeutics	N/A

See all ZENPEP 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 ZENPEP Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210		2027-02-20	Company disclosures
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210		2027-02-20	Company disclosures
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210		2027-02-20	Company disclosures
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210		2027-02-20	Company disclosures
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210		2027-02-20	Company disclosures
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210		2027-02-20	Company disclosures
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210		2027-02-20	Company disclosures

3) Low Certainty: US Patents for ZENPEP 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
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210		2024-07-05	Patent claims search
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210		2031-06-20	Patent claims search
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210		2040-03-30	Patent claims search
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210		2034-06-19	Patent claims search
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210		2027-02-20	Patent claims search
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210		2029-09-04	Patent claims search
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210		2034-12-31	Patent claims search

International Patents for ZENPEP

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008102264
Israel	200407
South Africa	200905630
Brazil	PI0807718
Chile	2008000517
Hong Kong	1142818
Spain	2674681

ZENPEP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: ZENPEP

Introduction to ZENPEP

ZENPEP, a pancreatic enzyme replacement therapy (PERT), is a crucial medication for patients suffering from Exocrine Pancreatic Insufficiency (EPI). This condition prevents the pancreas from producing enough enzymes to break down fat, protein, and carbohydrates, leading to malnutrition and other gastrointestinal symptoms.

Market Context and Acquisition

In 2020, Nestlé Health Science (NHSc) acquired ZENPEP from Allergan as part of a broader strategy to expand its medical nutrition business. This acquisition was contingent upon the regulatory approval of the AbbVie-Allergan merger, which was a significant deal valued at $63 billion[3].

Strategic Significance

The acquisition of ZENPEP marked a strategic move for Nestlé to enhance its portfolio of therapeutic products, particularly in the gastrointestinal health segment. According to Greg Behar, CEO of Nestlé Health Science, this move leveraged Nestlé's extensive experience in digestive diseases and aimed to drive rapid growth in this new business area[1].

Financial Performance of ZENPEP

Before the acquisition, ZENPEP had demonstrated strong financial performance. In 2018, the drug generated net sales of $237 million, indicating its market viability and the significant demand for PERTs[1].

Market Share and Competition

The market for EPI treatments is dominated by a few key players, with AbbVie and Allergan accounting for more than 95% of the market share. The divestiture of ZENPEP to Nestlé was part of regulatory efforts to maintain competition in the EPI drug market following the AbbVie-Allergan merger[2].

Market Dynamics

Growth Drivers

The global digestive enzymes market, which includes PERTs like ZENPEP, is expected to grow at a CAGR of 9.2% from 2022 to 2029, reaching a value of $1.414 billion by 2029. Key drivers include:

• Increased Focus on Sports Nutrition: Athletes' growing need for maintaining physical strength and overall health boosts the demand for digestive enzymes[5].
• Higher Adoption of Organic Foods: Consumer awareness about the health benefits of organic foods contributes to the market growth, although it may also shift consumer preferences away from dietary supplements[5].

Market Segments

The digestive enzymes market is segmented based on drugs, indications, end-users, and distribution channels. ZENPEP falls under the pancrelipase segment, which is indicated for conditions such as cystic fibrosis and chronic pancreatitis[5].

Challenges and Restraints

• Regulatory Approvals: The impending approval and regulatory scrutiny of new drugs can pose challenges to the market. For instance, the divestiture of ZENPEP was contingent upon regulatory approvals for the AbbVie-Allergan merger[3].
• Competition from Established Players: Despite Nestlé's acquisition, the company faces the challenge of competing with established pharmaceutical players like AbbVie and Allergan, which have significant experience and market presence[2].

Financial Trajectory

Revenue Projections

Given the growing demand for digestive enzymes and the specific need for PERTs, ZENPEP is expected to contribute significantly to Nestlé Health Science's revenue. The acquisition aligns with Nestlé's strategy to expand its medical nutrition business, which is likely to see substantial growth in the coming years.

Cost-Effectiveness and Pricing

The cost-effectiveness of ZENPEP and other PERTs can be influenced by drug price dynamics, including price increases during the exclusivity period and decreases after the loss of exclusivity. Studies have shown that these dynamics can significantly impact the cost per quality-adjusted life-year (QALY) gained, highlighting the need for careful pricing strategies[4].

Operational and Strategic Implications

Integration with Nestlé Health Science

Nestlé Health Science's acquisition of ZENPEP involves integrating the product into its existing portfolio of nutrition products. This integration is expected to leverage Nestlé's broad capabilities in medical nutrition, including its relationships with healthcare professionals and its distribution networks[1].

Expansion and Growth

The acquisition is part of Nestlé's broader strategy to grow its medical nutrition business. By expanding its product range to include ZENPEP, Nestlé aims to enhance its market presence and drive growth in the therapeutic nutrition segment.

Key Takeaways

• Strategic Acquisition: Nestlé's acquisition of ZENPEP is a strategic move to expand its medical nutrition business.
• Financial Performance: ZENPEP had significant net sales before the acquisition, indicating strong market demand.
• Market Growth: The global digestive enzymes market is expected to grow at a CAGR of 9.2% from 2022 to 2029.
• Challenges: The market faces challenges such as regulatory approvals and competition from established pharmaceutical companies.
• Cost-Effectiveness: Drug price dynamics play a crucial role in the cost-effectiveness of ZENPEP and other PERTs.

FAQs

Q: What is ZENPEP used for?

A: ZENPEP is used to treat Exocrine Pancreatic Insufficiency (EPI), a condition where the pancreas does not produce enough enzymes to break down fat, protein, and carbohydrates.

Q: Who acquired ZENPEP and why?

A: Nestlé Health Science acquired ZENPEP from Allergan as part of its strategy to expand its medical nutrition business and complement its existing portfolio of therapeutic products.

Q: What is the expected growth rate of the global digestive enzymes market?

A: The global digestive enzymes market is expected to grow at a CAGR of 9.2% from 2022 to 2029.

Q: What are the key drivers of the digestive enzymes market?

A: Key drivers include increased focus on sports nutrition and higher adoption of organic foods.

Q: What challenges does Nestlé face in the EPI drug market?

A: Nestlé faces challenges such as regulatory approvals and competition from established pharmaceutical companies like AbbVie and Allergan.

Sources

1. Nestlé Press Release: "Nestlé acquires Zenpep, expanding its medical nutrition business"[1]
2. Center for Biosimilars: "AbbVie, Allergan Merger Puts IL-23 Inhibitor Competition in Doubt"[2]
3. Genetic Engineering & Biotechnology News: "Allergan Sells Zenpep, Brazikumab as Regulators Review AbbVie $63B Deal"[3]
4. PubMed: "The Influence of US Drug Price Dynamics on Cost-Effectiveness Analyses"[4]
5. Data Bridge Market Research: "Global Digestive Enzymes Market – Industry Trends and Forecast to 2029"[5]