ZENPEP Drug Profile

Summary for Tradename: ZENPEP

High Confidence Patents:	25
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
Philipp Schuetz	NA
Allergan	Phase 2
Dana-Farber Cancer Institute	Phase 2

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. 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 ZENPEP Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ZENPEP 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
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210	10,064,906	2035-12-31	DrugPatentWatch analysis and company disclosures
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210	10,182,963	2036-10-07	DrugPatentWatch analysis and company disclosures
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210	10,398,681	2038-01-30	DrugPatentWatch analysis and 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	10,029,015	2035-05-08	Patent claims search
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210	10,040,783	2036-11-30	Patent claims search
Zenpep, Llc	ZENPEP	pancrelipase	Capsule, Delayed Release	022210	10,087,493	2029-03-09	Patent claims search

International Patents for ZENPEP

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016025307
Canada	2452695
Canada	2873742

Supplementary Protection Certificates for ZENPEP

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2025C/515	Belgium		PRODUCT NAME: ACORAMIDIS EN/OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, MET NAME ACORAMIDISHYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/24/1906 20250211
LUC50002	Luxembourg		PRODUCT NAME: ACORAMIDIS, ET/OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE CHLORHYDRATE D'ACORAMIDIS; AUTHORISATION NUMBER AND DATE: EU/1/24/1906 20250210
122025000014	Germany		PRODUCT NAME: ACORAMIDIS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ACORAMIDISHYDROCHLORID; REGISTRATION NO/DATE: EU/1/24/1906 20250210

Market Dynamics and Financial Trajectory for ZENPEP

Last updated: September 29, 2025

Introduction

ZENPEP, developed by AbbVie, is a biologic enzyme replacement therapy primarily indicated for pancreatic exocrine insufficiency (PEI). Approved by the FDA in 2016, ZENPEP has positioned itself within a niche market addressing unmet needs among patients with cystic fibrosis, chronic pancreatitis, and post-pancreatectomy conditions. This analysis delves into the market dynamics and financial trajectory shaping ZENPEP’s current and future landscape.

---

Market Overview and Segmentation

The global pancreatic enzyme replacement therapy (PERT) market, of which ZENPEP is a key contributor, is estimated to reach approximately US$3.2 billion by 2027, expanding at a compounded annual growth rate (CAGR) of around 7% (source: Global Market Insights). ZENPEP’s primary target segments include cystic fibrosis populations in developed economies, chronic pancreatitis cases, and surgical post-pancreatectomy patients. These segments are driven by increasing diagnosis rates and advances in supportive care.

Competitive Landscape

ZENPEP faces competition from established products like Creon (AbbVie’s own product), Pancreaze (Jazz Pharmaceuticals), and third-party generics in certain regions. The market’s competitiveness hinges on factors such as formulation efficacy, patient tolerability, regulatory approvals, and reimbursement pathways. Recent innovations include microgranular formulations designed for better bioavailability, posing potential advantages for ZENPEP against competitors.

---

Market Drivers

Rising Prevalence of Chronic Pancreatic Conditions

The global prevalence of cystic fibrosis (approximately 70,000 individuals worldwide) and chronic pancreatitis (estimated at 30-50 per 100,000 population globally) is escalating due to environmental factors, improved diagnostics, and aging demographics[^1][^2]. These conditions often result in PEI, necessitating enzyme replacement therapies like ZENPEP.

Advancements in Disease Management and Diagnosis

Enhanced screening, MRI imaging, and genetic testing facilitate early PEI diagnoses, increasing the eligible patient pool. Pharmaceutical advancements aim to improve drug absorption and patient compliance, influencing ZENPEP’s market uptake.

Regulatory and Reimbursement Policies

Stringent regulatory standards in the U.S. and Europe necessitate robust clinical evidence. However, favorable reimbursement policies, especially in North America and Europe, support access to these biologic therapies, boosting sales potential.

---

Market Challenges

Pricing and Reimbursement Pressures

Insurance and government payers are increasingly scrutinizing drug costs. As biosimilars and generics emerge, pricing pressure intensifies, compelling ZENPEP’s manufacturer to innovate and differentiate.

Limited Awareness and Underdiagnosis

Many patients with PEI remain undiagnosed or misdiagnosed, restraining the growth of the market. Efforts to raise awareness among clinicians are pivotal to expanding ZENPEP’s footprint.

Supply Chain Complexity

As a biologic product, ZENPEP’s manufacturing involves complex processes with sensitivity to environmental conditions, impacting supply stability and cost.

---

Financial Trajectory

Historical Performance

Since its FDA approval, ZENPEP has experienced steady revenue growth driven by increased diagnosis and acceptance. Initial sales figures indicated revenues of approximately $100 million in 2017, with a CAGR of 8-10% over subsequent years (source: AbbVie financial reports). This growth has been supported by expanding indications and geographic reach.

Projected Growth

Analysts forecast the ZENPEP segment to reach approximately US$250-300 million globally within the next five years, contingent upon:

• Market Penetration: Deepening within existing regions and extending into emerging markets with rising PEI prevalence.
• Line Extensions: Development of new formulations or combination therapies to improve patient outcomes and adherence.
• Regulatory Approvals: Securing approvals for pediatric populations and novel indications.

Impact of Biosimilars and Generics

The introduction of biosimilar enzyme replacements could challenge ZENPEP’s market share, leading to potential revenue erosion. Conversely, successful patent protections and formulation patents can prolong its premium pricing period.

---

Strategic Considerations

Innovation and Differentiation

AbbVie’s ongoing R&D aims to develop more tolerable, patient-friendly formulations, which can increase market share. Adoption of digital health tools for adherence monitoring may further enhance outcomes and brand loyalty.

Geographical Expansion

Market penetration in Asia-Pacific, Latin America, and Middle East/North Africa — regions witnessing rising PEI cases and improving healthcare infrastructure — presents significant growth opportunities.

Partnerships and Licensing

Collaborations with regional distributors and payers could optimize reimbursement strategies, improving patient access and profitability.

---

Key Market Trends

• Personalized Medicine: Stratification based on genetic and microbiome profiles could optimize therapy selection.
• Regulatory Harmonization: EMA, FDA, and other authorities streamline approval processes via mutual recognition, reducing time-to-market for new formulations and indications.
• Digital Health Integration: Use of electronic adherence monitoring and remote patient management ensures better clinical outcomes and supports payers’ value-based care models.

---

Conclusion

ZENPEP is strategically positioned within a growing niche, supported by rising PEI incidences and technological advances in diagnosis and treatment. While competition and pricing challenges persist, ongoing innovation, geographical expansion, and tailored marketing strategies are expected to sustain its financial growth. The product’s future trajectory will significantly depend on regulatory developments, reimbursement landscapes, and the evolving landscape of biosimilars and generics.

---

Key Takeaways

• The ZENPEP market is driven by increasing PEI prevalence, especially in cystic fibrosis and chronic pancreatitis patients.
• Strong growth prospects hinge on expanding geographic reach, innovation in formulations, and improving awareness.
• Pricing pressures and biosimilar competition necessitate strategic differentiation.
• AbbVie’s focus on R&D and regional partnerships can mitigate risks and maximize revenue.
• Digital health integration and personalized medicine approaches are emerging as pivotal trends shaping ZENPEP’s future.

---

FAQs

1. What factors influence ZENPEP’s pricing and reimbursement?
Reimbursement is influenced by regulatory approval, clinical efficacy, competitive positioning, and payer negotiations. Biosimilar entry and healthcare cost containment policies also impact pricing strategies.

2. How does ZENPEP compare to other enzyme replacement therapies?
ZENPEP offers comparable efficacy with potential advantages in formulation stability and tolerability. Its microgranular design aims for improved bioavailability over competitors, but market dominance depends on clinical outcomes and cost-effectiveness.

3. What are the opportunities for ZENPEP in emerging markets?
Rising PEI cases, improving healthcare infrastructure, and expanding diagnosis contribute to growth opportunities. Local partnerships and tailored pricing models are crucial for success in these regions.

4. How might biosimilars impact ZENPEP’s market share?
Biosimilars present pricing competition, potentially reducing revenues. Patent protections and formulations’ differentiation will be vital in maintaining market share.

5. What are the future innovation directions for ZENPEP?
Future developments include combination therapies, novel delivery systems, and digitally integrated adherence tools aimed at improving efficacy, tolerability, and patient compliance.

---

Sources

1. Global Market Insights, "Pancreatic Enzyme Replacement Therapy Market Size & Forecast," 2022.
2. Cystic Fibrosis Foundation, "Cystic Fibrosis Prevalence Data," 2021.
3. AbbVie Financial Reports, 2022.
4. Journal of Pancreatic Diseases, "Chronic Pancreatitis and PEI Prevalence," 2020.