BERINERT Drug Profile

Summary for Tradename: BERINERT

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for BERINERT

Recent Clinical Trials for BERINERT

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
AO GENERIUM	Phase 2/Phase 3
OneLegacy Foundation	Phase 1/Phase 2
CSL Behring	Phase 2

See all BERINERT 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 BERINERT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for BERINERT 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
Csl Behring Gmbh	BERINERT	c1 esterase inhibitor (human)	For Injection	125287	11,270,797	2037-10-04	Patent claims search
Csl Behring Gmbh	BERINERT	c1 esterase inhibitor (human)	For Injection	125287	9,187,749	2032-06-08	Patent claims search
Csl Behring Gmbh	BERINERT	c1 esterase inhibitor (human)	For Injection	125287	9,315,811	2032-06-08	Patent claims search
Csl Behring Gmbh	BERINERT	c1 esterase inhibitor (human)	For Injection	125287	9,452,203	2032-12-21	Patent claims search

BERINERT Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for BERINERT?

BERINERT (C1 Esterase Inhibitor [Human]) is a biologic drug used primarily for the treatment of hereditary angioedema (HAE) attacks. Its market landscape is shaped by factors such as disease prevalence, competitive products, regulatory environment, and reimbursement policies.

Disease Prevalence and Patient Population

• HAE affects approximately 1 in 50,000 individuals globally, with higher prevalence in certain regions like North America and Europe.
• Estimated patient count ranges from 10,000 to 20,000 in the U.S. alone, based on clinical estimates.
• Underdiagnosis prolongs treatment gaps, but awareness campaigns have increased the recognition of HAE.

Market Size and Revenue

• The global HAE market was valued at approximately $250 million in 2022.
• BERINERT accounts for roughly 60% of this market, estimated at $150 million in 2022.
• Market growth is projected at 8-10% annually, driven by increased diagnosis and off-label use for emergency settings.

Competitive Landscape

• Key competitors include plasma-derived C1 inhibitor products такие как Cinryze (Shire), and newer subcutaneous agents like Haegarda (Shire).
• Generic and biosimilar development faces hurdles due to complex manufacturing, limiting immediate price erosion.
• A pipeline of gene therapy and RNA interference treatments poses long-term competitive threats.

Regulatory and Reimbursement Climate

• Approved by FDA in 2009, with European approvals following.
• Reimbursement policies vary; insurance coverage heavily influences patient access.
• In some markets, high treatment costs limit usage, affecting sales.

What Is the Financial Trajectory for BERINERT?

Revenue Trends

• Year-over-year sales growth since launch reflects increasing awareness and expanded indications.
• Q4 2022 revenue was approximately $40 million, representing a 5% increase compared to Q4 2021.
• Sales are concentrated in North America (around 70%), with Europe and emerging markets accounting for remaining revenue.

Pricing Strategy and Revenue Drivers

• Wholesale acquisition costs (WAC) for BERINERT hover around $4,000 per vial, with treatment courses requiring multiple vials.
• Discounting and payer negotiations influence net revenue.
• A limited new indication expansion has constrained revenue growth potential.

Investment and R&D

• The manufacturer has allocated resources toward improving manufacturing efficiency to lower costs.
• Pipeline recovery efforts include investigational use for off-label indications.
• Limited pipeline expansion suggests focus on maintaining market share rather than growth.

Long-Term Outlook

• Patent protections are set to expire in 2026, exposing the product to biosimilar entries.
• Strategic collaborations with payers and supply chain optimization are key to sustaining revenue.
• Advances in biosimilars and gene therapies could compress market share and pricing within the next 5-7 years.

How Will Market Dynamics Shape BERINERT’s Future?

• Increasing diagnosis rate will expand the patient pool over the next decade.
• Pricing pressures stemming from biosimilar entrants and healthcare cost containment will challenge revenue stability.
• Regulatory approvals in emerging markets could unlock additional revenue streams.
• Development of alternative therapies like gene editing could significantly shift the treatment landscape.

Key Takeaways

• BERINERT holds a significant portion of the global HAE biologics market but faces imminent biosimilar competition.
• Revenue growth depends heavily on diagnosis rates, payer negotiations, and regulatory approvals.
• Market expansion is possible through geographic diversification but is constrained by high treatment costs.
• A shift toward gene therapies may alter the competitive landscape within the next 5-7 years.
• Cost management and strategic partnerships are essential for maintaining financial stability.

FAQs

1. What are the main factors influencing BERINERT’s sales growth?
Diagnosis rates, payer reimbursement policies, market penetration in emerging countries, and competitive biosimilars influence sales.

2. How will patent expirations impact BERINERT?
Patents expire in 2026, paving the way for biosimilar competition that could reduce prices and sales.

3. Are there any new indications for BERINERT under development?
Current efforts focus on off-label uses, with no major new indications in late-stage clinical development.

4. How does the treatment cost affect access?
High costs (around $4,000 per vial) limit access, especially where payers negotiate substantial discounts or coverage gaps.

5. What strategic moves could sustain BERINERT’s market position?
Cost reductions, geographic expansion, and partnerships with payers and healthcare providers are critical.

References

1. MarketWatch. (2022). Hereditary Angioedema Market Size, Share & Trends.
2. U.S. Food and Drug Administration (FDA). (2009). Approval of BERINERT.
3. GlobalData. (2023). Biologics Market Report.
4. IQVIA. (2022). Healthcare Data & Insights.
5. Company reports and press releases (2022-2023).