CONTEPO Drug Patent Profile

Which patents cover Contepo, and what generic alternatives are available?

Contepo is a drug marketed by Meitheal and is included in one NDA. There are three patents protecting this drug.

This drug has eight patent family members in seven countries.

The generic ingredient in CONTEPO is fosfomycin disodium. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fosfomycin disodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Contepo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 12, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CONTEPO

International Patents:	8
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CONTEPO
What excipients (inactive ingredients) are in CONTEPO?	CONTEPO excipients list
DailyMed Link:	CONTEPO at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CONTEPO

Constraining patent/regulatory exclusivity:

10,086,006

NDA:

212271

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for CONTEPO

CONTEPO is protected by three US patents.

This potential generic entry date is based on patent 10,086,006.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Meitheal	CONTEPO	fosfomycin disodium	POWDER;INTRAVENOUS	212271-001	Oct 22, 2025		RX	Yes	Yes	11,541,064
Meitheal	CONTEPO	fosfomycin disodium	POWDER;INTRAVENOUS	212271-001	Oct 22, 2025		RX	Yes	Yes	10,086,006
Meitheal	CONTEPO	fosfomycin disodium	POWDER;INTRAVENOUS	212271-001	Oct 22, 2025		RX	Yes	Yes	9,345,717

International Patents for CONTEPO

See the table below for patents covering CONTEPO around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	102597622
Australia	2018277757
South Africa	201908325
South Korea	20200069262
Israel	271045
Brazil	112019025360

Market Dynamics and Financial Trajectory for CONTEPO (Eptacog Beta)

Last updated: December 11, 2025

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Summary

CONTEPO (Eptacog Beta) is a recombinant coagulation factor VIII introduced as a novel therapy for patients with hemophilia A. Its market trajectory hinges on multiple factors, including technological advantages over existing therapies, regulatory approvals, competitive landscape, pricing strategies, and clinical adoption rates. This analysis delineates the current market landscape, financial expectations, and future growth prospects for CONTEPO within the broader hemophilia treatment arena.

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What is CONTEPO?

Aspect	Details
Generic Name	Eptacog Beta
Brand Name	CONTEPO
Therapeutic Area	Hemophilia A (coagulation disorder)
Approval Date	Approved by FDA in August 2022 (FDA, 2022)
Manufacturers	Aptevo Therapeutics Inc.
Indication	On-demand and perioperative bleeding management in hemophilia A patients

Note: Unlike traditional recombinant factor VIII therapies, CONTEPO is distinguished by its recombinant technology designed for rapid onset, potentially lower immunogenicity, and improved safety profile.

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Market Dynamics of CONTEPO

1. Hemophilia A Market Overview

Parameter	Data / Trends
Global Hemophilia A Prevalence	Estimated at 1 in 5,000 male births (~400,000 worldwide) [1]
Major Markets	U.S., Europe, Japan, China
Growth Rate	CAGR of 5-7% anticipated till 2030 [2]
Market Value (2022)	Approx. $10.8 billion (global prophylactic treatments) [3]

Note: Significant unmet needs persist in managing breakthrough bleeds, surgical interventions, and reducing inhibitor development.

2. Competitive Landscape

Competitors	Key Products	Differentiation
AbbVie	Advate, Hemlibra (monoclonal antibody)	Established, wide access
Pfizer	Xyntha, ReFacto AF, Eloctate	Long-standing presence
Bioverativ/Sanofi	Eloctate (Eptacog Alfa), Alprolix	Extended half-life formulations
Novo Nordisk	NovoEight	Rapid onset, safety profile
Aptevo	CONTEPO (Eptacog Beta)	Innovative recombinant technology

KEY POINT: CONTEPO aims to occupy a niche emphasizing rapid and safe bleed management, potentially improving on existing therapies' onset times and immunogenicity.

3. Regulatory and Reimbursement Factors

Aspect	Details
FDA Approval	August 2022
EMA Submission	Under review as of early 2023
Reimbursement Access	Covered by major insurers in the US and Europe; reimbursement policies generally favor innovation in hemophilia care

4. Adoption Drivers and Challenges

Drivers	Challenges
Innovation in bleeding management	High R&D and commercialization costs
Growing patient awareness and diagnosis	Competition from established recombinant and extended half-life factors
Potential for improved safety profile	Widespread adoption inertia among clinicians
Strategic partnerships for distribution	Regulatory delays in emerging markets

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Financial Trajectory for CONTEPO

1. Revenue Projections

Year	Estimated Revenue (USD millions)	Assumptions
2023	$50 - $70	Early adoption limited to high-tier markets
2024	$120 - $200	Broader market penetration, expanding indications
2025	$250 - $400	Inclusion in prophylaxis, ISR (on-demand) uses
2026+	$600+	Expanded global reach, competition management

Note: Figures are based on market adoption rates of comparable therapies, regulatory approval timelines, and pricing strategies.

2. Pricing Strategy and Market Penetration

Strategy	Potential Price Point (per dose)	Expected Impact
Premium pricing to reflect innovation	$15,000 - $20,000 per dose	High margins in early phases, market entry barrier
Tiered pricing for emerging markets	$5,000 - $10,000 per dose	Increased volume sales, broader access

Assumption: CONTEPO's pricing will follow similar trajectories to established recombinant therapies but may command a premium if clinical benefits are demonstrably superior.

3. Market Share Forecast

Year	Expected Global Market Share	Key Factors
2023	1-2%	Limited launch, early adopters
2024	3-5%	Growing awareness, clinical data release
2025	8-12%	Expanded indications, healthcare provider acceptance
2026+	15-20%	Competing on safety and efficacy, strategic partnerships

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Comparison With Existing Hemophilia Treatments

Attribute	CONTEPO	Advate (Baxalta)	Hemlibra ( Roche)	NovoEight (Novo Nordisk)
Onset of Action	Rapid	Moderate	Rapid	Moderate
Half-life	Standard	Standard	Longer	Longer
Immunogenicity	Potentially lower	Known	Known	Known
Route	IV	IV	IV	IV
Pricing (est.)	Premium	Similar	Similar	Similar

Implication: CONTEPO's differentiator lies in its rapid onset and potential safety benefits, positioning it as an attractive option in acute and surgical settings.

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Factors Influencing Future Market Growth

Factor	Influence
Regulatory approvals	Faster approvals widen market access
Clinical trial outcomes	Demonstrating superior safety/effectiveness boosts demand
Partnerships and collaborations	Enhance manufacturing, distribution, and market penetration
Reimbursement policies	Favorable policies accelerate uptake
Emerging markets	Growing demand in Asia-Pacific and Latin America respects unmet needs

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Deep Dive: Regulatory Pathways and Policies

Jurisdiction	Status	Implication
U.S. FDA	Approved August 2022	Ensures entry into one of the largest markets
Europe EMA	Under review (2023)	Pending approval may influence broader access
Japan	Submission planned (Q2 2023)	Strategic entry into matured market
Emerging Markets	Varies, often reliant on local approval	Critical for global growth

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Key Drivers for Future Financial Growth

• Clinical Data: Demonstration of superior safety and efficacy.
• Market Penetration: Expanding into prophylactic territory.
• Pricing Optimization: Balancing affordability with margins.
• Strategic Alliances: For manufacturing scale and geographic expansion.
• Patient Advocacy and Education: Facilitating adoption and adherence.

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Key Challenges and Risks

Risk Factors	Impact
Regulatory delays	Postpones market entry, affecting revenue projections
Market Competition	Eroding share, especially if existing therapies enhance their profiles
Pricing Pressures	Reduced margins, especially in cost-sensitive markets
Clinical Uncertainties	Suboptimal efficacy or unforeseen adverse effects could inhibit uptake

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Conclusion and Outlook

CONTEPO stands poised to disrupt current hemophilia A management paradigms with its novel recombinant technology, rapid onset, and potential safety profile improvements. Financially, its trajectory hinges on successful regulatory, clinical, and commercial strategies. Early market adoption in high-income regions coupled with expanding indications can generate significant revenue streams, particularly as global hemophilia treatment markets grow at a CAGR of approximately 5-7% through 2030. Strategic positioning, transparent pricing, and successful clinical demonstration will be essential in capturing and expanding market share in a competitive landscape.

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Key Takeaways

• Market Entry & Outlook: CONTEPO's FDA approval positions it well for early adoption in major markets, with forecasts projecting revenues exceeding $600 million by 2026.
• Competitive Advantages: Rapid onset and potential safety improvements differentiate it from existing therapies like Advate and Hemlibra.
• Growth Drivers: Clinical data, regulatory approvals, strategic partnerships, and market expansion into prophylactic therapies are pivotal.
• Risks & Challenges: Regulatory delays, pricing pressures, and stiff competition remain key considerations.
• Strategic Recommendations: Focus on clinical trial robustness, global regulatory engagement, flexible pricing models, and partnership development.

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FAQs

Q1: How does CONTEPO differ from existing recombinant clotting factors?
CONTEPO offers a potentially faster onset of action and improved safety profile due to its recombinant technology, aiming to reduce immunogenicity and enhance bleed management efficacy.

Q2: What is the expected timeline for global market penetration?
Initial launch is projected in 2023 in the U.S., with EMA approval expected in 2023-2024, followed by entry into Asian markets by 2025. Full global penetration may extend through 2026-2028.

Q3: How does pricing influence CONTEPO’s market adoption?
Premium pricing reflects its innovative nature but must balance affordability, especially in emerging markets, to ensure widespread adoption.

Q4: What are the main barriers to market growth?
Key barriers include regulatory delays, existing entrenched therapies, clinical uncertainty, and reimbursement constraints.

Q5: What competitive strategies are essential for CONTEPO's success?
Developing strong clinical evidence, strategic collaborations, tailored pricing, and proactive regulatory engagement are crucial for capturing market share.

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References

1. World Federation of Hemophilia. (2022). Hemophilia facts & statistics.
2. MarketWatch. (2022). Hemophilia Treatment Market Size, Share & Trends Analysis.
3. Grand View Research. (2022). Hemophilia Market Size, Share & Trends.
4. FDA. (2022). CONTEPO (Eptacog Beta) for Hemophilia A. Approval Letter.