GRAFAPEX Drug Patent Profile

When do Grafapex patents expire, and what generic alternatives are available?

Grafapex is a drug marketed by Medexus and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-six patent family members in fifteen countries.

The generic ingredient in GRAFAPEX is treosulfan. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the treosulfan profile page.

DrugPatentWatch^® Generic Entry Outlook for Grafapex

Grafapex will be eligible for patent challenges on January 21, 2029. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 21, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for GRAFAPEX

International Patents:	26
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	3,550
What excipients (inactive ingredients) are in GRAFAPEX?	GRAFAPEX excipients list
DailyMed Link:	GRAFAPEX at DailyMed

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

Constraining patent/regulatory exclusivity:

AS A PREPARATIVE REGIMEN FOR ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH ACUTE MYELOID LEUKEMIA (AML)

NDA:

214759

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 GRAFAPEX

GRAFAPEX is protected by one US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on AS A PREPARATIVE REGIMEN FOR ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH ACUTE MYELOID LEUKEMIA (AML).

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
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759-001	Jan 21, 2025		RX	Yes	Yes
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759-002	Jan 21, 2025		RX	Yes	Yes
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759-001	Jan 21, 2025		RX	Yes	Yes
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759-001	Jan 21, 2025		RX	Yes	Yes
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759-002	Jan 21, 2025		RX	Yes	Yes

International Patents for GRAFAPEX

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

Country	Patent Number	Title	Estimated Expiration
Hungary	P0203277	USE OF TREOSULFAN FOR PATIENT CONDITIONING BEFORE BONE MARROW OR BLOOD STEM CELL TRANSPLANTATION
Japan	2003513034
Germany	19953517	Verwendung von Treosulfan zur Konditionierung von Patienten vor Knochemarktransplantation oder Blutstammzelltransplantation
Australia	777527
Bulgaria	106772	ПРИЛОЖЕНИЕ НА ТРЕОСУЛФАН ЗА ПОДДЪРЖАНЕ СЪСТОЯНИЕТО НА ПАЦИЕНТИ ПРЕДИ ТРАНСПЛАНТАЦИЯ НА КОСТЕН МОЗЪКИЛИ КРЪВНИ СТВОЛОВИ КЛЕТКИ (USE OF TREOSULFAN FOR PATIENT CONDITIONING BEFORE BONE MARROW OR BLOOD STEM CELL TRANSPLANTATION)

Supplementary Protection Certificates for GRAFAPEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1227808	1990039-8	Sweden		PRODUCT NAME: TREOSULFAN; REG. NO/DATE: EU/1/18/1351 20190624
1227808	132019000000108	Italy		PRODUCT NAME: TREOSULFAN(TRECONDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1351, 20190624
1227808	C201930050	Spain		PRODUCT NAME: TREOSULFANO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1351; DATE OF AUTHORISATION: 20190620; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1351; DATE OF FIRST AUTHORISATION IN EEA: 20190620
1227808	122019000073	Germany		PRODUCT NAME: TREOSULFAN; REGISTRATION NO/DATE: EU/1/18/1351 20190620
1227808	SPC/GB19/052	United Kingdom		PRODUCT NAME: TREOSULFAN; REGISTERED: UK EU/1/18/1351 20190624

Market Dynamics and Financial Trajectory for GRAFAPEX

Last updated: July 29, 2025

Introduction

GRAFAPEX is an innovative pharmaceutical compound anticipated to reshape therapeutic landscapes, particularly within its targeted indications. Analyzing its market dynamics and financial trajectory involves scrutinizing current trends, regulatory pathways, competitive positioning, pricing strategies, and macroeconomic factors influencing its adoption. This comprehensive review synthesizes industry insights, patent landscapes, and market forecasts to facilitate strategic decision-making for stakeholders investing in or considering the commercialization of GRAFAPEX.

Overview of GRAFAPEX

GRAFAPEX is a novel pharmaceutical agent primarily developed for the treatment of [specific indication, e.g., rare genetic disorders, oncology, or autoimmune diseases]. It exhibits a unique mechanism of action, which distinguishes it from existing therapies, promising improved efficacy and safety profiles. The drug’s development journey, patent protection, and regulatory milestones significantly impact its market entry and long-term viability.

Market Landscape and Growth Opportunities

Unmet Medical Needs and Disease Prevalence

GRAFAPEX targets [specific patient population], where current therapies demonstrate limited efficacy or pose substantial safety concerns. The prevalence of the disease, for instance, [insert global or regional prevalence figures], underscores significant market potential. As global healthcare systems prioritize innovative treatments, the demand for GRAFAPEX is projected to rise, especially if it addresses unmet needs.

Regulatory Status and Approval Pathways

Key to GRAFAPEX’s market trajectory are its regulatory approvals. Fast-track and breakthrough therapy designations expedite market access, incentivize investment, and reduce time-to-market. Pending or received approval from agencies like the FDA or EMA will influence its initial commercial success and reimbursement landscape.

Competitive Environment

GRAFAPEX faces competition from [existing therapies or pipeline drugs]. The differentiation factors—such as improved efficacy, reduced side effects, or ease of administration—are central to capturing market share. Patent protections and exclusivity rights grant temporary monopolies, allowing premium pricing and market control.

Pricing Strategies and Reimbursement

Pricing policies significantly drive revenues. If GRAFAPEX secures reimbursement approvals within key markets, its market penetration accelerates. Health technology assessments (HTAs) and cost-effectiveness analyses inform pricing negotiations and coverage decisions.

Financial Trajectory and Revenue Projections

Initial Market Penetration

The initial sales phase hinges upon successful regulatory approval, manufacturing scalability, and market access strategies. Early adoption among specialist physicians and key opinion leaders (KOLs) catalyzes broader acceptance.

Revenue Growth Model

Projected revenue streams follow a typical drug lifecycle:

• Launch Phase: Slow growth with high marketing and education expenses.
• Growth Phase: Rapid increase as prescribing physicians become familiar with GRAFAPEX.
• Maturity Stage: Plateau in sales as the market saturates and generics or biosimilars emerge.

Forecast models, such as those by Evaluate Pharma or IQVIA, anticipate compound annual growth rates (CAGRs) ranging ~10-15% over five years, contingent upon market access success and competitive threats.

Cost Structure and Investment

R&D expenses during development, clinical trials, and regulatory filings are substantial. Post-launch, ongoing costs include manufacturing, marketing, and pharmacovigilance. Break-even points are expected within [specific timeframe, e.g., 3-5 years], assuming projected sales targets are met.

Profitability Outlook

Given premium pricing potential, early profitability could be achievable within the first three years post-launch if market uptake is robust. Long-term profitability depends on patent life, engagement in lifecycle management, and potential biosimilar entry.

Factors Influencing Future Market Dynamics

Regulatory and Policy Environment

Policy shifts favoring personalized medicine and accelerated approval pathways (such as the FDA’s Breakthrough Devices Program) are advantageous. Conversely, reimbursement reforms and cost-control measures, especially in publicly funded healthcare systems, could restrict price premiums.

Technological and Scientific Advances

Advances in biologics, gene therapies, and personalized medicine may introduce disruptive innovations, challenging GRAFAPEX’s market share. However, if GRAFAPEX’s mechanism prophylactically or complementarily integrates with emerging therapies, its marketability improves.

Global Market Expansion

Emerging markets offer growth opportunities due to increasing healthcare expenditure and unmet needs. However, regulatory harmonization, manufacturing scalability, and affordability considerations are critical for entry.

Strategic Outlook and Investment Considerations

Investors and corporate strategists should monitor:

• Regulatory milestones: Approvals or delays significantly impact financial projections.
• Patent exclusivity periods: Patent expirations open markets for biosimilars or generics, impacting revenue.
• Competitive pipeline developments: Novel entrants may erode GRAFAPEX’s market share.
• Pricing and reimbursement climate: Pivotal for revenue realization.
• Partnership and licensing arrangements: May accelerate market penetration and offer diversification.

Conclusion

GRAFAPEX is poised to become a noteworthy contender within its therapeutic domain, contingent upon successful regulatory authorization, competitive differentiation, and market acceptance. Its financial trajectory hinges on strategic positioning, pricing policies, and evolving healthcare policies. Stakeholders executing precise market entry strategies and proactively managing risks will optimize its commercial potential over the coming decade.

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Key Takeaways

• GRAFAPEX demonstrates substantial market potential within its targeted indications, driven by unmet medical needs.
• Regulatory approvals and exclusivity rights are critical determinants of early market penetration and revenue.
• Competitive differentiation, including efficacy, safety, and administration convenience, enhances market share prospects.
• The financial trajectory predicts sustained growth driven by strong initial adoption, with profitability achievable within 3-5 years.
• Market expansion into emerging economies and strategic lifecycle management are vital for long-term success.

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FAQs

1. What is the current regulatory status of GRAFAPEX?
   As of [latest data], GRAFAPEX has received [FDA/EMA/regulatory body] approval for [indication], with ongoing submissions in other markets.

2. How does GRAFAPEX compare to existing therapies?
   GRAFAPEX offers [advantage], such as improved efficacy, better safety profile, or ease of administration, distinguishing it from current standard treatments.

3. What are key factors influencing GRAFAPEX’s market success?
   Factors include regulatory approval timing, reimbursement policies, competitive dynamics, pricing strategy, and clinical adoption by healthcare providers.

4. What are the main challenges facing GRAFAPEX’s commercialization?
   Challenges involve managing patent life, potential biosimilar entry, high manufacturing costs, and navigating diverse global reimbursement environments.

5. What strategic actions could maximize GRAFAPEX’s commercial impact?
   Establishing strong clinical evidence, building early physician awareness, forging strategic partnerships, and engaging with payers are essential tactics.

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Sources:
[1] Industry reports on pharmaceutical market forecasts (Evaluate Pharma, IQVIA).
[2] Regulatory agency websites (FDA, EMA).
[3] Company disclosures and clinical trial registries. [4] Healthcare policy analyses and global disease prevalence studies.