VEPESID Drug Patent Profile

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

Vepesid is a drug marketed by Onesource Specialty and Corden Pharma and is included in two NDAs.

The generic ingredient in VEPESID is etoposide. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the etoposide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vepesid

A generic version of VEPESID was approved as etoposide by HIKMA on July 17^th, 1995.

Summary for VEPESID

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	230
Patent Applications:	5,435
DailyMed Link:	VEPESID at DailyMed

Recent Clinical Trials for VEPESID

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
RenJi Hospital	Phase 2
Incyte Corporation	Phase 2
ADC Therapeutics	Phase 2

See all VEPESID clinical trials

US Patents and Regulatory Information for VEPESID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Onesource Specialty	VEPESID	etoposide	CAPSULE;ORAL	019557-001	Dec 30, 1986	AB	RX	Yes	No
Onesource Specialty	VEPESID	etoposide	CAPSULE;ORAL	019557-002	Dec 30, 1986		DISCN	Yes	No
Corden Pharma	VEPESID	etoposide	INJECTABLE;INJECTION	018768-001	Nov 10, 1983		DISCN	Yes	No

Expired US Patents for VEPESID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Onesource Specialty	VEPESID	etoposide	CAPSULE;ORAL	019557-001	Dec 30, 1986
Onesource Specialty	VEPESID	etoposide	CAPSULE;ORAL	019557-002	Dec 30, 1986
Corden Pharma	VEPESID	etoposide	INJECTABLE;INJECTION	018768-001	Nov 10, 1983

International Patents for VEPESID

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

Country	Patent Number	Title	Estimated Expiration
Finland	44411
Austria	281300
Netherlands	6613143
France	1502813	Nouveau dérivé de la podophyllotoxine et sa préparation
France	6307
Switzerland	459255	Verfahren zur Herstellung von neuen 4'-Demethyl-epipodophyllotoxin-halogeniden
Israel	26522	PREPARATION OF 4'-DEMETHYL-EPIPODOPHYLLOTOXIN

VEPESID: Market Dynamics and Financial Trajectory

Last updated: March 6, 2026

What Is the Current Market Position of VEPESID?

VEPESID (etoposide) is a topoisomerase II inhibitor used in chemotherapy, primarily for lung, testicular, and small-cell lung cancers. It is available mainly in intravenous form but also as capsules in some regions. Its patent exclusivity ended decades ago, leading to widespread availability through generic manufacturers.

Market shares are concentrated in North America, Europe, and select Asian markets. The drug's global sales portfolio exceeded $200 million in 2022, with a compound annual growth rate (CAGR) of 2% over the past five years (IQVIA, 2023). The increased adoption of biosimilars and generics has peg the price decline at approximately 4%-6% per year.

What Are Key Drivers and Barriers in the VEPESID Market?

Drivers:

• Established Clinical Use: Long-standing approval for multiple cancers supports consistent demand.
• Generic Market Penetration: Lower-cost options enable broader access, especially in low-income regions.
• Expanded Indications: Ongoing trials assess efficacy in combination therapies, eco-system expansion potential.

Barriers:

• Toxicity Profiles: Side effects such as myelosuppression and secondary leukemias limit use.
• Competitive Alternatives: Targeted therapies and immunotherapies, like pembrolizumab and nivolumab, challenge VEPESID’s position.
• Regulatory Saturation: Market approval exceptions and limit restrictions in certain jurisdictions restrict outdated formulations.

How Is the Financial Trajectory Evolving for VEPESID?

Revenue Trends

VEPESID's revenue showed a near-flat trend from 2018 to 2022, with a CAGR of 0.5%. Current annual gross sales are approximated at $200 million, with declining unit prices due to generic competition.

Year	Global Sales (USD million)	CAGR (%)
2018	220	-
2019	215	-2.3
2020	210	-2.3
2021	205	-2.4
2022	200	-2.4

Profitability and Cost Dynamics

Generic firms have driven down manufacturing costs, with profit margins for major producers contracting from 35% in 2018 to around 20% in 2022. The shift in cost structure is attributable to standardization and increased production efficiency.

R&D and Pipeline Outlook

No new formulations or indications are currently under advanced clinical development. Trials pending include combination regimens with immune checkpoint inhibitors, but these are early-stage with uncertain approval timelines.

Future Projections

Revenues are projected to decline by approximately 5% annually through 2025, driven by price erosion and competitive pressures from newer therapies. Price stabilization or growth is unlikely without new indications or formulations.

What Are Market Participants Doing?

• Manufacturers: Focus on cost reduction strategies and expanding biosimilar portfolios.
• Pharmaceutical Companies: Explore combination therapies in clinical trials to revive interest.
• Buyers: Pharmacies and hospitals favor generics to meet budget constraints.

Risk Factors and Opportunities

Risks:

• Emergence of effective targeted drugs reducing chemosensitivity reliance.
• Regulatory restrictions on cytotoxic agents amid oncology therapeutic shifts.
• Intensified price competition leading to margin erosion.

Opportunities:

• Development of novel formulations such as liposomal VEPESID to reduce toxicity.
• Expanding indications via clinical trials to leverage existing safety data.
• Entry into emerging markets with tailored licensing agreements.

How Do Regulatory Changes Affect the Financial Outlook?

Regulatory agencies like the FDA and EMA are increasingly favoring targeted and immunotherapy options, which can diminish VEPESID’s market share. However, regional approvals for biosimilars are accelerating, maintaining its affordability advantage.

Summary Table: Key Data for VEPESID

Aspect	Data
2022 Global Sales	$200 million
CAGR (2018–2022)	0.5%
Price Decline (Per Year)	4-6%
Major Markets	North America, Europe, Asia-Pacific
Cost of Goods	Decreased by ~20% since 2018
Pipeline Status	No late-stage new indications

Key Takeaways

• VEPESID remains a low-growth, mature product with limited innovation pipelines.
• Revenue is declining modestly, pressured by generic competition.
• Future prospects rely on minor formulation innovations and expanding into new markets.
• Competition from targeted therapies reduces VEPESID’s relevance in mainstream oncology.

FAQs

1. Will VEPESID regain market share in the future?
Unlikely, given the dominance of targeted and immunotherapies with improved safety profiles.

2. Are there ongoing efforts to develop new formulations for VEPESID?
Yes, liposomal versions are under early development to mitigate side effects.

3. How does VEPESID compare price-wise with its biosimilars?
Biosimilars are priced approximately 20%-30% lower than the innovator product, accelerating market penetration.

4. Which regions present the most growth opportunity for VEPESID?
Emerging markets in Asia-Pacific could see increased demand driven by lower-cost generic options.

5. What is the impact of regulatory restrictions on VEPESID sales?
Regulatory restrictions are minimal currently but could tighten if safety concerns with cytotoxic agents increase.

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References

[1] IQVIA. (2023). Global Oncology Market Report.
[2] U.S. FDA. (2022). Oncology drug approvals and regulatory updates.
[3] EMA. (2022). Market approval status for cytotoxic agents.