KEPPRA Drug Patent Profile

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

Keppra is a drug marketed by Ucb Inc and is included in four NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-nine patent family members in twenty-five countries.

The generic ingredient in KEPPRA is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-five suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Keppra

A generic version of KEPPRA was approved as levetiracetam by MYLAN on November 4^th, 2008.

Summary for KEPPRA

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	4

Paragraph IV (Patent) Challenges for KEPPRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KEPPRA	Tablets	levetiracetam	1000 mg	021035	1	2007-01-24

US Patents and Regulatory Information for KEPPRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	KEPPRA	levetiracetam	INJECTABLE;INTRAVENOUS	021872-001	Jul 31, 2006	AP	RX	Yes	Yes
Ucb Inc	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-001	Sep 12, 2008	AB	RX	Yes	No	7,858,122		Y
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-001	Nov 30, 1999	AB	RX	Yes	No	8,802,142*PED				Y

International Patents for KEPPRA

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	52391	(S)-ALPHA-ETHYL-2-OXO-1-PYRROLIDINACETAMIDE
Cyprus	1567	(S)-ALPHA-ETHYL-2-OXO-1-PYRROLIDINEACETAMIDES
South Africa	200703096	Pharmaceutical compositions comprising levetiracetam and process for their preparation

Supplementary Protection Certificates for KEPPRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0162036	C300028	Netherlands		PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
0162036	SPC/GB00/030	United Kingdom		SPC/GB00/030: 20050514, EXPIRES: 20100514
0162036	2000C/032	Belgium		PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329

KEPPRA (Levetiracetam): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

KEPPRA (levetiracetam) is an antiepileptic drug primarily prescribed for partial-onset seizures. Since its approval in 2000, KEPPRA has established a significant market position, with a mature but evolving landscape influenced by generic competition, emerging indications, and patent statuses. This report evaluates KEPPRA’s current market dynamics, forecasted financial trajectory, and investment potential, emphasizing key drivers, constraints, and strategic considerations for stakeholders.

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What Is the Current Market Position of KEPPRA?

Market Share & Sales Performance

Metric	2022 Figures	Notes
Global sales (USD)	~$1.2 billion [1]	Consistent revenue, with North America accounting for ~70%
US market share	~55-60%	Dominates in epilepsy treatment precedents
Number of prescriptions (US)	~4 million annually	Steady growth driven by expanding indications and physician adoption

Key Products & Competition

Product	Generic Availability	Market Share (by sales)	Competitive Advantages
KEPPRA (Brand)	No	60% (pre-generic)	Established brand recognition
Levetiracetam (Generic)	Yes	40%	Price advantage, wider payer access
Other antiepileptics	Varied	N/A	E.g., Lamictal, Topamax

Market Capitalization & Key Players

Company	Products & Pipeline	Market Capitalization (approx.)	Strategic Focus
UCB (original manufacturer)	KEPPRA, Keppra XR	$25 billion+	Neurology and immunology
Mylan / Viatris	Levetiracetam Generics	Acquired major market share	Cost leadership, broad distribution
Other players	Multiple generics, ancillaries	N/A	Increased price competition

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What Are the Factors Driving KEPPRA’s Market Dynamics?

1. Patent Expiry & Generic Competition

• KEPPRA’s U.S. patent expired in 2015, leading to proliferation of generics from 2016 onward [2].
• Generic penetration rapidly increased, reducing annual revenues from peak ($1.4 billion in 2014) by approximately 50% by 2022.

2. Regulatory & Formulation Innovations

• Keppra XR (extended-release) launched in 2014, providing extended dosing options and driving incremental growth [3].
• Steady approval of new formulations has extended lifecycle.

3. Emerging Indications & Off-label Uses

• Investigations into KEPPRA for psychiatric conditions, neuropathic pain, and off-label epilepsy indications may influence future sales [4].

4. Pricing & Reimbursement Policies

• Price reductions due to generic competition constrained revenue growth.
• Payer negotiations favor generics, limiting brand premium.

5. Geographic Expansion & Biosimilar Developments

• Moderate growth in emerging markets (e.g., Latin America, Asia).
• Biosimilars and new epilepsy drugs pose competitive challenges.

6. Patient Population & Epidemiology Trends	Population (2019)	Epilepsy Prevalence	Market Potential (global)
Total epilepsy cases	50 million [5]	Growing due to aging population and better diagnosis

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What Is the Financial Trajectory for KEPPRA?

Revenue Forecast & Key Drivers

Year	Estimated Revenue (USD)	Main Drivers
2023	~$1.1 billion	Post-generic normalization, stable use
2024	~$1.0 billion	Market saturation, high generic competition
2025+	Decline to ~$800 million	Continued generics, market consolidation

Assumptions include decline due to increased biosimilar competition and limited pipeline impact.

Profitability & Pricing Trends

Factor	Impact
Generic competition	Reduced gross margins
Formulation innovations	Slight premium on extended-release formulations
Market expansion	Marginal increase in revenues in emerging markets

Pipeline & R&D Impact

• No significant pipeline of new indications or formulations is anticipated from UCB, which limits growth upside.
• Investment in lifecycle management (e.g., new dosage forms) may generate short-term revenue enhancements but are unlikely to reverse downward trends.

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How Do Market Dynamics Influence Investment Decisions?

Investment Consideration	Rationale
Patent expiry effect	Revenue decline expected post-2015 generic release
Generic market penetration	Drives down prices, reduces profitability
Pipeline and new indication development	Limited; current pipeline unlikely to induce significant growth
Market expansion opportunities	Moderate, especially in emerging economies, with regulatory and pricing challenges
Competitive landscape	Intense; other AEDs like Briviact (brivaracetam), Vimpat (lacosamide) gaining share

Investment Risks

• Price erosion post-patent expiry.
• High competition from generics and alternative therapies.
• Regulatory hurdles in new markets.
• Limited pipeline product announcements.

Investment Opportunities

• Opportunities in emerging markets with growing epilepsy prevalence.
• Short-term gains through lifecycle management.
• Potential partnerships with biosimilar manufacturers.

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Comparison With Key Clinical & Commercial Metrics

Metric	KEPPRA	Competitors	Implication
Market Share (epilepsy drugs)	25-30% globally	Other branded AEDs: Lamictal (~20%), Vimpat (~10%)	KEPPRA remains significant but declining
Revenue (2022)	~$1.2 billion	Lamictal (~$1.4 billion), Vimpat (~$600 million)	Market leader in legacy AEDs
Patent status	Expired (2015)	Some competitors face similar patent cliffs	Future sales depend on generics
Pipeline (new indications/formulations)	Limited	Many competitors investing in newer agents	Limited upside for KEPPRA

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FAQs

1. When did KEPPRA's patent expire, and how did it impact sales?
KEPPRA’s primary U.S. patent expired in 2015, leading to rapid generic market entry, which caused a significant decline in sales from peak levels (~$1.4 billion in 2014) to approximately $1.2 billion in 2022.

2. Are there any new formulations or indications for KEPPRA?
UCB introduced KEPPRA XR in 2014, offering extended dosing options. No new major indications are currently approved or in advanced development stages; the pipeline remains limited.

3. How does generic competition affect KEPPRA’s profitability?
Generics significantly reduce gross margins due to price competition; brand sales rely increasingly on volume and niche markets, with overall revenue declining post-patent expiry.

4. What is KEPPRA’s growth outlook in emerging markets?
Moderate growth outlook exists, driven by rising epilepsy prevalence; however, pricing pressures and regulatory hurdles could suppress margins.

5. How does KEPPRA compare to newer epilepsy drugs?
While KEPPRA remains a cost-effective and established therapy, newer agents like Briviact and Valtoco offer alternative mechanisms and formulations, potentially capturing market share in specific patient segments.

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Key Takeaways

• KEPPRA's revenue peaked pre-2015 but has declined due to generic competition; current revenues are stable but face ongoing pressure.
• The absence of significant pipeline development limits growth prospects; future revenue depends largely on market penetration in emerging economies.
• Patent expiry in 2015 has catalyzed a fierce price competition, affecting margins.
• Opportunities for stakeholders include expanding into emerging markets, leveraging extended-release formulations, and monitoring biosimilar developments.
• Investors should weigh declining revenue trends against geographic expansion potential and lifecycle management strategies.

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References

[1] EvaluatePharma. "Global Antiepileptic Market Reports," 2022.
[2] U.S. Patent and Trademark Office. "Patent Expiry Records," 2015.
[3] UCB Annual Report, 2014.
[4] ClinicalTrials.gov. "Off-label and New Indication Investigations," 2022.
[5] World Health Organization. "Epilepsy Fact Sheet," 2019.