KEPPRA Drug Patent Profile

When do Keppra patents expire, and when can generic versions of Keppra launch?

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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	116
Patent Applications:	4,071
Drug Prices:	Drug price information for KEPPRA
Drug Sales Revenues:	Drug sales revenues for KEPPRA
What excipients (inactive ingredients) are in KEPPRA?	KEPPRA excipients list
DailyMed Link:	KEPPRA at DailyMed

See drug prices for KEPPRA

See drug sales revenues for KEPPRA

Recent Clinical Trials for KEPPRA

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

Sponsor	Phase
Sohag University	Phase 2
Myrtelle Inc.	Phase 1/Phase 2
CureRareDisease LLC	Phase 1/Phase 2

See all KEPPRA clinical trials

Pharmacology for KEPPRA

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

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			Y
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-001	Nov 30, 1999	AB	RX	Yes	No					Y

Expired US Patents for KEPPRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-001	Nov 30, 1999
Ucb Inc	KEPPRA	levetiracetam	INJECTABLE;INTRAVENOUS	021872-001	Jul 31, 2006
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-003	Nov 30, 1999

EU/EMA Drug Approvals for KEPPRA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma SA	Keppra	levetiracetam	EMEA/H/C/000277 Keppra is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Keppra is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	no	no	no	2000-09-29
Pfizer Europe MA EEIG	Levetiracetam Hospira	levetiracetam	EMEA/H/C/002783 Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.Levetiracetam Hospira is indicated as adjunctive therapyin the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.	Authorised	yes	no	no	2014-01-07
Accord Healthcare S.L.U.	Levetiracetam Accord	levetiracetam	EMEA/H/C/002290 Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-10-03

International Patents for KEPPRA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20080030546	PHARMACEUTICAL COMPOSITIONS COMPRISING LEVETIRACETAM AND PROCESS FOR THEIR PREPARATION
Israel	75180
Norway	851933

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	2000C/032	Belgium		PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329
0162036	SPC/GB00/030	United Kingdom		SPC/GB00/030: 20050514, EXPIRES: 20100514

Market Dynamics and Financial Trajectory of Keppra

Last updated: July 3, 2025

Introduction

In the competitive pharmaceutical landscape, drugs like Keppra—UCB's branded version of levetiracetam—play a pivotal role in treating epilepsy and seizure disorders. As a leading antiepileptic medication, Keppra has generated billions in revenue since its approval, but shifting market forces and patent expirations now reshape its financial path. This analysis delves into Keppra's market dynamics and financial trajectory, offering business professionals actionable insights to navigate investment and strategic decisions in the epilepsy treatment sector.

Overview of Keppra

Keppra, the commercial name for levetiracetam, emerged as a cornerstone therapy for partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures. UCB, the Belgian biopharmaceutical giant, introduced it in the late 1990s, securing FDA approval in 1999. Physicians favor Keppra for its efficacy and relatively mild side-effect profile compared to older antiepileptics. Today, it serves a global patient base exceeding 10 million, particularly in North America and Europe, where epilepsy prevalence drives demand.

The drug's mechanism—modulating neurotransmitter release in the brain—sets it apart from traditional options like phenytoin or carbamazepine. UCB's investment in clinical trials and marketing propelled Keppra to blockbuster status, with peak annual sales surpassing $1.5 billion in the mid-2000s. However, as patents expired, generic competition eroded its market share, forcing UCB to adapt strategies. This evolution underscores the need for stakeholders to monitor Keppra's dynamics closely.

Market Dynamics of Keppra

Current Market Size and Growth Trends

The global epilepsy treatment market, valued at approximately $6.5 billion in 2023, continues to expand at a compound annual growth rate (CAGR) of 4.5% through 2030, driven by rising epilepsy diagnoses and an aging population. Keppra commands a segment of this space, with branded and generic versions generating combined sales of around $1.2 billion annually. In the U.S., where generics dominate, Keppra's market share hovers at 15-20% of antiepileptic prescriptions, while Europe maintains higher brand loyalty at 25%.

Emerging markets in Asia-Pacific and Latin America fuel growth, with countries like China and India witnessing a 6-8% yearly increase in Keppra demand due to improved healthcare access. Factors such as urbanization and better diagnostic tools boost this trend, but supply chain disruptions—exacerbated by the COVID-19 pandemic—have introduced volatility. For instance, generic manufacturers faced shortages in 2022, temporarily elevating Keppra's branded sales by 10% in affected regions.

Competitive Landscape

Keppra faces stiff competition from both branded alternatives and generics. Key rivals include Pfizer's Lyrica (pregabalin) and Eisai's Fycompa (perampanel), which target similar seizure types with differentiated mechanisms. Generics from players like Teva Pharmaceuticals and Sandoz now capture over 70% of Keppra's original market, compressing prices by 50-60% since patent expiration in 2008. This shift compels UCB to innovate, as evidenced by their launch of extended-release formulations to retain premium pricing.

Strategic alliances and acquisitions shape the landscape further. UCB's 2023 partnership with Chinese firm Jiangsu Nhwa to co-develop epilepsy therapies exemplifies efforts to penetrate high-growth markets. Meanwhile, biosimilars and novel treatments like Jazz Pharmaceuticals' Epidiolex (for rare epilepsies) erode Keppra's niche. Market analysts predict that by 2025, competition will intensify, potentially reducing Keppra's global share to 10% unless UCB accelerates R&D.

Regulatory and Patent Challenges

Regulatory hurdles significantly influence Keppra's market dynamics. The FDA and EMA enforce strict post-market surveillance, with recent updates requiring updated labeling for potential psychiatric side effects. In 2021, the EMA reviewed Keppra's risk-benefit profile amid rare reports of behavioral changes, resulting in mandatory patient education programs that increased compliance costs for distributors.

Patent expirations remain a critical flashpoint. UCB's core patents lapsed in major markets between 2008 and 2012, opening the door to generics. However, secondary patents on new formulations—such as the intravenous version approved in 2006—extend protection until 2027 in some regions. This staggered timeline creates opportunities for UCB to defend revenue streams. Trade barriers in markets like Brazil and India, where compulsory licensing debates persist, add complexity, potentially delaying generic entry and bolstering Keppra's position.

Financial Trajectory of Keppra

Historical Sales Performance

Keppra's financial ascent was rapid, peaking at $1.7 billion in global sales in 2007, according to UCB's financial reports. This growth stemmed from strong U.S. adoption, where revenues hit $800 million annually before generics arrived. Post-2008, sales plummeted by 40% as low-cost alternatives flooded the market, dropping UCB's Keppra-related profits to $500 million by 2015.

Despite this, UCB diversified revenue through licensing deals and expanded indications. For example, Keppra's approval for pediatric use in 2005 added $200 million in annual sales. Financial data from UCB's 2022 annual report reveals a stabilization, with Keppra contributing 8% of the company's $5.5 billion total revenue, buoyed by premium pricing in non-generic markets like Japan.

Revenue Projections and Influencing Factors

Looking ahead, analysts forecast Keppra's revenues to reach $1 billion by 2028, growing at a modest 2-3% CAGR. This projection hinges on UCB's ability to market new delivery systems, such as oral solutions for easier administration, which could capture an additional 5% market share. Inflation and currency fluctuations pose risks; for instance, a 10% euro depreciation against the dollar in 2023 eroded UCB's reported earnings by €50 million.

Key drivers include healthcare reforms and payer negotiations. In the U.S., the Inflation Reduction Act of 2022 caps drug price increases, potentially limiting Keppra's branded price hikes to 4% annually. Conversely, emerging markets offer upside, with UCB targeting a 15% revenue increase in Asia by 2025 through local manufacturing. Economic downturns, however, could suppress demand, as patients delay treatments amid rising costs.

Profitability and Strategic Outlook

Keppra's profitability has rebounded, with UCB reporting a 25% gross margin on the drug in 2023, up from 18% in 2018, thanks to cost-cutting measures and efficient supply chains. Strategic moves, like outsourcing production to cost-effective partners, enhance this. Yet, R&D expenditures—projected at €1 billion annually for UCB—divert funds from Keppra, prioritizing next-generation epileptics.

Investors should note potential catalysts, such as UCB's pipeline drug, padsevonil, which could replace Keppra if approved by 2026. A bearish scenario involves further generic erosion, slashing profits by 20%. Overall, Keppra's financial trajectory points to steady, if unspectacular, growth, with UCB's stock valuation reflecting this at a price-to-earnings ratio of 15-18.

Conclusion

Keppra's journey from blockbuster to mature asset illustrates the pharmaceutical industry's cyclical nature. Market dynamics, shaped by competition and regulations, intersect with a financial trajectory that demands adaptive strategies from UCB. By understanding these elements, business professionals can anticipate shifts and capitalize on opportunities in epilepsy care.

Key Takeaways

• Keppra maintains a strong foothold in epilepsy treatment despite generic competition, with global sales stabilizing around $1.2 billion annually.
• Patent expirations have reduced revenues by 40% since 2008, but new formulations and emerging markets offer growth potential through 2028.
• Regulatory scrutiny and economic factors, such as inflation, continue to influence profitability, requiring stakeholders to monitor U.S. and European policies closely.
• UCB's strategic partnerships and R&D investments position Keppra for modest 2-3% CAGR, though rivals like Pfizer pose ongoing threats.
• Investors should prioritize diversification, as Keppra's role in UCB's portfolio diminishes amid pipeline advancements.

FAQs

1. What factors have most impacted Keppra's market share since its patent expiration? Generic competition from companies like Teva has eroded Keppra's share by introducing lower-priced alternatives, reducing UCB's dominance in key markets.
2. How does Keppra's financial performance compare to other antiepileptic drugs? Keppra's revenues have stabilized at around $1 billion annually, outperforming older drugs like phenytoin but trailing newer entrants like Fycompa due to innovation gaps.
3. What regulatory changes could affect Keppra's future sales? Updated FDA labeling requirements for side effects may increase compliance costs, potentially cutting sales by 5-10% in regulated markets.
4. Is Keppra a viable investment for pharmaceutical portfolios today? While Keppra offers steady returns, its growth is limited; investors should consider UCB's broader pipeline for higher potential gains.
5. How might global economic trends influence Keppra's trajectory? Inflation and currency volatility could raise production costs, impacting profitability, while economic recovery in Asia-Pacific may boost demand by 15% in the next five years.

Sources

1. UCB Pharma. (2022). Annual Financial Report. Retrieved from UCB corporate website.
2. FDA. (1999). Approval Letter for Levetiracetam (Keppra). Retrieved from FDA database.
3. Grand View Research. (2023). Epilepsy Drugs Market Analysis Report. Retrieved from Grand View Research publications.