LEVETIRACETAM - Generic Drug Details

What are the generic sources for levetiracetam and what is the scope of freedom to operate?

Levetiracetam is the generic ingredient in six branded drugs marketed by Ucb Inc, Am Regent, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hikma Farmaceutica, Hospira Inc, Jubilant Generics, Micro Labs, MSN, Mylan Labs Ltd, Prinston Inc, Sagent Pharms, Sun Pharm Inds Ltd, Xgen Pharms, B Braun Medical, Baxter Hlthcare Corp, Caplin, Gland, Hikma, Hq Spclt Pharma, Nexus, Actavis Mid Atlantic, Ajenat Pharms, Alembic, Amneal Pharms, Apotex Inc, Aurobindo Pharma, Bionpharma, Chartwell Molecular, Hetero Labs Ltd Iii, Lupin Ltd, Pharm Assoc, Pharmobedient Cnsltg, Quagen, Strides Pharma, Taro, Tolmar, Tripoint, Actavis Elizabeth, Actavis Labs Fl Inc, Adaptis, Aiping Pharm Inc, Anda Repository, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Overseas, Ph Health, Pharmadax Inc, Rouses Point Pharms, Sandoz, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Aprecia Pharms, Accord Hlthcare, Alkem Labs Ltd, China Resources, Fosun Pharma, Granules, Ingenus Pharms Llc, Invagen Pharms, Lupin, Mpp Pharma, Mylan, Orbion Pharms, Oxford Pharms, Rising, Torrent Pharms, Viwit Pharm, Watson Labs Inc, Zhejiang Jingxin, and Zydus Pharms Usa Inc, and is included in one hundred and nine NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Levetiracetam has ninety-two patent family members in thirty countries.

There are thirty-five drug master file entries for levetiracetam. Eighty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LEVETIRACETAM

International Patents:	92
US Patents:	10
Tradenames:	6
Applicants:	79
NDAs:	109
Drug Master File Entries:	35
Finished Product Suppliers / Packagers:	84
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	245
Patent Applications:	6,969
Drug Prices:	Drug price trends for LEVETIRACETAM
Drug Sales Revenues:	Drug sales revenues for LEVETIRACETAM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVETIRACETAM
What excipients (inactive ingredients) are in LEVETIRACETAM?	LEVETIRACETAM excipients list
DailyMed Link:	LEVETIRACETAM at DailyMed

See drug prices for LEVETIRACETAM

See drug sales revenues for LEVETIRACETAM

Recent Clinical Trials for LEVETIRACETAM

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

Sponsor	Phase
Nebraska Methodist Health System	PHASE3
Ayal A. Aizer, MD	PHASE2
Tanta University	PHASE3

See all LEVETIRACETAM clinical trials

Generic filers with tentative approvals for LEVETIRACETAM

Applicant	Application No.	Strength	Dosage Form
		750MG	TABLET;ORAL
		250MG	TABLET;ORAL
		500MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for LEVETIRACETAM

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for LEVETIRACETAM

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for LEVETIRACETAM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KEPPRA XR	Extended-release Tablets	levetiracetam	1000 mg	022285	2	2011-01-07
KEPPRA	Tablets	levetiracetam	1000 mg	021035	1	2007-01-24

US Patents and Regulatory Information for LEVETIRACETAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma	LEVETIRACETAM	levetiracetam	SOLUTION;ORAL	078582-001	Jan 15, 2009	AA	RX	No	No
Pharm Assoc	LEVETIRACETAM	levetiracetam	SOLUTION;ORAL	201157-001	Jun 4, 2015	AA	RX	No	No
Actavis Labs Fl Inc	LEVETIRACETAM	levetiracetam	TABLET;ORAL	077408-003	Mar 2, 2009		DISCN	No	No
Sun Pharm Industries	LEVETIRACETAM	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	091285-002	Sep 12, 2011		DISCN	No	No
Sandoz	LEVETIRACETAM	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	091668-002	Nov 1, 2012		DISCN	No	No
Watson Labs Inc	LEVETIRACETAM	levetiracetam	TABLET;ORAL	078797-003	Jan 15, 2009		DISCN	No	No
Rouses Point Pharms	LEVETIRACETAM	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	202524-002	Aug 27, 2012		DISCN	No	No

Expired US Patents for LEVETIRACETAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-004	Jan 6, 2006	4,943,639*PED
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-001	Nov 30, 1999	4,837,223
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-003	Nov 30, 1999	4,837,223
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-001	Nov 30, 1999	4,943,639*PED
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-002	Jul 31, 2015	6,471,992
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015	6,471,992
Ucb Inc	KEPPRA	levetiracetam	INJECTABLE;INTRAVENOUS	021872-001	Jul 31, 2006	4,943,639*PED

EU/EMA Drug Approvals for LEVETIRACETAM

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma SA	Keppra	levetiracetam	EMEA/H/C/000277Keppra 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/002783Levetiracetam 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/002290Levetiracetam 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
Pharmathen S.A.	Matever	levetiracetam	EMEA/H/C/002024Matever 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.Matever 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
Actavis Group PTC ehf	Levetiracetam Actavis	levetiracetam	EMEA/H/C/002355Levetiracetam Actavis 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 Actavis 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
Actavis Group PTC ehf	Levetiracetam Actavis Group	levetiracetam	EMEA/H/C/002305Levetiracetam Actavis Group 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 Actavis Group is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from 1 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	2011-12-04
Sun Pharmaceutical Industries Europe B.V.	Levetiracetam Sun	levetiracetam	EMEA/H/C/002051Levetiracetam Sun 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 Sun is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four 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 Sun concentrate is an alternative for patients when oral administration is temporarily not feasible.	Authorised	yes	no	no	2011-12-14

International Patents for LEVETIRACETAM

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	013106	ОРАЛЬНАЯ СИСТЕМА ДОСТАВКИ ЛЕКАРСТВЕННОГО ПРЕПАРАТА (ВАРИАНТЫ) (ORAL DRUG DELIVERY SYSTEM)
China	1856299
Brazil	PI0414305
Japan	5666075
Japan	6640069
European Patent Office	2968994	FORME PHARMACEUTIQUE À DISPERSION RAPIDE CONTENANT DU LÉVÉTIRACÉTAM (RAPID DISPERSE DOSAGE FORM CONTAINING LEVETIRACETAM)
World Intellectual Property Organization (WIPO)	2007012439

Supplementary Protection Certificates for LEVETIRACETAM

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

Market Dynamics and Financial Trajectory for Levetiracetam

Last updated: July 27, 2025

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Introduction

Levetiracetam, marketed primarily under brand names such as Keppra and Keppra XR, is a widely prescribed antiepileptic drug (AED) used for treating various seizure disorders. Since its FDA approval in 1999, it has become a cornerstone in epilepsy management globally, with a significant impact on the pharmaceutical market. This analysis explores the current market dynamics, growth drivers, competitive landscape, and projected financial trajectory of levetiracetam over the coming years.

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Market Overview and Size

The global epilepsy drug market was valued at approximately USD 4.7 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.5% from 2023 to 2030.[1] Levetiracetam accounts for a dominant share within this segment, driven by its favorable safety profile, minimal drug interactions, and broad-spectrum efficacy.

In terms of geographical distribution, North America remains the largest market, owing to high disease prevalence, established healthcare infrastructure, and significant R&D investments. The Asia-Pacific region presents substantial growth prospects due to rising awareness, increasing healthcare expenditure, and expanding access to epilepsy therapies.

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Market Dynamics

Demand Drivers

1. Increasing Prevalence of Epilepsy: According to the World Health Organization, approximately 50 million people worldwide suffer from epilepsy, with a significant proportion in low-to-middle-income countries. The rising burden of neurological disorders directly fuels demand for effective anticonvulsants like levetiracetam [2].

2. Shift Toward Favorable AEDs: Pharmacological advancements have led to the preference for newer AEDs, such as levetiracetam, over traditional options like phenytoin. Its tolerability and fewer side effects enhance patient compliance, fostering sustained demand [3].

3. Expanding Indications: Beyond epilepsy, levetiracetam shows promise in managing neuropathic pain, psychiatric disorders, and as adjunct therapy, broadening its clinical utility and expanding market opportunities.

4. Generic Entry and Pricing Dynamics: The expiration of patents in developed markets has ushered in a wave of generic levetiracetam products, significantly reducing treatment costs and increasing accessibility, particularly in emerging economies [4].

Supply Chain and Manufacturing

The manufacturing of levetiracetam involves complex synthetic routes and stringent quality controls, impacting supply stability and pricing. Major pharmaceutical companies, including UCB Pharma (original developer), Teva, Mylan, and Sandoz, dominate production. The proliferation of generic manufacturers has contributed to a competitive landscape, driving down prices and accelerating market penetration.

Competitive Landscape

The competitive environment is characterized by a mix of branded and generic products. While UCB retains a strong position, generics account for over 60% of sales in mature markets. Patent expiry, occurring in the early 2010s, catalyzed a surge in generic availability, which has substantially compressed profit margins for original innovators [5].

Emerging competitors are focusing on differentiated formulations—such as extended-release or combination therapies—aimed at improving patient adherence and outcomes.

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Financial Trajectory and Market Forecasts

Revenue Trends

The revenue from levetiracetam largely depends on regional market penetration, pricing strategies, and generics’ impact. The peak sales of branded levetiracetam in 2019 exceeded USD 2.2 billion globally[6]. However, this figure has plateaued due to aggressive price erosion from generics.

Future Growth Projections

Despite generic competition, the overall market for levetiracetam is expected to sustain growth, driven by:

• Expanding Epidemiology: The global increase in epilepsy diagnoses, aged populations, and concomitant neurological disorders sustain demand.

• New Indications & Formulations: Ongoing research into additional therapeutic uses and advanced formulations (e.g., long-acting injectables) could unlock additional revenue streams.

• Geographical Expansion: Emerging markets, including China and India, are expected to see robust growth owing to increasing healthcare access and affordability.

Analysts project that the global levetiracetam market will reach USD 2.8 billion by 2030, with a CAGR of approximately 2.5%–3.0% during 2023–2030 (including generics and branded variants) [1].

Profitability and Pricing Dynamics

Price reductions due to generic competition have compressed margins; however, volume-driven sales and expanding indications provide offsetting growth avenues. The branded segment retains higher profit margins but faces pressure from generics, which dominate in volume sales.

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Regulatory and Patent Landscape

Patent expirations, notably UCB's original patents, have facilitated widespread generic manufacturing, intensifying market competition. Regulatory channels now favor biosimilar and generic approval processes, further stimulating market accessibility. Continuous regulatory updates and patent litigations influence future market entries and financial outcomes.

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Market Challenges

• Pricing Pressures: Intense competition has led to significant price erosion, impacting revenues from branded levetiracetam.

• Market Saturation: In mature markets, growth opportunities are increasingly limited, necessitating innovation and diversification.

• Regulatory Hurdles: Navigating approval pathways for new formulations or indications requires substantial investment.

• Patient Compliance: While levetiracetam is well-tolerated, emerging side effects or adverse reactions can impact its continued use.

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Key Market Opportunities

• Diversification into alternative delivery systems (injectables, sustained-release formulations).

• Development of combination therapies targeting multiple neurological conditions.

• Expansion into underserved markets with significant epilepsy burdens.

• Enhancement of pharmacovigilance to increase trust and adherence.

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Conclusion

Levetiracetam’s market dynamics reflect a mature but resilient segment within the epilepsy therapeutics landscape. Innovation, competitive pricing, and expanded indications are pivotal to sustaining its financial trajectory. While patent expiries and generics have curtailed peak revenues, ongoing demand driven by epilepsy prevalence and therapeutic applications ensures a steady, albeit moderated, growth path for the foreseeable future.

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Key Takeaways

• The global levetiracetam market is projected to reach USD 2.8 billion by 2030, growing modestly at 2.5%–3.0% CAGR, primarily driven by expanding epidemiology and new indications.

• Patent expirations facilitated rapid generic entry, significantly reducing revenues from branded formulations, but increased overall accessibility.

• North America remains dominant, with emerging markets offering substantial growth opportunities amid rising healthcare investments.

• Competitive pressures necessitate innovation in formulations and expansion into new therapeutic areas to maintain profitability.

• Regulatory landscapes and patent strategies remain critical considerations for stakeholders aiming to optimize financial outcomes.

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FAQs

1. How has patent expiration affected levetiracetam’s market?
Patent expirations led to widespread generic manufacturing, decreasing prices and allowing increased access, but reduced revenues for original branded products.

2. What are the primary drivers of growth in the levetiracetam market?
Growing epilepsy prevalence, expanding indications, improved formulations, and penetration into emerging markets are key drivers.

3. Which regions are expected to see the most growth?
Emerging markets in Asia-Pacific, Latin America, and the Middle East are projected to experience the highest growth due to increased healthcare infrastructure and affordability.

4. Are there innovations on the horizon for levetiracetam?
Yes, ongoing research explores extended-release formulations, combination therapies, and alternative delivery mechanisms.

5. What challenges threaten levetiracetam’s market stability?
Intense generic competition, price erosion, regulatory hurdles, and potential adverse effects pose ongoing challenges.

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References

[1] MarketWatch. "Global Epilepsy Drugs Market Size, Share & Trends Analysis Report," 2022.
[2] WHO. "Epilepsy Fact Sheet," 2022.
[3] UCB Pharma Annual Report, 2021.
[4] IMS Health Data, 2022.
[5] EvaluatePharma. "Levetiracetam Market Overview," 2022.
[6] GlobalData. "Pharmaceutical Sales Analytics," 2019.