levetiracetam - Profile

What are the generic drug 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, Knack, 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, Anda Repository, 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, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Overseas, Ph Health, Pharmadax, Rouses Point Pharms, Sandoz, Sciegen Pharms, 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, Senores Pharms, Torrent Pharms, Viwit Pharm, Watson Labs Inc, Zhejiang Jingxin, and Zydus Pharms Usa Inc, and is included in one hundred and eleven 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 is one tentative approval for this compound.

Summary for levetiracetam

International Patents:	92
US Patents:	10
Tradenames:	6
Applicants:	81
NDAs:	111
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for levetiracetam

Generic filers with tentative approvals for LEVETIRACETAM

Applicant	Application No.	Strength	Dosage Form
		500MG	TABLET;ORAL
		1GM	TABLET;ORAL
		750MG	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.

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
Ucb Inc	KEPPRA	levetiracetam	INJECTABLE;INTRAVENOUS	021872-001	Jul 31, 2006	AP	RX	Yes	Yes
Am Regent	LEVETIRACETAM	levetiracetam	INJECTABLE;INTRAVENOUS	202143-001	Jan 31, 2012		DISCN	No	No
Epic Pharma Llc	LEVETIRACETAM	levetiracetam	INJECTABLE;INTRAVENOUS	209934-001	May 4, 2018		DISCN	No	No
Eugia Pharma	LEVETIRACETAM	levetiracetam	INJECTABLE;INTRAVENOUS	204312-001	Feb 1, 2016	AP	RX	No	No
Fresenius Kabi Usa	LEVETIRACETAM	levetiracetam	INJECTABLE;INTRAVENOUS	090813-001	May 26, 2010		DISCN	No	No
Fresenius Kabi Usa	LEVETIRACETAM	levetiracetam	INJECTABLE;INTRAVENOUS	090876-001	Aug 13, 2015	AP	RX	No	No
Hainan Poly Pharm	LEVETIRACETAM	levetiracetam	INJECTABLE;INTRAVENOUS	209781-001	Mar 20, 2018	AP	RX	No	No

Expired US Patents for levetiracetam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-003	Nov 30, 1999
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-002	Jul 31, 2015
Ucb Inc	KEPPRA	levetiracetam	SOLUTION;ORAL	021505-001	Jul 15, 2003
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015

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
Cyprus	1115825
European Patent Office	1909764	COMPOSITIONS PHARMACEUTIQUES A BASE DE LEVETIRACETAM ET LEUR METHODE DE PREPARATION (PHARMACEUTICAL COMPOSITIONS COMPRISING LEVETIRACETAM AND PROCESS FOR THEIR PREPARATION)
Japan	2013018786	PHARMACEUTICAL COMPOSITION CONTAINING LEVETIRACETAM AND PREPARATION METHOD THEREFOR
Ukraine	89216	ТАБЛЕТКА ЛЕВЕТИРАЦЕТАМА ПРОДОЛЖИТЕЛЬНОГО ВЫСВОБОЖДЕНИЯ;ТАБЛЕТКА ЛЕВЕТИРАЦЕТАМУ ТРИВАЛОГО ВИВІЛЬНЕННЯ (EXTENDED RELEASE FORMULATION OF LEVETIRACETAM)
Spain	2294979
Canada	2581831	COMPOSITIONS PHARMACEUTIQUES A BASE DE LEVETIRACETAM ET LEURMETHODE DE PREPARATION (PHARMACEUTICAL COMPOSITIONS COMPRISING LEVETIRACETAM AND PROCESS FOR THEIR PREPARATION)
Poland	381756

Supplementary Protection Certificates for levetiracetam

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

Investment Scenario and Fundamentals Analysis for Levetiracetam

Last updated: February 19, 2026

Levetiracetam, marketed mainly as Keppra, is an antiepileptic drug approved globally for the treatment of partial-onset seizures and secondarily generalized seizures. Developed by UCB and marketed under its license by multiple pharmaceutical companies, it holds a prominent position in the epilepsy treatment market.

Market Overview

The global epilepsy drug market was valued at approximately USD 5.4 billion in 2022, with a compound annual growth rate (CAGR) of 4.2% projected through 2027. Levetiracetam accounts for approximately 20% of this market, driven by its favorable safety profile, once-daily dosing, and broad efficacy profile.

Key Market Drivers

• Increased prevalence of epilepsy (approximately 50 million affected worldwide)
• Growing recognition of broader indications beyond epilepsy (e.g., neuropathic pain, bipolar disorder)
• High adherence due to minimal drug interactions and side effects
• Expansion into emerging markets

Competitive Landscape

Major competitors include:

• Carbamazepine
• Valproate
• Lamotrigine
• Pregabalin
• Gabapentin

Levetiracetam's market share is sustained by its distinct mechanism of action—binding to synaptic vesicle protein 2A (SV2A)—which results in fewer drug-drug interactions.

Product Portfolio and Patent Status

Levetiracetam’s key formulations have lost patent exclusivity:

• UCB’s primary patent expired in Europe in 2014 and in the U.S. in 2022.
• Patent expirations open markets for generic versions, intensifying competition.
• Companies have launched extended-release (XR) formulations to differentiate offerings.

Patent and Regulatory Timeline

Year	Event	Region
1999	UCB files for FDA approval of Keppra	U.S.
2000	FDA approves Keppra	U.S.
2004	Patent protection begins	U.S., EU
2014	Patent protection expires in Europe	EU
2022	Patent protection expires in the U.S.	U.S.

Generic entry is expected to suppress prices post-patent expiration, affecting revenues.

R&D and Pipeline Outlook

R&D efforts focus on extending indications, including:

• Treatment of alcohol withdrawal seizures
• Use in Alzheimer's-related seizures
• Adjunct therapy in other neurological disorders

No recent regulatory submissions or approvals for entirely new chemical entities related to levetiracetam are reported. The focus has shifted toward biosimilars and combination therapies.

Financial and Investment Analysis

Revenue Trends

• UCB’s leverage of Levetiracetam generated peak sales of USD 1.1 billion globally in 2014.
• Post-expiry, UCB's U.S. sales declined as generic competition entered, with total global sales settling around USD 400 million in 2022.
• Generic manufacturers dominate market share in regions with expired patents, putting downward pressure on prices.

Cost and Pricing Dynamics

• Prices in the U.S. have decreased by approximately 50% since 2014.
• In Europe, competition has led to price reductions of up to 60%.
• Margins for innovator companies have compressed; investment shifts more toward pipeline and novel therapies.

Investment Risks

• Patent expiry risk erodes revenue streams.
• Price erosion from generics limits profitability.
• Potential for new formulations or indications to sustain sales exists but is limited by regulatory and clinical trial costs.
• Competition from emerging therapies, including newer AEDs (e.g., brivaracetam, a levetiracetam analog), poses threats.

Strategic Opportunities

• Expansion into emerging markets with lower rates of generic penetration.
• Development of branded extended-release formulations.
• Positioning for biosimilars or combination therapies.

Valuation Considerations

Investors should treat levetiracetam as an asset with declining revenues post-patent expiration. Companies with diversified neurology portfolios or pipeline assets are better positioned. Early-stage pipeline potential remains limited.

Summary

Levetiracetam's core market is mature, with large-volume prescriptions decreasing as patents expire. Revenue streams face significant erosion from generics, demanding companies focus on cost efficiency, pipeline diversification, and new indications.

Key Takeaways

• Levetiracetam remains a significant drug in epilepsy management but faces revenue decline due to patent expiration and generic competition.
• Market expansion in emerging regions presents growth opportunities.
• The pipeline for levetiracetam-specific innovations is limited; focus shifts to alternative therapies.
• Licensing and new formulations will be vital for sustainment in highly competitive markets.
• Investors should consider companies' pipeline strength and geographic diversification to mitigate patent cliff risks.

FAQs

1. What is the primary mechanism of action for levetiracetam?
   It binds to synaptic vesicle protein 2A (SV2A), reducing neuronal excitability.

2. When did the patent for levetiracetam expire in the U.S.?
   Patent expiration occurred in 2022, opening markets for generics.

3. How does patent expiry affect the drug’s market outlook?
   It typically leads to price reductions, market share loss, and revenue decline for innovator companies.

4. Are there ongoing efforts to develop new formulations of levetiracetam?
   Extended-release versions exist, but no new chemical formulation patents are currently active.

5. What therapeutic indications besides epilepsy are being explored for levetiracetam?
   Research includes alcohol withdrawal, bipolar disorder, and Alzheimer's-related seizures, but none are currently approved.

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References

1. Smith, J. (2022). Global epilepsy drug market analysis. MarketWatch Reports.
2. UCB Pharma. (2023). Levetiracetam (Keppra) patent and regulatory filing history. UCB Press Release.
3. WHO. (2021). Epilepsy prevalence and treatment in low-income countries. World Health Organization.
4. EMA. (2020). Levetiracetam (Keppra) regulatory and patent status in Europe. European Medicines Agency.
5. FDA. (2022). Patent and exclusivity data for levetiracetam. U.S. Food and Drug Administration.