Levetiracetam - Generic Drug Details

What are the generic sources for levetiracetam and what is the scope of patent protection?

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 Inc, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, 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, Endo Operations, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Overseas, 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, Dr Reddys Labs Ltd, Fosun Pharma, Granules, Ingenus Pharms Llc, Invagen Pharms, Lupin, Mylan, Nostrum Labs Inc, 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-eight 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:	80
NDAs:	109
Drug Master File Entries:	35
Finished Product Suppliers / Packagers:	88
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	225
Patent Applications:	6,336
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
University of North Carolina, Chapel Hill	Phase 4
AgeneBio	Phase 2
Hamilton Health Sciences Corporation	Phase 3

See all levetiracetam clinical trials

Generic filers with tentative approvals for LEVETIRACETAM

Applicant	Application No.	Strength	Dosage Form
		250MG	TABLET;ORAL
		500MG	TABLET;ORAL
		1GM	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	TABLET;ORAL	078042-004	Jan 15, 2009	AB	RX	No	No
Ingenus Pharms Llc	LEVETIRACETAM	levetiracetam	TABLET;ORAL	079042-001	Jan 15, 2009	AB	RX	No	No
Gland Pharma Ltd	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	206880-001	Oct 25, 2017	AP	RX	No	No
Fresenius Kabi Usa	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	208619-001	Jan 31, 2023		DISCN	No	No
Msn	LEVETIRACETAM	levetiracetam	TABLET;ORAL	214815-004	Oct 7, 2022	AB	RX	No	No
Baxter Hlthcare Corp	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	217059-002	Oct 2, 2023	AP	RX	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	021035-001	Nov 30, 1999	4,837,223
Ucb Inc	KEPPRA	levetiracetam	SOLUTION;ORAL	021505-001	Jul 15, 2003	4,943,639*PED
Ucb Inc	KEPPRA	levetiracetam	INJECTABLE;INTRAVENOUS	021872-001	Jul 31, 2006	4,943,639*PED
Ucb Inc	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-001	Sep 12, 2008	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	207958-001	Jul 31, 2015	6,471,992

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/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
Pharmathen S.A.	Matever	levetiracetam	EMEA/H/C/002024 Matever 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
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
Actavis Group PTC ehf	Levetiracetam Actavis Group	levetiracetam	EMEA/H/C/002305 Levetiracetam 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
Actavis Group PTC ehf	Levetiracetam Actavis	levetiracetam	EMEA/H/C/002355 Levetiracetam 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
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

International Patents for levetiracetam

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0518506	tablete e formulaÇço de liberaÇço prolongada de levetiracetam
European Patent Office	1909770	COMPOSITION A LIBERATION ORALE CONTROLEE CONTENANT DU LEVETIRACETAM (ORAL CONTROLLED RELEASE COMPOSITION CONTAINING LEVETIRACETAM)
Germany	05815688
Japan	6170234
South Korea	101164881
World Intellectual Property Organization (WIPO)	2006123357

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

Introduction to Levetiracetam

Levetiracetam, commonly known by its brand name Keppra, is an antiepileptic medication used to treat various types of seizures, including myoclonic, tonic-clonic, and partial-onset seizures. The market for levetiracetam has been experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The global levetiracetam market is anticipated to witness substantial growth from 2023 to 2031. The market size is expected to expand at a remarkable Compound Annual Growth Rate (CAGR) during this period. As of 2023, the global levetiracetam market size was notable, and it is projected to continue its upward trend due to increasing demand and advancements in medical treatments[1][3][4].

Segmentation of the Market

The levetiracetam market is segmented based on several criteria:

Type

• The market is segmented into tablets, injections, and solutions. The tablet segment accounted for a significant share of the global levetiracetam market in 2023 and is expected to continue growing[1][3].

Application

• The primary applications include myoclonic treatment, tonic-clonic seizures treatment, and other medical treatments. The myoclonic treatment segment is expected to expand at a significant CAGR, retaining its position throughout the forecast period[1][4].

Geographical Regions

• The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region provides detailed insights into revenue share, current trends, and future growth prospects[1][4].

Market Drivers

Several factors are driving the growth of the levetiracetam market:

Increasing Prevalence of Epilepsy

• The rising incidence of epilepsy and related seizure disorders is a major driver. As the global population grows and ages, the demand for effective antiepileptic medications like levetiracetam increases[3].

Advancements in Medical Treatments

• Continuous advancements in medical treatments and the development of new formulations (e.g., extended-release tablets) are enhancing the market's growth potential[1][4].

Strong Clinical Pipeline

• Pharmaceutical companies like UCB Pharma are investing heavily in research and development, which includes expanding their product portfolios and launching new products. This strong clinical pipeline supports the market's growth[2].

Market Restraints

Despite the positive outlook, there are several challenges affecting the market:

Generic Competition

• The loss of exclusivity for branded versions of levetiracetam, such as Keppra, has led to increased generic competition. This has impacted revenue, particularly in regions like the U.S. and Japan[2].

Regulatory Challenges

• Regulatory hurdles and the high cost associated with bringing new drugs to market can slow down the growth of the levetiracetam market[4].

Financial Performance of Key Players

Companies like UCB Pharma, which is a major player in the levetiracetam market, have reported significant financial performance:

Revenue and Net Sales

• UCB Pharma's revenue reached €2.925 billion in the first six months of 2022, with net sales increasing by 2% to €2.705 billion. The growth was driven by the continued success of products like CIMZIA and BRIVIACT, as well as the addition of FINTEPLA[2].

Impact of Acquisitions

• The acquisition of Zogenix, Inc. has had a mixed impact on UCB's financials, with higher operating expenses but also increased other operating income. This has resulted in a decrease in profit due to higher amortization charges and fees[2].

Regional Analysis

The market is segmented into several key regions, each with its own growth dynamics:

North America

• This region is a significant market for levetiracetam, driven by high healthcare spending and advanced medical infrastructure. However, generic competition, especially in the U.S., is a notable challenge[1][4].

Europe

• Europe also represents a substantial market, with countries like Germany and the UK contributing significantly to the region's growth[1][4].

Asia-Pacific

• The Asia-Pacific region is expected to grow rapidly due to increasing healthcare expenditure and a large patient population. Countries like China and India are key drivers of this growth[1][4].

Competitive Landscape

The levetiracetam market is competitive, with several key players:

UCB Pharma

• UCB Pharma is a leading player, focusing on strategy building and expanding its product portfolio. Other companies like Eisai Inc. are also significant competitors[1][2].

Market Concentration Rate

• The market concentration rate indicates a competitive landscape with several major players, but there is still room for new entrants and market expansion[4].

Future Market Opportunities

Despite the challenges, there are several opportunities for growth:

Emerging Markets

• Regions like South America and the Middle East & Africa offer untapped potential for market expansion due to growing healthcare needs and increasing access to medications[1][4].

New Formulations and Indications

• The development of new formulations and potential new indications for levetiracetam could further expand the market[1][3].

Key Takeaways

• The global levetiracetam market is expected to grow significantly from 2023 to 2031.
• The market is driven by increasing demand for antiepileptic medications and advancements in medical treatments.
• Generic competition and regulatory challenges are key restraints.
• UCB Pharma and other major players are focusing on expanding their product portfolios and clinical pipelines.
• Emerging markets and new formulations offer future growth opportunities.

FAQs

What are the primary applications of levetiracetam?

Levetiracetam is primarily used for myoclonic treatment, tonic-clonic seizures treatment, and other medical treatments.

Which region is expected to grow rapidly in the levetiracetam market?

The Asia-Pacific region is expected to grow rapidly due to increasing healthcare expenditure and a large patient population.

How has generic competition affected the levetiracetam market?

Generic competition, especially in regions like the U.S. and Japan, has impacted revenue for branded versions of levetiracetam.

What are the key drivers of the levetiracetam market?

The key drivers include the increasing prevalence of epilepsy, advancements in medical treatments, and a strong clinical pipeline.

Which companies are major players in the levetiracetam market?

UCB Pharma and Eisai Inc. are among the major players in the levetiracetam market.

Cited Sources:

1. Cognitive Market Research: Levetiracetam Market Report 2024 (Global Edition)
2. UCB: Strong first six months – UCB with continued delivery and strong resilience
3. Market Research Intellect: Global Levetiracetam Drugs Market Size, Trends and Projections
4. GlobeNewswire: Levetiracetam Market Size and Outlook to 2022-2029 Worldwide Analysis by Business Trends, Share, Future Demand, Progress Insight, Industry Statistics, Key Regions, Leading Players, Revenue.