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-four 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:	3,497
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	TABLET;ORAL	021035-001	Nov 30, 1999	AB	RX	Yes	No	8,802,142*PED				Y
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-004	Jan 6, 2006	AB	RX	Yes	Yes	8,802,142*PED				Y
Ucb Inc	KEPPRA	levetiracetam	SOLUTION;ORAL	021505-001	Jul 15, 2003	AA	RX	Yes	Yes
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 XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-002	Feb 12, 2009	AB	RX	Yes	Yes	7,858,122		Y

Expired US Patents for KEPPRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-002	Nov 30, 1999	4,943,639*PED
Ucb Inc	KEPPRA	levetiracetam	INJECTABLE;INTRAVENOUS	021872-001	Jul 31, 2006	4,943,639*PED
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	4,943,639*PED
Ucb Inc	KEPPRA	levetiracetam	SOLUTION;ORAL	021505-001	Jul 15, 2003	4,837,223
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-003	Nov 30, 1999	4,943,639*PED

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
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 KEPPRA

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

Country	Patent Number	Title	Estimated Expiration
China	85105307
Denmark	163501
Israel	75179	(S)-ALPHA-ETHYL-2-OXO-1-PYRROLIDINEACETAMIDE,ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT
Japan	S60252461	(S)-ALPHA-ETHYL-2-OXO-1-PYRROLIDINE ACETAMIDE, MANUFACTURE AND PHARMACEUTICAL COMPOSITION
Spain	8608485
Spain	551366

Supplementary Protection Certificates for KEPPRA

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
0162036	SPC/GB00/030	United Kingdom		SPC/GB00/030: 20050514, EXPIRES: 20100514

Market Dynamics and Financial Trajectory for KEPPRA

Overview of KEPPRA

KEPPRA, also known as levetiracetam, is a widely used antiepileptic drug developed by UCB S.A. It is prescribed for the treatment of various types of seizures and has been a significant contributor to the company's revenue.

Market Position and Share

KEPPRA has historically been a dominant player in the antiepileptic drugs market. However, its market share has been impacted by several factors, including generic competition and the emergence of new antiepileptic drugs.

Dominance and Decline

In the early 2000s, KEPPRA drove UCB to significant sales gains, with a 34% growth in 2005, reaching €560 million in revenues[5]. However, in recent years, KEPPRA's sales have declined due to generic erosion. For instance, in Japan, the generic erosion started early in 2022 and was stronger than expected, leading to a 22% decrease in net sales for KEPPRA[3].

Geographic Performance

North America

In North America, particularly in the U.S., KEPPRA faced significant generic competition. The generic erosion in the U.S. market, which began in March 2022, impacted KEPPRA's performance, although it was somewhat compensated by continued growth in European and international markets[3].

Europe and Other Regions

While KEPPRA's sales declined in certain regions like Japan, it maintained a strong presence in Europe and other international markets. This balanced out some of the losses incurred due to generic competition in other areas[3].

Financial Impact

Revenue Trends

The revenue from KEPPRA has been a substantial part of UCB's overall financial performance. However, the decline in KEPPRA's sales due to generic competition has affected UCB's net sales. For example, in the first six months of 2022, KEPPRA's net sales were €744 million, but this was impacted by generic erosion in the U.S. and Japan[3].

Adjusted Financials

Despite the decline in KEPPRA's sales, UCB's overall revenue has been supported by the growth of other products such as CIMZIA and BRIVIACT. The company's underlying profitability (adjusted EBITDA) has been maintained, although it was slightly impacted by higher operating expenses and amortization charges related to acquisitions and product launches[3].

Competitive Landscape

Market Competition

The antiepileptic drugs market is highly competitive, with several key players including Pfizer and GSK plc. KEPPRA's market position has been challenged by the introduction of generics and other second-generation antiepileptic drugs that offer high tolerability and safety, such as Lamotrigine (Lamictal) and Brivaracetam (Briviact)[4].

Product Differentiation

UCB has maintained its market presence through product differentiation. For example, BRIVIACT, another antiepileptic drug by UCB, has shown significant growth and differentiates itself from KEPPRA through its unique mode of action[3].

Regulatory and Market Drivers

Regulatory Approvals

The market for antiepileptic drugs, including KEPPRA, is driven by regulatory approvals and the launch of new-generation drugs. The increasing number of drugs receiving regulatory approvals in regions like Europe and Asia Pacific is expected to drive the demand for these drugs[1].

Government Initiatives

Government initiatives and awareness campaigns, such as the Intersectoral Global Action Plan on Epilepsy and the Global Campaign Against Epilepsy, have also contributed to the growth of the epilepsy drugs market. These initiatives increase patient awareness and drive the adoption of effective epilepsy treatments[4].

Future Outlook

Generic Competition

The future outlook for KEPPRA is likely to be influenced by continued generic competition. As more generics enter the market, KEPPRA's sales are expected to decline further, although UCB's diversified product portfolio is expected to mitigate some of this impact[3].

Emerging Markets

The growth in emerging markets, particularly in the Asia Pacific region, is expected to provide opportunities for UCB and other players in the antiepileptic drugs market. The increasing prevalence of epilepsy and favorable government initiatives in these regions are anticipated to drive market growth[4].

Key Takeaways

• KEPPRA has been a significant contributor to UCB's revenue but faces declining sales due to generic competition.
• The drug's performance varies geographically, with declines in North America and Japan but stable growth in Europe and other international markets.
• UCB's overall financial performance is supported by a diversified product portfolio, including CIMZIA and BRIVIACT.
• Regulatory approvals and government initiatives are key drivers for the antiepileptic drugs market.
• Emerging markets, especially in the Asia Pacific region, offer growth opportunities despite the challenges posed by generic competition.

FAQs

What is KEPPRA used for?

KEPPRA, or levetiracetam, is used for the treatment of various types of seizures and is an antiepileptic drug.

Why has KEPPRA's sales declined?

KEPPRA's sales have declined primarily due to generic competition, especially in regions like the U.S. and Japan.

How does KEPPRA's performance vary geographically?

KEPPRA's sales have declined in North America and Japan due to generic competition but have maintained a strong presence in Europe and other international markets.

What other products support UCB's financial performance?

UCB's financial performance is supported by other products such as CIMZIA and BRIVIACT, which have shown significant growth.

What are the key drivers for the antiepileptic drugs market?

Key drivers include regulatory approvals, government initiatives, and increasing patient awareness, particularly in emerging markets.

Sources

1. Fortune Business Insights - Antiepileptic Drugs [AED] Market Size, Trends | Forecast, 2032
2. GSK - Full-year and fourth quarter 2022 results announcement
3. UCB - Strong first six months – UCB with continued delivery and strong resilience
4. Grand View Research - Epilepsy Drugs Market Size & Share Analysis Report, 2030
5. PharmaTimes - Keppra drives UCB to healthy sales gain in '05