KEPPRA XR Drug Patent Profile

Which patents cover Keppra Xr, and when can generic versions of Keppra Xr launch?

Keppra Xr is a drug marketed by Ucb Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in sixteen countries.

The generic ingredient in KEPPRA XR is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Keppra Xr

A generic version of KEPPRA XR was approved as levetiracetam by MYLAN on November 4^th, 2008.

Summary for KEPPRA XR

International Patents:	18
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	132
Clinical Trials:	116
Patent Applications:	3,497
Drug Prices:	Drug price information for KEPPRA XR
Drug Sales Revenues:	Drug sales revenues for KEPPRA XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KEPPRA XR
DailyMed Link:	KEPPRA XR at DailyMed

See drug prices for KEPPRA XR

See drug sales revenues for KEPPRA XR

Recent Clinical Trials for KEPPRA XR

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

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

See all KEPPRA XR clinical trials

Pharmacology for KEPPRA XR

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for KEPPRA XR

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

US Patents and Regulatory Information for KEPPRA XR

KEPPRA XR is protected by one US patents.

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 XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-001	Sep 12, 2008	AB	RX	Yes	No			Y
Ucb Inc	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-002	Feb 12, 2009	AB	RX	Yes	Yes			Y

Expired US Patents for KEPPRA XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-001	Sep 12, 2008

EU/EMA Drug Approvals for KEPPRA XR

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
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
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

International Patents for KEPPRA XR

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

Country	Patent Number	Title	Estimated Expiration
South Africa	200707250	Extended release formulation of levetiracetam
China	85105301
U.S.S.R.	1428195	CПOCOБ ПOЛУЧEHИЯ ( S)-AЛЬФA-ЭTИЛ-2-OKCO-1-ПИPPOЛИДИHAЦETAMИДA (METHOD OF PRODUCING (S)-ALPHA-ETHYL-2-OXO-1-PYRROLIDINEACETAMIDE)
Poland	257386
Lithuania	2584

Supplementary Protection Certificates for KEPPRA XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0162036	SPC/GB00/030	United Kingdom		SPC/GB00/030: 20050514, EXPIRES: 20100514
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

KEPPRA XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KEPPRA XR

Introduction to KEPPRA XR

KEPPRA XR, the extended-release formulation of levetiracetam, is a prominent antiepileptic drug (AED) developed and marketed by UCB Pharma. It is designed for once-daily administration, enhancing patient compliance compared to the immediate-release version of Keppra.

Market Leadership and Sales Performance

As of 2019, levetiracetam, the active ingredient in KEPPRA XR, was the market leader in the epilepsy drug market. It was forecasted to maintain its leadership with estimated sales of approximately $540 million in the major markets of the United States, France, Germany, Italy, Spain, the United Kingdom, and Japan[1].

Market Size and Growth Projections

The epilepsy drugs market, which includes KEPPRA XR, was valued at USD 7.6 billion in 2023 and is projected to grow to USD 10.9 billion by 2032, with a compound annual growth rate (CAGR) of 4.06% from 2024 to 2032. This growth is driven by increasing global prevalence of epilepsy, enhanced diagnostic techniques, and ongoing advancements in drug development[3].

Challenges in the Epilepsy Drug Market

Despite the positive outlook, the market faces several challenges. The high cost of advanced treatments limits accessibility, particularly in developing regions. Additionally, side effects associated with some AEDs can impact patient compliance and treatment outcomes, potentially slowing market growth[3].

Generic Erosion and Market Impact

Generic erosion has been a significant factor in the epilepsy drug market. By 2014, the market experienced a decline in sales due to generic competition, particularly affecting second-generation AEDs. However, the emergence of third-generation AEDs, including KEPPRA XR, has helped mitigate this impact. These newer drugs, although more expensive, offer better therapeutic options and have contributed to market recovery[1].

UCB Pharma's Financial Performance

UCB Pharma, the manufacturer of KEPPRA XR, has seen mixed financial results in recent years. In the first six months of 2022, UCB's revenue increased by 5% to €2.925 billion, driven by the growth of its product portfolio, including CIMZIA and BRIVIACT, and the addition of FINTEPLA following the acquisition of Zogenix. However, the company faced challenges such as generic competition to VIMPAT in the U.S. and E KEPPRA in Japan, which impacted net sales and profitability[2].

Impact of Generic Competition on KEPPRA XR

KEPPRA XR itself has not been significantly affected by generic competition since it is not available in a generic form. However, the generic erosion of other UCB products, such as VIMPAT and E KEPPRA, has had an impact on UCB's overall financial performance. The loss of exclusivity for these products has led to a decline in sales and profitability for UCB[2].

Regional Market Dynamics

The epilepsy drug market varies significantly by region. The North American region holds a substantial share of the market, driven by a high prevalence of epilepsy and increased awareness of the condition. The Asia Pacific region is expected to experience the highest CAGR of 6.8% during the forecast period, fueled by supportive government initiatives and the introduction of new-generation AEDs[3].

Competitive Landscape

UCB Pharma is one of the major key players in the epilepsy drug market, alongside other pharmaceutical companies. The competitive landscape is characterized by the development and marketing of both branded and generic AEDs. Emerging agents and third-generation AEDs are crucial in maintaining market growth despite generic competition[3].

Patient Compliance and Therapeutic Efficacy

KEPPRA XR's extended-release formulation enhances patient compliance by reducing the frequency of dosing to once daily. Clinical studies have shown that levetiracetam is effective in reducing seizure frequency, with between 20% and 40% of patients experiencing a significant reduction in seizures. Its lack of interaction with other medications makes it a versatile add-on therapy[4].

Safety and Side Effects

While KEPPRA XR is generally well-tolerated, it carries risks associated with other AEDs, such as increased suicidal thoughts or behavior, coordination difficulties, and other adverse reactions. Monitoring for these side effects is crucial to ensure patient safety[5].

Future Outlook and Growth Drivers

The future outlook for KEPPRA XR and the broader epilepsy drug market is optimistic. Ongoing research and development are yielding more effective and safer treatments. Increased awareness, improved diagnostic techniques, and supportive government initiatives will continue to drive demand for these medications.

Key Takeaways

• KEPPRA XR remains a market leader in the epilepsy drug market due to its efficacy and convenience.
• The epilepsy drug market is expected to grow from USD 7.6 billion in 2023 to USD 10.9 billion by 2032.
• Generic erosion affects the market, but emerging third-generation AEDs help maintain growth.
• UCB Pharma faces challenges from generic competition but continues to grow through its diverse product portfolio.
• Patient compliance and therapeutic efficacy are enhanced by KEPPRA XR's extended-release formulation.
• Safety monitoring is essential due to potential side effects associated with AEDs.

FAQs

Q: What is KEPPRA XR, and how does it differ from the immediate-release version of Keppra? A: KEPPRA XR is the extended-release formulation of levetiracetam, designed for once-daily administration, making it more convenient for patients compared to the immediate-release version which requires multiple daily doses.

Q: What are the key drivers of the epilepsy drug market growth? A: The growth is driven by the increasing global prevalence of epilepsy, enhanced diagnostic techniques, and ongoing advancements in drug development.

Q: How does generic erosion impact the epilepsy drug market? A: Generic erosion leads to a decline in sales for branded drugs but is mitigated by the uptake of newer, higher-priced third-generation AEDs.

Q: What are the potential side effects of KEPPRA XR? A: KEPPRA XR carries risks such as increased suicidal thoughts or behavior, coordination difficulties, and other adverse reactions, necessitating careful monitoring.

Q: What is the forecasted growth rate for the epilepsy drug market? A: The market is expected to grow at a CAGR of 4.06% from 2024 to 2032, reaching USD 10.9 billion by 2032.

Cited Sources:

1. Decision Resources, "The Epilepsy Drug Market Will Remain Relatively Flat Through 2019..."
2. UCB, "Strong first six months – UCB with continued delivery and strong resilience"
3. SNS Insider, "Epilepsy Drugs Market Size, Share & Growth Report 2032"
4. Epilepsy Foundation, "Levetiracetam XR"
5. UCB USA, "Keppra XR Current COL 3-2024 Effective 12Mar2024-en"