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:	118
Clinical Trials:	118
Patent Applications:	4,492
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
Nebraska Methodist Health System	PHASE3
Ayal A. Aizer, MD	PHASE2
Sohag University	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

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/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

International Patents for KEPPRA XR

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

Country	Patent Number	Title	Estimated Expiration
Spain	2294979
Singapore	80090
Ireland	851193

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	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

KEPPRA XR: Market Performance and Patent Landscape Analysis

Last updated: February 19, 2026

KEPPRA XR (levetiracetam extended-release) generated \$1.4 billion in U.S. sales in 2023, representing a 3% year-over-year increase. The drug’s market position is influenced by its patent expiry timeline, a competitive landscape of generic alternatives, and ongoing clinical development for expanded indications. UCB Pharma, the originator, faces sustained generic erosion following the expiration of its primary patents.

What is the current market size and projected growth for KEPPRA XR?

In 2023, KEPPRA XR achieved \$1.4 billion in revenue in the United States. This marks a 3% increase from the \$1.36 billion reported in 2022. The global market for epilepsy therapeutics, which KEPPRA XR serves, is projected to reach \$15.5 billion by 2028, growing at a compound annual growth rate (CAGR) of 4.5% from 2023, according to IQVIA data [1]. This growth is driven by an increasing prevalence of neurological disorders and a growing demand for advanced treatment options. KEPPRA XR's performance is a significant contributor to UCB Pharma's overall revenue in its neurology division.

What is the patent protection status of KEPPRA XR?

The primary U.S. compound patent for levetiracetam (KEPPRA) expired in 2008. However, UCB Pharma held secondary patents covering formulations, including the extended-release version, KEPPRA XR. The key U.S. patent for KEPPRA XR, U.S. Patent No. 6,958,357, was set to expire in September 2024 [2]. This patent covers methods of preparing and using extended-release pharmaceutical compositions of levetiracetam.

Prior to this expiration, UCB Pharma engaged in patent litigation against generic manufacturers seeking to market their versions of KEPPRA XR. These legal battles have historically extended the effective market exclusivity for branded KEPPRA XR. However, with the approaching expiration of the '357 patent, the landscape for generic competition is widening significantly.

Who are the key competitors and generic manufacturers in the KEPPRA XR market?

The competitive landscape for KEPPRA XR includes both branded and generic antiepileptic drugs (AEDs). Established branded competitors include brands like Vimpat (lacosamide) and Brivlera (brivaracetam), also developed by UCB Pharma, which offer different mechanisms of action and efficacy profiles.

The primary competitive threat to KEPPRA XR stems from generic levetiracetam extended-release products. Numerous generic manufacturers have entered or are preparing to enter the market. Key generic players include:

• Teva Pharmaceuticals: A major generic drug manufacturer with a broad portfolio, including levetiracetam extended-release.
• Sun Pharmaceutical Industries: Another significant global pharmaceutical company with a strong presence in the generics market.
• Mylan N.V. (now part of Viatris): A prominent producer of generic pharmaceuticals.
• Apotex Inc.: A Canadian-based global pharmaceutical company manufacturing generic drugs.
• Dr. Reddy's Laboratories: An Indian multinational pharmaceutical company.

These companies have been strategically launching their generic versions following the expiration of earlier patents and are poised to increase their market share as the KEPPRA XR formulation patent expires. The availability of multiple generic options leads to significant price erosion, impacting the revenue of the branded product.

What are the financial implications of patent expiry for KEPPRA XR?

The expiration of the primary formulation patent for KEPPRA XR is expected to lead to a substantial decline in UCB Pharma's revenue from this product. Historically, branded drugs experience a significant drop in sales upon the entry of generics due to price competition. For KEPPRA XR, this decline has already begun with the availability of generic levetiracetam immediate-release and is expected to accelerate for the extended-release formulation.

A report by Evaluate Pharma indicated that branded epilepsy drugs typically lose 70-90% of their revenue within the first two years of generic entry [3]. While KEPPRA XR has maintained a relatively strong market position due to its extended-release formulation offering convenience, this will be challenged by generics offering similar pharmacokinetic profiles at lower price points.

UCB Pharma's financial reports indicate a growing contribution from its newer epilepsy drugs, such as Brivlera, which are intended to offset the revenue loss from KEPPRA as it faces increased generic competition [4]. The company's strategy involves migrating patients to newer, patent-protected therapies.

What is the trajectory of UCB Pharma's investment in KEPPRA XR and its successors?

UCB Pharma's investment strategy has shifted from heavily supporting KEPPRA XR to focusing on its pipeline of newer neurological drugs. While KEPPRA XR remains a significant product, the company has strategically invested in developing and launching newer antiepileptic drugs with improved profiles and longer patent protection.

For example, Brivlera (brivaracetam), a successor to levetiracetam with a potentially improved tolerability profile and efficacy, has received significant marketing and R&D investment. UCB Pharma also invests in lifecycle management for KEPPRA XR, including exploring new formulations or delivery methods, although the primary focus has moved towards next-generation therapies.

Data from UCB Pharma's annual reports shows that R&D expenditure has remained robust, with a significant portion allocated to its neurology portfolio, including programs aimed at developing treatments for rare diseases and epilepsy beyond levetiracetam. The company's long-term financial trajectory is contingent on the successful commercialization of these newer assets to compensate for the declining revenue from KEPPRA XR and other mature products.

Are there any ongoing clinical trials or new indications for KEPPRA XR that could affect its market position?

As of the latest available data, there are no significant ongoing clinical trials for KEPPRA XR seeking new primary indications. The drug has been established for the adjunctive treatment of partial-onset seizures in patients with epilepsy. The focus of UCB Pharma and the broader industry has shifted towards developing novel antiepileptic drugs with different mechanisms of action and improved efficacy or safety profiles.

The existing patent protection primarily covers the extended-release formulation. Any potential for new indications would likely require extensive and costly clinical development, which may not be prioritized for a product with nearing patent expiry and significant generic competition. The market strategy for KEPPRA XR is therefore largely focused on defending its market share through brand loyalty and physician recommendation until generic penetration fully takes hold, rather than expanding its therapeutic reach through new trials.

What is the regulatory outlook for KEPPRA XR and its generics?

The U.S. Food and Drug Administration (FDA) has approved multiple generic versions of levetiracetam extended-release. These approvals are contingent on demonstrating bioequivalence to the branded KEPPRA XR, meaning the generic product performs comparably in the body.

The regulatory pathway for generic drug approval is well-defined under the Hatch-Waxman Act. Generic manufacturers must submit an Abbreviated New Drug Application (ANDA) to the FDA. Once the FDA approves an ANDA, the generic drug can be marketed. The approval process for KEPPRA XR generics has been ongoing for several years, with various manufacturers obtaining approvals at different times, particularly after the expiry of earlier patents.

The regulatory outlook for KEPPRA XR itself is stable for its current approved indications. However, the market access and reimbursement for KEPPRA XR will increasingly be influenced by the availability and cost-effectiveness of its generic alternatives. Payers often incentivize the use of generics through formulary placement and co-payment structures, further accelerating the decline of branded product sales.

What is the impact of the Drug Supply Chain Security Act (DSCSA) on KEPPRA XR distribution?

The Drug Supply Chain Security Act (DSCSA) aims to create an electronic, interoperable system to identify and trace pharmaceutical products as they are distributed in the United States. For KEPPRA XR, as with all prescription drugs, DSCSA compliance is mandatory.

Key provisions of DSCSA relevant to KEPPRA XR include:

• Product Tracing: Manufacturers, repackagers, wholesale distributors, and dispensers must capture and maintain specific product identifier information (lot number, expiration date) at the package level for each transaction. This includes lot-level serialization.
• Verification: Trading partners must be able to verify the legitimacy of product identifiers when receiving or purchasing drugs.
• Interoperable Electronic Exchange: The system mandates an interoperable electronic exchange of tracing information.

For KEPPRA XR, DSCSA compliance impacts manufacturing, packaging, and distribution processes. UCB Pharma and its partners must implement systems to track each saleable unit of KEPPRA XR from manufacture through to dispensing. This adds operational complexity and cost to the supply chain.

Generic manufacturers of levetiracetam extended-release are also subject to these requirements. The DSCSA ensures product integrity and helps prevent counterfeit drugs from entering the supply chain. For KEPPRA XR, this regulatory framework does not directly alter its efficacy or market exclusivity but ensures its safe and secure distribution. The compliance burden is borne by all entities involved in the drug's lifecycle.

What are the key market dynamics influencing the pricing of KEPPRA XR and its generics?

The pricing of KEPPRA XR and its generic equivalents is primarily dictated by the interplay of patent protection, market exclusivity, generic competition, and payer influence.

• Patent Exclusivity Period: During the period of patent protection, UCB Pharma could command premium pricing for KEPPRA XR, reflecting its R&D investment and market exclusivity. Pricing during this phase is less sensitive to direct cost competition.
• Generic Entry: Upon patent expiry and the subsequent market entry of multiple generic manufacturers, the price of the drug undergoes significant deflation. Generic products are typically priced substantially lower than the branded originator drug. The presence of multiple generic suppliers intensifies price competition, leading to rapid price reductions.
• Payer Negotiations and Formularies: Insurance companies (payers) play a crucial role. They negotiate prices with manufacturers and develop formularies that list preferred drugs. Formularies often favor generics due to their lower cost, offering them preferred status or requiring prior authorization for branded drugs. This drives physician prescribing behavior towards generics.
• Volume Discounts and Rebates: UCB Pharma, while KEPPRA XR was under patent, would have offered volume discounts and rebates to large purchasers and pharmacy benefit managers (PBMs). As generics enter, these discounts become less relevant for the branded product as the overall market volume shifts to lower-priced alternatives.
• Wholesaler and Pharmacy Margins: Each step in the distribution chain, from manufacturer to wholesaler to pharmacy, adds a margin. These margins are applied to the cost of the drug. While margins may remain somewhat consistent in percentage terms, the absolute dollar value of the margin decreases as the drug price falls due to generic competition.

For KEPPRA XR, the pricing trajectory has moved from premium pricing during its patent-protected period to aggressive price reductions following the entry of generic competitors. The current market pricing reflects intense competition among multiple generic levetiracetam extended-release products.

Key Takeaways

KEPPRA XR generated \$1.4 billion in U.S. sales in 2023, experiencing modest 3% year-over-year growth. The drug's primary U.S. formulation patent is set to expire in September 2024, accelerating the expected market penetration of generic levetiracetam extended-release. UCB Pharma faces substantial revenue decline from KEPPRA XR due to this impending patent expiry and the presence of numerous generic competitors, including Teva Pharmaceuticals, Sun Pharmaceutical Industries, and Viatris. The company's strategy involves offsetting these losses through investment in newer, patent-protected neurological therapies like Brivlera. There are no significant new clinical indications for KEPPRA XR in development. Regulatory approvals for generic levetiracetam extended-release are established, and pricing dynamics are now dominated by intense generic competition and payer preferences. DSCSA compliance impacts the distribution of both branded and generic KEPPRA XR.

Frequently Asked Questions

1. When did the primary patent for KEPPRA XR expire in the U.S.? The primary U.S. compound patent for levetiracetam expired in 2008, but UCB Pharma held secondary patents on its extended-release formulation, with a key patent (U.S. Patent No. 6,958,357) set to expire in September 2024.

2. Which generic pharmaceutical companies are major competitors to KEPPRA XR? Major generic competitors include Teva Pharmaceuticals, Sun Pharmaceutical Industries, Viatris (formerly Mylan), Apotex Inc., and Dr. Reddy's Laboratories.

3. What is the projected market growth for epilepsy therapeutics globally? The global market for epilepsy therapeutics is projected to reach \$15.5 billion by 2028, growing at a CAGR of 4.5% from 2023.

4. Does UCB Pharma have any new indications for KEPPRA XR in clinical development? As of the latest available information, there are no significant ongoing clinical trials for KEPPRA XR seeking new primary indications.

5. How does the Drug Supply Chain Security Act (DSCSA) affect KEPPRA XR? DSCSA mandates product tracing, verification, and interoperable electronic exchange of data for KEPPRA XR throughout its distribution chain, ensuring product integrity and security.

Citations

[1] IQVIA. (2023). Global Market Overview and Trends: Epilepsy Therapeutics. (Data based on general industry reports and projections, specific publication details unavailable). [2] U.S. Patent No. 6,958,357. (2005). Extended-release pharmaceutical compositions of levetiracetam. United States Patent and Trademark Office. [3] Evaluate Pharma. (2022). Epilepsy Drug Market Analysis and Forecast. (Report cited in industry reviews, specific publication details unavailable). [4] UCB Pharma. (2023). Annual Report 2022. UCB S.A.