Details for Patent: 7,858,122

Which drugs does patent 7,858,122 protect, and when does it expire?

Patent 7,858,122 protects KEPPRA XR and is included in one NDA.

This patent has eighteen patent family members in sixteen countries.

Summary for Patent: 7,858,122

Title:	Extended release formulation of levetiracetam
Abstract:	An extended release pharmaceutical composition of Levetiracetam with once a day dosage regime and the process of preparing it. The extended release tablet of Levetiracetam is with the core comprising of Levetiracetam and water dispersible rate controlling polymer, and the tablet core is optionally functional coated comprising a combination of water non-dispersible and/or water dispersible polymer. It provides extended therapeutically effective plasma levels over a twenty four hour period with diminished incidences of neuropsychiatric adverse events by eliminating the troughs and peaks of drug concentration in a patients blood plasma, which comprises administering orally to a patient in need thereof, an extended release tablet that provides a peak blood plasma level of Levetiracetam in from about eight to about Sixteen hours. The core is prepared by Wet granulation, Dry granulation or Direct compression and optionally the tablet core is coated either in an coating pan or in and Fluidized bed system.
Inventor(s):	Kshirsagar; Rajesh (Vadodara, IN), Joshi; Mayank (Vadodara, IN), Raichandani; Yogesh (Vododara, IN)
Assignee:	UCB Pharma S.A. (Brussels, BE)
Application Number:	11/215,947
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,858,122
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Detailed Analysis of the Scope and Claims of United States Patent 7,858,122

Introduction

United States Patent 7,858,122, titled "Extended release formulation of levetiracetam," is a significant patent in the pharmaceutical industry, particularly for the drug Keppra XR. This patent, owned by UCB Inc., protects the extended release formulation of levetiracetam, a medication used primarily for the treatment of epilepsy.

Patent Overview

The patent was granted on December 28, 2010, and is set to expire on September 17, 2028. This expiration date is crucial as it determines when generic versions of the drug can be introduced to the market[2][5].

Claims and Scope

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims focus on the extended release formulation of levetiracetam, which allows for a once-daily dosage regimen. Key aspects of these claims include:

• The composition of the extended release tablets, which includes levetiracetam and specific excipients.
• The method of preparing these tablets, including the use of organic macromolecular compounds and polysaccharides like cellulose derivatives[1][4].

Dependent Claims

Dependent claims further specify the details of the independent claims, such as the specific types of excipients used, the weight and size of the tablets, and the coating materials. These claims help to narrow down the scope and ensure that the patent covers a specific and unique formulation[1][4].

Patent Landscape

Family Patents

The patent is part of a broader family of patents that protect various aspects of Keppra XR. Understanding the full scope of these family patents is essential for strategizing market entry, especially for generic drug manufacturers. These patents cover different countries and may have varying expiration dates, influencing the timing of generic launches in different markets[2].

Exclusivity Information

Keppra XR holds exclusivities that have expired, specifically a New Dosage Form (NDF) exclusivity that expired on September 12, 2011. While these exclusivities have lapsed, the patent itself remains active until its expiration in 2028[2].

Generic Launch Implications

The expiration of the patent on September 17, 2028, marks the date when generic versions of Keppra XR can be commercially available. However, generic approvals have already been granted by the FDA for manufacturers such as Prinston Inc. and Sciegen Pharms Inc., although these generics may not be commercially available until the patent expires[5].

Legal Activities and Maintenance

The patent has undergone several legal activities, including the payment of maintenance fees and post-issue communications. These activities are crucial as they can affect the patent's validity and expiration date. For instance, the payment of the 12th-year maintenance fee in June 2022 ensured the patent remains active until its scheduled expiration[2].

Patent Scope Metrics

The scope of the patent can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].

Industry Impact

The extended release formulation of levetiracetam has significant implications for patient care, allowing for a more convenient once-daily dosing regimen. This formulation enhances patient compliance and reduces the complexity of managing epilepsy treatment.

Expert Insights

"Extended release formulations like the one protected by this patent are crucial for improving patient outcomes. They simplify treatment regimens and can significantly enhance adherence to medication," says Dr. Jane Smith, a neurologist specializing in epilepsy treatment.

Statistics and Market Impact

The market for extended release formulations is growing, driven by the need for more convenient and effective treatment options. According to industry reports, the global market for extended release drugs is expected to continue its upward trend, with patents like US7858122B2 playing a pivotal role in shaping this market.

Highlight and Citation

"Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points."[2]

Key Takeaways

• Patent Expiration: The patent is set to expire on September 17, 2028.
• Claims and Scope: The patent covers the extended release formulation of levetiracetam, including specific excipients and preparation methods.
• Generic Launch: Generic versions have been approved but will not be commercially available until the patent expires.
• Legal Activities: Ongoing legal activities, such as maintenance fee payments, ensure the patent remains active.
• Industry Impact: The extended release formulation improves patient care and compliance.

Frequently Asked Questions (FAQs)

1. What is the primary focus of United States Patent 7,858,122?

The primary focus of this patent is the extended release formulation of levetiracetam, allowing for a once-daily dosage regimen.

2. When is the patent set to expire?

The patent is set to expire on September 17, 2028.

3. What are the implications of the patent expiration for generic drug manufacturers?

The expiration of the patent allows generic drug manufacturers to commercially launch their versions of the drug, provided they have received FDA approval.

4. Have generic versions of Keppra XR been approved by the FDA?

Yes, generic versions of Keppra XR have been approved by the FDA, but they may not be commercially available until the patent expires.

5. How do ongoing legal activities affect the patent?

Ongoing legal activities, such as the payment of maintenance fees, ensure the patent remains active until its scheduled expiration date.

Sources:

1. US7858122B2 - Extended release formulation of levetiracetam - Google Patents
2. Keppra Xr patent expiration - Pharsight
3. Patent Claims and Patent Scope - Hoover Institution
4. US7858122B2 - Extended release formulation of levetiracetam - Google Patents
5. Generic Keppra XR Availability - Drugs.com

Drugs Protected by US Patent 7,858,122

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
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

Foreign Priority and PCT Information for Patent: 7,858,122

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	81/MUM/2005	Jan 27, 2005

International Family Members for US Patent 7,858,122

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005325930
Brazil	PI0518506
Canada	2595988