Details for Patent: 10,220,042

Which drugs does patent 10,220,042 protect, and when does it expire?

Patent 10,220,042 protects OXTELLAR XR and is included in one NDA.

This patent has fourteen patent family members in ten countries.

Summary for Patent: 10,220,042

Title:	Modified release preparations containing oxcarbazepine and derivatives thereof
Abstract:	Controlled-release preparations of oxcarbazepine and derivatives thereof for once-a-day administration are disclosed. The inventive compositions comprise solubility- and/or release enhancing agents to provide tailored drug release profiles, preferably sigmoidal release profiles. Methods of treatment comprising the inventive compositions are also disclosed.
Inventor(s):	Bhatt; Padmanabh P. (Rockville, MD), Kidane; Argaw (Montgomery Village, MD), Edwards; Kevin (Lovettsville, VA)
Assignee:	Supernus Pharmaceuticals, Inc. (Rockville, MD)
Application Number:	15/834,401
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,220,042
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Understanding the Scope and Claims of United States Patent 10,220,042

Introduction

The United States Patent 10,220,042, titled "Modified release preparations containing hydroxypropyl methyl cellulose," is a significant patent in the pharmaceutical industry, particularly in the realm of drug delivery systems. This patent addresses the development of modified release formulations, which are crucial for optimizing the efficacy and safety of pharmaceuticals.

Background

Modified release formulations are designed to control the rate and timing of drug release, which can enhance patient compliance, reduce side effects, and improve therapeutic outcomes. The patent in question focuses on using high molecular weight hydroxypropyl methyl cellulose (HPMC) to achieve zero-order release profiles.

Key Claims and Scope

Main Claim: Modified Release Preparations

The primary claim of the patent revolves around the use of high molecular weight HPMC to create modified release preparations. These preparations are designed to release the active pharmaceutical ingredient (API) at a constant rate over a prolonged period, which is known as zero-order release[4].

Use of Hydroxypropyl Methyl Cellulose (HPMC)

HPMC is a critical component in these formulations. The patent specifies the use of high molecular weight HPMC, which is essential for achieving the desired release profile. HPMC acts as a hydrophilic matrix that swells upon contact with aqueous fluids, controlling the release of the API[4].

Optional Hydrophobic Excipients

In addition to HPMC, the patent also mentions the optional use of hydrophobic excipients. These excipients can further modulate the release rate by creating a barrier that slows down the dissolution of the API. This combination of hydrophilic and hydrophobic components allows for a more precise control over the drug release kinetics[4].

Zero-Order Release Profile

The patent emphasizes the achievement of a zero-order release profile, where the rate of drug release is constant and independent of the concentration of the API. This profile is particularly beneficial as it ensures a consistent therapeutic effect over the entire dosing interval, reducing the risk of peak and trough effects associated with immediate release formulations[4].

Patent Landscape and Implications

Competitive Landscape

In the pharmaceutical industry, the development of modified release formulations is highly competitive. Patents like US 10,220,042 play a crucial role in protecting intellectual property and preventing generic or biosimilar versions from entering the market prematurely. The scope of this patent limits the ability of competitors to develop similar formulations without infringing on the patented claims[3].

Regulatory Considerations

The approval of generic or biosimilar products often involves Abbreviated New Drug Applications (ANDAs) or Biologics License Applications (BLAs). Patents like US 10,220,042 can be a significant barrier to the approval of these applications, as they must navigate around the patented claims to avoid infringement. This is evident in various ANDA litigation cases where patent infringement is a central issue[2].

Impact on Pharmaceutical Innovation

The patent landscape, as influenced by US 10,220,042, affects innovation in the pharmaceutical industry. The strict requirements for patent claims, particularly the enablement and written description doctrines under 35 U.S.C. § 112, make it challenging for innovators to secure broad patent protection. This can lead to a narrow scope of protection, allowing competitors to design around the patented claims with minor modifications, thus undermining the exclusivity intended by the patent[3].

Method of Manufacture

Spray Granulation and Fluidized Bed Granulation

While the patent US 10,220,042 does not specifically detail the method of manufacture, similar patents in the field often involve advanced manufacturing techniques such as spray granulation or fluidized bed granulation. These methods ensure uniform distribution of the API and excipients, which is critical for achieving consistent release profiles[1].

Conclusion

The United States Patent 10,220,042 is a significant contribution to the field of pharmaceutical formulations, particularly in the area of modified release preparations. The patent's focus on high molecular weight HPMC and optional hydrophobic excipients to achieve zero-order release profiles highlights the complexity and innovation in drug delivery systems.

Key Takeaways

• Modified Release Formulations: The patent emphasizes the use of high molecular weight HPMC for achieving zero-order release profiles.
• Hydrophobic Excipients: Optional use of hydrophobic excipients to modulate the release rate.
• Competitive Landscape: The patent protects intellectual property and limits competitors from developing similar formulations.
• Regulatory Implications: Significant barrier to ANDA and BLA approvals due to patent infringement concerns.
• Impact on Innovation: Strict patent claim requirements affect the scope of protection and innovation in the pharmaceutical industry.

FAQs

1. What is the primary focus of the United States Patent 10,220,042?

   • The primary focus is on modified release preparations using high molecular weight hydroxypropyl methyl cellulose (HPMC) to achieve zero-order release profiles.

2. What role do hydrophobic excipients play in these formulations?

   • Hydrophobic excipients can be used optionally to further modulate the release rate by creating a barrier that slows down the dissolution of the API.

3. How does this patent impact the competitive landscape in the pharmaceutical industry?

   • The patent protects intellectual property and prevents competitors from developing similar formulations without infringing on the patented claims.

4. What are the regulatory implications of this patent?

   • It acts as a significant barrier to the approval of ANDAs and BLAs, as these applications must navigate around the patented claims to avoid infringement.

5. How does the patent landscape affect innovation in the pharmaceutical industry?

   • The strict requirements for patent claims make it challenging for innovators to secure broad patent protection, allowing competitors to design around the patented claims with minor modifications.

Drugs Protected by US Patent 10,220,042

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-001	Oct 19, 2012	AB	RX	Yes	No						TREATMENT OF PARTIAL-ONSET SEIZURES
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-002	Oct 19, 2012	AB	RX	Yes	No						TREATMENT OF PARTIAL-ONSET SEIZURES
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-003	Oct 19, 2012	AB	RX	Yes	Yes						TREATMENT OF PARTIAL-ONSET SEIZURES

International Family Members for US Patent 10,220,042

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E496623
Australia	2007242984
Canada	2597740