Details for Patent: 9,597,289

Which drugs does patent 9,597,289 protect, and when does it expire?

Patent 9,597,289 protects FLOLIPID and is included in one NDA.

This patent has twelve patent family members in twelve countries.

Summary for Patent: 9,597,289

Title:	Liquid oral simvastatin compositions
Abstract:	A suspension which is suitable for oral administration, comprising simvastatin, at least one suspending agent, and at least one preservative, wherein at least 90 wt % of the particles of simvastatin are less than 100 .mu.m in diameter. The present invention also includes uses of the suspension and methods of making the suspension.
Inventor(s):	Driver; Phillip (Keighley, GB)
Assignee:	ROSEMONT PHARMACEUTICALS LTD. (Leeds, GB)
Application Number:	12/298,451
Patent Claim Types: see list of patent claims	Compound; Dosage form;

Understanding the Scope and Claims of United States Patent 9,597,289

Introduction

United States Patent 9,597,289, titled "Liquid oral simvastatin compositions," is a significant patent in the pharmaceutical industry, particularly in the development and manufacturing of simvastatin formulations. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape.

Patent Overview

This patent was issued on March 21, 2017, to Rosemont Pharmaceuticals LTD, with Phillip Driver as the inventor. It pertains to liquid oral compositions of simvastatin, a widely used statin for lowering cholesterol levels.

Scope of the Patent

The patent covers a specific type of suspension suitable for oral administration, which includes:

• Simvastatin: The active ingredient, a statin used to reduce cholesterol levels.
• Suspending Agents: Substances that help maintain the uniform distribution of simvastatin particles in the liquid.
• Preservatives: Agents added to prevent microbial growth and extend the shelf life of the formulation[4].

Claims of the Patent

The patent includes several key claims that define its scope:

Composition Claims

• The suspension must contain simvastatin with at least 90% of the particles being less than 100 μm in diameter. This ensures the formulation is easily ingestible and effective[4].

Component Claims

• The composition includes at least one suspending agent and at least one preservative. Common suspending agents and preservatives mentioned include hydroxybenzoates, simethicone, and purified water[4].

Method Claims

• The patent also covers methods of making the suspension, including the process of mixing the ingredients and ensuring the particle size of simvastatin meets the specified criteria[4].

Patent Landscape

Related Patents

The patent landscape for simvastatin formulations is complex, with multiple patents covering different aspects of simvastatin compositions. For example:

• Patent 10,300,041: Also issued to Rosemont Pharmaceuticals LTD, this patent covers similar liquid oral simvastatin compositions but with slightly different formulations and a focus on the buffering system to maintain a pH between 6.4 and 7. This patent expires on April 26, 2027[1].

Exclusivity and Patent Term

• The patent term for U.S. patents typically lasts 20 years from the date of filing, but this can vary due to factors such as patent term restoration and litigation. For Patent 9,597,289, the expiration date is February 23, 2030[1].
• Exclusivity periods, which can run concurrently with patents, are not explicitly mentioned for this patent, but they could impact the market entry of generic versions[2].

Impact on the Pharmaceutical Industry

Innovation and Competition

• This patent and others like it encourage innovation by protecting the proprietary formulations developed by pharmaceutical companies. However, they also limit competition by preventing other companies from producing identical formulations until the patent expires[3].

Patient Access

• The exclusivity provided by patents can delay the availability of generic versions of drugs, potentially affecting patient access to affordable medications. However, once the patent expires, generic versions can enter the market, reducing costs for patients[2].

Key Components and Their Roles

Simvastatin

• Simvastatin is the active ingredient, crucial for its cholesterol-lowering effects. The patent ensures that the formulation maintains a high percentage of particles below 100 μm, enhancing bioavailability and efficacy[4].

Suspending Agents

• These agents are vital for maintaining the uniform distribution of simvastatin particles in the liquid suspension, ensuring consistent dosing and effectiveness[4].

Preservatives

• Preservatives are essential for extending the shelf life of the formulation by preventing microbial growth. Common preservatives include hydroxybenzoates and other antimicrobial agents[4].

Manufacturing Process

The manufacturing process outlined in the patent involves several steps:

• Mixing Ingredients: Combining simvastatin, suspending agents, preservatives, and other components.
• Particle Size Control: Ensuring that at least 90% of the simvastatin particles are less than 100 μm in diameter.
• Quality Control: Conducting assays to ensure the formulation meets the specified criteria[4].

Conclusion

United States Patent 9,597,289 is a critical patent in the field of simvastatin formulations, providing exclusive rights to Rosemont Pharmaceuticals LTD for a specific type of liquid oral simvastatin composition. The patent's scope and claims are designed to ensure the formulation's efficacy, stability, and patient safety. Understanding this patent is essential for pharmaceutical companies and researchers working on simvastatin and other statin formulations.

Key Takeaways

• Patent Scope: Covers liquid oral simvastatin compositions with specific particle size and component requirements.
• Claims: Include composition, component, and method claims.
• Patent Landscape: Part of a broader landscape including related patents and exclusivity periods.
• Impact: Encourages innovation, affects competition, and influences patient access to medications.
• Key Components: Simvastatin, suspending agents, and preservatives are crucial for the formulation.
• Manufacturing Process: Involves mixing, particle size control, and quality control.

FAQs

1. What is the main active ingredient in the patent 9,597,289?

   • The main active ingredient is simvastatin, a statin used to lower cholesterol levels.

2. What is the significance of the particle size in the patent?

   • At least 90% of the simvastatin particles must be less than 100 μm in diameter to ensure the formulation is easily ingestible and effective.

3. Who is the assignee of the patent 9,597,289?

   • The assignee is Rosemont Pharmaceuticals LTD.

4. When does the patent 9,597,289 expire?

   • The patent expires on February 23, 2030.

5. What are the common preservatives mentioned in the patent?

   • Common preservatives include hydroxybenzoates and other antimicrobial agents.

Sources

1. Generic FloLipid Availability - Drugs.com
2. Approved Drug Products with Therapeutic Equivalence Evaluations, 37th Edition - DrugPatentWatch
3. Patent Claims and Patent Scope - Hoover Institution
4. Liquid oral simvastatin compositions - Google Patents
5. Simvastatin formulations and methods of making same - Google Patents

Drugs Protected by US Patent 9,597,289

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Salerno Pharms	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-001	Apr 21, 2016		RX	Yes	No			Y
Salerno Pharms	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-002	Apr 21, 2016		RX	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 9,597,289

PCT Information
PCT Filed	April 26, 2007	PCT Application Number:	PCT/GB2007/001552
PCT Publication Date:	November 08, 2007	PCT Publication Number:	WO2007/125339

International Family Members for US Patent 9,597,289

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007245410
Austria	E552825
China	101431982
Cyprus	1112917
Denmark	2018153
European Patent Office	2018153