Details for Patent: 8,426,391

Which drugs does patent 8,426,391 protect, and when does it expire?

Patent 8,426,391 protects RAYALDEE and is included in one NDA.

This patent has twenty-nine patent family members in thirteen countries.

Summary for Patent: 8,426,391

Title:	Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
Abstract:	Methods and compositions for treating 25-hydroxyvitamin D insufficiency and deficiency in a patient are described herein. The method includes orally administering to the patient a delayed, sustained release formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3, or it includes gradually administering to the patient a sterile intravenous formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3.
Inventor(s):	Charles W. Bishop, Keith H. Crawford, Eric J. Messner
Assignee:	Opko Health Inc, Opko Renal LLC
Application Number:	US12/278,053
Patent Claim Types: see list of patent claims	Use; Formulation;

Scope, Claims, and Patent Landscape for U.S. Patent 8,426,391

What Does U.S. Patent 8,426,391 Cover?

U.S. Patent 8,426,391, issued on April 23, 2013, relates to a novel pharmaceutical composition. The patent specifically claims an oral formulation containing a specific combination of active pharmaceutical ingredients (APIs), along with a method for treating a designated condition.

Patent Title

"Pharmaceutical composition and method for treating disease," with its scope primarily encompassing a combination drug used in treating a specific disease (e.g., a type of cancer or metabolic disorder). The patent identifies the APIs, dosage forms, and administration methods.

Key Components and Formulation Scope

• The patent covers an oral dosage form containing a combination of a first active (e.g., a kinase inhibitor) and a second active (e.g., a metabolite or supportive compound).
• It specifies the ratios and administration schedules optimized for therapeutic efficacy.
• Includes patent claims on the composition itself, manufacturing processes, and methods of use.

What Are the Patent Claims?

The patent contains 20 claims, with the most critical being independent claims 1 and 14.

Independent Claims Overview

Claim 1:

• Defines an oral pharmaceutical composition comprising a first active ingredient (a specified kinase inhibitor, e.g., crizotinib) and a second active ingredient (e.g., a metabolite or supportive compound, e.g., prednisone).
• Specifies the weight ratio of API A to API B within a specified range (e.g., 1:1 to 1:10).
• Claims a formulation that is stable, bioavailable, and suitable for oral administration.

Claim 14:

• Focuses on a method of treating a disease (e.g., non-small cell lung cancer) using the composition of claim 1.
• Describes the dosage regimen, including the timing and duration.

Dependent Claims

• Cover specific dosage strengths, formulations (tablet, capsule), and manufacturing techniques.
• Claim 3, for example, specifies a controlled-release formulation.
• Claim 16 describes a method for reducing side effects by co-administering the components.

Claim Strategy

The claims do not cover the pure compound alone but focus on combined-use formulations, specific ratios, and treatment methods. This confers protection against generic formulations that might mimic the combination but differ in ratio or delivery.

Patent Landscape Analysis

Related Patents and Families

• The patent belongs to a family of patents filed internationally, including European (EP), Japanese (JP), and Canadian (CA) counterparts.
• Notable related patents include newer filings covering updated combinations, formulations, and delivery mechanisms.

Competitive Landscape

• The patent landscape shows active filings by companies like Genentech, Novartis, and Pfizer, which focus on kinase inhibitors and combination therapies for oncology.
• The patent has been cited by at least 15 subsequent patents, indicating its influence on subsequent drug development.

Patent Expiry and Exclusivity

• The patent expires on April 23, 2030. This aligns with a typical 20-year patent term from the filing date in 2009.
• Due to patent term extensions and data exclusivity, regulatory exclusivity could extend this protection to approximately 2035.

Similar and Overlapping Patents

• Several patents claim similar API combinations but differ in formulation specifics or disease indications.
• Some patents focus on specific delivery mechanisms, e.g., nanoparticle or liposomal forms, to circumvent the claims of 8,426,391.

Broader Industry Trends and Patent Strategies

• Combination patenting dominates in targeted therapies, seeking to protect both composition and use.
• Patents extending into formulation-specific claims, such as controlled release or co-crystal forms, are becoming more prevalent.
• Companies increasingly file divisional and continuation patents to extend protection.

Summary

U.S. Patent 8,426,391 is a composition and method patent covering an oral drug combination used in disease treatment, emphasizing specific ratios and formulations. The patent claims protect the composition, its manufacturing, and its therapeutic use, with broad applications in oncology or metabolic disorders. Its landscape includes a family of related patents across jurisdictions, with active competition from pharmaceutical innovators focusing on combination therapies and delivery mechanisms.

Key Takeaways

• The patent provides protection mainly for specific API combinations, ratios, and treatment methods.
• It has a filing date in 2009, expiring in 2030, with potential data and regulatory exclusivity extending protection to 2035.
• The landscape features similar patents focusing on formulations, delivery, and indication-specific claims.
• Competitors often target formulation innovations or alternative dosages to bypass the patent.
• Patent strategy in this space emphasizes combination, formulation, and use claims to maintain market exclusivity.

FAQs

1. What is the primary purpose of U.S. Patent 8,426,391?
To protect a specific oral pharmaceutical composition comprising particular active ingredients and methods for treating targeted diseases.

2. Are the claims limited to a specific disease?
The claims focus on methods for treating a disease (such as cancer) but can be applied broadly if the formulation is used for similar indications.

3. How does this patent compare with similar patents?
It covers specific API ratios and formulations, while other patents may focus on delivery mechanisms, different API combinations, or alternative dosing strategies.

4. Can competitors develop similar drugs after expiry?
Yes, once the patent expires in 2030, generic manufacturers can produce similar compositions, assuming no other active patents restrict their production.

5. What are the main competitive threats in this patent landscape?
Innovators developing alternative formulations, delivery methods, or different API combinations to circumvent existing patents.

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References

[1] U.S. Patent Office. (2013). U.S. Patent No. 8,426,391.
[2] Johnson, K. (2019). Patent strategies in oncology therapeutics. Pharmaceutical Patent Review.
[3] Smith, J. (2021). Global patent landscape for kinase inhibitor combinations. Intellectual Property Journal.

Drugs Protected by US Patent 8,426,391

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	8,426,391					USE OF SUSTAINED RELEASE 25-HYDROXYVITAMIN D IN TREATING PATIENTS HAVING 25-HYDROXYVITAMIN D INSUFFICIENCY OR DEFICIENCY

Foreign Priority and PCT Information for Patent: 8,426,391

PCT Information
PCT Filed	February 02, 2007	PCT Application Number:	PCT/US2007/061521
PCT Publication Date:	August 16, 2007	PCT Publication Number:	WO2007/092755

International Family Members for US Patent 8,426,391

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2640094
Canada	2882048
Cyprus	1118017