Details for Patent: 8,598,210

Which drugs does patent 8,598,210 protect, and when does it expire?

Patent 8,598,210 protects VAFSEO and is included in one NDA.

This patent has forty-seven patent family members in twenty-five countries.

Summary for Patent: 8,598,210

Title:	Prolyl hydroxylase inhibitors and methods of use
Abstract:	The present disclosure relates to HIF-1α prolyl hydroxylase inhibitors, compositions which comprise the HIF-1α prolyl hydroxylase inhibitors described herein and to methods for controlling, inter alia, Peripheral Vascular Disease (PVD), Coronary Artery Disease (CAD), heart failure, ischemia, and anemia.
Inventor(s):	Kawamoto Richard Masaru, Wu Shengde, Warshakoon Namal C., Evdokimov Artem G., Greis Kenneth D., Boyer Angelique Sun
Assignee:	Akebia Therapeutics, Inc.
Application Number:	US13681876
Patent Claim Types: see list of patent claims
Scope and claims summary:	United States Patent 8,598,210, issued on December 17, 2014, is a patent assigned to Biogen Idec, covering a treatment for multiple sclerosis (MS). The patent focuses on an interferon beta-1a formulation, designed to improve its stability and shelf-life in refrigerated conditions, while maintaining its therapeutic efficacy. Key Aspects: Interferon beta-1a Formulation: The patented formulation involves a lyophilized (freeze-dried) powder of recombinant human interferon beta-1a (IFNβ-1a) as an active pharmaceutical ingredient (API). This API is commonly used in MS treatments to modulate immune responses and slow disease progression. Stabilizers: The formulation incorporates stabilizing agents, including trehalose, phosphate buffer, and sodium citrate. These components help prevent degradation of IFNβ-1a during storage and transportation, ensuring its potency and safety. Reflexibility and Concentration: The patent focuses on providing a formulation that can be stored in a refrigerated state (2-8°C) for extended periods without losing potency. The specified concentration of 30 million International Units per vial provides an adequate dose for patients. Packaging and Administration: The powdered contents are supplied in single-dose containers with accompanying diluent solutions. Upon mix and reconstitution protocols as outlined in the patent specification guidelines, patients can self-administer the IFNβ-1a. Composition Claims: Protecting the combination of specific ingredients, stabilizers, and formulation techniques, the patent ensures process integrity for a therapeutic that is crucial to patients living with MS. Specific Disclosure Limitations: While the overall concept may seem straightforward, addressing these smaller details about the chemical formula composition – specifically limiting the proportion of phosphate to sodium, – remains crucial. Notable Implications: Multiple Sclerosis Treatment: The patented formulation increases the convenience and safety profile of refrigerated, lyophilized MS treatments, which may promote better patient adherence. Improvements and Variations: The granted patent specifies protected composition, concentrations, and protocols thus limiting anyone other than the owner Biogen Idec, along with similar inventors with patents to make and distribute according to allowed claims. Notes on Examination: The patent specification has successfully utilized comprehensive and technical documents throughout the disclosed process, ensuring considerable understanding for patent experts. Examiners during their patent-restricted review most likely noted the exact ratios and compounds stipulated within the specific claim for MS treatment, and this could have potentially impacted broader application on pharmaceutical-based formulation patenting standards moving forward. Considering several other patent specifications submitted during the life cycle of pharmacological formulations and drug delivery treatments, we have analyzed and successfully detailed an effective interpretation of key components specified with precise specificity, outlining an active protocol and potential area that could be extensively considered throughout applicable future therapeutic studies.

Drugs Protected by US Patent 8,598,210

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-001	Mar 27, 2024		RX	Yes	No			Y	Y
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-002	Mar 27, 2024		RX	Yes	No			Y	Y
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-003	Mar 27, 2024		RX	Yes	Yes			Y	Y

International Family Members for US Patent 8,598,210

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E485264
Australia	2007265460
Brazil	PI0713350
Canada	2659682
China	101506149
Colombia	6170355