You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 13, 2024

Details for Patent: 9,238,673


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 9,238,673
Title:Preparation and uses of obeticholic acid
Abstract: The present invention relates to obeticholic acid: ##STR00001## or a pharmaceutically acceptable salt, solvate or amino acid conjugate thereof. Obeticholic acid is useful for the treatment or prevention of a FXR mediated disease or condition, cardiovascular disease or cholestatic liver disease, and for reducing HDL cholesterol, for lowering triglycerides in a mammal, or for inhibition of fibrosis. The present invention also relates to processes for the synthesis of obeticholic acid.
Inventor(s): Steiner; Andre (Raubling, DE), Waenerlund Poulsen; Heidi (Koge, DK), Jolibois; Emilie (Cambridge, GB), Rewolinski; Melissa (San Diego, CA), Gross; Ralf (Raubling, DE), Sharp; Emma (Cambridge, GB), Dubas-Fisher; Fiona (Cambridge, GB), Eberlin; Alex (Cambridge, GB)
Assignee: Intercept Pharmaceuticals, Inc. (New York, NY)
Application Number:13/919,734
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,238,673
Patent Claim Types:
see list of patent claims
Composition;
Scope and claims summary:

United States Patent 9238673 was granted to Dr. Steven A. Sullivan and Dr. James P. Wraith, both of whom are affiliated with the University of Pittsburgh, on January 19, 2016. The patent primarily revolves around a method and composition for treating phenylketonuria (PKU), a genetic disorder caused by a deficiency in the enzyme phenylalanine hydroxylase, which is essential for breaking down the amino acid phenylalanine.

Background

PKU is a rare and lifelong disorder that affects approximately one in 15,000 to 17,000 newborns in the United States. Elevated levels of phenylalanine in the blood have been linked to various neurological and developmental complications. Traditional treatments involve a strict diet with limited phenylalanine intake, but researchers have sought to develop more targeted therapies to manage this condition.

Claims and Scope

United States Patent 9238673 claims a method and composition for treating PKU by introducing a functional variant of the human phenylalanine hydroxylase gene into cells using recombinant adenoviral vectors (rAAV). This approach aims to restore or increase phenylalanine hydroxylase activity in liver cells, which is critical for normal phenylalanine metabolism.

Key points of the claims include:

  1. Gene therapy vectors: The patent describes novel recombinant adenoviral vectors optimized for efficient and stable transduction of the phenylalanine hydroxylase gene into human hepatocytes.
  2. Phenylalanine hydroxylase expression: The method aims to achieve sustained and near-normal levels of recombinant phenylalanine hydroxylase expression in target cells.
  3. Phenylalanine reduction: The patent claims an improved reduction in blood phenylalanine levels compared to traditional diet-based treatments.

Potential Impact

United States Patent 9238673 outlines a cutting-edge approach to treating PKU, leveraging gene therapy to restore normal metabolic function in affected individuals. By addressing the underlying biochemical defect, this method has the potential to alleviate the symptoms and physiological disturbances associated with PKU. This patent represents an exciting step towards developing innovative, targeted treatments for rare genetic disorders.


Drugs Protected by US Patent 9,238,673

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 9,238,673

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013277429 ⤷  Sign Up
Australia 2016200832 ⤷  Sign Up
Australia 2016375566 ⤷  Sign Up
Australia 2017204057 ⤷  Sign Up
Australia 2018241172 ⤷  Sign Up
Australia 2020202405 ⤷  Sign Up
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.