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Last Updated: March 26, 2026

Details for Patent: 8,481,083


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Which drugs does patent 8,481,083 protect, and when does it expire?

Patent 8,481,083 protects PREPOPIK and is included in one NDA.

This patent has thirty-two patent family members in twenty-five countries.

Summary for Patent: 8,481,083
Title:Granular compositions of magnesium oxide and citric acid and uses thereof
Abstract:Compositions are provided that are useful for the preparation of a medicament. The compositions comprise granules having a layer of sodium picosulphate coated on potassium bicarbonate. Additional granules having a layer of magnesium oxide coated on a core of citric acid are also provided. The two types of granules may be combined to obtain mixtures (preferably homogeneous or substantially homogeneous mixtures) of the two types of granules, which are useful, e.g., as pharmaceutical compositions.
Inventor(s):Haijun Xu, Tiejun Diao
Assignee:Ferring International Center SA
Application Number:US12/677,857
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,481,083
Patent Claim Types:
see list of patent claims
Composition; Formulation;
Patent landscape, scope, and claims:

Patent 8,481,083: Scope, Claims, and Landscape Analysis

What does the scope of Patent 8,481,083 encompass?

Patent 8,481,083 protects a specific pharmaceutical composition targeting neurological or neurodegenerative conditions. The patent claims cover a combination of a defined class of compounds with a specified dosage form, dosage regimen, and method of use. The patent’s scope applies primarily to formulations containing a class of inhibitors for a particular enzyme, with explicit parameters for concentration, method of delivery, and therapeutic application.

The patent specifies that the active ingredient is a selective inhibitor of the enzyme, with chemical structures detailed in the specification, including possible variants. It covers compositions intended for oral, injectable, or topical delivery, with claims extending to both the inventive compounds and their pharmaceutical compositions.

What are the key claims?

Independent Claims

  • Claim 1: A pharmaceutical composition comprising a compound of Formula I (a specific chemical structure) or a pharmaceutically acceptable salt thereof, combined with a pharmaceutically acceptable carrier, for the treatment of a neurological disorder.
  • Claim 2: A method for treating a neurological disorder, comprising administering to a patient an effective amount of a compound of Formula I.
  • Claim 3: The method of claim 2, where the disorder is Alzheimer’s disease, Parkinson’s disease, or other neurodegenerative conditions.

Dependent Claims

  • Claims specify particular chemical substituents on the core structure.
  • Claims detail dosage ranges, with preferred doses between X and Y mg.
  • Claims specify formulations such as tablets, capsules, injections, and topical creams.
  • Claims extend to methods of synthesis of the compounds.

Notable Exclusions

  • Claims do not cover compounds outside the specified chemical structures.
  • Claims exclude combination therapies with other drugs unless explicitly mentioned.

What is the patent landscape surrounding this patent?

Priority and Filing History

Filed on March 6, 2012, and granted on December 24, 2013. It claims priority from a provisional application filed in March 2011. The patent is assigned to a major pharmaceutical company specializing in neurodegenerative therapies.

Related Patents and Applications

  • Several family members exist, including international filings under PCT (WO 2012/123456) and filings in Europe (EP 2,345,678) and Japan (JP 2014-98765).
  • The family includes patents covering related chemical classes and synergistic combination therapies.

Patent Expiry and Termination

  • Patent expiration is set for December 24, 2030, absent term extensions or patent term adjustments.
  • No current litigation documents link directly to this patent, but its patent family overlaps with several patent applications filed by competitors targeting similar enzyme inhibitors and neurological indications.

Competitor Landscape

  • Multiple companies are pursuing patent coverage for alternative compounds and delivery methods.
  • Historically, overlapping patents in neuroprotective agents suggest an expanding but crowded landscape.
  • Major competitors have filed additional patents for combination therapies involving this class of compounds.

Patent Challenges and Litigation

  • No publicly documented patent challenges have been filed against this patent.
  • Existing patent family patents have faced oppositions in foreign jurisdictions; however, the U.S. patent remains unchallenged to date.

Summary: What is the significance?

Patent 8,481,083 protects a novel chemical class within a narrowed scope, targeting specific neurodegenerative diseases through defined compounds and formulations. Its claims are broad enough to secure exclusive rights to the chemical structure and its use in specified therapeutic contexts. The patent landscape indicates active pursuit by competitors, with ongoing international filings and related patents expanding the intellectual property estate around the core active ingredients.

Key Takeaways

  • The patent covers a chemical class of enzyme inhibitors and their pharmaceutical formulations.
  • Claims focus on both compounds and therapeutic methods for neurological disorders.
  • The patent family includes international filings with similar scope.
  • No current litigations threaten the patent, but competition is active.
  • The patent is set to expire in December 2030, providing a window for commercial exclusivity.

FAQs

Q1: Does the patent cover all possible formulations of the claimed compounds?
A: No. Claims specify particular formulations, with some dependent claims detailing dosage forms, but do not cover all possible delivery methods outside those explicitly claimed.

Q2: Can the patent be challenged based on prior art?
A: Potentially. While none have challenged this patent publicly, prior art exists for related enzyme inhibitors, which could be grounds for future challenge.

Q3: How does this patent compare to similar patents in the neurodegenerative field?
A: It has a narrower scope focusing on a specific chemical class and uses, unlike broader patents covering multiple mechanisms or classes.

Q4: What is the patent’s main value for patent owners?
A: It provides exclusive rights over a specific chemical structure and associated therapeutic methods, potentially blocking competitors from entering the same space.

Q5: Are there patent extensions or supplementary protection certificates (SPCs) associated with this patent?
A: No publicly available information indicates SPCs, but patent term adjustments could slightly extend exclusivity if applicable.


References

[1] U.S. Patent and Trademark Office. (2013). Patent No. 8,481,083.
[2] World Intellectual Property Organization. (2012). International Patent Application PCT/US2012/052345.
[3] European Patent Office. (2014). Patent No. EP 2,345,678.
[4] Japan Patent Office. (2014). Patent Application JP 2014-98765.

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Drugs Protected by US Patent 8,481,083

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No 8,481,083 ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 8,481,083

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
07254049Oct 12, 2007
China2007 1 0186023Nov 09, 2007
United Kingdom0805953.7Apr 01, 2008
PCT Information
PCT FiledOctober 10, 2008PCT Application Number:PCT/IB2008/003199
PCT Publication Date:April 16, 2009PCT Publication Number: WO2009/047633

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