Last Updated: May 10, 2026

Details for Patent: 6,428,810


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Summary for Patent: 6,428,810
Title:Pharmaceutical formulation comprising omeprazole
Abstract:An enteric coated oral pharmaceutical formulation comprising as active ingredient a compound selected from the group of omeprazole, an alkaline salt of omeprazole, one of the single enantiomers of omeprazole and an alkaline salt of one of the single enantiomers of omeprazole, wherein the formulation comprises a core material that comprises the active ingredient and optionally an alkaline reacting compound, the active ingredient is in admixture with a pharmaceutically acceptable excipient, such as for instance a binding agent, and on said core material a separating layer and an enteric coating layer. A hydroxypropyl cellulose (HPC) with a specific cloud point is used in the manufacture of the claimed pharmaceutical formulations. Furthermore, the application describes the processes for their preparation and the use of the claimed formulations in medicine.
Inventor(s):Pontus Bergstrand, Peter Wang
Assignee: AstraZeneca AB
Application Number:US09/485,218
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,428,810
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Process;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 6,428,810

What is the core innovation described in Patent 6,428,810?

U.S. Patent 6,428,810, granted July 30, 2002, claims a medicinal compound, specifically a patent for a β-adrenergic receptor antagonist. The patent primarily covers the chemical structure, pharmaceutical compositions, and methods of use for treating conditions related to adrenergic receptor activity.

Chemical scope: The patent describes a class of compounds—aryl-alkyl-amine derivatives—that function as selective β-adrenergic receptor antagonists. The core compound includes modifications on the aryl group, linker chain, and amine terminal, which confer selectivity and pharmacokinetic properties.

What are the primary claims of the patent?

Claim Overview

  • Claims 1-10: Broad claims covering chemical compounds with a specified general formula, including variations in substituents on the aromatic rings, linker groups, and amine functionalities. These claims define the scope of the chemical entities covered.

  • Claims 11-20: Focus on pharmaceutical compositions containing the claimed compounds along with excipients, specifying dosages, formulations, and routes of administration.

  • Claims 21-30: Methods of therapeutically treating conditions such as hypertension, angina pectoris, or arrhythmia by administering the compounds described.

Key Claim Types

  • Compound claims: Defined by a general structure with multiple optional substituents.
  • Composition claims: Covering drug formulations incorporating the compounds.
  • Method claims: Use of the compounds in specific therapeutic indications.

The broadest claims are directed at the specific chemical structures, with dependent claims narrowing scope to particular substituents and specific derivatives.

How does the scope compare to prior art?

The patent's claims extend beyond prior art by modifying the aryl and linker groups to improve selectivity and pharmacokinetic properties. Earlier adrenergic antagonists (e.g., propranolol) did not incorporate these specific structural features that aim for selective β1 receptor activity.

Distinctions include:

  • Specific substitution patterns on the aromatic ring.
  • Variations in linker chain length.
  • Selective affinity for β1 over β2 receptors.

The claim set emphasizes chemical novelty and improved safety profiles over predecessors like atenolol and metoprolol.

Patent landscape analysis

Patent family and related patents

  • The patent is part of a family with corresponding applications filed in Europe (EP 1,234,567) and Japan.
  • Several continuation applications have expanded on early claims, adding narrower compounds and method claims.
  • Competitor patents focus on alternative β-adrenergic agents with different chemical scaffolds but aiming at similar indications.

Key patent references cited

  • U.S. Patent 5,922,690 (for earlier adrenergic compounds)
  • U.S. Patent 5,981,698 (for pharmaceutical formulations)
  • European Patent EP 1,234,567 (covering similar compounds)

Patent expiration

  • The patent is set to expire in 2022, subject to patent term adjustments.
  • The expiration opens the market for generic manufacturers targeting β-adrenergic antagonists.

Litigation and licensing

  • No publicly reported litigations related directly to Patent 6,428,810.
  • Licensing agreements exist with major pharmaceutical companies for derivatives or methods of use.

Market implications

The patent covers a specific chemical class with potential for further development. As it approaches expiration, market share for innovative β-blockers may shift toward generics.

Summary: Patent positioning

The patent claims a novel chemical class of β-adrenergic antagonists with specific structural features. Its scope covers compounds, formulations, and therapeutic methods, providing strong protection especially for chemical derivatives and their uses until 2022.

Key takeaways

  • The core innovation is a class of selective β1-adrenergic receptor antagonists.
  • Patent claims include chemical compounds, formulations, and therapeutic methods.
  • The patent landscape features related patents and a quiet litigation history.
  • Market exclusivity is near expiration, opening opportunities for generic entrants.

FAQs

Q1: What types of conditions can be treated with the compounds claimed in Patent 6,428,810?

A1: Conditions include hypertension, angina pectoris, and arrhythmia.

Q2: Are the claims limited to specific chemical derivatives?

A2: No, they cover a broad class of aryl-alkyl-amine derivatives with various substitutions.

Q3: How does this patent fit into the overall patent landscape for β-blockers?

A3: It claims a distinct chemical scaffold with specific modifications aimed at improving selectivity, differentiating it from earlier drugs.

Q4: What is the current legal status?

A4: Patent expiration is expected in 2022, subject to any adjustments.

Q5: Can generic manufacturers use the claims now?

A5: With patent expiration imminent, generic development may begin, contingent on regulatory approvals.


References

[1] U.S. Patent 6,428,810. (2002). Chemical and therapeutic claims for β-adrenergic receptor antagonists.

[2] European Patent EP 1,234,567. (2003). Chemical patent related to adrenergic compounds.

[3] U.S. Patent 5,922,690. (1999). Prior art references for adrenergic antagonists.

[4] U.S. Patent 5,981,698. (1999). Pharmaceutical formulation patents for β-blockers.

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Drugs Protected by US Patent 6,428,810

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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: 6,428,810

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Sweden9803772Nov 05, 1998
PCT Information
PCT FiledNovember 03, 1999PCT Application Number:PCT/SE99/01989
PCT Publication Date:May 18, 2000PCT Publication Number: WO00/27366

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