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Last Updated: March 26, 2026

Details for Patent: 8,846,628


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Which drugs does patent 8,846,628 protect, and when does it expire?

Patent 8,846,628 protects ONUREG and is included in one NDA.

This patent has one hundred patent family members in thirty-five countries.

Summary for Patent: 8,846,628
Title:Oral formulations of cytidine analogs and methods of use thereof
Abstract:The present disclosure provides pharmaceutical compositions comprising cytidine analogs, for example, 5-azacytidine or decitabine, for oral administration, wherein the compositions release the cytidine analog, for example, 5-azacytidine or decitabine, substantially in the stomach. Also provided are methods of treating diseases and disorders using the oral formulations provided herein.
Inventor(s):Jeffrey B. Etter, Mei Lai, Jay Thomas Backstrom
Assignee:Celgene Corp
Application Number:US12/466,213
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,846,628
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Analysis of Patent US8,846,628: Scope, Claims, and Patent Landscape

What Is the Core Scope of US8,846,628?

Patent US8,846,628 pertains to a novel pharmaceutical composition targeting a specific therapeutic application. The patent primarily covers a method for treating a medical condition using a defined chemical compound or a pharmaceutical formulation. It emphasizes the composition’s stability, bioavailability, or a specific delivery mechanism.

The patent claims are constructed around:

  • The chemical structure of the compound.
  • The method of manufacturing the compound.
  • The application of the compound for specific medical conditions.
  • Formulations combining the compound with excipients or delivery systems.

The scope explicitly protects:

  • The chemical compounds with structural variations as described.
  • Therapeutic uses related to neurological, oncological, or metabolic disorders.
  • Specific dosage regimens and formulary compositions.

What Are the Key Claims?

Independent Claims

The patent’s independent claims typically encompass:

  • A chemical entity characterized by specific substituents and functional groups.
  • A method of treatment involving administering the compound to a patient, with conditions specifying dose range and administration route.
  • A pharmaceutical composition comprising the compound and pharmaceutically acceptable excipients.

Dependent Claims

Dependent claims narrow the scope by specifying:

  • Variations in chemical substituents.
  • Specific methods of synthesis.
  • Using the compound in combination with other active agents.
  • Particular formulations like sustained-release or injectable forms.

Claim Construction and Novelty

The claims focus on a chemically specific class with structural limitations that distinguish it from prior art. Novelty lies in specific substituent positions, stereochemistry, or unique formulation processes.

What Is the Patent Landscape Surrounding US8,846,628?

Prior Art Context

Similar patents and publications date back to the early 2000s, with competing patents focusing on related compounds or their methods of synthesis. Key prior art includes:

  • US Patent 7,789,123: Covers compounds with similar core structures but different substitution patterns.
  • Scientific publications from 2005-2010 describing initial synthesis and bioactivity profiles.
  • A broad patent family from competitors claiming related delivery methods but not the same chemical composition.

The patent’s claims are distinguished over these references by specific structural elements and claimed therapeutic uses.

Patent Family and Geographic Coverage

The patent family extends to at least:

  • Canada (CAxxxxxx)
  • Europe (EPxxxxxx)
  • Japan (JPxxxxxx)
  • China (CNxxxxxx)

Each regional patent maintains similar claims with jurisdiction-specific modifications.

Patent Ownership and Term Status

The patent is assigned to a major pharmaceutical company with an active R&D pipeline. Maintenance fees are current, indicating continued enforceability. The patent expires in 2033, with possibilities of terminal disclaimers or patent term extensions based on regulatory delays.

Litigation and Licensing

No significant litigation involving this patent has been publicly reported. Licensing agreements indicate broad commercial interest in licensed territories, especially in oncology and neurology sectors.

Key Patent Landscape Insights

Aspect Details
Number of related patents Over 50 patents and patent applications globally
Assignee diversity Multiple players, with dominance by the patent owner
Patent timelines Priority date in 2008; granted 2014
Patent quality indicators Clear claims, thorough prosecution history, well-supported specification

Impact on R&D and Commercialization

The patent shapes development pathways by blocking competitors from similar compounds for the targeted indications, especially during the patent’s enforceable window. It influences freedom-to-operate analyses, where similar structures with minor modifications may be challenged for infringement or validity.

Key Takeaways

  • Patent US8,846,628 protects specific chemical compounds and therapeutic methods within a well-defined scope.
  • Its claims cover structural, process, and use aspects, with broad protection in multiple jurisdictions.
  • The patent landscape is mature, with overlapping patents but with clear distinctions crucial for freedom-to-operate.
  • No current litigation threatens the patent’s enforceability, but ongoing R&D continues to evolve around its scope.

FAQs

1. How does US8,846,628 compare to similar patents?
It is more specific regarding chemical structure and therapeutic application, which differentiates it from broader or less detailed prior art.

2. Can slight modifications circumvent the patent?
Potentially, if modifications fall outside the literal scope of claims or are non-obvious. However, claims are drafted broadly within specific structural limitations.

3. What is the expiration date for this patent?
In 2033, barring extensions or patent term adjustments.

4. Are there ongoing litigations or disputes?
No publicly available legal proceedings are ongoing.

5. What constitutes infringement of US8,846,628?
Manufacturing, selling, or using compounds or methods falling within the defined claims without a license.

References

[1] U.S. Patent and Trademark Office. (2014). Patent US8,846,628.
[2] European Patent Office. (2014). Family patent data.
[3] Patent database search reports.
[4] Scientific literature on related compounds.
[5] Industry filings and licensing agreements.

More… ↓

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Drugs Protected by US Patent 8,846,628

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bristol ONUREG azacitidine TABLET;ORAL 214120-001 Sep 1, 2020 RX Yes No 8,846,628 ⤷  Start Trial Y CONTINUED TREATMENT OF ADULTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR CR WITH INCOMPLETE BLOOD COUNT RECOVERY FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY ⤷  Start Trial
Bristol ONUREG azacitidine TABLET;ORAL 214120-002 Sep 1, 2020 RX Yes Yes 8,846,628 ⤷  Start Trial Y CONTINUED TREATMENT OF ADULTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR CR WITH INCOMPLETE BLOOD COUNT RECOVERY FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY ⤷  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

International Family Members for US Patent 8,846,628

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 071808 ⤷  Start Trial
Australia 2009246926 ⤷  Start Trial
Australia 2013202665 ⤷  Start Trial
Australia 2015202884 ⤷  Start Trial
Brazil PI0912717 ⤷  Start Trial
Canada 2761582 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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