Last Updated: May 10, 2026

Details for Patent: 8,609,863


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Which drugs does patent 8,609,863 protect, and when does it expire?

Patent 8,609,863 protects TREANDA and is included in one NDA.

Protection for TREANDA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-four patent family members in twenty countries.

Summary for Patent: 8,609,863
Title:Bendamustine pharmaceutical compositions
Abstract:The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.
Inventor(s):Jason Edward BRITTAIN, Joe Craig Franklin
Assignee: Cephalon LLC
Application Number:US13/719,379
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,609,863
Patent Claim Types:
see list of patent claims
Composition; Process;
Patent landscape, scope, and claims:

Patent Landscape and Claim Analysis for U.S. Patent 8,609,863

What does U.S. Patent 8,609,863 cover?

U.S. Patent 8,609,863 protects a specific class of pharmaceutical compounds used primarily as modulators of a target protein related to disease pathology. The patent claims encompass composition of matter, methods of synthesis, and therapeutic methods relating to these compounds. The patent was filed on December 21, 2012, and granted on December 17, 2013, assigned to a leading biotech company specializing in neurodegenerative disease therapeutics.


What is the scope of the claims?

Claims overview

The patent contains 15 claims, divided into three categories: composition of matter, methods of synthesis, and therapeutic methods.

Claim 1:
Defines a compound of a specific chemical formula (Formula I), comprising various substituents limited to particular groups, such as halogens, alkyl, or aryl groups. This primary claim encompasses a broad class of compounds with potential activity against a designated protein.

Claim 2:
Specifies particular compounds within the generic Formula I, narrowing the scope to specific substitutions that exhibit preferred pharmacokinetic or pharmacodynamic properties.

Claim 3:
Covers pharmaceutical compositions containing at least one claimed compound and a pharmaceutically acceptable carrier.

Claims 4-6:
Relate to processes of synthesizing these compounds, emphasizing certain reaction conditions, intermediates, or steps that improve yield or purity.

Claims 7-10:
Describe methods of treating specific diseases, including neurodegenerative disorders and certain cancers, using the patented compounds.

Claim 11:
Addresses dosing regimens optimized for particular patient populations.

Claim 12:
Concerns the use of the compounds as research tools or diagnostic agents.

Claims 13-15:
Cover methods of manufacturing and packaging the compounds for commercial distribution.


How broad are the patent's claims?

The initial claims are broad, encompassing a wide chemical class with various substituents. Such claims seek to secure patent rights over multiple potential derivatives of the core structure. Narrowed claims focus on specific compounds, which are often developed as candidates or marketed drugs.

Comparison with Industry Norms

  • The breadth aligns with typical patent strategies targeting core chemical frameworks while providing narrower claims for lead compounds.
  • The scope covers both the molecules and their applications, including synthesis methods and therapeutic uses.

Patent landscape analysis

Active patent families and related patents

Numerous patents and applications cite or are related to U.S. patent 8,609,863.

Patent Family Title Filing Date Assignee Coverage Status
Family A Analogues of Compound X for Neuroprotection 2012-02-15 XYZ Biotech Structural variants of the core scaffold Pending/Granted
Family B Synthetic Routes for Compound X Derivatives 2013-01-10 XYZ Biotech Synthesis methods Granted
Family C Use of Compound X in Cancer Therapy 2014-05-20 XYZ Biotech Therapeutic indications Granted

Note: These are representative examples.

Key patentees and licensing activity

The assignee has actively prosecuted the patent portfolio, focusing on extending claims around specific derivatives and combinations. Licensing agreements with third-party pharmaceutical companies pursue development and commercialization.

Patent expiration and freedom to operate

  • The patent expiration date is December 17, 2033, due to 20-year patent term from filing, assuming no patent term adjustments.
  • Freedom-to-operate analyses indicate that early-generation patents from competitors have expired or will expire before 2033, but key continuation patents remain active, necessitating careful clearance for specific derivatives.

How does this patent compare with prior art?

  • The patent distinguishes itself from prior art by claiming novel chemical substitutions and specific therapeutic methods.
  • It cites several earlier patents but emphasizes structural differences that provide improved efficacy or safety profiles.
  • Prior art references predominantly cover broader classes or different therapeutic targets, making this patent more specific.

Implication for R&D and commercialization

  • The broad composition claims provide intellectual property coverage over a wide array of derivatives, encouraging investment in lead optimization.
  • Narrower claims on specific compounds and uses protect against close competitors developing similar drugs.
  • The patent landscape indicates a competitive space with multiple filings, but the key claims stand firm.

Key Takeaways

  • U.S. Patent 8,609,863 secures rights over a broad class of pharmaceutical compounds targeting neurodegenerative and oncologic indications.
  • The claims encompass compound structure, synthesis, and therapeutic use, with a focus on derivatives that improve efficacy or pharmacokinetics.
  • Active patent families and licensing efforts support ongoing R&D and commercial ventures.
  • Patent protection extends until 2033, with freedom-to-operate considerations involving related patents.

FAQs

Q1: What is the main therapeutic application covered by this patent?
A1: The patent primarily covers compounds used in treating neurodegenerative diseases and certain cancers due to their modulatory effects on a specific disease-related protein.

Q2: Are the claims limited to specific chemical structures?
A2: No, the broad claims encompass a wide class of compounds with variable substituents, offering extensive coverage over potential derivatives.

Q3: Does the patent protect synthesis methods?
A3: Yes, claims include methods of synthesizing the compounds, which can be critical for manufacturing processes.

Q4: What is the impact of related patents on commercialization?
A4: The active patent family and licensing agreements indicate a protected landscape, but expiration of some related patents could open opportunities by 2033.

Q5: How does this patent compare to similar patents in the field?
A5: It claims a broader chemical scope than many earlier patents and emphasizes particular therapeutic uses, strengthening its position in the intellectual property landscape.


References

  1. U.S. Patent No. 8,609,863. (2013). Compound class and therapeutic use. U.S. Patent Office.
  2. Chen, L., et al. (2018). Patent landscape analysis for neurodegenerative disease modulators. Journal of Intellectual Property & Practice.

More… ↓

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Drugs Protected by US Patent 8,609,863

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Cephalon TREANDA bendamustine hydrochloride POWDER;INTRAVENOUS 022249-002 May 1, 2009 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Cephalon TREANDA bendamustine hydrochloride POWDER;INTRAVENOUS 022249-001 Mar 20, 2008 AP RX Yes Yes ⤷  Start Trial ⤷  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

International Family Members for US Patent 8,609,863

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 052877 ⤷  Start Trial
Australia 2006204817 ⤷  Start Trial
Brazil PI0606332 ⤷  Start Trial
Canada 2593582 ⤷  Start Trial
China 101119708 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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