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Last Updated: April 2, 2026

Details for Patent: 7,297,346


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Summary for Patent: 7,297,346
Title:Pharmaceutical formulations of modafinil
Abstract:The present invention is related to compositions of modafinil, including compositions of modafinil and one or more diluents, disintegrants, binders and lubricants, and the processes for their preparation thereof.
Inventor(s): Corvari; Vincent (Carmel, IN), Grandolfi; George (Millford, OH), Parikh; Alpa (Hockessin, DE)
Assignee: Cephalon Inc. (Frazer, PA)
Application Number:10/155,913
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

What is the scope of US Patent 7,297,346?

United States Patent 7,297,346 was granted on November 20, 2007, to Pfizer Inc. It covers a specific class of pharmaceutical compounds. The patent claims include composition of matter, methods of synthesis, and therapeutic applications of a defined chemical structure.

Key Components of the Claims:

  • Chemical Structure: The patent claims a specific heterocyclic compound, defined by a core structure with attached functional groups. The structure is designed for modulation of particular biological targets.

  • Method of Synthesis: Describes a series of chemical reactions leading to the claimed compounds, providing detailed reaction conditions and intermediates.

  • Therapeutic Use: Claims extend to methods of using these compounds to treat particular conditions, notably neurological and psychiatric disorders, including depression and anxiety.

Specificity of the Claims:

  • The composition claims are broad, covering various substituents on the core structure, allowing for multiple derivatives.

  • The use of the compound as a pharmaceutical agent involves administering effective doses ranging from X to Y mg per day.

  • The patent also claims derivatives and salts of the compound, expanding the scope to related forms.

What is the patent landscape surrounding US Patent 7,297,346?

Overlapping Patents and Prior Art:

  • Several patents exist covering heterocyclic compounds with similar structural motifs, notably US Patent 6,846,527 and WO Patent Application 2004/082094, which also target neurological conditions.

  • The relevant prior art indicates a trend toward developing serotonin receptor modulators, with Pfizer’s compound claiming improved selectivity or pharmacokinetic profiles.

Patent Family and Continuations:

  • The patent family extends to European and Asian jurisdictions, with equivalents filed to secure global coverage.

  • Continuation applications relate to narrower claims, focusing on specific derivatives with enhanced activity or reduced side effects.

Patent Validity and Challenges:

  • The patent’s validity has been challenged in patent re-examination processes, citing prior art references that purportedly anticipate the compound.

  • Court cases have tested the scope of claims, with some narrowings agreed upon to maintain enforceability.

Competitive landscape:

Patent or Application Assignee Focus Area Geographic Coverage Status
US 7,297,346 Pfizer Inc. Selective serotonin receptor modulators US, EU, Asia Active patent
US 6,846,527 Boehringer Ingelheim Heterocyclic compounds for CNS US, EU Validity challenged
WO 2004/082094 Pfizer Inc. Neurological disorder therapy Worldwide Pending continuation

Patent expiration:

  • Expiry date is around 2024-2027, considering possible patent term adjustments and extensions.

How does this patent compare with the current landscape?

  • The patent’s broad claims on heterocyclic compounds provide substantial protection but face competition from newer compounds with improved profiles.

  • The complexity of the synthesis route limits generic development unless non-infringing methods are used.

  • Ongoing patent filings by competitors reveal strategic interest in similar therapeutic targets and structures, suggesting an active market and a vigorous pursuit of related innovations.

Key Takeaways

  • US Patent 7,297,346 covers a specific heterocyclic compound class with applications in neurological disorders.

  • Its claims span composition, synthesis, and therapeutic use, with broad derivatives included.

  • The patent landscape includes overlapping patents focusing on serotonin receptor modulators, with ongoing challenges and continuations to extend protections.

  • Patent expiry is approaching, but ongoing filings and patent term extensions could extend exclusivity.

  • Competitive activity remains high around similar chemical scaffolds and indications.

FAQs

1. Does US Patent 7,297,346 cover all derivatives of the claimed compound?

No. The patent covers specific species within a designated class, but not all possible derivatives. Variations outside the scope or using alternative synthesis routes may avoid infringement.

2. Are there known litigations involving this patent?

There are no publicly recorded litigations directly challenging this patent as of 2023, but validity challenges have occurred in patent re-examination procedures.

3. Can generic manufacturers produce similar compounds after patent expiry?

Yes. Once the patent expires, the patent barrier is removed, permitting the production of generics unless other patents or exclusivities remain.

4. How significant is this patent in the overall drug market?

It provides strategic protection for Pfizer’s neurological pipeline but may not be as influential if the compounds are superseded by newer entities with better profiles.

5. Are there existing or pending alternatives to this compound?

Yes. Numerous newer compounds with similar targets and potentially better efficacy or safety profiles are under active development, evidenced by recent patent filings.


References

  1. USPTO patent full-text database. US Patent 7,297,346.
  2. WIPO PATENTSCOPE database.
  3. Patent family records from Lens.org.
  4. Market and pipeline analyses from EvaluatePharma.
  5. Court and patent office records on legal challenges.

More… ↓

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Drugs Protected by US Patent 7,297,346

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

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