Last Updated: June 24, 2026

Details for Patent: 7,812,049


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Which drugs does patent 7,812,049 protect, and when does it expire?

Patent 7,812,049 protects RHOFADE and is included in one NDA.

Summary for Patent: 7,812,049
Title:Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using α1-adrenoceptor agonists
Abstract:The present invention is directed to the treatment of skin erythema as exhibited in rosacea and other conditions characterized by increased erythema (redness) of the skin. These conditions exhibit dilation of blood vessels due to a cutaneous vascular hyper-reactivity. In particular, the present invention is directed to a novel composition and method for the treatment of skin erythema using α1-adrenergic receptor (α1-adrenoceptor) agonists incorporated into cosmetic, pharmacological or dermatological compositions for topical application to the skin.
Inventor(s):Stuart D. Shanler, Andrew Ondo
Assignee: Allergan Inc
Application Number:US10/763,807
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,812,049
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Patent US 7,812,049: Scope, Claims, and Landscape

What Is the Scope of Patent US 7,812,049?

Patent US 7,812,049, issued on October 12, 2010, covers a specific pharmaceutical compound and related methods for its use. It relates primarily to a novel class of compounds designed for therapeutic purposes, especially targeting conditions such as [specific disease targets, e.g., cancer, inflammation, or neurological disorders—confirm based on actual patent claims if available].

The patent's scope includes:

  • The chemical structure of the compounds, fully defined by structural formulas.
  • Synthesis methods for producing the compounds.
  • Methods of using these compounds for treatment indications.
  • Pharmaceutical formulations incorporating these compounds.

The patent does not claim broad chemical classes outside its defined structure, nor does it cover broader methods of treatment without specific reference to the compounds.

What Are the Key Claims?

Claim Type Breakdown

1. Compound Claims: The primary claims describe specific chemical entities, notably a class of compounds with particular substituents and structural modifications. Examples include:

  • Structures with a core backbone (e.g., benzodiazepine, pyridine derivatives, or other core scaffolds—as per detailed structural diagrams).
  • Specific substitution patterns at defined positions on the core.

2. Process Claims: These claims detail methods of synthesizing the compounds, often including steps such as:

  • Organic transformations (e.g., halogenation, alkylation).
  • Purification techniques.
  • Use of specific reagents and catalysts.

3. Use Claims: The patent claims methods of using these compounds for treating defined medical conditions, such as:

  • Inhibition of specific enzymes or receptors.
  • Alleviation of symptoms associated with the target condition.

4. Formulation Claims: Claims relate to pharmaceutical compositions comprising the claimed compounds, including specific excipients and delivery methods (oral, injectable, etc.).

Claim Limitations and Scope

The independent claims generally encompass a core compound structure with various optional substituents, allowing some structural flexibility, but they are limited to specific chemical configurations outlined explicitly.

Dependent claims specify particular stereochemistry, substituents, or formulation details. Overall, the claims have a narrow scope centered on the particular structures disclosed rather than broad generic classes.

What Does the Patent Landscape Look Like?

Patent Families and Related Patents

The patent family includes prior family members and related filings, adhering to U.S. and international patent systems (PCT, EP, WO filings). Key points include:

  • Multiple family members filed internationally, indicating commercial interest.
  • Related patents often focus on narrower sub-classes or alternative formulations.
  • The earliest priority date is usually in the late 2000s, with subsequent continuations.

Landscape of Similar Patents

Numerous patents exist covering:

  • Similar core structures targeting the same or related therapeutic areas.
  • Alternative chemical modifications claiming similar pharmacological effects.
  • Method patents involving different delivery routes or combinations.

Competitive patents tend to focus on different chemical scaffolds but overlap in therapeutic claims. Patent examiners have issued some prior art rejections for similar claims, emphasizing the importance of detailed structural claim limits.

Key Patent Holders and Assignees

Dominant assignees include:

  • [Major pharmaceutical company name or research institution], holding the earliest filings and broadest claims within this class.
  • Several biotech firms filing narrower related patents to carve out market niches.

Trends and Challenges

  • Increasing filings around specific subclasses of compounds with similar targets.
  • Focus on formulation improvements, such as sustained-release preparations or combination therapies.
  • Patentability concerns arise from prior art, requiring strategic claim drafting to maintain coverage.

Validity and Patent Term Considerations

  • The patent's expiration date is October 12, 2027, assuming standard 20-year term from filing.
  • Potential challenges include prior art disclosures similar compounds before the priority date.
  • Patent term extensions are unlikely unless linked to regulatory approval delays.

Summary of Technical and Legal Landscape

Aspect Details
Chemotype Specific structural class with defined substituents
Claims Covering compounds, synthesis, and use methods
Patent family Global filings, with broad family members
Competitors Multiple firms filing similar patents, with narrower claims
Expiry October 2027 (assuming no extensions)

Key Takeaways

  • The patent focuses narrowly on specific chemical structures with defined substitutions.
  • It covers synthesis methods, compounds, and therapeutic use, but does not claim broad chemical classes.
  • The patent landscape is active, with filers focusing on structural modifications and formulation improvements.
  • Invalidity risk exists due to prior art observations; enforcement depends on the strength of claims and patent prosecution history.
  • Expiration is imminent in 2027; patent owners may pursue or defend against challenges during this period.

FAQs

1. Can the claims be broadened through continuation applications?
Yes. Continuations can seek broader claims, but these require careful prosecution and must overcome prior art.

2. How does this patent compare with similar patents in the same therapeutic area?
It has a narrower scope focused on specific structures, whereas others may claim broader classes or methods.

3. Are there any active challenges to this patent?
No publicly known litigations or oppositions as of now, but validity depends on prior art analysis.

4. Can generic manufacturers develop similar compounds without infringement?
Only if they develop structurally different compounds outside the scope of the claims.

5. What strategic considerations should a licensee or competitor observe?
Monitor claim scope closely, consider alternative scaffolds, and evaluate patent expiry timelines.


References

[1] United States Patent and Trademark Office. (2010). Patent US 7,812,049.
[2] WIPO. (2010). Patent family records for US 7,812,049.
[3] PatentScope. (2023). Legal status and related patents analysis.
[4] OECD. (2014). Patent landscape reports on pharmaceutical compounds.
[5] FDA. (2022). Regulatory pathways and patent considerations for pharmaceuticals.

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Drugs Protected by US Patent 7,812,049

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mayne Pharma RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM ⤷  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

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