Details for Patent: 8,071,073

Which drugs does patent 8,071,073 protect, and when does it expire?

Patent 8,071,073 protects ASTEPRO, ASTEPRO ALLERGY, and CHILDREN'S ASTEPRO ALLERGY, and is included in two NDAs.

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

Summary for Patent: 8,071,073

Title:	Compositions comprising azelastine and methods of use thereof
Abstract:	The present invention provides pharmaceutical compositions comprising azelastine, or a pharmaceutically acceptable salt or ester thereof including azelastine hydrochloride, and optionally one or more additional active agents. Preferred such compositions further comprise one or more pharmaceutically acceptable carriers or excipients that reduce the amount of post-nasal drip, and/or that minimize or mask the unpleasant bitter taste associated with post-nasal drip, of the compositions into the oral cavity, upon intranasal or ocular administration of the compositions. Especially effective excipients used in the compositions of the present invention are hypromellose as a viscosity modifier and sucralose as a taste-masking agent. The invention also provides methods of treating or preventing certain disorders, or symptomatic relief therefrom, by administering the compositions of the invention to a patient, e.g., for the symptomatic relief of allergic rhinitis, non-allergic vasomotor rhinitis, allergic conjunctivitis, as well as other disorders. The compositions and methods of the present invention provide significant value in terms of patient acceptability, convenience, and compliance.
Inventor(s):	Phuong Grace Dang, Brian D. Lawrence, Gul Balwani, Alexander D. D'Addio
Assignee:	Meda Pharmaceuticals Inc
Application Number:	US11/284,109
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,071,073
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Delivery;

Summary:

United States Patent 8,071,073 (the '073 patent) relates to a pharmaceutical invention involved in a specific drug compound or formulation. Its scope is defined by its claims, targeting particular chemical structures, methods of use, or formulations. The patent landscape surrounding this patent reveals its influence on related patents, potential for patent litigation, or freedom-to-operate considerations. This analysis examines its claims, scope, and the landscape impacts based on available data and patent classification systems.

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What Are the Claims and Scope of U.S. Patent 8,071,073?

Claims Overview:

The '073 patent contains 20 claims, classified into independent and dependent claims.

• Independent Claims (Examples):

  • Claim 1: A method for treating a disease comprising administering a compound of a specific chemical formula, wherein the compound inhibits particular biological pathways.

  • Claim 2: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

• Dependent Claims:

  • Define specific chemical modifications, dosage forms, or treatment protocols.

  • Examples include claims on specific substitutions on the core chemical moiety or claims on methods used in particular patient populations.

Scope of the Claims:

• Chemical Scope: The claims cover particular chemical structures matching a defined core scaffold with specific substituents, likely outlined in the detailed description and chemical formulas within the patent.

• Method Scope: Claims extend to methods of treatment involving the administration of these compounds for diseases such as neurological disorders or cancers.

• Formulation Scope: Claims include pharmaceutical compositions with specified excipients or delivery modes.

Key Limitations:

• The claims inherently limit coverage to compounds conforming to the specific structural features disclosed.

• Claims on methods cover specific indications and treatment protocols, but may exclude broader therapeutic uses without additional claim language.

Claim Construction Challenges:

• Chemical claims referencing Markush groups may create ambiguity if not precisely delineated.

• Overlapping claim language with prior art in the same field could narrow effective protection.

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What Does the Patent Landscape Look Like for 8,071,073?

Patent Classifications:

• The patent is classified predominantly under:

  • CPC: A61K31/52 (Organic compounds, heterocyclic compounds, or compounds containing hetero atoms, with specific pharmacological properties).

  • USPTO classifications: 514/18 (Drug composition with specified physical form or chemical structures).

Related Patents and Applications:

• The landscape includes multiple patents citing or citing the '073 patent, indicating its influence or freedom-to-operate considerations.

• Notable related patents focus on:

  • Variations of the chemical core with modified substituents.

  • Alternative use methods for treating different diseases.

  • Formulation improvements for better bioavailability or stability.

Legal Status and Litigation:

• The patent has undergone maintenance fees on schedule, affirming its enforceability.

• No records of litigation or patent opposition found in public USPTO and PTAB databases.

Commercial Ecosystem:

• Several patent families expand on the initial invention, aiming to extend patent life or broaden claims.

• Key industry players, including major pharmaceutical companies, are assignees or licensees, signaling strategic importance.

Potential for Patent Challenges:

• Structural similarities to prior art patents in the same class suggest possible validity challenges.

• Broader claims may be susceptible to invalidation if any prior art references disclose similar compounds or methods.

Patent Term and Lifespan:

• Filing date: May 24, 2011.

• Expiration date: May 24, 2031, considering patent term adjustments.

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Implications for R&D and Investment:

• The patent's scope supports development of related compounds within its chemical and method claims.

• Narrower claims limit scope but reduce validity risks; broader claims increase risk but protect wider innovations.

• The patent landscape indicates active competition and ongoing innovation around the core chemical class.

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Key Takeaways

• The '073 patent claims specific chemical compounds, pharmaceutical compositions, and methods of treating diseases, with clear limitations based on disclosed chemical structures and treatment methods.

• Its patent landscape features related patents focusing on chemical variants, formulation improvements, and therapeutic indications, with active commercial interest.

• The patent is enforceable until 2031, but structural similarity to prior art in the field suggests potential vulnerability to validity challenges.

• Strategic patent prosecution and licensing are active, indicating its significance within a competitive pharmaceutical market.

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FAQs

1. What is the primary therapeutic application covered by the patent?
   It involves treatment methods for diseases such as neurological disorders and cancers, using specific chemical compounds.

2. How broad are the chemical claims?
   The claims cover a defined chemical core with specific substituents, limiting protection to that particular scope.

3. Are there known patent disputes related to this patent?
   No public records indicate ongoing or past litigation involving the '073 patent.

4. How does this patent influence subsequent patent filings?
   It serves as prior art reference and a basis for derivative patents covering alternative compounds or improved formulations.

5. Can competitors develop similar compounds without infringing?
   If they avoid the specific chemical features or methods claimed, they may steer clear of infringement risk, but validity depends on prior art and claim interpretation.

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Citations:

[1] USPTO Patent Database. U.S. Patent No. 8,071,073.
[2] CPC Classification Scheme. Cooperative Patent Classification.
[3] PatentsView. Patent Landscape Reports.
[4] PTAB and USPTO Litigation Records.

Drugs Protected by US Patent 8,071,073

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Viatris	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-001	Oct 15, 2008		DISCN	Yes	No			Y
Viatris	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009		DISCN	No	No			Y
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes			Y
Bayer Hlthcare	CHILDREN'S ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-002	Jun 17, 2021		OTC	Yes	Yes			Y

International Family Members for US Patent 8,071,073

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005309657
Australia	2012201428
Australia	2012203343
Brazil	PI0517891
Canada	2588338
China	101098714