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Details for Patent: 8,518,919

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Which drugs does patent 8,518,919 protect, and when does it expire?

Patent 8,518,919 protects ASTEPRO and is included in one NDA.

This patent has twenty-eight patent family members in twenty countries.

Summary for Patent: 8,518,919

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.
Inventor(s):	Dang; Phuong Grace (Corona, CA), Lawrence; Brian D. (Somerset, NJ), Balwani; Gul (West Windsor, NJ), D'Addio; Alexander D. (Piscataway, NJ)
Assignee:	MEDA Pharmaceuticals Inc. (Somerset, NJ)
Application Number:	13/294,069
Patent Claim Types: see list of patent claims	Use; Composition; Delivery; Formulation;

Drugs Protected by US Patent 8,518,919

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Patent Submitted
Mylan Speciality Lp	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-001	Oct 15, 2008		DISCN	No	No						TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS
Mylan Speciality Lp	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009	AB	RX	Yes	Yes						TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS

Non-Orange Book US Patents Family Members for Patent 8,518,919

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,071,073	Compositions comprising azelastine and methods of use thereof
8,758,816	Compositions comprising azelastine and methods of use thereof

International Patents Family Members for US Patent 8,518,919

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005309657
Australia	2012201428
Australia	2012203343
Brazil	PI0517891