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, 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: 8,518,919
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 Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 8,518,919 |
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 | Submissiondate |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Speciality Lp | ASTEPRO | azelastine hydrochloride | SPRAY, METERED;NASAL | 022203-001 | Oct 15, 2008 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS | See Plans and Pricing | ||||
Mylan Speciality Lp | ASTEPRO | azelastine hydrochloride | SPRAY, METERED;NASAL | 022203-002 | Aug 31, 2009 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS | See Plans and Pricing | ||||
Bayer Hlthcare | ASTEPRO ALLERGY | azelastine hydrochloride | SPRAY, METERED;NASAL | 213872-001 | Jun 17, 2021 | OTC | Yes | Yes | See Plans and Pricing | See Plans and Pricing | OTC USE: ALLERGY SYMPTOM RELIEVER; TEMPORARY RELIEF OF THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES: NASAL CONGESTION, RUNNY NOSE, SNEEZING AND ITCHY NOSE | See Plans and Pricing | ||||
Bayer Hlthcare | CHILDREN'S ASTEPRO ALLERGY | azelastine hydrochloride | SPRAY, METERED;NASAL | 213872-002 | Jun 17, 2021 | OTC | Yes | Yes | See Plans and Pricing | See Plans and Pricing | OTC USE: ALLERGY SYMPTOM RELIEVER; TEMPORARY RELIEF OF THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES: NASAL CONGESTION, RUNNY NOSE, SNEEZING AND ITCHY NOSE | See Plans and Pricing | ||||
>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 8,518,919
Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
---|---|---|---|---|---|
Australia | 2005309657 | See Plans and Pricing | |||
Australia | 2012201428 | See Plans and Pricing | |||
Australia | 2012203343 | See Plans and Pricing | |||
Brazil | PI0517891 | See Plans and Pricing | |||
Canada | 2588338 | See Plans and Pricing | |||
China | 101098714 | See Plans and Pricing | |||
Cyprus | 1121330 | See Plans and Pricing | |||
>Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |