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Generated: October 22, 2017
Which drugs does patent 8,518,919 protect, and when does it expire?
| 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; |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Speciality Lp | ASTEPRO | azelastine hydrochloride | SPRAY, METERED;NASAL | 022203-001 | Oct 15, 2008 | DISCN | No | No | ► Subscribe | ► Subscribe | 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 | ► Subscribe | ► Subscribe | TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS | |||
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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 | ► Subscribe | |||||||||||||
| 8,758,816 | Compositions comprising azelastine and methods of use thereof | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 2005309657 | ► Subscribe | |||||||||||||
| Australia | 2012201428 | ► Subscribe | |||||||||||||
| Australia | 2012203343 | ► Subscribe | |||||||||||||
| Brazil | PI0517891 | ► Subscribe | |||||||||||||
| Canada | 2588338 | ► Subscribe | |||||||||||||
| China | 101098714 | ► Subscribe | |||||||||||||
| Denmark | 2377557 | ► Subscribe | |||||||||||||
| Denmark | 2522365 | ► Subscribe | |||||||||||||
| European Patent Office | 1827499 | ► Subscribe | |||||||||||||
| European Patent Office | 2377557 | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
Subscribe for complete access.
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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