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Details for Patent: 9,259,428

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Patent 9,259,428 protects DYMISTA and is included in one NDA. There has been one Paragraph IV challenge on Dymista.

Protection for DYMISTA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-one patent family members in twenty-six countries.

Summary for Patent: 9,259,428

Title:Combination of azelastine and fluticasone for nasal administration
Abstract: A pharmaceutical product or formulation, which comprises azelastine or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, and a steroid, or a pharmaceutical acceptable salt, solvate or physiologically functional derivative thereof, preferably the product or formulation being in a form suitable for nasal or ocular administration.
Inventor(s): Lulla; Amar (Mumbai, IN), Malhotra; Geena (Mumbai, IN)
Assignee: Cipla Limited (Mumbai, IN)
Application Number:14/661,720
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 218th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Meda Pharms
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012RXYes9,259,428*PED► subscribeY
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Non-Orange Book Patents for Patent: 9,259,428

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
8,937,057Combination of azelastine and mometasone for nasal administration► subscribe
8,304,405Combination of azelastine and ciclesonide for nasal administration► subscribe
8,163,723Combination of azelastine and steroids► 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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International Patent Family for Patent: 9,259,428

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
United Kingdom2389530► subscribe
Georgia, Republic ofPI20105143► subscribe
Israel165771► 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.

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