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Serving 500+ biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Federal Trade Commission
Chubb
Fish and Richardson
Baxter
Argus Health
US Department of Justice
Accenture
Farmers Insurance

Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,168,620

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Which drugs does patent 8,168,620 protect, and when does it expire?


Patent 8,168,620 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-four patent family members in twenty-seven countries.

Summary for Patent: 8,168,620

Title:Combination of azelastine and steroids
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 pharmaceutically 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:10/518,016
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form; Use; Composition; Process;

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
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012ABRXYesYes8,168,620*PED► SubscribeY
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Foreign Priority and PCT Information for Patent: 8,168,620

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom0213739.6Jun 14, 2002
PCT Information
PCT FiledJune 13, 2003PCT Application Number:PCT/GB03/02557
PCT Publication Date:December 24, 2003PCT Publication Number: WO03/105856

Non-Orange Book Patents for Patent: 8,168,620

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
8,933,060Combination of azelastine and ciclesonide for nasal administration► Subscribe
9,259,428Combination of azelastine and fluticasone for nasal administration► Subscribe
8,163,723Combination of azelastine and steroids► Subscribe
8,318,709Combination of azelastine and mometasone for nasal administration► Subscribe
8,937,057Combination of azelastine and mometasone for nasal administration► 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: 8,168,620

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Russian Federation2005100781► Subscribe
Portugal2075000► Subscribe
Luxembourg92269► Subscribe
South Korea101301558► Subscribe
South Korea20110113782► 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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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Moodys
Federal Trade Commission
Colorcon
Dow
Citi
Cerilliant
Deloitte
Chinese Patent Office
Harvard Business School

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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