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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Queensland Health
UBS
Farmers Insurance
Medtronic
AstraZeneca
Federal Trade Commission
Cantor Fitzgerald
Julphar

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,163,723

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Which drugs does patent 8,163,723 protect, and when does it expire?

Patent 8,163,723 protects DYMISTA and is included in one NDA.

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-five patent family members in twenty-seven countries.
Summary for Patent: 8,163,723
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 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:12/879,515
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,163,723
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;

Drugs Protected by US Patent 8,163,723

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 DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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

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Foreign Priority and PCT Information for Patent: 8,163,723

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom0213739.6Jun 14, 2002

Non-Orange Book US Patents Family Members for Patent 8,163,723

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
8,318,709 Combination of azelastine and mometasone for nasal administration ➤ Sign Up
8,168,620 Combination of azelastine and steroids ➤ Sign Up
9,259,428 Combination of azelastine and fluticasone for nasal administration ➤ Sign Up
8,937,057 Combination of azelastine and mometasone for nasal administration ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Baxter
Teva
QuintilesIMS
Mallinckrodt
Moodys
Express Scripts
Accenture
Chinese Patent Office

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