Details for Patent: 8,163,723

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 fifty-seven 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;

Analyzing the Scope and Claims of United States Patent 8,163,723

Introduction

United States Patent 8,163,723, assigned to Meda Pharmaceuticals Inc., is a significant patent in the pharmaceutical industry, particularly in the realm of nasal spray formulations. This patent involves a combination of azelastine and fluticasone propionate, two active ingredients commonly used to treat allergic rhinitis and other nasal conditions.

Background of the Patent

The patent was granted on April 24, 2012, and it pertains to specific formulations and methods of preparation for nasal sprays containing azelastine hydrochloride and fluticasone propionate. These ingredients are well-known for their anti-inflammatory and antihistamine properties, respectively[4].

Key Claims of the Patent

The patent includes several key claims that define its scope:

Composition Claims

• The patent claims cover pharmaceutical compositions that include a combination of azelastine hydrochloride and fluticasone propionate. These compositions are formulated as nasal sprays, specifically as metered-spray suspensions[4].
• The claims also specify the presence of various excipients, such as preservatives, thickening agents, and solvents, which are essential for the stability and efficacy of the nasal spray[1].

Formulation Claims

• The patent details the formulation process, including the preparation of the suspension and the use of specific solvents like propylene glycol and glycerol. It also mentions the inclusion of surface-active agents and buffer systems to maintain the pH and stability of the formulation[1].

Dosage and Administration Claims

• The claims specify the dosage forms and administration methods for the nasal spray. This includes the metered dose delivery system, which ensures a consistent amount of the active ingredients is dispensed with each use[4].

Scope of the Patent

The scope of the patent is broad yet specific, covering various aspects of the formulation and use of azelastine and fluticasone propionate in nasal sprays.

Therapeutic Indications

• The patent covers the use of the formulation for treating allergic rhinitis, including seasonal and perennial forms, as well as other allergic conditions such as allergic conjunctivitis[1].

Pharmaceutical Forms

• The patent encompasses different pharmaceutical forms, including nasal sprays, drops, and suspensions. However, the primary focus is on the nasal spray formulation[1].

Patent Landscape

The patent landscape surrounding U.S. Patent 8,163,723 is complex and involves several key players and considerations:

Competing Patents

• Other pharmaceutical companies have developed similar formulations, but the specific combination and formulation process claimed in this patent provide a unique advantage. For instance, the combination of azelastine and fluticasone propionate in a single nasal spray is a distinctive feature of this patent[4].

Litigation and Disputes

• The patent has been involved in litigation, particularly regarding the construction of disputed claim terms. A Markman hearing was held in 2016 to clarify these terms, which is crucial for determining the scope of the patent and potential infringement[2].

Regulatory Compliance

• The patent holder must comply with regulatory requirements, such as submitting patent information to the FDA, which is a standard practice for innovator drug companies to ensure that their patents are recognized and respected[5].

Impact on the Pharmaceutical Industry

The impact of U.S. Patent 8,163,723 on the pharmaceutical industry is significant:

Market Dominance

• The patent provides Meda Pharmaceuticals Inc. with a competitive edge in the market for nasal spray formulations, allowing them to dominate the segment for allergic rhinitis treatments[4].

Innovation

• The patent encourages innovation by protecting the specific formulation and preparation methods, which can drive further research and development in related areas[1].

Patient Benefits

• Patients benefit from the availability of an effective and convenient treatment option for allergic rhinitis, which improves their quality of life[4].

Challenges and Future Directions

Despite its significance, the patent faces several challenges and future directions:

Expiration and Generic Competition

• The patent will eventually expire, allowing generic versions of the formulation to enter the market. This could reduce the market share of the original product and increase competition[2].

Regulatory Changes

• Changes in regulatory requirements or guidelines could affect the patent's validity or the approval process for similar formulations[5].

Continuous Innovation

• The pharmaceutical industry is highly dynamic, and continuous innovation is necessary to maintain market relevance. This includes developing new formulations, delivery systems, or combinations of active ingredients[1].

Key Takeaways

• Unique Formulation: The patent covers a unique combination of azelastine and fluticasone propionate in a nasal spray formulation.
• Broad Scope: The patent encompasses various pharmaceutical forms and therapeutic indications.
• Regulatory Compliance: The patent holder must comply with FDA regulations and submit patent information.
• Market Impact: The patent provides a competitive edge and drives innovation in the pharmaceutical industry.
• Future Directions: The patent faces challenges such as expiration and generic competition, necessitating continuous innovation.

FAQs

Q: What are the active ingredients in the nasal spray formulation covered by U.S. Patent 8,163,723? A: The active ingredients are azelastine hydrochloride and fluticasone propionate.

Q: What is the primary therapeutic indication for this nasal spray formulation? A: The primary therapeutic indication is for the treatment of allergic rhinitis.

Q: What is the significance of the Markman hearing in the context of this patent? A: The Markman hearing was held to clarify the construction of disputed claim terms, which is crucial for determining the scope of the patent and potential infringement.

Q: How does the patent impact the pharmaceutical industry? A: The patent provides a competitive edge, encourages innovation, and ensures the availability of an effective treatment option for allergic rhinitis.

Q: What are the potential challenges facing this patent in the future? A: The patent faces challenges such as expiration, generic competition, and regulatory changes.

Sources

1. EP1519731B1 - Combination of azelastine and fluticasone
2. Meda - Morris James LLP
3. Patent Claims Research Dataset - USPTO
4. DYMISTA- azelastine hydrochloride and fluticasone propionate spray, metered
5. in the united states district court for the district of delaware meda

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	Submissiondate
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	AB	RX	Yes	No

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

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0213739.6	Jun 14, 2002

International Family Members for US Patent 8,163,723

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1519731		CA 2013 00023	Denmark
European Patent Office	1519731		92269	Luxembourg
European Patent Office	1519731		PA2013023	Lithuania