PATANASE Drug Patent Profile

Which patents cover Patanase, and when can generic versions of Patanase launch?

Patanase is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in PATANASE is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Patanase

A generic version of PATANASE was approved as olopatadine hydrochloride by APOTEX INC on October 8^th, 2014.

Summary for PATANASE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	4
Patent Applications:	1,138
Drug Prices:	Drug price information for PATANASE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PATANASE
What excipients (inactive ingredients) are in PATANASE?	PATANASE excipients list
DailyMed Link:	PATANASE at DailyMed

See drug prices for PATANASE

See drug sales revenues for PATANASE

Recent Clinical Trials for PATANASE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Glenmark Pharmaceuticals Ltd. India	Phase 2
Alcon Research	Phase 4
Alcon Research	Phase 2

See all PATANASE clinical trials

Paragraph IV (Patent) Challenges for PATANASE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PATANASE	Nasal Spray	olopatadine hydrochloride	0.665 mg/ Spray	021861	1	2009-06-29

US Patents and Regulatory Information for PATANASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008		DISCN	Yes	No

Expired US Patents for PATANASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008	5,116,863*PED
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008	7,977,376*PED
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008	8,399,508*PED

International Patents for PATANASE

See the table below for patents covering PATANASE around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	9203155	DERIVADO [B,E] OXEPINA COMO AGENTE ANTIALERGICO.
South Korea	20040025919
Australia	2002310461

Supplementary Protection Certificates for PATANASE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0799044	02C0040	France		PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
3043773	2190041-0	Sweden		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426
3043773	21C1057	France		PRODUCT NAME: MOMETASONE OU L'UN DE SES SELS AVEC OLOPATADINE OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: NL52121 20211026; FIRST REGISTRATION: AT - 140638 20210426

PATANASE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Patanase

Introduction to Patanase

Patanase, also known by its generic name olopatadine, is a prescription nasal spray used to treat nasal symptoms of allergic rhinitis, such as congestion, sneezing, and runny or itchy nose. It belongs to the class of intranasal antihistamines.

Market Size and Growth

The U.S. nasal spray market, which includes Patanase, was valued at USD 10.32 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 8.8% during the forecast period from 2023 to 2030[1].

Segmentation and Market Share

By Product Type

The corticosteroids segment dominated the U.S. nasal spray market in 2022, but intranasal antihistamines, such as Patanase, also hold a significant share. Patanase is one of the key products in this segment, known for its efficacy in treating allergic rhinitis[1].

By Application

The nasal allergies segment, which includes the use of Patanase, dominated the market in 2022. This segment is driven by the growing population suffering from respiratory conditions leading to nasal allergies[1].

Financial Performance and Revenue

Revenue Predictions

The global allergic rhinitis drugs market, which includes Patanase, is expected to see significant growth. While specific revenue figures for Patanase are not provided, the overall market for allergic rhinitis drugs is forecasted to grow substantially, driven by increasing prevalence of allergic rhinitis and new product launches[4].

Sales and Market Share

Patanase, as a prescription-based nasal spray, contributes to the revenue of its manufacturers. For instance, companies like Alcon (now part of Novartis) and other pharmaceutical giants have seen significant sales from their nasal spray products. Novartis, for example, has reported strong sales growth in its pharmaceutical division, which includes products like Patanase[3].

Key Drivers of Growth

Increasing Prevalence of Allergic Rhinitis

The growing prevalence of allergic rhinitis and other chronic respiratory diseases is a key driver for the market growth of Patanase. As more people suffer from these conditions, the demand for effective treatments like Patanase increases[1].

R&D and New Product Launches

Manufacturers are heavily investing in research and development (R&D) to develop new and improved products. This includes new formulations and delivery mechanisms for nasal sprays, which can enhance the market position of products like Patanase[1].

Government Initiatives and Awareness Programs

Government initiatives and programs aimed at increasing awareness about infectious diseases and respiratory health also contribute to the growth of the nasal spray market, including Patanase. These initiatives can lead to higher adoption rates of these products[1].

Distribution Channels

Drug Stores & Retail Pharmacies

The distribution of Patanase is primarily through drug stores and retail pharmacies, which dominated the market in 2022. The availability of diverse product choices and the presence of skilled pharmacists in these outlets contribute to the sales of Patanase[1].

Online Pharmacies

The over-the-counter (OTC) segment, although not directly applicable to Patanase as it is a prescription drug, is expected to grow. However, online pharmacies are becoming increasingly important for prescription drugs as well, offering convenience and accessibility that can boost sales[1].

Competitive Landscape

Patanase operates in a competitive market with other intranasal antihistamines and corticosteroids. Key players in the U.S. nasal spray market include Johnson & Johnson Services Inc., Bayer AG, GSK plc, and Viatris, Inc. These companies are involved in various strategies such as mergers and acquisitions, new product launches, and R&D investments to consolidate their market positions[1].

Challenges and Opportunities

Generic Equivalents

The launch of generic equivalents can pose a challenge to branded products like Patanase. However, the growing R&D investments for novel drugs and the increasing number of launches of generic equivalents can also drive segmental growth as manufacturers adapt to these changes[1].

Consumer Preference for Non-Medicated Alternatives

There is an increasing consumer preference for non-medicated and drug-free alternatives, which could impact the sales of prescription nasal sprays like Patanase. However, the efficacy and targeted relief provided by Patanase are likely to maintain its market share[1].

Impact of COVID-19

The COVID-19 pandemic has had various impacts on the pharmaceutical industry, including changes in consumer behavior and healthcare priorities. However, the demand for nasal sprays like Patanase has remained relatively stable due to the ongoing need for treatments for allergic rhinitis and other respiratory conditions[4].

Key Takeaways

• Market Growth: The U.S. nasal spray market, including Patanase, is projected to grow at a CAGR of 8.8% from 2023 to 2030.
• Segment Dominance: The nasal allergies segment, which includes Patanase, dominated the market in 2022.
• R&D Investments: Manufacturers are investing heavily in R&D to develop new products, driving market growth.
• Distribution Channels: Drug stores and retail pharmacies are the primary distribution channels for Patanase.
• Competitive Landscape: The market is competitive with key players like Johnson & Johnson, Bayer AG, and GSK plc.

FAQs

Q: What is Patanase used for? A: Patanase is used to treat nasal symptoms of allergic rhinitis, such as congestion, sneezing, and runny or itchy nose.

Q: What is the projected growth rate of the U.S. nasal spray market? A: The U.S. nasal spray market is projected to grow at a CAGR of 8.8% from 2023 to 2030.

Q: Which segment dominated the U.S. nasal spray market in 2022? A: The corticosteroids segment dominated the U.S. nasal spray market in 2022, but the nasal allergies segment, which includes Patanase, also holds a significant share.

Q: What are the key drivers of growth for Patanase? A: The growing prevalence of allergic rhinitis, R&D investments, and government initiatives are key drivers of growth for Patanase.

Q: How has the COVID-19 pandemic impacted the market for Patanase? A: The COVID-19 pandemic has had a minimal impact on the demand for Patanase, as the need for treatments for allergic rhinitis and other respiratory conditions remains steady.

Cited Sources

1. Fortune Business Insights - U.S. Nasal Spray Market Size, Share, Trends | Growth [2030]
2. Perrigo - Annual Report
3. Fierce Pharma - Novartis makes strong start for the year
4. GlobeNewswire - Allergic Rhinitis Drugs Market Report 2020-2030