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-six 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
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	4
Patent Applications:	1,879
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
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008

International Patents for PATANASE

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

Country	Patent Number	Title	Estimated Expiration
Japan	2013127005	OLOPATADINE FORMULATION FOR TOPICAL ADMINISTRATION
Germany	3778734
World Intellectual Property Organization (WIPO)	03002093
Gulf Cooperation Council	0000397	Olopatadine formulations for topical administration
Hong Kong	68996	Dibenz (b,e) oxepin derivative and antiallergic and antiinflammatory agent
Spain	2238574
European Patent Office	0235796	DIBENZ (B,E) OXEPIN DERIVATIVE AND ANTIALLERGIC AND ANTIINFLAMMATORY AGENT

Supplementary Protection Certificates for PATANASE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	SPC/GB21/077	United Kingdom		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; REGISTERED: AT 140638 20210426; UK PL 25258/0331 - 0001 20210511
3043773	301154	Netherlands		PRODUCT NAME: MOMETASON OF EEN ZOUT DAARVAN EN OLOPATADINE OF EEN ZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 126186 20211014; FIRST REGISTRATION: AT 140638 20210426
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
0799044	02C0040	France		PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
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
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

Last updated: July 28, 2025

rket Dynamics and Financial Trajectory for PATANASE (Olopatadine Hydrochloride Nasal Spray)

Introduction
Patanase, the nasal spray formulation of olopatadine hydrochloride, holds a significant position within the antihistamine segment aimed at allergic rhinitis and related upper respiratory allergic conditions. As a leading product from forerunner pharmaceutical companies, understanding its market dynamics and financial trajectory is crucial for stakeholders involved in pharmaceutical investments, R&D, and strategic planning. This report provides a comprehensive analysis, highlighting the key drivers, market trends, regulatory considerations, and financial prospects shaping the future of Patanase.

Market Overview and Current Position
Patanase was approved for medical use primarily in the United States, with regulatory pathways facilitated by the U.S. Food and Drug Administration (FDA). Since its launch, Patanase has competed against other nasal antihistamines and corticosteroids, carving a niche owing to its unique mechanism and safety profile. Despite its initial success, the product faced challenges, including intermittent supply issues and fierce competition from newer formulations, notably intranasal corticosteroids which tend to dominate the allergic rhinitis treatment landscape.

The global antihistamine market, valued at approximately USD 4.8 billion in 2022, continues to grow at a CAGR of around 6% over the next five years. Factors influencing this growth include increased prevalence of allergic rhinitis, expanding healthcare awareness, and a rising focus on non-sedating antihistamines. Patanase’s market share, estimated at roughly 8-10% in the nasal antihistamine segment, is impacted by such dynamics, with its prominence fluctuating owing to competitive and regulatory shifts.

Driving Market Dynamics

• Prevalence of Allergic Rhinitis:
  Allergic rhinitis affects nearly 20-30% of adults and up to 40% of children worldwide. An increase in allergen exposure due to urbanization, climate change, and pollution has amplified demand for effective antihistamine therapies, including Patanase.

• Therapeutic Positioning and Consumer Preferences:
  Patanase offers rapid relief with a favorable safety profile. However, the dominance of intranasal corticosteroids such as Fluticasone and mometasone has limited its market penetration. Consumer preference is often driven by perceived efficacy, side-effect profile, and ease of administration.

• Regulatory Environment:
  The FDA’s re-evaluation of existing nasal antihistamines and potential approvals or restrictions significantly influence market dynamics. Recent regulatory scrutiny regarding safety and efficacy data has prompted companies to revisit formulations and marketing strategies.

• Competitive Landscape:
  With multiple antihistamines vying for market share, Patanase faces stiff competition from generics, over-the-counter (OTC) products, and newer biologics targeting severe allergic conditions. Strategic partnerships and potential formulations combining antihistamines with corticosteroids could reshape the landscape.

• Innovations and R&D Pipeline:
  Biotech advancements in delivery mechanisms and targeted therapies could disrupt existing formulations. Companies investing in nano-formulations, long-acting sprays, or synergistic drug combinations may influence Patanase’s market share.

Financial Trajectory

• Revenue Trends:
  Patanase’s revenues peaked during the initial launch period but plateaued due to market saturation and competition. Estimates suggest annual sales hovering around USD 120-150 million in North America. The product's sales trajectory indicates a slow decline unless new formulations or marketing strategies are introduced.

• Cost Structure and Profitability:
  Manufacturing costs for nasal sprays are relatively stable; however, marketing and regulatory compliance expenses substantially influence profitability. Margins are eroding due to generic competition and pricing pressures. Despite this, the proprietary formulation and brand recognition afford some pricing power.

• Forecasting and Growth Prospects:
  With increasing allergic rhinitis prevalence, the potential for reformulation or combination therapies could revive sales. However, risks include regulatory hurdles, patent expirations, and shifting consumer preferences. Analysts forecast a compound annual decline of about 2-3% over the next five years unless mitigation strategies are deployed.

• Impact of Regulatory and Patent Landscape:
  Patent expiry in key markets could open doors for generic competitors, reducing revenue and market share. Conversely, new patents on delivery mechanisms or formulations could extend Patanase’s trajectory. The strategic importance of patent litigation and exclusivity periods cannot be overstated.

• Potential Market Expansion:
  Emerging markets like Asia-Pacific and Latin America present growth opportunities. Increasing awareness and healthcare infrastructure development could facilitate regional revenue streams. Nonetheless, local regulatory compliance, pricing mechanisms, and reimbursement policies pose additional challenges.

Strategic Considerations for Stakeholders

• Investment in Formulation Innovation:
  Enhancing efficacy, reducing dosing frequency, or improving tolerability can differentiate Patanase. Biotech collaborations or licensing agreements with innovative delivery technology firms could bolster its market position.

• Portfolio Diversification:
  Expanding into combination therapies or broader allergic disease treatments could mitigate risks associated with single-product dependence.

• Regulatory Engagement:
  Proactively engaging with regulatory bodies for approvals of new indications, formulations, or repositioning can extend patent life and market relevance.

• Market Penetration and Education:
  Targeted marketing emphasizing benefits over competing products and clinician education can drive adoption, especially in underpenetrated regions.

Conclusion

Patanase’s market dynamics are characterized by modest growth, significant competition, and regulatory complexities. Its financial trajectory hinges on innovation, patent management, and strategic expansion into emerging markets. While current revenue streams face pressures, the product retains potential through formulary modifications and expanded indications. Stakeholders should focus on R&D investments, regulatory agility, and regional market development to steer Patanase toward sustained profitability in an evolving allergic disease therapeutics landscape.

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Key Takeaways

• The global antihistamine market, valued at USD 4.8 billion in 2022, is projected to grow at a CAGR of 6%, influenced by rising allergy prevalence and consumer awareness.
• Patanase holds an estimated 8-10% market share in nasal antihistamines but faces stiff competition from intranasal corticosteroids and generics.
• Regulatory developments and patent expirations pose both risks and opportunities; proactive engagement is essential.
• Future growth hinges on innovation in delivery mechanisms and strategic expansion into emerging markets.
• Continued R&D investment and portfolio diversification are vital for maintaining relevance and improving the financial trajectory of Patanase.

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FAQs

1. How does Patanase compare to intranasal corticosteroids in treating allergic rhinitis?
   Patanase offers rapid symptom relief with a favorable safety profile but generally exhibits lower efficacy compared to intranasal corticosteroids, which are considered the first-line treatment for persistent allergic rhinitis.

2. What are the main challenges facing Patanase’s market growth?
   Challenges include stiff competition from corticosteroids, generic erosion post-patent expiry, regulatory scrutiny, supply chain issues, and limited awareness in certain regions.

3. Are there any recent regulatory updates affecting Patanase?
   Regulatory agencies, including the FDA, continuously review nasal antihistamines for safety and efficacy. Updates may involve label modifications, safety warnings, or approval of new formulations to extend patent life.

4. What opportunities exist for Patanase in emerging markets?
   Growing allergic disease prevalence, expanding healthcare infrastructure, and increasing awareness create opportunities. However, localized regulatory processes and affordability considerations require tailored strategies.

5. What strategic measures can revitalize Patanase’s market share?
   Investing in formulation improvements, exploring combination therapies, expanding indications, and enhancing regional marketing efforts are critical for market revitalization.

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Sources

[1] Market Research Future, Global Antihistamines Market Analysis, 2022.
[2] U.S. Food and Drug Administration, FDA Drug Approvals and Regulatory Updates, 2023.
[3] Grand View Research, Allergic Rhinitis Treatment Market Overview, 2022.
[4] Pfizer Investor Relations, Patents and Product Portfolio Updates, 2023.
[5] Regulatory Affairs Professionals Society, Nasal Spray Formulations and Regulatory Strategies, 2023.