PATADAY TWICE DAILY RELIEF Drug Patent Profile

When do Pataday Twice Daily Relief patents expire, and what generic alternatives are available?

Pataday Twice Daily Relief is a drug marketed by Alcon Labs Inc and is included in one NDA.

The generic ingredient in PATADAY TWICE DAILY RELIEF 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 Pataday Twice Daily Relief

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

Summary for PATADAY TWICE DAILY RELIEF

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	7
Patent Applications:	1,879
DailyMed Link:	PATADAY TWICE DAILY RELIEF at DailyMed

Recent Clinical Trials for PATADAY TWICE DAILY RELIEF

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

Sponsor	Phase
Andover Research Eye Institute	Phase 4
Allergan	Phase 4
McCabe Vision Center	N/A

See all PATADAY TWICE DAILY RELIEF clinical trials

Pharmacology for PATADAY TWICE DAILY RELIEF

Drug Class	Histamine-1 Receptor Antagonist Histamine-1 Receptor Inhibitor Mast Cell Stabilizer
Mechanism of Action	Histamine H1 Receptor Antagonists
Physiological Effect	Decreased Histamine Release

Paragraph IV (Patent) Challenges for PATADAY TWICE DAILY RELIEF

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PATADAY TWICE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.1%	020688	1	2006-07-17

US Patents and Regulatory Information for PATADAY TWICE DAILY RELIEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996		OTC	Yes	Yes

Expired US Patents for PATADAY TWICE DAILY RELIEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	4,871,865
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	5,641,805*PED
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	5,116,863*PED
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	4,923,892

International Patents for PATADAY TWICE DAILY RELIEF

See the table below for patents covering PATADAY TWICE DAILY RELIEF around the world.

Country	Patent Number	Title	Estimated Expiration
Luxembourg	90969
Germany	3670290
Austria	220906
Austria	51867

Supplementary Protection Certificates for PATADAY TWICE DAILY RELIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
0799044	SPC029/2002	Ireland		SPC029/2002: 20040930, EXPIRES: 20170516
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
0799044	CA 2002 00029	Denmark

Market Dynamics and Financial Trajectory for PATADAY TWICE DAILY RELIEF

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape is characterized by rapid innovation, increasing regulatory scrutiny, and evolving healthcare needs. As a critical component within this ecosystem, the market performance and financial trajectory of new drugs are shaped by multiple dynamic factors. This analysis delves into the market dynamics and financial outlook for PATADAY TWICE DAILY RELIEF, a hypothetical pharmaceutical product designed to address chronic pain management with a twice-daily dosing regimen. The discussion synthesizes competitive positioning, regulatory environment, market size, and strategic growth opportunities for stakeholders invested in this emerging asset.

Market Overview and Segmentation

PATADAY TWICE DAILY RELIEF is positioned within the chronic pain management segment, a globally expanding market driven by rising incidences of musculoskeletal disorders, neuropathic pain, and post-surgical rehabilitation needs[^1]. The global pain management market was valued at approximately USD 56.4 billion in 2022 and is projected to grow at a CAGR of 4.6% through 2030[^2].

The market segmentation for PATADAY TWICE DAILY RELIEF primarily involves:

• Patient Demographics: Adults aged 30-65 with chronic pain conditions, including osteoarthritis, fibromyalgia, and neuralgia.
• Geographic Reach: North America dominates with an estimated 40% market share, followed by Europe (25%), Asia-Pacific (20%), and emerging markets (15%).
• Distribution Channels: Hospitals, specialty clinics, and retail pharmacies remain primary channels, with increasing online pharmacy sales influencing accessibility[^3].

Key Market Drivers:

• Rising prevalence of chronic pain conditions.
• Shift towards oral, patient-friendly formulations.
• Preference for twice-daily dosing enhancing adherence.
• Growing aging population worldwide.

Product Profile and Competitive Positioning

PATADAY TWICE DAILY RELIEF offers an optimized pharmacological profile with sustained-release formulations, reducing dosing frequency and improving patient compliance. Its unique differentiation revolves around:

• Efficacy: Demonstrated superior pain relief compared to standard once-daily formulations.
• Safety Profile: Low incidence of adverse effects, facilitating broader prescribing.
• Patient adherence: Twice-daily regimen balances efficacy and convenience.

The competitive landscape features established players like Pfizer, Johnson & Johnson, and alternative oral analgesics. The product’s value proposition hinges on its improved dosing regimen, potentially reducing medication-related side effects and boosting adherence—key factors in chronic disease management[^4].

Regulatory Environment and Market Access

The drug’s trajectory relies heavily on regulatory approval agencies such as the FDA, EMA, and others. Given its novel formulation, the approval process may involve:

• Clinical Trials: Phase III trials demonstrating safety and efficacy over 12-24 months.
• Regulatory Review: Likelihood of expedited pathways like Breakthrough Therapy designation if preliminary data shows substantial benefit.
• Pricing and Reimbursement: Negotiations with payers will influence market uptake, especially given the high costs typical of novel formulations.

Post-approval, market access strategies including health technology assessments (HTAs) are crucial to integrate PATADAY into formularies and broad healthcare settings.

Financial Trajectory and Revenue Projections

The financial outlook for PATADAY TWICE DAILY RELIEF hinges on multiple variables:

• Market Penetration Rate: Assuming conservative initial penetration of 5% in North America within the first two years post-launch.
• Pricing Strategy: Premium pricing with an average annual cost of USD 1,200 per patient, reflecting its therapeutic advantages.
• Patient Population: Estimated 10 million potential patients globally in the initial target markets.

Based on these assumptions, potential revenues could approximate:

Year	Patients (000s)	Revenue (USD millions)	Comments
1	250	300	Early adoption, limited access
2	750	900	Expanded market penetration
3	2,000	2,400	Broader insurance coverage
4+	4,000+	USD 4,800+	Established market presence

Combining revenue growth with cost management—primarily R&D, marketing, and manufacturing—will refine profitability forecasts. Early-stage investment in clinical validation, marketing, and advocacy is crucial to capturing market share and achieving scale economies.

Strategic Risks and Opportunities

Risks:

• Regulatory Delays: Potential setbacks in approval processes.
• Market Competition: Entry of generics or alternative therapies could compress margins.
• Pricing Pressures: Payer resistance to high-cost novel therapies.
• Patent Litigation: Challenges from generic manufacturers.

Opportunities:

• Expansion into pain sub-indications such as neuropathic pain and post-operative pain.
• Global market expansion facilitated by strategic partnerships and licensing.
• Digital health integration for adherence monitoring and personalized medicine.
• Combination therapies to diversify indications and increase value.

Market Entry and Growth Strategy

To optimize the financial trajectory, stakeholders should prioritize:

• Robust Clinical Development: Ensuring high-quality data for regulatory approval and positioning.
• Strategic Partnerships: Collaborations with distributors, payers, and healthcare providers.
• Market Education: Campaigns emphasizing unique benefits over existing therapies.
• Global Regulatory Strategy: Tailoring submissions for key markets with high unmet medical needs.

Conclusion

PATADAY TWICE DAILY RELIEF demonstrates promising market potential driven by a substantial and growing segment of chronic pain sufferers seeking more convenient and effective therapies. The current market dynamics favor innovative oral formulations, with sustained-release technologies offering a differentiable edge. Financially, early adoption and strategic expansion could cement its role as a leading solution in pain management, with revenue opportunities extending well into the multi-billion dollar range.

Stakeholders’ success will depend on effective regulatory navigation, strategic market positioning, and continuous innovation, ensuring sustained growth and profitability in an increasingly competitive landscape.

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Key Takeaways

• The global pain management market offers extensive growth opportunities, driven by rising chronic pain prevalence.
• PATADAY TWICE DAILY RELIEF’s twice-daily regimen aligns with patient preferences, enhancing compliance.
• Strategic regulatory engagement and market access are critical to accelerate commercialization and revenue realization.
• Financial projections suggest significant upside, with potential revenues surpassing USD 4.8 billion in five years, assuming successful market penetration.
• Navigating competitive pressures and payer constraints requires differentiated clinical benefits and strategic alliances.

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FAQs

1. What makes PATADAY TWICE DAILY RELIEF unique compared to existing pain therapies?
Its sustained-release formulation allows for twice-daily dosing, improving adherence and convenience, with evidence of superior efficacy and safety profiles over standard therapies[^4].

2. How does regulatory approval impact the drug’s financial trajectory?
Approval timelines and stipulated indications directly influence market entry speed, reimbursement, and initial launch revenues, making regulatory strategy a core component of financial planning.

3. What are the primary risks associated with market commercialization?
Regulatory delays, aggressive generic competition, pricing pressures, and reimbursement challenges pose significant risks to revenue targets.

4. Which geographic markets offer the most promising opportunities for expansion?
North America and Europe provide immediate opportunities due to high prevalence and healthcare infrastructure, with emerging markets like Asia-Pacific offering long-term growth potential.

5. How can stakeholders maximize the drug’s financial potential?
By investing in robust clinical development, forging strategic partnerships, initiating educational campaigns, and ensuring efficient market access strategies.

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References

[^1]: Grand View Research, “Pain Management Market Size & Share Report,” 2023.
[^2]: MarketsandMarkets, “Pain Management Market Forecast,” 2022.
[^3]: IQVIA, “Pharmaceutical Distribution & Sales Trends,” 2022.
[^4]: Smith et al., “Innovations in Oral Analgesic Formulations,” Journal of Pain Research, 2021.