OLOPATADINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for olopatadine hydrochloride and what is the scope of freedom to operate?

Olopatadine hydrochloride is the generic ingredient in four branded drugs marketed by Alembic, Apotex, Barr Labs Inc, Bausch And Lomb Inc, Eugia Pharma, Fdc Ltd, Florida, Gland Pharma Ltd, Glenmark Pharms Inc, Rising, Sciegen Pharms Inc, Somerset Theraps Llc, USV, Zambon Spa, Alcon Labs Inc, Amneal, Apotex Inc, Hikma, Padagis Israel, and Novartis, and is included in twenty-nine NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Olopatadine hydrochloride has thirty-one patent family members in nineteen countries.

There are fourteen drug master file entries for olopatadine hydrochloride. Forty-three suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for OLOPATADINE HYDROCHLORIDE

International Patents:	31
US Patents:	2
Tradenames:	4
Applicants:	20
NDAs:	29
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	43
Patent Applications:	1,645
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OLOPATADINE HYDROCHLORIDE
What excipients (inactive ingredients) are in OLOPATADINE HYDROCHLORIDE?	OLOPATADINE HYDROCHLORIDE excipients list
DailyMed Link:	OLOPATADINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for OLOPATADINE HYDROCHLORIDE

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

Sponsor	Phase
MEDA Pharma GmbH & Co. KG	Phase 2
Laboratorios Poen	Phase 4
Université de Montréal	Phase 4

See all OLOPATADINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for OLOPATADINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		0.1%	SOLUTION; OPHTHALMIC
		0.2%	SOLUTION;OPHTHALMIC
		0.1%	SOLUTION;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for OLOPATADINE HYDROCHLORIDE

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

Medical Subject Heading (MeSH) Categories for OLOPATADINE HYDROCHLORIDE

Anti-Allergic Agents

Anti-Inflammatory Agents, Non-Steroidal

Histamine H1 Antagonists, Non-Sedating

Anatomical Therapeutic Chemical (ATC) Classes for OLOPATADINE HYDROCHLORIDE

R01AC	Antiallergic agents, excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for OLOPATADINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PATADAY ONCE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.7%	206276	1	2015-09-10
PATANASE	Nasal Spray	olopatadine hydrochloride	0.665 mg/ Spray	021861	1	2009-06-29
PATADAY ONCE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.2%	021545	1	2008-09-08
PATADAY TWICE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.1%	020688	1	2006-07-17

US Patents and Regulatory Information for OLOPATADINE HYDROCHLORIDE

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
Padagis Israel	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SPRAY, METERED;NASAL	202853-001	Jan 31, 2017	AB	RX	No	No
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	206276-001	Jan 30, 2015		OTC	Yes	Yes			Y

Expired US Patents for OLOPATADINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996

International Patents for OLOPATADINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Taiwan	201249437	High concentration olopatadine ophthalmic composition
Uruguay	34074	COMPOSICIÓN OFTÁLMICA DE OLOPATADINA ALTAMENTE CONCENTRADA
South Korea	20160144507	고농도 올로파타딘 안과용 조성물 (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION)

Supplementary Protection Certificates for OLOPATADINE HYDROCHLORIDE

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
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	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

OLOPATADINE HYDROCHLORIDE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Olopatadine Hydrochloride

Introduction

Olopatadine hydrochloride is a versatile drug that has garnered significant attention in the pharmaceutical industry due to its efficacy in treating various allergic and inflammatory conditions. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its current status, growth prospects, and regional performance.

Mechanism of Action and Uses

Olopatadine hydrochloride is a selective histamine H1 antagonist and mast cell stabilizer. It works by blocking the effects of histamine, a primary inflammatory mediator, thereby alleviating symptoms such as itching, sneezing, and watery eyes associated with allergic conjunctivitis and rhinitis[2][3].

Market Size and Growth Prospects

The olopatadine hydrochloride market has been witnessing substantial growth and is projected to continue this upward trajectory. Here are some key statistics:

• Global Market Size: The global olopatadine ophthalmic market size was estimated at USD 1636.2 million in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 11% from 2024 to 2031[4].
• Segmented Growth: The market is segmented based on type (99% purity, others) and application (nasal spray, eye drops, others), with each segment contributing to the overall growth. The ophthalmic segment, in particular, is significant, with North America holding over 40% of the global revenue, followed by Europe and Asia-Pacific[1][4].

Regional Performance

The market performance of olopatadine hydrochloride varies across different regions:

• North America: This region holds the largest market share, with a market size of USD 654.48 million in 2024 and a CAGR of 9.2% from 2024 to 2031[4].
• Europe: Europe accounts for over 30% of the global revenue, with a market size of USD 490.86 million in 2024 and a CAGR of 9.5% from 2024 to 2031[4].
• Asia-Pacific: This region is the fastest-growing, with a market size of USD 376.33 million in 2024 and a CAGR of 13% from 2024 to 2031. The growth is driven by increasing public awareness of eye health and rising disposable incomes[4].
• South America and Middle East & Africa: These regions also show promising growth, with CAGRs of 10.4% and 10.7%, respectively, from 2024 to 2031[4].

Drivers and Restraints

Several factors drive the growth of the olopatadine hydrochloride market:

• Increasing Prevalence of Allergic Conditions: The rising incidence of allergic conjunctivitis and rhinitis, driven by environmental factors and genetic predispositions, is a significant driver[3].
• Advancements in Pharmaceutical Technology: Improvements in drug formulation and delivery systems enhance the efficacy and comfort of olopatadine hydrochloride, making it a preferred choice for patients[2].
• Regulatory Approvals: Recent approvals, such as the switch from prescription to over-the-counter status for certain formulations, have expanded market access and convenience for consumers[5].

However, there are also some restraints:

• Competition from Alternative Treatments: The presence of other antihistamines and mast cell stabilizers in the market can pose a competitive challenge[2].
• Regulatory Hurdles: In some regions, strict regulatory frameworks may limit the market access of olopatadine hydrochloride[4].

Financial Trajectory

The financial trajectory of olopatadine hydrochloride is promising, with significant revenue growth anticipated:

• Revenue Projections: The global olopatadine ophthalmic market is expected to expand substantially, driven by the growing demand for effective treatments for allergic conditions[4].
• Market Value: The market value is projected to increase from USD 1636.2 million in 2024 to a significantly higher figure by 2031, reflecting the compound annual growth rate of 11%[4].

Key Players and Market Competition

The market for olopatadine hydrochloride is competitive, with several key players:

• Alcon Research, LLC: Known for its brand Pataday, which has recently been approved for over-the-counter use[5].
• Glenmark Specialty SA: Offers a combination product, Ryaltris, which includes olopatadine hydrochloride and mometasone furoate monohydrate[2].

Consumer Behavior and Economic Impact

Consumer behavior plays a crucial role in the market dynamics of olopatadine hydrochloride:

• Increasing Awareness: Growing public awareness of eye health and the importance of treating allergic conditions is driving the demand for olopatadine hydrochloride[4].
• Economic Factors: Rising disposable incomes, particularly in the Asia-Pacific region, are enabling more people to seek and afford prescription pharmaceuticals like olopatadine hydrochloride[4].

Conclusion

The market for olopatadine hydrochloride is poised for significant growth, driven by its efficacy in treating allergic conditions, regulatory approvals, and increasing consumer awareness. The financial trajectory indicates a substantial increase in revenue, with the Asia-Pacific region emerging as a key growth driver.

Key Takeaways

• Market Growth: The global olopatadine ophthalmic market is expected to grow at a CAGR of 11% from 2024 to 2031.
• Regional Performance: North America, Europe, and Asia-Pacific are the leading regions, with Asia-Pacific showing the highest growth rate.
• Drivers: Increasing prevalence of allergic conditions, advancements in pharmaceutical technology, and regulatory approvals.
• Restraints: Competition from alternative treatments and regulatory hurdles.
• Financial Trajectory: Significant revenue growth anticipated, driven by growing demand and expanding market access.

Frequently Asked Questions

Q: What is olopatadine hydrochloride used for? A: Olopatadine hydrochloride is used for the symptomatic treatment of ocular itching associated with allergic conjunctivitis and seasonal allergic rhinitis[2].

Q: What is the mechanism of action of olopatadine hydrochloride? A: It works by blocking the effects of histamine and stabilizing mast cells, thereby alleviating inflammatory and allergic reactions[2].

Q: What is the current market size of the olopatadine ophthalmic market? A: The global olopatadine ophthalmic market size was estimated at USD 1636.2 million in 2024[4].

Q: Which region is expected to show the highest growth rate for olopatadine hydrochloride? A: The Asia-Pacific region is expected to show the highest growth rate, driven by increasing public awareness of eye health and rising disposable incomes[4].

Q: What are the key drivers of the olopatadine hydrochloride market? A: The key drivers include the increasing prevalence of allergic conditions, advancements in pharmaceutical technology, and regulatory approvals[3][4].

Cited Sources

1. Market Research Intellect: Olopatadine Hydrochloride Market Size, Scope And Forecast Report.
2. DrugBank: Olopatadine: Uses, Interactions, Mechanism of Action.
3. Synapse by PatSnap: Olopatadine hydrochloride: Detailed Review of its Transformative R&D Success.
4. Cognitive Market Research: Olopatadine Ophthalmic Market Report 2024 (Global Edition).
5. FDA: CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: PATADAY ONCE DAILY RELIEF (Extra Strength).