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, Glenmark Pharms Inc, Rising, Sciegen Pharms, Somerset, Somerset Theraps Llc, USV, Zambon Spa, Alcon Labs Inc, Amneal, Apotex Inc, Hikma, Padagis Israel, and Novartis, and is included in thirty-three 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-two patent family members in twenty countries.

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

Summary for OLOPATADINE HYDROCHLORIDE

International Patents:	32
US Patents:	2
Tradenames:	4
Applicants:	21
NDAs:	33
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	43
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
Michael Marchand, MD	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
Sciegen Pharms	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	204723-001	Dec 5, 2017		DISCN	No	No
Glenmark Pharms Inc	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	219557-001	Feb 28, 2025		OTC	No	No
Padagis Israel	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SPRAY, METERED;NASAL	202853-001	Jan 31, 2017	AB	RX	No	No
Eugia Pharma	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	204812-001	Dec 18, 2015		OTC	No	No
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008		DISCN	Yes	No
Alembic	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	209919-001	Dec 7, 2018		OTC	No	No
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	206276-001	Jan 30, 2015		OTC	Yes	Yes	8,791,154		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	5,116,863*PED
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008	7,977,376*PED
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	4,923,892
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	8,399,508*PED
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 ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004	5,641,805*PED

International Patents for OLOPATADINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
South Korea	101689924
Japan	2014515355
Spain	2587869
Russian Federation	2613715	ОФТАЛЬМОЛОГИЧЕСКАЯ КОМПОЗИЦИЯ С ВЫСОКОЙ КОНЦЕНТРАЦИЕЙ ОЛОПАТАДИНА (OPHTHALMIC COMPOSITION WITH HIGH CONCENTRATION OF OLOPATADINE)
Ukraine	114597	ОФТАЛЬМОЛОГІЧНА КОМПОЗИЦІЯ З ВИСОКОЮ КОНЦЕНТРАЦІЄЮ ОЛОПАТАДИНУ (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION)
South Korea	20200053635	고농도 올로파타딘 안과용 조성물 (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION)
Taiwan	201249437	High concentration olopatadine ophthalmic composition

Supplementary Protection Certificates for OLOPATADINE HYDROCHLORIDE

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	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	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	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	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

Market Overview and Financial Trajectory for Olopatadine Hydrochloride

Last updated: February 12, 2026

Olopatadine hydrochloride, an antihistamine used primarily for allergic conjunctivitis and rhinitis, has maintained a steady market presence due to its efficacy and safety profile. Its global market is driven by increasing allergy prevalence and rising awareness of allergic conditions.

Market Size and Growth Trends

As of 2022, the global allergic conjunctivitis treatment market was valued at approximately $1.5 billion. Olopatadine hydrochloride products comprise roughly 70% of this segment, translating to an estimated $1.05 billion in revenue. The compound exhibits a compound annual growth rate (CAGR) of 4-6% projected through 2027, driven by demographic shifts, urbanization, and increased allergy diagnostics.

Key Market Players and Product Approvals

Major pharmaceutical companies producing olopatadine formulations include:

• Alcon (Novartis): Markets Pataday and Patanol for ocular allergies. Pataday is a once-daily formulation, boosting adherence and sales.
• Alcon (AbbVie): Has the branded patent and significant market share.
• Others: Mylan, Santen, and Teva offer generic versions, increasing competition.

Ongoing regulatory approvals expand indications and formulations:

• Topical ocular solutions
• Nasal sprays for allergic rhinitis
• Potential for combination products

Patent and Regulatory Landscape

The original patents for Patanol expired around 2018 in key markets, leading to increased generic entry. Patents on Pataday expired around 2020–2022. Generic availability has driven price competition, impacting revenues for branded products.

Regulatory environments favor approval of generic formulations. Stringent regulatory requirements for bioequivalence and safety remain hurdles for new entrants but have generally lowered barriers for generics.

Pricing and Revenue Trends

Pricing varies by region:

• North America: Branded products retail at $20–$30 per eye drop bottle.
• Europe and Asia: Prices range from $10–$20, with generics priced below $10.

Post-patent expiration, generic versions reduced prices by approximately 40–60%, shrinking profit margins for branded players but increasing overall market volume.

Market Drivers and Barriers

• Drivers: Rising allergy prevalence, improved diagnosis, consumer preference for convenient formulations, expanded indications.
• Barriers: Patent expirations, generic competition, regulatory hurdles, market access issues in emerging markets.

Financial Outlook

Projected revenues for olopatadine-based products are expected to decline gradually in developed markets due to patent expiry but may stabilize or grow in emerging markets with expanding healthcare infrastructure. Market analysts forecast:

Year	Market Value (USD billion)	Growth Rate (%)
2022	1.05	—
2025	1.2	4–6
2027	1.3	4–6

The shift toward combination therapies and new administration routes may open additional revenue streams, offsetting declines.

Emerging Opportunities

• Development of sustained-release formulations
• Combination products with other anti-allergic agents
• Expanded indications for nasal sprays or systemic delivery systems

Summary

Olopatadine hydrochloride remains a significant segment within allergy therapeutics. Patent expirations have introduced price pressures, but demand persists due to the prevalence of allergic conditions. Companies focusing on formulations innovation and expanding geographic access will influence future financial trajectories.

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Key Takeaways

• The worldwide market for olopatadine products was approximately $1.05 billion in 2022.
• Patent expirations have driven generic competition, reducing prices and profit margins.
• The market growth rate is approximately 4-6% annually through 2027.
• Opportunities exist in extended-release formulations and combination therapies.
• Emerging markets present growth potential due to increasing allergy awareness and improving healthcare infrastructure.

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FAQs

1. What factors influence olopatadine hydrochloride's market share?
Patents, competitor product entries, regulatory approvals, and regional healthcare policies impact its market share.

2. How do patent expiries affect revenue?
Patent expiries usually lead to a sharp decline in branded product revenues due to generic competition and price reductions.

3. Are there new formulations in development?
Yes; sustained-release ocular formulations and combination therapies are under exploration to sustain market relevance.

4. Which regions offer the most growth potential?
Emerging markets like Asia-Pacific and Latin America show increasing demand driven by allergy prevalence and healthcare access expansion.

5. What are the main barriers to market expansion?
Regulatory challenges, intellectual property rights, and market access limitations hinder rapid growth in certain regions.

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References

1. MarketWatch. "Global Allergic Conjunctivitis Treatment Market." 2022.
2. Allied Market Research. "Olopatadine Hydrochloride Market Analysis." 2022.
3. U.S. Patent Office. "Patent expiry dates for Pataday and Patanol." 2022.
4. EvaluatePharma. "Pharmaceutical Revenue Trends." 2023.
5. GlobalData Healthcare. "Future Opportunities in Allergy and Immunology Market." 2023.