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Last Updated: December 22, 2024

OLOPATADINE HYDROCHLORIDE Drug Patent Profile


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When do Olopatadine Hydrochloride patents expire, and what generic alternatives are available?

Olopatadine Hydrochloride is a drug 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, Amneal, Apotex Inc, Hikma, and Padagis Israel. and is included in twenty-five NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Olopatadine Hydrochloride

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

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Drug patent expirations by year for OLOPATADINE HYDROCHLORIDE
Recent Clinical Trials for OLOPATADINE HYDROCHLORIDE

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SponsorPhase
MEDA Pharma GmbH & Co. KGPhase 2
Laboratorios PoenPhase 4
Michael Marchand, MDPhase 4

See all OLOPATADINE HYDROCHLORIDE clinical trials

Pharmacology for OLOPATADINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for OLOPATADINE HYDROCHLORIDE
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
Alembic OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 209919-001 Dec 7, 2018 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sciegen Pharms Inc OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204723-001 Dec 5, 2017 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SPRAY, METERED;NASAL 213757-001 Aug 19, 2020 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch And Lomb Inc OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 206087-001 Dec 5, 2017 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 090918-001 Dec 5, 2017 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Gland Pharma Ltd OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 209619-001 Aug 2, 2019 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Usv OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 203152-001 Dec 7, 2015 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

OLOPATADINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

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).

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