OPTIVAR Drug Patent Profile

Which patents cover Optivar, and when can generic versions of Optivar launch?

Optivar is a drug marketed by Norvium Bioscience and is included in one NDA.

The generic ingredient in OPTIVAR is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Optivar

A generic version of OPTIVAR was approved as azelastine hydrochloride by APOTEX INC on April 30^th, 2009.

Summary for OPTIVAR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	114
Patent Applications:	1,732
DailyMed Link:	OPTIVAR at DailyMed

Paragraph IV (Patent) Challenges for OPTIVAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OPTIVAR	Ophthalmic Solution	azelastine hydrochloride	0.05%	021127	1	2006-12-13

US Patents and Regulatory Information for OPTIVAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	OPTIVAR	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021127-001	May 22, 2000		DISCN	Yes	No

Expired US Patents for OPTIVAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	OPTIVAR	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021127-001	May 22, 2000
Norvium Bioscience	OPTIVAR	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021127-001	May 22, 2000

International Patents for OPTIVAR

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

Country	Patent Number	Title	Estimated Expiration
Croatia	P920668	PREPARATIONS CONTAINING AZELASTINE FOR APPLICATION IN THE NOSE AND/OR TO THE EYE
Canada	1319322	MEDICAMENTS CONTENANT DE L'AZELASTINE POUR APPLICATION DANS LE NEX OU DANS LES YEUX (AZELASTINE-CONTAINING MEDICAMENTS FOR APPLICATION IN THE NOSE AND/OR EYE)
Japan	H01153639	DRUG USED IN NOSE OR EYE AND ITS PRODUCTION
Greece	3007202

Supplementary Protection Certificates for OPTIVAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	13C0067	France		PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
0316633	99C0012	Belgium		PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
1519731	C300740	Netherlands		PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE

OPTIVAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ophthalmic Drugs: A Focus on Optivar

Introduction

The global ophthalmic drugs market is experiencing significant growth, driven by various factors including the increasing prevalence of eye-related disorders, advancements in drug development, and a rising geriatric population. This article will delve into the market dynamics and financial trajectory of ophthalmic drugs, with a specific focus on Optivar, a medication used to treat allergic conjunctivitis.

Global Ophthalmic Drugs Market Overview

Market Size and Growth

The global ophthalmic drugs market was valued at approximately USD 35.09 billion in 2022 and is projected to reach USD 47.79 billion by 2030, growing at a CAGR of 5.34% during the forecast period from 2024 to 2030[1][3][4].

Key Drivers

• Increasing Prevalence of Eye Disorders: The rising burden of eye diseases such as cataracts, glaucoma, diabetic retinopathy, and eye allergies is a significant driver of market growth.
• Advancements in Drug Development: Innovations in drug formulation technologies, including gene therapies and new pharmacologic agents, are enhancing treatment efficacy.
• Aging Population: The global increase in the geriatric population is contributing to a higher demand for ophthalmic drugs.
• Clinical Trials and Product Development: Increased clinical trials and product development activities are expected to drive revenue growth in the ophthalmic drugs market[1][3][4].

Regional Dynamics

North America

North America is expected to dominate the global ophthalmic drugs market, driven by a high disease burden, rising consumer awareness, proactive government measures, technological advancements, and improvements in healthcare infrastructure. The region is projected to grow at a CAGR of over 8% from 2024 to 2029[1][3][4].

Asia-Pacific

The Asia-Pacific region is anticipated to witness the fastest growth rate, driven by the increasing burden of ophthalmic disorders and rising consumer awareness. Countries like China and India are seeing improvements in healthcare facilities and the development of novel technologies[3][4].

Market Segments

Generic Drugs

The generic drugs segment is projected to witness the fastest growth rate due to cost-effectiveness and the patent expiry of branded drugs. Government initiatives to increase the development of generic drugs are also supporting this segment's growth[4].

Optivar: A Specific Example

What is Optivar?

Optivar is an ophthalmic solution used to treat allergic conjunctivitis. It contains the active ingredient azelastine, which is an antihistamine that reduces the symptoms of allergic reactions in the eyes.

Market Position

While specific financial data for Optivar is not widely available, it is part of the broader ophthalmic drugs market that is experiencing significant growth. Optivar, being a branded drug, faces competition from generic alternatives, but its efficacy and brand recognition help maintain its market presence.

Pricing and Accessibility

The cost for Optivar 0.05% ophthalmic solution is around $160 for a supply of 6 milliliters, depending on the pharmacy. This pricing reflects the general trend of ophthalmic drugs, where branded products tend to be more expensive than their generic counterparts[5].

Financial Trajectory of Ophthalmic Drugs

Revenue Growth

The global ophthalmic drugs market is expected to grow at a CAGR of 8.34% from 2024 to 2030, reaching USD 66.06 billion by 2030. This growth is driven by the increasing prevalence of eye diseases, advancements in drug delivery, and increased investments in research and development[4].

Major Players

Companies like Novartis AG, Pfizer Inc., Regeneron Pharmaceuticals Inc., Merck & Co., Inc., AbbVie Inc., and others are key players in the ophthalmic drugs market. These companies are investing heavily in research and development to bring new and innovative treatments to the market[4].

Impact of Technological Advancements

Drug Delivery Innovations

Advancements in drug delivery technologies, such as gene therapies and new pharmacologic agents, are significantly impacting the ophthalmic drugs market. These innovations are enhancing treatment efficacy and patient outcomes, driving market growth[3][4].

Telemedicine and E-commerce

The incorporation of telemedicine and e-commerce has increased the diagnosis and treatment of ophthalmic diseases, further boosting the demand for ophthalmic drugs. This shift has been particularly pronounced since the easing of lockdown restrictions and the administration of vaccines[1].

Regulatory Environment

Favorable Reimbursement Policies

Favorable reimbursement policies and a supportive regulatory environment in regions like North America are encouraging drug innovation and patient access to treatments. These policies are crucial for the growth of the ophthalmic drugs market[3][4].

Key Takeaways

• The global ophthalmic drugs market is projected to grow significantly, driven by the increasing prevalence of eye disorders and advancements in drug development.
• North America is expected to dominate the market, while the Asia-Pacific region is anticipated to witness the fastest growth.
• Generic drugs are expected to grow rapidly due to their cost-effectiveness and government support.
• Optivar, as part of the broader ophthalmic drugs market, benefits from the overall market growth but faces competition from generic alternatives.
• Technological advancements and favorable regulatory environments are key drivers of market growth.

FAQs

What is the projected market size of the global ophthalmic drugs market by 2030?

The global ophthalmic drugs market is projected to reach USD 66.06 billion by 2030, growing at a CAGR of 8.34% from 2024 to 2030[4].

Which region is expected to dominate the ophthalmic drugs market?

North America is expected to dominate the global ophthalmic drugs market due to its high disease burden, rising consumer awareness, and advanced healthcare infrastructure[1][3][4].

What are the key drivers of the ophthalmic drugs market?

Key drivers include the increasing prevalence of eye-related disorders, advancements in drug development technologies, and a rising geriatric population[1][3][4].

How is the generic drugs segment performing in the ophthalmic drugs market?

The generic drugs segment is expected to witness the fastest growth rate due to cost-effectiveness and government initiatives to increase the development of generic drugs[4].

What is the role of telemedicine in the ophthalmic drugs market?

Telemedicine has increased the diagnosis and treatment of ophthalmic diseases, boosting the demand for ophthalmic drugs, especially since the easing of lockdown restrictions and the administration of vaccines[1].

Sources

1. Research and Markets: Ophthalmic Drugs - Market Insights, Competitive Landscape, and Market Forecasts.
2. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results.
3. Mordor Intelligence: Global Ophthalmic Drugs Market Size Research - Industry Trends & Share.
4. Grand View Research: Ophthalmic Drugs Market Size & Share | Industry Report 2030.
5. Drugs.com: Optivar Prices, Coupons, Copay Cards & Patient Assistance.