ACULAR Drug Patent Profile

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

Acular is a drug marketed by Abbvie and Allergan and is included in three NDAs. There is one patent protecting this drug.

The generic ingredient in ACULAR is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Acular

A generic version of ACULAR was approved as ketorolac tromethamine by MYLAN on May 16^th, 1997.

Summary for ACULAR

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	23
Patent Applications:	4,765
Drug Prices:	Drug price information for ACULAR
What excipients (inactive ingredients) are in ACULAR?	ACULAR excipients list
DailyMed Link:	ACULAR at DailyMed

See drug prices for ACULAR

See drug sales revenues for ACULAR

Recent Clinical Trials for ACULAR

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

Sponsor	Phase
Emory University	Early Phase 1
University of Louisville	Phase 4
Arthroplasty Foundation, Inc.	Phase 4

See all ACULAR clinical trials

Pharmacology for ACULAR

Drug Class	Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

US Patents and Regulatory Information for ACULAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	AT	RX	Yes	Yes
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997		DISCN	No	No
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes	8,008,338*PED				Y

Expired US Patents for ACULAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	5,110,493*PED
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	4,089,969
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	4,454,151*PED

International Patents for ACULAR

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

Country	Patent Number	Title	Estimated Expiration
Austria	A573780
Hungary	210610
Israel	87724	OPHTHALMIC COMPOSITIONS,THEIR PREPARATION AND USE
Italy	8367315
Japan	H01104023	PRESERVING SYSTEM FOR OPHTHALMIC MEDICINE
Japan	S6254792
South Africa	9002357

Supplementary Protection Certificates for ACULAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	15C0090	France		PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	2015/071	Ireland		PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	76/2015	Austria		PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730
1534313	CA 2015 00072	Denmark		PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730

Market Dynamics and Financial Trajectory of Ophthalmic Drugs: A Focus on ACULAR and the Broader Market

Introduction to Ophthalmic Drugs Market

The global ophthalmic drugs market is experiencing significant growth, driven by several key factors. These include the rising prevalence of ocular conditions, advancements in drug delivery technologies, and increased investment in research and development[1][3][4].

Market Size and Growth Projections

The global ophthalmic drugs market was estimated at USD 37.82 billion in 2023 and is projected to grow at a CAGR of 8.34% from 2024 to 2030, reaching approximately USD 51.46 billion by 2029[1][3].

Key Drivers of Market Growth

Rising Prevalence of Ocular Conditions

The increasing prevalence of retinal disorders, such as age-related macular degeneration and diabetic macular edema, is a significant driver of the market. These conditions are more common among the aging population, which is growing globally[1][3][4].

Advancements in Drug Delivery Technologies

Advances in drug delivery systems, including sustained-release technologies and intravitreal implants, are enhancing treatment outcomes and patient compliance. These innovations are crucial in managing chronic eye disorders effectively[1][3].

Research and Development

Increased investment by public and private organizations in research and development is propelling the market forward. For example, the National Eye Institute's funding for glaucoma treatment research highlights the commitment to advancing ophthalmic therapeutics[1].

Regional Dynamics

North America

North America dominates the ophthalmic drugs market, accounting for approximately 44.99% of the global market share in 2023. This is due to the region's high healthcare expenditure, favorable government initiatives, and the presence of strong regulatory entities[1][3].

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 developing novel technologies, improving healthcare facilities, and expanding market penetration[1][3][4].

Segment Overview: Prescription Drugs

Prescription ophthalmic drugs, including those for glaucoma, dry eye, and retinal disorders, account for approximately 65% of the market share. These drugs are critical due to their potency and the need for medical oversight[3].

Anti-VEGF Agents

Anti-VEGF agents, such as aflibercept, are leading the market with a significant share. These agents are crucial for treating conditions that cause swelling or growth of new blood vessels around the retina, such as neovascular age-related macular degeneration and diabetic macular edema[1].

Financial Trajectory of Key Players

While the specific financial trajectory of ACULAR (a brand of ketorolac tromethamine, an NSAID used for treating pain and inflammation after cataract surgery) is not detailed in the sources, we can look at broader trends and financial performances of companies in the ophthalmic drugs market.

Revenue and Growth Trends

Companies like Acutus Medical, which operates in related medical device sectors, have shown significant revenue growth. For instance, Acutus Medical reported a 156% increase in revenue from continuing operations in the third quarter of 2024 compared to the same period in 2023[5].

Market Competition and Innovation

Leading companies in the ophthalmic drugs market, such as Regeneron Pharmaceuticals Inc., Bayer AG, and Novartis AG, are focusing on innovation to gain a competitive edge. Strategic collaborations, acquisitions, and the development of advanced drug delivery systems are key strategies[3].

Ocular Drug Delivery Market

The ocular drug delivery market, closely related to ophthalmic drugs, is projected to reach USD 115.5 billion by 2032, growing at a CAGR of 5.5% from 2023 to 2032. This growth is driven by advancements in ocular drug delivery technologies and the rising prevalence of eye disorders among the aging population[4].

Future Opportunities and Challenges

Increasing Research and Development

Future opportunities include increasing research and development for novel drugs, growing focus on combination therapies, and expansion in emerging markets. However, potential disruptions such as gene therapies and regenerative medicine may reshape the market landscape[3].

Market Expansion in Emerging Regions

The Asia Pacific region offers significant opportunities due to the rising incidence of eye-related disorders and increasing healthcare expenditure. This region is expected to grow at the highest rate during the forecast period[1][3][4].

Key Takeaways

• The global ophthalmic drugs market is projected to grow significantly, driven by the rising prevalence of ocular conditions and advancements in drug delivery technologies.
• North America leads the market, while the Asia Pacific region is expected to witness the fastest growth.
• Prescription ophthalmic drugs, particularly anti-VEGF agents, dominate the market.
• Companies are focusing on innovation, strategic collaborations, and expanding their product portfolios to maintain market competitiveness.

FAQs

What is the projected growth rate of the global ophthalmic drugs market?

The global ophthalmic drugs market is projected to grow at a CAGR of 8.34% from 2024 to 2030[1].

Which region dominates the ophthalmic drugs market?

North America dominates the ophthalmic drugs market, accounting for approximately 44.99% of the global market share in 2023[1].

What are the key drivers of the ophthalmic drugs market growth?

Key drivers include the rising prevalence of ocular conditions, advancements in drug delivery technologies, and increased investment in research and development[1][3][4].

Which segment leads the ophthalmic drugs market?

Prescription ophthalmic drugs, particularly anti-VEGF agents, lead the market, accounting for a significant share of global revenue[1][3].

What are the future opportunities in the ophthalmic drugs market?

Future opportunities include increasing research and development for novel drugs, growing focus on combination therapies, and expansion in emerging markets[3].

Cited Sources:

1. Grand View Research - Ophthalmic Drugs Market Size & Share | Industry Report 2030
2. Acutus Medical - Acutus Medical Reports Fourth Quarter and Full Year 2022 Financial Results
3. Mordor Intelligence - Global Ophthalmic Drugs Market Size Research - Industry Trends & Share
4. Allied Market Research - Ocular Drug Delivery Market Statistics, Growth Forecast- 2032
5. GlobeNewswire - Acutus Medical Reports Third Quarter and Year-To-Date 2024 Financial Results