ACUVAIL Drug Patent Profile

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

Acuvail is a drug marketed by Abbvie and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-three patent family members in twenty-five countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Acuvail

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

Summary for ACUVAIL

International Patents:	63
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	11
Patent Applications:	4,765
Drug Prices:	Drug price information for ACUVAIL
What excipients (inactive ingredients) are in ACUVAIL?	ACUVAIL excipients list
DailyMed Link:	ACUVAIL at DailyMed

See drug prices for ACUVAIL

Recent Clinical Trials for ACUVAIL

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

Sponsor	Phase
Stephen J. Kim, MD	Phase 1
National Eye Institute (NEI)	Phase 1
Allergan	Phase 1

See all ACUVAIL clinical trials

Pharmacology for ACUVAIL

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

Paragraph IV (Patent) Challenges for ACUVAIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACUVAIL	Ophthalmic Solution	ketorolac tromethamine	0.45%	022427	1	2011-08-24

US Patents and Regulatory Information for ACUVAIL

ACUVAIL is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes	8,992,952		Y
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes	9,192,571		Y
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes	8,512,717		Y
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes	7,842,714		Y	Y

Expired US Patents for ACUVAIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009	8,992,952

International Patents for ACUVAIL

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

Country	Patent Number	Title	Estimated Expiration
Australia	2004263149	Compositions for delivery of therapeutics into the eyes and methods for making and using same
Germany	602004023516
Canada	2796071	COMPOSITIONS DE KETOROLAC POUR LA CICATRISATION DE LESIONS CORNEENNES (KETOROLAC COMPOSITIONS FOR CORNEAL WOUND HEALING)
Colombia	6321226	COMPOSICIONES DE KETOROLAC TROMETAMINA PARA TRATAR O PREVENIR EL DOLOR OCULAR

Supplementary Protection Certificates for ACUVAIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
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	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

ACUVAIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ACUVAIL

Introduction to ACUVAIL

ACUVAIL, a ketorolac tromethamine solution, is a nonsteroidal anti-inflammatory drug (NSAID) used primarily for the treatment of pain and inflammation following cataract surgery. Here, we will delve into the market dynamics and financial trajectory of this ophthalmic drug.

Market Context: Ophthalmic Drugs

The global ophthalmic drugs market is experiencing significant growth, driven by increasing prevalence of eye diseases and advancements in medical treatments. As of 2021, the ophthalmic drugs market was valued at USD 32.9 billion and is projected to reach USD 62.55 billion by 2030, growing at a CAGR of 7.4% during the forecast period[1].

Segmentation and Competitive Landscape

ACUVAIL falls under the NSAID segment of ophthalmic drugs, which, while not the largest segment, is crucial for post-surgical care. The dominant segment in the ophthalmic drugs market is anti-VEGF (Vascular Endothelial Growth Factor) medications, which are used to treat conditions like age-related macular degeneration (AMD) and diabetic macular edema[1].

Clinical Efficacy and Market Acceptance

Clinical trials have shown that ACUVAIL is effective in reducing anterior chamber inflammation and ocular pain following cataract surgery. For instance, studies indicated that patients receiving ACUVAIL had a significantly higher incidence of clearing of anterior chamber inflammation compared to those receiving a vehicle solution[4].

Regional Market Performance

The ophthalmic drugs market is geographically segmented into North America, Europe, Asia-Pacific, and LAMEA. North America, being the largest market, is expected to grow at a CAGR of 6.7% during the forecast period. This growth is attributed to the high prevalence of eye illnesses and increased public awareness of eye ailments in the region[1].

Key Players and Strategic Moves

Companies like Allergan (now part of AbbVie), which has a strong presence in the ophthalmic market, play a significant role in the distribution and marketing of drugs like ACUVAIL. Allergan's historical financial reports show a strong revenue stream from ophthalmic products, which has been a key contributor to their overall financial performance[5].

Financial Performance of Allergan

In the past, Allergan has reported substantial revenues from its ophthalmic product line. For example, in 2009, Allergan's product net sales were $4,447.6 million, with a significant portion coming from ophthalmic products. Although the specific financial details for ACUVAIL are not separately disclosed, the overall performance of Allergan's ophthalmic segment indicates a robust market presence[5].

Impact of Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of ophthalmic drugs. New FDA guidelines, such as those under the Prescription Drug User Fee Act, provide a structured method for evaluating the risks and benefits of these drugs in clinical studies. Compliance with these regulations can influence the approval and launch of drugs like ACUVAIL, thereby affecting their market performance[1].

Market Growth Drivers

Several factors drive the growth of the ophthalmic drugs market, including:

• Increasing Prevalence of Eye Diseases: The rising incidence of eye diseases such as cataracts, glaucoma, and AMD fuels the demand for ophthalmic drugs.
• Advancements in Medical Treatments: Continuous innovation in ophthalmic treatments, including the development of new drugs and therapies, contributes to market growth.
• Public Awareness: Growing public awareness of eye ailments and the importance of timely treatment also drives market expansion[1].

Challenges and Opportunities

Despite the growth potential, the ophthalmic drugs market faces challenges such as:

• Regulatory Hurdles: Strict regulatory requirements can delay the approval and launch of new drugs.
• Competition: The market is highly competitive, with several major players vying for market share.
• Economic Factors: Economic downturns can impact healthcare spending and, consequently, the demand for ophthalmic drugs.

However, opportunities exist in emerging markets, particularly in the Asia-Pacific region, where there is a large patient population with a relatively low treatment rate[1].

Key Takeaways

• Market Growth: The ophthalmic drugs market, including NSAIDs like ACUVAIL, is expected to grow significantly.
• Clinical Efficacy: ACUVAIL has demonstrated effectiveness in clinical trials.
• Regional Performance: North America is the largest market, but Asia-Pacific is the fastest-growing region.
• Regulatory Impact: Compliance with FDA guidelines is crucial for drug approval and market success.
• Market Drivers: Increasing prevalence of eye diseases, advancements in treatments, and public awareness drive market growth.

FAQs

Q: What is ACUVAIL used for? A: ACUVAIL is used for the treatment of pain and inflammation following cataract surgery.

Q: How effective is ACUVAIL in clinical trials? A: ACUVAIL has shown significant efficacy in clearing anterior chamber inflammation and resolving ocular pain in clinical trials[4].

Q: Which region is the largest market for ophthalmic drugs? A: North America is the largest market for ophthalmic drugs, expected to grow at a CAGR of 6.7% during the forecast period[1].

Q: What are the key drivers of the ophthalmic drugs market? A: The key drivers include increasing prevalence of eye diseases, advancements in medical treatments, and growing public awareness of eye ailments[1].

Q: How does the regulatory environment impact ophthalmic drugs like ACUVAIL? A: The regulatory environment, including FDA guidelines, plays a crucial role in the approval and launch of ophthalmic drugs, influencing their market performance[1].

Cited Sources

1. Straits Research: Ophthalmic Drugs Market Size to Grow at a CAGR of 7.4% by 2030.
2. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results.
3. PwC Australia: Can life sciences find sustainable growth in the upturn?
4. DailyMed: Label: ACUVAIL - ketorolac tromethamine solution/drops.
5. Annual Reports: Allergan Annual Report 2009.