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NEVANAC Drug Patent Profile

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

Nevanac is a drug marketed by Harrow Eye and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in NEVANAC is nepafenac. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nepafenac profile page.

DrugPatentWatch^® Generic Entry Outlook for Nevanac

Nevanac was eligible for patent challenges on August 19, 2009.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 2, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NEVANAC

International Patents:	27
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	25
Patent Applications:	2,384
Drug Prices:	Drug price information for NEVANAC
What excipients (inactive ingredients) are in NEVANAC?	NEVANAC excipients list
DailyMed Link:	NEVANAC at DailyMed

See drug prices for NEVANAC

See drug sales revenues for NEVANAC

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NEVANAC

Constraining patent/regulatory exclusivity:

8,071,648

NDA:

021862

Dosage:

SUSPENSION/DROPS;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for NEVANAC

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

Sponsor	Phase
Kafrelsheikh University	Phase 4
Ifocus Oyeklinikk	Phase 4
The Research Council of Norway	Phase 4

See all NEVANAC clinical trials

Pharmacology for NEVANAC

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

US Patents and Regulatory Information for NEVANAC

NEVANAC is protected by three US patents.

This potential generic entry date is based on patent 8,071,648.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes	7,834,059
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes	8,071,648		Y
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes	8,324,281		Y

Expired US Patents for NEVANAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005	5,475,034

EU/EMA Drug Approvals for NEVANAC

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Nevanac	nepafenac	EMEA/H/C/000818 Nevanac is indicated for:, , , prevention and treatment of postoperative pain and inflammation associated with cataract surgery;, reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients., ,	Authorised	no	no	no	2007-12-11

International Patents for NEVANAC

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0716600
Uruguay	29238	FORMULACIONES DE NEPAFENAC PARA SU ADMINISTRACION TOPICA
Argentina	052252	FORMULACIONES TOPICAS DE NEPAFENAC

Supplementary Protection Certificates for NEVANAC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0716600	C00716600/01	Switzerland		PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
0999825	C300622	Netherlands		PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
0999825	122013000085	Germany		PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503

NEVANAC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of NEVANAC

Introduction to NEVANAC

NEVANAC, a brand name for the drug nepafenac, is a non-steroidal anti-inflammatory drug (NSAID) primarily used to treat pain and inflammation following eye surgeries and in managing various ocular conditions. Its effectiveness in delivering targeted relief with minimal side effects has made it a vital component in ophthalmic treatments.

Market Size and Growth

The nepafenac market, which includes NEVANAC, is experiencing significant growth. The market is projected to grow at a compound annual growth rate (CAGR) of over 7% in the coming years, driven by increasing healthcare expenditures, rising awareness about eye health, and advancements in drug formulations[1].

Key Drivers of Market Growth

Increasing Demand for Effective Pain Management

The growing prevalence of eye surgeries and age-related ocular conditions is boosting the demand for nepafenac. NEVANAC's ability to reduce inflammation and pain more effectively than other NSAIDs, leading to faster recovery and better quality of life for patients, is a major driver of this demand[1][3].

Technological Advancements

Innovations such as nanoemulsion and sustained-release formulations have enhanced the bioavailability and therapeutic efficacy of nepafenac. These advanced drug delivery technologies improve patient compliance and outcomes, making NEVANAC a preferred choice in ophthalmic treatments[1].

Collaborations and Mergers

Collaborations between pharmaceutical companies and research institutions are driving innovation in the nepafenac market. Recent mergers and acquisitions, such as Harrow's acquisition of the exclusive U.S. rights to NEVANAC, are expected to drive further innovation and growth in the market[1][2].

Financial Trajectory

Revenue Projections

The acquisition of NEVANAC by Harrow is expected to be financially accretive. Harrow anticipates that the revenue contribution from these products will grow significantly, with net revenues expected to be between $135 million and $143 million in 2023, and adjusted EBITDA to be between $44 million and $50 million. These figures are expected to ramp up during 2024 and beyond[2].

Investment Opportunities

The nepafenac market, including NEVANAC, offers promising investment opportunities due to its expanding applications, growing demand, and robust growth trajectory. Investors can capitalize on the rising demand for effective pain management solutions and the increasing adoption of advanced drug delivery technologies[1].

Market Trends

Advanced Drug Delivery Technologies

The integration of advanced technologies such as nanoemulsion and sustained-release formulations is a significant trend in the nepafenac market. These technologies enhance the bioavailability and therapeutic efficacy of nepafenac, providing better patient outcomes[1].

Combination Therapies

Recent collaborations have resulted in the development of combination therapies that offer enhanced pain relief and anti-inflammatory effects. These combination therapies are further expanding the therapeutic applications of nepafenac[1].

Regulatory and Commercial Activities

Harrow's acquisition of the U.S. rights to NEVANAC includes a one-time payment of $130 million at closing, with up to an additional $45 million payable in a milestone payment. This transaction is expected to close subject to customary closing conditions, including clearance under the Hart-Scott Rodino Antitrust Improvements Act[2].

Competitive Landscape

The nepafenac market is competitive, with several key players focusing on strengthening their product portfolios and expanding their business. Companies like Targetmol and Cayman Chemical are among those actively involved in the market[4].

Regional Analysis

The global nepafenac market, including NEVANAC, is analyzed across major regions such as North America, Europe, Asia Pacific, South America, and the Middle East and Africa. Each region has its own market size, revenue share, and forecasted growth, reflecting varying demand and market dynamics[4].

Patient Outcomes and Cost Efficiency

NEVANAC's effectiveness in managing pain and inflammation translates into cost savings for healthcare systems. By reducing the need for additional medications and minimizing postoperative complications, NEVANAC helps lower overall healthcare costs, making it a valuable addition to treatment protocols[1].

Key Takeaways

• Market Growth: The nepafenac market is expected to grow at a CAGR of over 7%, driven by increasing healthcare expenditures and advancements in drug formulations.
• Technological Advancements: Innovations in drug delivery technologies are enhancing the efficacy and patient compliance of NEVANAC.
• Financial Projections: Harrow's acquisition of NEVANAC is expected to be financially accretive, with significant revenue and EBITDA growth anticipated.
• Investment Opportunities: The market offers promising investment opportunities due to its expanding applications and growing demand.
• Patient Outcomes: NEVANAC improves patient outcomes by reducing inflammation and pain more effectively than other NSAIDs.

FAQs

What is NEVANAC used for?

NEVANAC is used to treat pain and inflammation following eye surgeries and in managing various ocular conditions.

How does NEVANAC work?

NEVANAC works by inhibiting the enzymes responsible for inflammation and pain, delivering targeted relief with minimal side effects.

What are the key drivers of the nepafenac market growth?

The key drivers include increasing demand for effective pain management, technological advancements, and collaborations and mergers in the pharmaceutical industry.

What are the financial projections for Harrow after acquiring NEVANAC?

Harrow expects net revenues to be between $135 million and $143 million in 2023, with adjusted EBITDA to be between $44 million and $50 million, ramping up during 2024 and beyond.

How does NEVANAC impact healthcare costs?

NEVANAC reduces healthcare costs by minimizing the need for additional medications and postoperative complications, thus lowering overall healthcare expenditures.

Sources

1. Market Research Intellect: "Cutting-Edge Solutions: The Rise of Nepafenac in Chemicals & Materials"
2. Business Wire: "Harrow Enters into Agreement to Acquire Exclusive U.S. Rights to ILEVRO®, NEVANAC®, VIGAMOX®, MAXIDEX®, and TRIESENCE®"
3. LIU Digital Commons: "Investigation of Dosing Interval Differences for Nepafenac Ophthalmic Suspensions"
4. Cognitive Market Research: "Nepafenac Market Report 2024 (Global Edition)"
5. Harrow Investors: "Harrow Closes Acquisition of U.S. Rights to ILEVRO®, NEVANAC®, VIGAMOX®, MAXIDEX®, and TRIESENCE®"