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Last Updated: December 26, 2024

NEPAFENAC - Generic Drug Details

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What are the generic drug sources for nepafenac and what is the scope of patent protection?

Nepafenac is the generic ingredient in two branded drugs marketed by Harrow Eye and is included in two NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nepafenac has one hundred and twenty-one patent family members in twenty-eight countries.

There are eight drug master file entries for nepafenac. Two suppliers are listed for this compound.

Summary for NEPAFENAC

International Patents:	121
US Patents:	6
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	45
Patent Applications:	3,811
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEPAFENAC
What excipients (inactive ingredients) are in NEPAFENAC?	NEPAFENAC excipients list
DailyMed Link:	NEPAFENAC at DailyMed

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

Generic Entry Date for NEPAFENAC^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 8,071,648 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 NEPAFENAC

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

Sponsor	Phase
Kafrelsheikh University	Phase 4
Vistar Eye Center	N/A
Virginia Polytechnic Institute and State University	N/A

See all NEPAFENAC clinical trials

Pharmacology for NEPAFENAC

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

Anatomical Therapeutic Chemical (ATC) Classes for NEPAFENAC

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for NEPAFENAC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ILEVRO	Ophthalmic Suspension	nepafenac	0.3%	203491	1	2015-12-21

US Patents and Regulatory Information for NEPAFENAC

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Glossary

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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	⤷ Subscribe				⤷ Subscribe
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes	9,662,398	⤷ Subscribe	Y			⤷ Subscribe
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes	8,071,648	⤷ Subscribe	Y			⤷ Subscribe
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes	8,921,337	⤷ Subscribe	Y			⤷ Subscribe
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes	8,324,281	⤷ Subscribe	Y			⤷ Subscribe
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes	7,947,295	⤷ Subscribe	Y			⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for NEPAFENAC

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012	5,475,034	⤷ Subscribe
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005	5,475,034	⤷ Subscribe
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012	6,403,609	⤷ Subscribe
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012	7,947,295	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for NEPAFENAC

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for NEPAFENAC

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Country	Patent Number	Title	Estimated Expiration
South Korea	20120062846	OPHTHALMIC COMPOSITIONS CONTAINING A SYNERGISTIC COMBINATION OF TWO POLYMERS	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2011068872		⤷ Subscribe
Cyprus	1110780		⤷ Subscribe
Canada	2839928	COMPOSITIONS OPHTALMOLOGIQUES CONTENANT UNE ASSOCIATION SYNERGIQUE DE DEUX POLYMERES (OPHTHALMIC COMPOSITIONS CONTAINING A SYNERGISTIC COMBINATION OF TWO POLYMERS)	⤷ Subscribe
Japan	2015061886	カルボキシビニルポリマー含有ナノ粒子懸濁物 (CARBOXYVINYL POLYMER-CONTAINING NANOPARTICLE SUSPENSION)	⤷ Subscribe
South Korea	101147046		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NEPAFENAC

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0716600	C00716600/01	Switzerland	⤷ Subscribe	PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
0999825	C300622	Netherlands	⤷ Subscribe	PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
0999825	122013000085	Germany	⤷ Subscribe	PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
0999825	CA 2013 00055	Denmark	⤷ Subscribe	PRODUCT NAME: NEPAFENAC (3 MG/ML), HERUNDER NEPAFENAC I KOMBINATION MED GLACTOMANNANPOLYMERER, ISAER 3 MG/ML NEPAFENAC I KOMBINATION MED GALACTOMANNANPOLYMERER, SAMT OFTALMISKE SAMMENSAETNINGER DERAF; REG. NO/DATE: EU1/07/433/002 20130503
0999825	92301	Luxembourg	⤷ Subscribe	PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

NEPAFENAC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nepafenac

Introduction to Nepafenac

Nepafenac is a non-steroidal anti-inflammatory drug (NSAID) primarily used to treat pain and inflammation following eye surgeries, particularly cataract surgery. It is also indicated for reducing the risk of postoperative macular edema in patients with diabetes undergoing cataract surgery in the European Union[2].

Market Size and Growth

The nepafenac market is experiencing robust growth, driven by several key factors. As of 2023, the global nepafenac market was valued at a significant figure, and it is anticipated to grow at a compound annual growth rate (CAGR) of over 7% in the coming years. This growth is fueled by increasing healthcare expenditures, rising awareness about eye health, and advancements in drug formulations[1][3].

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. Its effectiveness in managing pain and inflammation with minimal side effects makes it a vital component in ophthalmic treatments[1].

Advancements in Drug Formulations

Technological advancements such as nanoemulsion and sustained-release formulations have enhanced the bioavailability and therapeutic efficacy of nepafenac. These innovations improve patient compliance and outcomes, driving the demand for nepafenac in the chemicals and materials market[1].

Collaborations and Partnerships

Collaborations between pharmaceutical companies and research institutions are driving innovation in the nepafenac market. These partnerships aim to develop new formulations and expand the therapeutic applications of nepafenac, leading to enhanced pain relief and anti-inflammatory effects[1].

Financial Trajectory

Investment Opportunities

The nepafenac market presents lucrative 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].

Cost-Efficiency

Nepafenac'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, nepafenac helps lower overall healthcare costs, making it a valuable addition to treatment protocols[1].

Mergers and Acquisitions

The nepafenac market is experiencing a surge in mergers and acquisitions as companies aim to strengthen their market position and expand their product portfolios. These strategic moves are expected to drive further innovation and growth in the market[1].

Key Players and Market Competition

The nepafenac market is dominated by several key players, including Targetmol, Merck, Cayman Chemical, ApexBio Technology, and others. These companies are focusing on strategy building models to strengthen their product portfolios and expand their business in the global market[3][5].

Regional Analysis

The global nepafenac market has been segmented into major regions such as North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region contributes significantly to the market size and growth, with varying trends and drivers influencing the regional dynamics[3].

Technological Trends

Advanced Drug Delivery Systems

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 innovations are fueling market growth and attracting investment[1].

Clinical Efficacy and Safety

Studies have shown that nepafenac ophthalmic suspension 0.1% is safe and effective for preventing and treating ocular inflammation and pain associated with cataract surgery. Clinical trials have demonstrated that nepafenac reduces inflammation and pain more effectively than other NSAIDs, leading to faster recovery and better quality of life for patients[4].

Market Challenges and Restraints

Despite the positive growth trajectory, the nepafenac market faces some challenges. These include commercial risks such as declining growth in certain segments and challenges in the development and marketing of new products. Additionally, the market is influenced by factors such as regulatory approvals and the competitive landscape[2].

Future Outlook

The future of the nepafenac market looks promising, driven by ongoing research and development activities, advancements in drug formulations, and increasing demand for effective pain management solutions. As technological advancements continue to enhance its formulation and delivery, nepafenac is set to play an increasingly important role in healthcare and industrial applications[1].

Key Takeaways

Robust Growth: The nepafenac market is expected to grow at a CAGR of over 7% in the coming years.
Technological Advancements: Innovations in drug formulations such as nanoemulsion and sustained-release formulations are driving market growth.
Cost-Efficiency: Nepafenac helps lower overall healthcare costs by reducing the need for additional medications and minimizing postoperative complications.
Market Competition: Key players are focusing on strategy building models to strengthen their product portfolios.
Clinical Efficacy: Nepafenac is safe and effective for preventing and treating ocular inflammation and pain associated with cataract surgery.

Frequently Asked Questions (FAQs)

Q: What is nepafenac primarily used for? A: Nepafenac is primarily used to treat pain and inflammation following eye surgeries, particularly cataract surgery.

Q: What are the key drivers of the nepafenac market growth? A: The key drivers include increasing demand for effective pain management, advancements in drug formulations, and collaborations between pharmaceutical companies and research institutions.

Q: Which companies are major players in the nepafenac market? A: Major players include Targetmol, Merck, Cayman Chemical, ApexBio Technology, and others.

Q: What are the technological trends in the nepafenac market? A: Advanced drug delivery systems such as nanoemulsion and sustained-release formulations, as well as the development of combination therapies, are significant trends.

Q: Is nepafenac safe and effective for ophthalmic use? A: Yes, clinical trials have shown that nepafenac ophthalmic suspension 0.1% is safe and effective for preventing and treating ocular inflammation and pain associated with cataract surgery.

Cited Sources:

Market Research Intellect: "Cutting Edge Solutions: The Rise of Nepafenac in Chemicals & Materials"[1]
Wikipedia: "Nepafenac"[2]
Cognitive Market Research: "Nepafenac Market Report 2024 (Global Edition)"[3]
PubMed: "Nepafenac ophthalmic suspension 0.1% for the prevention and treatment of ocular inflammation and pain associated with cataract surgery"[4]
Valuates Reports: "Global Nepafenac Market Research Report 2024"[5]

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.