NAVSTEL Drug Patent Profile

When do Navstel patents expire, and when can generic versions of Navstel launch?

Navstel is a drug marketed by Alcon Pharms Ltd and is included in one NDA.

The generic ingredient in NAVSTEL is calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate. There are two hundred and eighty-two drug master file entries for this compound. Additional details are available on the calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate profile page.

Summary for NAVSTEL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	97
Patent Applications:	4,437
DailyMed Link:	NAVSTEL at DailyMed

US Patents and Regulatory Information for NAVSTEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Pharms Ltd	NAVSTEL	calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	022193-001	Jul 24, 2008		DISCN	No	No

Expired US Patents for NAVSTEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon Pharms Ltd	NAVSTEL	calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	022193-001	Jul 24, 2008	5,409,904
Alcon Pharms Ltd	NAVSTEL	calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	022193-001	Jul 24, 2008	7,084,130
Alcon Pharms Ltd	NAVSTEL	calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	022193-001	Jul 24, 2008	5,578,578

International Patents for NAVSTEL

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

Country	Patent Number	Title	Estimated Expiration
Brazil	0116353	Solução de irrigação intraocular dotada de caracterìsticas de fluxo aperfeiçoadas
Portugal	1343474
European Patent Office	1343474	SOLUTIONS POUR IRRIGATIONS INTRAOCULAIRES A FLUIDITE AMELIOREE (INTRAOCULAR IRRIGATING SOLUTION HAVING IMPROVED FLOW CHARACTERISTICS)
Denmark	1343474
South Korea	20070087252	INTRAOCULAR IRRIGATING SOLUTION HAVING IMPROVED FLOW CHARACTERISTICS
South Africa	200303557	INTRAOCULAR IRRIGATING SOLUTION HAVING IMPROVED FLOW CHARACTERISTICS

Supplementary Protection Certificates for NAVSTEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0933372	13/2008	Austria		PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
2957286	132019000000021	Italy		PRODUCT NAME: PATIROMER SORBITEX CALCIUM E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1179, 20170721
2365988	2018C/006	Belgium		PRODUCT NAME: PATIROMER SORBITEX CALCIUM OF EERDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2365988	LUC00061	Luxembourg		PRODUCT NAME: PATIROMER SORBITEX CALCIUM ET TOUS LES SELS ET DERIVES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286	C02957286/01	Switzerland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017
0933372	PA2008006	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712

NAVSTEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ophthalmic Drugs: A Focus on NAVSTEL and the Broader Market

Introduction to Ophthalmic Drugs Market

The ophthalmic drugs market is a significant segment within the pharmaceutical industry, driven by increasing prevalence of eye-related disorders and an aging population. Here, we will delve into the market dynamics and financial trajectory of ophthalmic drugs, with a specific focus on NAVSTEL and the broader market context.

Market Size and Growth

The U.S. ophthalmic drugs market was estimated at USD 15.53 billion in 2023 and is anticipated to grow at a CAGR of 7.4% from 2024 to 2030[1]. This growth is largely attributed to the rising incidence of eye disorders such as diabetic retinopathy, age-related macular degeneration (AMD), and dry eye disease.

Key Segments in the Ophthalmic Drugs Market

Therapeutic Segments

The retinal disorders segment held the largest revenue share of 36.7% in 2023, driven by the increasing prevalence of conditions like diabetic retinopathy and AMD. Technological advancements and strategic collaborations, such as the FDA approval of EYLEA HD (aflibercept) for treating wet AMD and diabetic retinopathy, are significant drivers[1].

Drug Types

The prescription drugs segment dominates the market, with branded drugs accounting for the largest share. The generic drugs segment, however, is expected to show the fastest growth due to the expiry of branded drug patents and government encouragement for generic drug development[1].

NAVSTEL: A Specific Example

NAVSTEL is a sterile intraocular irrigating solution used during surgical procedures, including those requiring a relatively long duration. Here’s how it fits into the broader market dynamics:

Regulatory Approval

NAVSTEL received FDA approval in 2008, which is a critical milestone for any pharmaceutical product. Regulatory approvals are essential for market entry and acceptance[5].

Market Position

While NAVSTEL is not a blockbuster drug like anti-VEGF agents or treatments for AMD, it plays a crucial role in ophthalmic surgeries. Its market position is niche but vital, as it addresses a specific need in the surgical segment.

Financial Trajectory of Ophthalmic Drugs

Revenue Growth

The ophthalmic drugs market is expected to see significant revenue growth, driven by the increasing demand for treatments and the high prevalence of eye disorders. The global ophthalmology drugs and devices market is projected to grow at a CAGR of 6.4% from 2024 to 2030, reaching USD 50.16 billion by 2029 in North America alone[4].

Cost and Pricing Dynamics

The financial trajectory is also influenced by cost and pricing dynamics. High-cost therapies, such as those for AMD and diabetic retinopathy, are becoming more prevalent. However, the generic drugs segment is expected to grow rapidly due to cost-effectiveness and the expiry of branded drug patents[1].

Impact of Government and Public Support

Government investments and public support play a crucial role in driving the market. For instance, approvals from regulatory bodies like the FDA and support from public and private bodies to boost sales of prescription ophthalmic drugs are key factors[1].

Challenges and Opportunities

Formulary Management and High-Cost Therapies

Managing high-cost therapies is a significant challenge. Health systems need to consider both the cost of goods and the cost to deliver the service. Engaging revenue cycle teams and building formulary management tools into electronic health records (EHRs) are essential strategies[2].

Technological Advancements

Technological advancements and strategic collaborations are driving the growth of the ophthalmic drugs market. Innovations in treatments, such as the development of long-term therapies for conditions like glaucoma and dry eye, are expected to support market growth[1].

Regional Insights

North America Dominance

North America dominates the ophthalmology drugs and devices market due to high R&D expenditure, high healthcare spending, and a high prevalence of eye diseases. Government investments in eye research also contribute to the region's growth[4].

Key Takeaways

• The U.S. ophthalmic drugs market is growing at a CAGR of 7.4% from 2024 to 2030.
• The retinal disorders segment holds the largest revenue share.
• Prescription and branded drugs dominate the market, but generic drugs are expected to grow rapidly.
• NAVSTEL, as a niche product, plays a crucial role in ophthalmic surgeries.
• Government support and technological advancements are key drivers of market growth.

FAQs

1. What is the current size and growth rate of the U.S. ophthalmic drugs market?

   • The U.S. ophthalmic drugs market was estimated at USD 15.53 billion in 2023 and is anticipated to grow at a CAGR of 7.4% from 2024 to 2030[1].

2. Which segment holds the largest revenue share in the ophthalmic drugs market?

   • The retinal disorders segment held the largest revenue share of 36.7% in 2023[1].

3. What is the significance of NAVSTEL in the ophthalmic drugs market?

   • NAVSTEL is a sterile intraocular irrigating solution used during surgical procedures, addressing a specific need in the surgical segment[5].

4. How do government investments impact the ophthalmic drugs market?

   • Government investments in eye research and support for prescription ophthalmic drugs are significant drivers of market growth[1][4].

5. What are the challenges in managing high-cost ophthalmic therapies?

   • Managing high-cost therapies involves considering both the cost of goods and the cost to deliver the service, as well as engaging revenue cycle teams and building formulary management tools into EHRs[2].

Cited Sources:

1. Grand View Research - U.S. Ophthalmic Drugs Market Size | Industry Report, 2030
2. ASHP - Strategic Directions in System Formulary, Drug Policy, and High-Cost Drugs Whitepaper
3. Balaxi Pharmaceuticals - Medicines for Frontier Markets - Annual Report 2021
4. Maximize Market Research - Ophthalmology Drugs and Devices Market - Industry Analysis 2030
5. FDA - NDA 22-193 - Navstel MedR Report