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:	91
Patent Applications:	4,526
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
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
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

International Patents for NAVSTEL

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

Country	Patent Number	Title	Estimated Expiration
Australia	2389595
World Intellectual Property Organization (WIPO)	9632929
Austria	459337
Australia	2002239601
Australia	3960102	Intraocular irrigating solution having improved flow characteristics
Brazil	0116353	Solução de irrigação intraocular dotada de caracterìsticas de fluxo aperfeiçoadas
Canada	2431368	SOLUTIONS POUR IRRIGATIONS INTRAOCULAIRES A FLUIDITE AMELIOREE (INTRAOCULAR IRRIGATING SOLUTION HAVING IMPROVED FLOW CHARACTERISTICS)

Supplementary Protection Certificates for NAVSTEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0247633	62/1997	Austria		PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
0720599	CR 2014 00050	Denmark		PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
0933372	PA2008006	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0933372	PA2008006,C0933372	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0933372	SPC/GB08/018	United Kingdom		PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
0521471	SPC/GB03/033	United Kingdom		PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321
0521471	C300125	Netherlands		PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106

Last updated: July 21, 2026

NAVSTEL (Drug) market dynamics and financial trajectory: sales drivers, competition, exclusivity, and revenue exposure

Navstel’s market trajectory is not assessable from the information provided. There is not enough reliable, complete data to identify the active ingredient, approved indications, dosage forms, FDA approval date, U.S. launch timing, manufacturer, channel mix, pricing history, or current commercial sales. Without those inputs, a defensible market- and finance-oriented analysis (including exclusivity/Orange Book status, generic/biosimilar threat timing, and litigation/Paragraph IV risk) cannot be produced.

What is NAVSTEL’s active ingredient, indication mix, and dosing form distribution?

Answer (data required): NAVSTEL cannot be mapped to a specific drug product profile (active ingredient, strength, dosage form, and labeled indications) from the information available.

Which FDA-approved indications drive sales for NAVSTEL?

Answer (data required): Indication-level revenue drivers cannot be determined without the FDA label for the specific NAVSTEL product.

How is NAVSTEL marketed by specialty vs primary care channels?

Answer (data required): Channel mix cannot be determined without commercial reporting for NAVSTEL’s product.

What are NAVSTEL’s wholesale acquisition cost (WAC) and net price levels?

Answer (data required): Pricing and net-to-gross levels require product-specific pricing data.

How competitive is NAVSTEL’s landscape: which drugs substitute and how fast do payers switch?

Answer (data required): Competitor mapping cannot be completed without identifying NAVSTEL’s therapeutic class and mechanism of action.

Are there therapeutic rivals with faster access programs or lower copays?

Answer (data required): Payer design, formulary placement, and access programs cannot be assessed without plan and reimbursement data for NAVSTEL’s class.

Does NAVSTEL face step therapy or prior authorization barriers?

Answer (data required): Reimbursement restrictions depend on the labeled indication and payer policies for NAVSTEL’s specific NDC.

How do biosimilars or generics affect NAVSTEL indirectly via class competition?

Answer (data required): Cross-competitor substitution needs NAVSTEL’s ingredient and class.

When does NAVSTEL lose exclusivity: what is the Orange Book status and patent expiration timeline?

Answer (data required): Exclusivity loss timing cannot be calculated without Orange Book/NDA or BLA identifiers for NAVSTEL.

What patents protect NAVSTEL under Orange Book listings?

Answer (data required): Patent numbers, assignees, and expiration dates cannot be listed without Orange Book access.

What is NAVSTEL’s exclusivity type: NCE, 3-year, 5-year, 7-year, or pediatric?

Answer (data required): Exclusivity classification requires the specific FDA approval history.

When could Paragraph IV litigation create earlier generic entry risk?

Answer (data required): Filing dates and relevant settlement windows cannot be evaluated without the litigation record.

What generic entry risks exist for NAVSTEL and what launch scenarios are plausible?

Answer (data required): Generic launch timing cannot be evaluated without knowing NAVSTEL’s patent estate, method/formulation coverage, and any filed ANDA challenges.

How many ANDAs have been filed against NAVSTEL, and what do they challenge?

Answer (data required): ANDA and Paragraph IV records cannot be enumerated without the relevant NDA reference and patent list.

How strong is NAVSTEL’s patent estate against bioequivalent and formulation workarounds?

Answer (data required): Patent strength assessment requires claim-level content and expiration mapping.

What NAVSTEL patent litigation affects timelines and damages exposure?

Answer (data required): Litigation status and settlement posture cannot be determined without case dockets, court filings, and settlement terms.

Are there scheduled trials, injunction outcomes, or stay periods impacting entry?

Answer (data required): Trial and injunction timelines depend on the specific litigation docket.

Do settlement agreements include “no-AG” or design-around limitations?

Answer (data required): Settlement terms require access to the relevant agreement and court record.

What is NAVSTEL’s FDA regulatory status: approval pathway, REMS, and post-marketing requirements?

Answer (data required): Regulatory status cannot be established without the product’s FDA NDA/BLA details.

Is NAVSTEL subject to a REMS or specific post-marketing commitments?

Answer (data required): REMS requirements and PMCs depend on the specific approval.

Did NAVSTEL use an accelerated pathway or label expansions that changed the revenue outlook?

Answer (data required): The label change history cannot be determined without the FDA review timeline.

How do NAVSTEL’s manufacturing and supply constraints affect revenue stability?

Answer (data required): Manufacturing risks cannot be tied to NAVSTEL without plant-level data, quality records, and supply history.

Are there FDA warning letters, 483 observations, or batch recalls tied to NAVSTEL?

Answer (data required): Quality and compliance events require product-specific regulatory inspection history.

Can contract manufacturing switching drive gross margin volatility for NAVSTEL?

Answer (data required): Margin volatility requires cost-of-goods data and supply chain contracts.

NAVSTEL financial trajectory: revenue curve, margin profile, and funding dynamics

Answer (data required): NAVSTEL’s financial trajectory cannot be quantified without revenue, profitability, and earnings-release data tied to the specific company and product.

What are NAVSTEL annual sales, growth rate, and peak-year estimate range?

Answer (data required): Sales volumes and revenue require product-level market data.

What gross margin and SG&A leverage does NAVSTEL show as it scales?

Answer (data required): Margin profile requires financial statement or segment disclosure mapped to NAVSTEL.

Is NAVSTEL cash-flow positive, or does it rely on parent-company funding?

Answer (data required): Funding status needs company financials.

How sensitive is NAVSTEL revenue to price erosion and rebate pressure?

Answer (data required): Price and rebate sensitivity require net pricing and payer mix.

How does NAVSTEL compare with peer drugs in its class on adoption speed and durability?

Answer (data required): Peer comparison requires NAVSTEL’s MOA/class and a set of labeled competitors with comparable launch timelines.

Which peers show similar reimbursement behavior and formulary outcomes?

Answer (data required): Peer set depends on NAVSTEL’s therapeutic category.

What is the typical time-to-peak and time-to-recession for comparable products?

Answer (data required): Requires class-level adoption studies tied to known products.

---

Key Takeaways

• NAVSTEL’s market dynamics and financial trajectory cannot be assessed with the information available because the specific drug product (active ingredient, NDA/NDC, indications, and manufacturer) is not identified.
• A defensible analysis requires at minimum the product identity to link FDA regulatory status, Orange Book exclusivity/patents, generic entry risk, and commercial sales/price-rebate dynamics.

FAQs

1. What is NAVSTEL’s NDA/BLA number and which Orange Book patents list its exclusivity?
2. Has any generic or biosimilar been approved or had an ANDA/Paragraph IV filing against NAVSTEL?
3. What is NAVSTEL’s labeled indication and what patient population drives formulary placement?
4. What is NAVSTEL’s pricing history and net-to-gross trend over the last 12 to 36 months?
5. Are there any NAVSTEL supply disruptions, recalls, or manufacturing quality events that affected sales?

References

1. [No sources can be cited because NAVSTEL’s specific FDA product identifiers and label/patent records were not provided.]