VUSION Drug Patent Profile

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

Vusion is a drug marketed by Mylan and is included in one NDA. There is one patent protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in VUSION is miconazole nitrate; white petrolatum; zinc oxide. There are twenty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the miconazole nitrate; white petrolatum; zinc oxide profile page.

DrugPatentWatch^® Generic Entry Outlook for Vusion

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 30, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VUSION

International Patents:	1
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	2
Patent Applications:	5,422
Drug Prices:	Drug price information for VUSION
What excipients (inactive ingredients) are in VUSION?	VUSION excipients list
DailyMed Link:	VUSION at DailyMed

See drug prices for VUSION

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

NDA:

021026

Dosage:

OINTMENT;TOPICAL

^*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 VUSION

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

Sponsor	Phase
Image Dermatology P.C.	Early Phase 1
Stiefel, a GSK Company	Phase 4
GlaxoSmithKline	Phase 4

See all VUSION clinical trials

Pharmacology for VUSION

Drug Class

Azole Antifungal

US Patents and Regulatory Information for VUSION

VUSION is protected by one US patents.

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
Mylan	VUSION	miconazole nitrate; white petrolatum; zinc oxide	OINTMENT;TOPICAL	021026-001	Feb 16, 2006		RX	Yes	Yes

Expired US Patents for VUSION

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan	VUSION	miconazole nitrate; white petrolatum; zinc oxide	OINTMENT;TOPICAL	021026-001	Feb 16, 2006

International Patents for VUSION

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

Country	Patent Number	Title	Estimated Expiration
Austria	42039
Australia	3775885
Australia	569602
Canada	1250522	COMPOSITIONS POUR SOINS DERMATOLOGIQUES (SKIN CARE COMPOSITIONS)
European Patent Office	0149561	SKIN CARE COMPOSITIONS

VUSION (Verteporfin/VUSION) Market Dynamics and Financial Trajectory: Revenue Trend, Demand Drivers, Pricing, Competition, and Exclusivity Risk

Last updated: June 3, 2026

VUSION’s financial trajectory hinges on (1) adoption of the product in eligible clinical workflows, (2) payer reimbursement and pass-through economics, and (3) the pace of share loss to competing photodynamic-therapy and ophthalmic portfolio products plus eventual generic or pathway-driven erosion risks, where relevant. Without verified commercialization figures and an authoritative U.S. FDA/Orange Book and patent-litigation dossier for “VUSION,” a complete, accurate revenue and exclusivity-based forecast cannot be produced.

What is VUSION’s FDA status and how does it shape near-term sales?

Featured snippet answer: VUSION’s market timing depends on the exact FDA approval (label scope), route of administration, and whether FDA-listed exclusivities and any Orange Book-listed patents exist for each dosage form.

Which FDA label and dosage form does VUSION have in the U.S.?

Featured snippet answer: Sales ramp and utilization are label-driven. A narrow indication produces slower penetration; broader labeling supports faster prescriber adoption and higher pharmacy channel throughput.

Does VUSION use an expedited pathway or have exclusivity protections?

Featured snippet answer: Exclusivity protections determine when generic or follow-on products can enter via ANDA or 505(b)(2), and whether Paragraph IV challenges are economically viable.

What is VUSION’s Orange Book listing footprint?

Featured snippet answer: A dense Orange Book footprint (patents tied to the label and formulation) delays generic entry; a thin footprint increases the probability of earlier erosion.

How do pricing, reimbursement, and channel strategy drive VUSION revenue?

Featured snippet answer: VUSION revenue is primarily a function of net price (after rebates and discounts), payer coverage behavior, and the intensity of channel placement.

What payer economics determine VUSION net sales?

Key drivers:

• Coverage policy decisions for the underlying indication.
• Prior authorization rates and medical-necessity criteria.
• Specialty pharmacy vs buy-and-bill alignment (if administered via clinic workflows).

How do manufacturers typically reduce pricing friction for photodynamic-therapy style products?

• Outcomes-based contracting where payers require evidence of clinical utility.
• Volume-tier discounts that accelerate provider migration to the branded product.
• Narrow channel distribution to control returns and inventory.

What market dynamics affect VUSION adoption and market share?

Featured snippet answer: Adoption depends on clinical integration, physician training friction, and workflow compatibility.

How fast can VUSION diffuse into practice?

Adoption velocity is driven by:

• Ease of use and training burden.
• Compatibility with existing devices, light delivery systems, or standard-of-care pathways.
• Institutional formularies and protocol updates.

What limits switching from existing therapies?

• Clinical comfort with current standards.
• Reimbursement continuity for established regimens.
• Outcomes evidence required by payers and hospital committees.

Who competes with VUSION, and how does comparative efficacy affect profitability?

Featured snippet answer: Competitive pressure shapes both unit demand and pricing power.

Which therapy classes overlap with VUSION?

Potential overlap categories:

• Photodynamic therapy regimens.
• Local ophthalmic or dermatologic procedural treatments, depending on VUSION’s labeled indication.
• Follow-on brands using alternative photosensitizers or delivery systems.

How does product differentiation translate into gross margin?

• Strong differentiation supports premium pricing.
• Weak differentiation pulls net price down through rebates and competitive contracting.

When does VUSION lose exclusivity, and what does that mean for financial erosion?

Featured snippet answer: The exclusivity end date determines the “cliff” risk window for biosimilar-like pathway analogs (if applicable) or generic erosion under ANDA/505(b)(2).

What exclusivity types should be modeled for revenue risk?

• Patent expirations listed in Orange Book.
• Regulatory exclusivities tied to initial approvals (and any pediatric exclusivity, if present).
• Potential loss of orphan exclusivity (if applicable).
• Work-sharing and approvals that can trigger earlier-than-patent relief in certain formulations.

How is exclusivity mapped to expected market share loss?

• Generic entry typically produces an immediate pricing reset.
• Long-tail erosion depends on the number and strength of remaining formulation/method patents, as well as settlement timing.

What patent estate protects VUSION, and how strong is it financially?

Featured snippet answer: A strong estate delays generic substitution, preserving net price and protecting operating margin.

How many patents cover VUSION, and what are they for?

Patent categories to assess:

• Drug substance and polymorphs.
• Drug product/formulation (stability, solubilization, excipients).
• Method of use tied to the label.
• Device or administration-related claims if applicable.

What is the litigation landscape for VUSION generics or follow-ons?

Key litigation signals:

• Paragraph IV filings.
• Injunction history and trial milestones.
• Settlement terms that define “design-around” or delayed entry.

What generic entry risks exist for VUSION?

Featured snippet answer: Entry risk is highest where (1) Orange Book coverage is sparse, (2) formulation and method claims are weak or easy to design around, and (3) patent estates have adverse district-court or Federal Circuit history.

Which pathway would likely drive entry if exclusivity ends?

• ANDA if it qualifies as a chemically equivalent drug product.
• 505(b)(2) if it relies on literature/bridge data.
• For biologics, biosimilar pathways apply, but the “VUSION” dossier must be verified for biologic status.

How does VUSION’s financial trajectory compare with similar ophthalmic or photodynamic-therapy brands?

Featured snippet answer: Without verified unit and net sales data for VUSION, the comparison must be based on verified product class behavior: ramp-to-peak timeline, rebate pressure, and post-expiry erosion curves typical for the relevant therapeutic category.

What benchmarks normally predict post-launch revenue ceilings?

• Time to formulary listing across major payers and health systems.
• Rate of switching from incumbent therapies.
• Persistence once institutional protocols stabilize.

Market outlook: What are the revenue drivers and downside risks for VUSION?

Featured snippet answer: Upside requires sustained clinician adoption and payer acceptance at stable net prices; downside comes from competitive displacement, unfavorable coverage decisions, or earlier-than-expected erosion triggers.

Upside drivers

• Expanded label scope.
• Improved reimbursement posture and lower authorization friction.
• Better real-world outcomes supporting coverage renewal.

Downside risks

• Competitive replacements that undercut net price.
• Budget tightening by large payers leading to formulary tier shifts.
• Regulatory or litigation events that alter launch timelines.

Key Takeaways

• VUSION’s revenue trajectory is driven by label-driven adoption, payer economics, and channel integration.
• Exclusivity and Orange Book breadth are the primary determinants of post-loss-of-protection erosion timing and magnitude.
• Competitive pressure shapes both unit demand and net pricing, which flows through to gross margin and operating income.
• A complete exclusivity-driven financial forecast requires a verified FDA label, Orange Book listing, and patent/litigation map for “VUSION.”

FAQs

1. What does VUSION’s net pricing depend on: rebates, buy-and-bill economics, or payer authorization?
2. Which patent types for VUSION most effectively delay follow-on substitution?
3. How do settlement agreements typically change the timing of generic entry for drugs like VUSION?
4. What market-share signals best predict whether VUSION can expand beyond initial formulary wins?
5. How should investors model the revenue impact of exclusivity expiration for a single branded product?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-06-03).

DrugChatter Q&A for VUSION

Does Vusion treat candidal diaper dermatitis?