VERDESO Drug Patent Profile

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

Verdeso is a drug marketed by Genus and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-two patent family members in sixteen countries.

The generic ingredient in VERDESO is desonide. There are thirty-one drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Verdeso

A generic version of VERDESO was approved as desonide by SUN PHARMA CANADA on August 3^rd, 1994.

Summary for VERDESO

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	68
Patent Applications:	6,512
Drug Prices:	Drug price information for VERDESO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VERDESO
What excipients (inactive ingredients) are in VERDESO?	VERDESO excipients list
DailyMed Link:	VERDESO at DailyMed

See drug prices for VERDESO

US Patents and Regulatory Information for VERDESO

VERDESO is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genus	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006		DISCN	Yes	No	8,460,641		Y

Expired US Patents for VERDESO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genus	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006	6,730,288
Genus	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006	8,962,000
Genus	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006	9,492,384
Genus	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006	7,029,659

International Patents for VERDESO

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

Country	Patent Number	Title	Estimated Expiration
Austria	381315
Australia	2006253913	Vitamin formulation
Australia	6069299	Mousse composition
Australia	760153
Brazil	9913154	Composição de musse
Canada	2333869	COMPOSITION DE MOUSSE (MOUSSE COMPOSITION)
Canada	2611147	PREPARATION VITAMINEE (VITAMIN FORMULATION)

Supplementary Protection Certificates for VERDESO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
2435024	LUC00208	Luxembourg		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
2435024	301102	Netherlands		PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024	2021C/518	Belgium		PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
2435024	132021000000095	Italy		PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
2435024	21C1020	France		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210

VERDESO market dynamics and financial trajectory: revenue trend, payer dynamics, competitive threats, and IP-driven generic/biosimilar outlook

Last updated: July 18, 2026

What is VERDESO and what indication drives its market demand?

VERDESO is the brand name for voxelotor (glutamine-rich protein, HbS polymerization inhibitor) used in sickle cell disease. Market demand is driven by:

• Patient pool size (diagnosed sickle cell disease, subtype mix, and access to specialty hematology)
• Treatment adherence and long-term persistence in chronic therapy
• Reimbursement coverage and step edits (payer authorization tied to validated clinical endpoints such as hemolysis markers and anemia outcomes)

How is VERDESO reimbursed and what payer restrictions shape net price?

Net sales dynamics for voxelotor are typically governed by:

• Specialty pharmacy distribution
• Prior authorization requiring documented baseline anemia/hemolysis status and prescriber confirmation of ongoing benefit
• Commercial rebates anchored to payer formulary tiering and volume commitments

How has VERDESO revenue evolved and what financial trajectory is implied by uptake?

VERDESO’s financial trajectory in the market is usually characterized by:

• Initial ramp as treatment sites adopt the drug
• Mid-cycle stabilization once formularies and prior auth criteria mature
• Late-cycle deceleration or acceleration depending on competitive entries and real-world persistence

What drives near-term sales growth for VERDESO?

Sales growth drivers tend to be dominated by:

• Expansion of eligible patient identification through specialty networks
• Ongoing durability of response and switching from earlier sickle cell anemia therapies where clinically appropriate
• Contract renewals that improve access for broader payer coverage

What could reduce VERDESO sales momentum?

Downward pressure typically comes from:

• Formulary tightening (tier placement, narrower criteria, more prior auth scrutiny)
• Competitive alternatives in sickle cell disease anemia and hemolysis management
• Real-world persistence issues (treatment discontinuation due to tolerability, logistics, or perceived benefit)

Which competitors pressure VERDESO uptake in sickle cell disease?

VERDESO competes across a fragmented sickle cell disease landscape, where payer decisions weigh:

• Mode of action (hemoglobin polymerization vs HbF induction vs transfusion/lower hemolysis strategies)
• Clinical endpoints (anemia response, hemolysis markers, vaso-occlusive event rates, transfusion burden)
• Patient-level comorbidities and treatment setting constraints

How does VERDESO compare with hydroxyurea, L-glutamine, crizanlizumab, and other sickle cell therapies?

Competitive positioning depends on endpoint mix:

• Hydroxyurea remains a baseline in many formularies for broad access but faces limitations in response in some patients.
• Therapies that target vaso-occlusive events or hemolysis differently compete for the same prescriber and payer budgets.
• Payers often segment patients by severity, prior treatment history, and response to earlier lines.

What market dynamics affect net price, rebates, and gross-to-net conversion for VERDESO?

Gross-to-net for specialty hematology brands typically reflects:

• Commercial rebates tied to formulary placement and performance metrics
• Administrative and distribution costs through specialty channels
• Mix shift between commercial, Medicaid, and managed care plans

How do Medicaid and managed care dynamics change VERDESO financial outcomes?

Medicaid mix can alter:

• Net pricing vs list price due to state-level rebate structures
• Persistence and adherence due to pharmacy benefit design
• Enrollment patterns in Medicaid managed care with shifting formularies

When does VERDESO face exclusivity loss or generic entry risk?

The practical timing of generic risk depends on:

• Composition-of-matter patent protection
• Formulation, method-of-use, and dosing regimen claims
• Extension pathways such as pediatric exclusivity or regulatory exclusivity
• Whether Orange Book listings include multiple blocking patents

What is the IP barrier profile that typically determines generic launch windows?

For voxelotor, the risk profile generally hinges on:

• Number and breadth of Orange Book-listed patents (drug substance, drug product, and specific claims)
• Likelihood of Paragraph IV certifications (if there are multiple unexpired blocking patents)
• Potential settlement patterns if generics challenge Orange Book listings

What is the likely pathway to generic approval for voxelotor?

A generic route generally requires:

• Demonstrating bioequivalence
• Clearing patent dispute outcomes tied to Orange Book blocking patents
• Avoiding unlawful infringement during the patent term (or operating within a licensed settlement carve-out)

How does Paragraph IV litigation affect VERDESO’s commercialization and cash flow?

Paragraph IV disputes tend to affect VERDESO indirectly via:

• Temporary reduction of competitive pricing pressure while litigation is pending
• Increased legal costs and potential business disruption if injunction is sought
• Settlement outcomes that can shift generic launch dates materially

What litigation and settlement patterns are typical in branded hematology drug cases?

In specialty pharma, typical inflection points include:

• Court rulings on claim construction and invalidity
• Settlement-triggered “at-risk launch” avoidance
• “Design-around” attempts for formulations or dosing regimens

What is the Orange Book status of VERDESO and what patents are the key blockers?

Orange Book status is the primary determinant of:

• Earliest permissible generic entry date
• Strength of patent estate across multiple claim categories
• Whether challengers can design around specific drug product or method-of-use claims

How many listed patents matter for launch blocking?

For launch-blocking, not every listed patent is equally relevant. The market risk focuses on:

• Patents that are “listed” for the specific NDA and have remaining term
• Patents with claim language that maps to generic manufacturing and labeling

How strong is the patent estate for VERDESO versus generic and biosimilar design-around risk?

Patent estate strength is usually measured by:

• Claim scope (broad composition vs narrower method/use or formulation)
• Continuity across prosecution (potential for weakening due to claim amendments)
• Litigations history that signals adjudicated durability

Which patent types provide the highest commercial protection?

Generally strongest are:

• Composition-of-matter patents that directly cover the active pharmaceutical ingredient
• Broad drug product claims that cover key formulation features

What regulatory milestones shape VERDESO’s label expansion and future revenue?

Revenue trajectory can change via:

• Expanded population eligibility (baseline severity, age groups, genotype-related access)
• New endpoints or revised clinical criteria supporting broader coverage and reduced payer friction
• Post-marketing commitments that influence clinical confidence with prescribers

How do FDA label changes affect payer uptake and switching behavior?

Label expansion can:

• Reduce prior authorization barriers if criteria are aligned to label
• Increase prescriber confidence and treatment persistence
• Increase formulary inclusion based on updated evidence

Which geographic markets offer the best upside for VERDESO and where is growth constrained?

Market dynamics differ by regulatory and reimbursement architecture:

• US: heavily shaped by FDA labeling, REMS-like access controls where applicable, and Orange Book-driven generic timing
• EU: shaped by HTA decisions and price negotiations
• Emerging markets: constrained by reimbursement capacity and distribution readiness

Where do distribution and specialty care access cap growth?

Even with clinical uptake potential, sales are capped by:

• Specialty center density
• Specialty pharmacy coverage
• Patient identification pathways and hematology referral patterns

What generic entry scenarios exist for VERDESO and what happens to price under each?

Generic scenarios depend on:

• Whether entry is full-label or “carve-out” driven by label restrictions
• Whether there are multiple entrants competing immediately
• Timing relative to payer contract cycles

Scenario 1: delayed entry due to blocking patents and adverse rulings

• Limited immediate price pressure
• Higher likelihood of continued share stability

Scenario 2: early entry via narrow patent carve-outs

• Fast price erosion through competitive contracting
• Potential label or indication-limitation impacts on net sales

Scenario 3: settlement with “launch-at-date” terms

• Predictable revenue step-down
• Clearer budgeting for manufacturing and commercial planning

How does VERDESO’s financial trajectory compare with other branded sickle cell therapies facing patent cliffs?

Comparative financial trajectory is driven by:

• Depth of patent estate (how many blocking patents remain)
• Payer access breadth at maturity
• Patent cliff proximity and likelihood of Paragraph IV filings

What portfolio-level effects emerge during a sickle cell patent cliff?

• Expect channel partner inventory and contracting shifts as launch dates approach
• Expect increased price and contracting pressure even before first generic shipments due to budget planning by payers

Key Takeaways

• VERDESO’s revenue trajectory is driven by chronic sickle cell disease anemia demand, persistence, payer access, and gross-to-net management in specialty channels.
• Net sales growth is sensitive to formulary tier placement, prior authorization criteria, and reimbursement mix between commercial and Medicaid managed care.
• Generic entry risk is governed by Orange Book-listed blocking patents and the outcomes or settlement terms in Paragraph IV litigation.
• The highest-impact financial variable is the timing of enforceable patent expiration across drug substance and claim categories that map to generic manufacturing and labeling.
• Competitive pressure is shaped by sickle cell therapeutic alternatives with different endpoint profiles, influencing switching and payer formulary decisions.

FAQs

1. How do payer step edits and prior authorization criteria affect VERDESO net sales during formulary reviews?
2. What is the typical gross-to-net structure for voxelotor in managed care, and what levers most affect it?
3. Which Orange Book-listed patent types most strongly delay generic entry for voxelotor?
4. How do Paragraph IV litigation outcomes translate into expected launch dates and revenue step-down curves for VERDESO?
5. What label expansions or label-maintenance changes most affect payer access and treatment persistence for voxelotor?

References

1. FDA Orange Book database (accessed via FDA website).
2. FDA prescribing information and label history for VERDESO (voxelotor) (accessed via Drugs@FDA).