SOOLANTRA Drug Patent Profile

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

Soolantra is a drug marketed by Galderma Labs Lp and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in sixteen countries.

The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Soolantra

A generic version of SOOLANTRA was approved as ivermectin by EDENBRIDGE PHARMS on October 24^th, 2014.

Summary for SOOLANTRA

International Patents:	46
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	7
Drug Prices:	Drug price information for SOOLANTRA
Drug Sales Revenues:	Drug sales revenues for SOOLANTRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOOLANTRA
What excipients (inactive ingredients) are in SOOLANTRA?	SOOLANTRA excipients list
DailyMed Link:	SOOLANTRA at DailyMed

See drug prices for SOOLANTRA

See drug sales revenues for SOOLANTRA

Recent Clinical Trials for SOOLANTRA

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

Sponsor	Phase
Humanis Saglık Anonim Sirketi	PHASE1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2
Zydus Worldwide DMCC	Phase 3

See all SOOLANTRA clinical trials

Pharmacology for SOOLANTRA

Drug Class

Antiparasitic Pediculicide

Paragraph IV (Patent) Challenges for SOOLANTRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SOOLANTRA	Cream	ivermectin	1%	206255	1	2016-12-30

US Patents and Regulatory Information for SOOLANTRA

SOOLANTRA is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	9,233,118
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	9,782,425
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	9,089,587

Expired US Patents for SOOLANTRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	7,550,440
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	8,093,219
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	11,033,565

International Patents for SOOLANTRA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2014287408
Australia	2014287422
Brazil	112016000335

Supplementary Protection Certificates for SOOLANTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1620113	C300756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
1620113	CA 2015 00045	Denmark		PRODUCT NAME: IVERMECTIN, 22, 23-DIHYDROAVERMECTINB1A + 22,23-DIHRODROAVERMECTIN B1B FOR USE IN THE TREATMNET OF RESACEA; NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402
1620113	PA2015033	Lithuania		PRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402

Soolantra (ivermectin 1% cream) Market Dynamics and Financial Trajectory: Sales Trend, Pricing, Exclusivity, and Competitive Pressure

Last updated: June 22, 2026

Soolantra (ivermectin 1% cream) remains a niche US dermatology asset tied to rosacea. Its financial trajectory is shaped by (1) rosacea incidence and diagnosis rates, (2) treatment persistence versus topical alternatives, (3) payer coverage and net price pressure, (4) competitive cannibalization from branded and generic topical dermatology products, and (5) the patent and exclusivity timeline governing generic entry risk.

What drives Soolantra sales dynamics in US rosacea dermatology?

Soolantra is positioned for inflammatory lesions of rosacea. The core market dynamics are prescription behavior, payer restrictions, and channel mix.

Key demand drivers

• Diagnosis and treatment initiation: Rosacea treatment expands with dermatologist and primary care diagnosis patterns. Growth tends to track diagnosis rates and formulary inclusion rather than incidence alone.
• Treatment switching and persistence: Topical rosacea therapy competes on symptom control, tolerability, and time-to-response, which drives refill rates and “stay-on” behavior.
• Formulary design: Coverage often determines whether Soolantra is a preferred branded option or a step-therapy product.
• Seasonality: Rosacea symptom flares can create intra-year demand variation, particularly in higher-clinic-volume regions.

Key supply and commercial constraints

• Single-format exposure: Soolantra’s branded exposure is primarily the 1% cream format. That limits cross-formulation expansion.
• Manufacturer scale economics: A cream SKU requires stable manufacturing and distribution to avoid stock interruptions that can shift patient starts to competitors.
• Marketing intensity: Brand spend influences dermatologist awareness and early adoption. Diminishing incremental impact typically accelerates once a product loses “new-to-dermatology” attention.

How have Soolantra US pricing and payer coverage evolved, and what does that mean for net revenue?

Soolantra’s revenue trajectory is constrained by net price, rebates, and formulary access. For dermatology topicals, net pricing is usually a negotiation outcome rather than a list-price story.

Commercial levers that move net sales

• Placement vs peers: If Soolantra is placed behind alternatives, prescriber adoption slows and net price rises become harder to defend.
• Rebate intensity: As branded pricing matures, rebate pressure generally increases.
• Step therapy: If payers require failure of lower-cost actives before approval, conversion rates fall.
• Generic leakage risk: Even before final generic approvals, market rumors and near-expiry dynamics can shift prescriber preference.

Revenue math that matters

• In mature topical categories, net revenue is more sensitive to volume than pricing after rebate compression. Soolantra’s trajectory is therefore more exposed to persistence and formulary access than to list price changes.

What is the Orange Book status of Soolantra (ivermectin) and what does that imply for generic entry risk?

Soolantra’s exclusivity and patent landscape drive generic timelines. Generic erosion risk is the largest swing factor for a branded topical asset once the exclusivity window narrows.

How the market typically reprices near exclusivity events

• Pre-entry share shift: Dermatology prescribers may standardize on competitors if a generic is viewed as inevitable.
• Payer contracting behavior: PBMs and wholesalers often press for steeper discounts ahead of anticipated launches.
• Legal overhang: Paragraph IV litigation can delay entry but also encourages payer switching due to uncertainty management.

Outcome for financial trajectory

• If exclusivity remains intact, Soolantra net sales tend to show gradual decline or flat performance.
• If exclusivity is near expiration with available workaround risk, the trajectory can step down abruptly after final regulatory and litigation outcomes.

When does Soolantra lose exclusivity, and what are the key exclusivity time gates?

For a branded dermatology topical, the financial trajectory is usually segmented by:

1. Active patent protection period
2. Regulatory exclusivity runway
3. Paragraph IV or other litigation delays
4. First generic launch and subsequent second-wave products
5. Net price compression phase

The exact dates depend on the Orange Book listing for the NDA reference product and the specific patents listed for the approved strength and dosage form. Those time gates determine whether Soolantra behaves like a “steady-maturity brand” or a “decline-after-entry” asset.

How many patents protect Soolantra, and what types of patents matter most for competitive erosion?

Patent estate composition is the differentiator between “generic early entry” and “generic delayed entry with platform workarounds.”

Patent types that typically matter for topical products

• Composition of matter: Covers the drug substance, usually strongest but depends on how far it is from origination.
• Formulation patents: Cream base, excipients, rheology, and stability can create protectable differences for generics.
• Method-of-use patents: Dosing, patient selection, or clinical effect definitions can block certain label carve-outs.
• Manufacturing process: Process constraints can drive costly generic replication.

Financial implication

• Formulation and process patents tend to slow “instant substitution” even when the active ingredient is old.
• Method-of-use can lead to label fragmentation, which limits payer-driven switching.

Which companies challenge Soolantra, and what does patent litigation change about launch timing?

For market dynamics, litigation changes the timeline more than the ultimate regulatory outcome. A legal stay can delay generic entry enough to preserve the branded asset’s cash flow.

Competitive and legal mechanics

• Paragraph IV (ANDA) challenges: Can shorten or eliminate automatic exclusivity barriers but usually triggers stays.
• Settlement agreements: Often define a date-specific entry or “no launch until” structure.
• Injunction risk: Even if litigation ends favorably later, a branded company can delay entry via injunctions if patents are found valid and infringed.

Financial trajectory effect

• Litigation outcomes can produce a two-phase revenue profile:
  • Run-up phase: continued brand sales while generic entry is blocked
  • Drop phase: rapid erosion once generic launch is permitted

What formulations are protected for Soolantra, and how does that affect generic product design?

For topicals, generic risk often shifts from “active ingredient” to “delivery system equivalence.”

Typical formulation design constraints

• Cream base viscosity and spreadability
• Active stability against oxidation or degradation
• Uniformity and particle dispersion (when relevant)
• Packaging and shelf-life characteristics

Market impact

• If protectable formulation characteristics block simple equivalence, generic entry may require costly reformulation or may be delayed by further litigation.

How does Soolantra compare with alternative rosacea treatments on market competitiveness?

Soolantra competes with multiple topical rosacea regimens, including:

• Other topical anti-inflammatory and antimicrobial agents
• Topical vasomodulators
• Combination strategies used by dermatology practices

Where Soolantra tends to win

• When prescribers view efficacy for inflammatory lesions as strong and tolerability as favorable
• When payer access makes it a low-friction choice for ongoing therapy

Where Soolantra tends to lose

• When competitors gain preferred formulary placement
• When newer agents show better speed-to-response or tolerability in real-world use

Commercial outcome

• Competitive substitution is often faster once payers place a branded product on a non-preferred tier or introduce lower-cost alternatives with simpler prior authorization.

What biosimilar risk exists for Soolantra, and does it apply?

Soolantra is not a biologic. Biosimilar risk does not apply to ivermectin cream.

What generic entry risks exist for Soolantra in the US, and what launch scenarios are most likely?

Generic entry risks depend on the number and strength of listed patents, plus the type of patent coverage relevant to dosage form and labeling.

Launch scenarios

• Delayed first generic: Fewer brands switch until a clear entry date is established.
• No-interchange or label-limited substitution: Brand may retain share if generics do not match labeled patient populations or dosing directions.
• Multiple generic waves: Net price can drop further after the first generic establishes procurement benchmarks.

Financial implication

• The first generic typically drives the steepest percentage sales decline.
• Subsequent entrants accelerate price erosion and can cap brand recovery if the payer system fully resets contracting.

How does FDA regulatory status and pathway history affect Soolantra market resilience?

Soolantra’s market resilience depends on:

• The underlying NDA approval scope
• The label indications and dosage form specificity
• The robustness of listed patents attached to the approved product

If FDA changes labeling or if generics launch with carve-outs, market behavior shifts. If labeling remains fully aligned, substitution tends to be faster and more complete.

What does Soolantra’s financial trajectory look like relative to other mature dermatology brands?

For mature topical rosacea assets:

• Demand growth is often modest after the initial adoption curve.
• Revenue is usually eroded by price compression and competitor placement.
• Brands with strong patent estates show slower erosion.
• Brands facing imminent generic entry show a stepwise decline once barriers clear.

Soolantra’s trajectory should therefore be modeled as a mature brand cash-flow profile with exclusivity-gated step risk. The magnitude and timing of the step depend on Orange Book–listed protection and litigation/settlement outcomes.

Key data table: market and IP drivers that determine Soolantra revenue path

Revenue driver	What it affects	Why it matters for trajectory
Formulary positioning	Net price and share	Determines whether dermatologists treat Soolantra as preferred or restricted
Treatment persistence	Volume retention	Topicals compete on symptom control; refill rates determine steady-state sales
Patent estate strength	Generic delay	Strong formulation and method-of-use coverage can defer erosion
Litigation and settlements	Entry timing	A stay pushes revenue preservation; settlement defines entry date
Competition tiering	Switching behavior	Preferred alternatives accelerate branded decline
Net rebate pressure	Margin and net revenue	Branded net price often falls as maturity increases

Key takeaways

• Soolantra’s financial trajectory is primarily driven by payer access, treatment persistence, and the timing of generic-entry barriers.
• Patent and litigation time gates create step-change risk: revenue often stays stable or declines gradually while barriers hold, then drops after first generic launches.
• For topical rosacea, generic substitution is sensitive to formulation and label alignment, not just the active ingredient.

FAQs

1. How does payer step therapy affect Soolantra patient starts versus competitors?
2. What patent categories for topical ivermectin matter most for blocking ANDA approvals?
3. What generic launch scenarios typically produce the fastest Soolantra net sales decline?
4. How do dermatology prescribing patterns influence Soolantra persistence and annual renewal rates?
5. What Orange Book listing details most directly predict the timing of generic erosion for Soolantra?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-06-23).
2. U.S. Patent and Trademark Office. Patent full-text and image databases. (Accessed 2026-06-23).

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