SOHONOS Drug Patent Profile

Which patents cover Sohonos, and what generic alternatives are available?

Sohonos is a drug marketed by Ipsen and is included in one NDA. There are nine patents protecting this drug.

This drug has fifty-nine patent family members in twenty-three countries.

The generic ingredient in SOHONOS is palovarotene. One supplier is listed for this compound. Additional details are available on the palovarotene profile page.

DrugPatentWatch^® Generic Entry Outlook for Sohonos

Sohonos will be eligible for patent challenges on August 16, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 16, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SOHONOS

International Patents:	59
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	113
Drug Prices:	Drug price information for SOHONOS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOHONOS
What excipients (inactive ingredients) are in SOHONOS?	SOHONOS excipients list
DailyMed Link:	SOHONOS at DailyMed

See drug prices for SOHONOS

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

Constraining patent/regulatory exclusivity:

FOR THE REDUCTION IN VOLUME OF NEW HETEROTOPIC OSSIFICATION IN ADULTS AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER FOR FEMALES AND 10 YEARS AND OLDER FOR MALES WITH FIBRODYSPLASIA OSSIFICANS PROGRESSIVA (FOP)

NDA:

215559

Dosage:

CAPSULE;ORAL

^*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.

Pharmacology for SOHONOS

Drug Class

Retinoid

US Patents and Regulatory Information for SOHONOS

SOHONOS is protected by nine US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on FOR THE REDUCTION IN VOLUME OF NEW HETEROTOPIC OSSIFICATION IN ADULTS AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER FOR FEMALES AND 10 YEARS AND OLDER FOR MALES WITH FIBRODYSPLASIA OSSIFICANS PROGRESSIVA (FOP).

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
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-004	Aug 16, 2023		RX	Yes	No	12,138,245
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-003	Aug 16, 2023		RX	Yes	No
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-005	Aug 16, 2023		RX	Yes	Yes	9,314,439
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-005	Aug 16, 2023		RX	Yes	Yes	11,622,959
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-005	Aug 16, 2023		RX	Yes	Yes	12,023,312
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-005	Aug 16, 2023		RX	Yes	Yes

EU/EMA Drug Approvals for SOHONOS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Ipsen Pharma	Sohonos	palovarotene	EMEA/H/C/004867Treatment of fibrodysplasia ossificans progressiva.	Refused	no	no	yes		2023-07-17

International Patents for SOHONOS

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

Country	Patent Number	Title	Estimated Expiration
Australia	2011296080
Brazil	112013004685
Canada	2809374
Chile	2013000580
China	103200937
China	111773213

SOHONOS market dynamics and financial trajectory: pricing, demand drivers, payer access, competition, and earnings exposure

Last updated: June 7, 2026

Executive summary SOHONOS (utilizing therapeutics in US market: be aware of dosing shifts and payer restrictions as key levers) is in early-commercial scaling, with financial performance shaped primarily by (1) US payer contracting and prior authorization adoption, (2) persistence and dose intensity, (3) competitive substitution pressure from established and emerging therapies used for the same orphan or targeted indication, and (4) manufacturing supply stability that affects refill-driven revenue. The near-term revenue trajectory is most sensitive to formulary placement and net price realization versus list price, while the mid-term trajectory is most sensitive to head-to-head or class-level uptake dynamics and any label expansions that expand addressable patient volume.

What is SOHONOS and what market does it compete in?

SOHONOS is an orally dosed prescription therapy positioned for a specific patient population within its therapeutic area. Its market dynamics track the economics of specialty pharmaceuticals: high upfront adoption effort, concentrated prescriber influence, heavy payer gatekeeping, and revenue concentration by a limited set of channels and accounts.

Key market structure for SOHONOS uptake

• Specialty pharmacy distribution and hub services drive first dispensing speed.
• Prior authorization and step therapy determine earliest payer adoption.
• Specialty utilization management and copay support influence patient retention and switching delay.
• Claims-based persistence becomes the dominant revenue driver after the initial launch ramp.

What demand signals determine SOHONOS financial trajectory?

The commercial trajectory usually hinges on:

• New starts per month (measure of conversion from eligible patient base)
• Days supply and refill cadence (measure of persistence)
• Specialty pharmacy fill rate and delays (measure of supply and operational friction)
• Net pricing versus list and payer mix (measure of revenue per prescription)

Because SOHONOS pricing and access are the main levers after launch, net-to-gross and contracted discounts are typically the first gap between reported topline and modeled demand.

How does SOHONOS pricing and payer access shape revenue growth?

For specialty therapies, revenue trajectory correlates tightly with the gap between gross and net price.

Net price drivers

• Formulary tier and utilization management rules (PA criteria and renewal timing)
• Discounting via rebates and managed care contracting
• Specialty pharmacy dispensing fees and billing practices
• Patient out-of-pocket burden and copay assistance restrictions

Access timeline: what matters and when

Launch-year performance is dominated by:

• 1H: coverage determination, PA standardization, and early payer wins
• 2H: broader formulary placement, fewer denials, faster approvals, reduced administrative friction
• Year 2: persistence and payer expansion that smooths volatility from initial uptake

What financial trajectory should investors expect for SOHONOS?

A specialty drug’s revenue path typically follows a ramp, then plateau or step-up with expansion or reduced payer friction.

Early commercialization pattern

• Revenue grows faster than volume-based claims once distribution channels stabilize.
• Net revenue can lag list price changes as contracts renew.
• Gross margin is sensitive to manufacturing costs, supply allocation, and specialty distribution cost-to-serve.

Trajectory inflection points

Revenue step-ups generally come from:

• Additional payer coverage and broader benefit design
• Geographic expansion in covered patient groups
• Demonstrated effectiveness leading to reduced discontinuation
• Any label expansion that increases eligible population

Revenue downshifts generally come from:

• Preferential placement of competing therapies
• Payer push for step therapy or narrower PA criteria
• Safety or tolerability signals affecting persistence

When does SOHONOS face exclusivity pressure or generic entry risk?

For branded specialty medicines, exclusivity pressure is assessed using three timelines: patent term end, regulatory exclusivity expiry, and anticipated approval pathway timing for generics or biosimilars (if applicable to the molecule class).

What to monitor for SOHONOS exclusivity

• Patent expiration schedule (composition, method-of-use, and formulation)
• Regulatory exclusivity in the US (application pathway dependent)
• Any Paragraph IV filings (if present) and litigation timelines
• Settlement agreements that define “design-around” or launch dates

Which patents protect SOHONOS and how strong is the patent estate?

Patent strength for revenue durability depends on whether SOHONOS is protected by:

• Composition-of-matter patents (highest barrier)
• Method-of-use patents tied to specific dosing regimens and patient selections
• Formulation or manufacturing method patents (barriers to generic substitution even after composition expiry)
• Orange Book-listed patents that constrain FDA approval design-arounds

Patent estate impact on commercial risk

• If composition patents dominate, generic launch is delayed until near term expiration.
• If method-of-use and formulation patents dominate, the generic may launch but with narrower use, leading to slow penetration or limited physician adoption.

What is the Orange Book status of SOHONOS?

Orange Book status is central to assessing:

• Number of listed patents
• Patent types by category (drug substance, drug product, method of use)
• Expiration dates and any later than expected listed patents that extend usable exclusivity
• Whether “use” restrictions can be used for litigation leverage

What generic entry risks exist for SOHONOS?

Generic entry risk should be modeled through:

• Whether FDA can approve via Abbreviated New Drug Application (ANDA) on launch day
• Whether listed use patents will trigger Paragraph IV challenges
• Likely litigation duration and probability of settlement
• Whether a generic launch would be “full” (no meaningful clinical or label constraints) or “partial” (limited to non-patented indications or regimens)

Common specialty-drug penetration dynamics

Even with approval, generics often achieve slower penetration if:

• The brand has strong persistence and prescriber familiarity
• Payers require PA for generic and brand
• Safety and dosing convenience create switching friction
• Manufacturer supply constraints affect access

How does SOHONOS compare with competing therapies in market share dynamics?

SOHONOS competition is typically shaped by:

• Therapeutic class switching costs (treatment history)
• Clinical differentiation that affects prescribing
• Payer preferences driven by total cost of care
• Institutional formularies versus community adoption rates

Competitive forces that determine share

• Coverage and net price competitiveness relative to incumbents
• Evidence strength in real-world settings and adherence support
• Product handling, dosing convenience, and tolerability profile
• Contracting leverage by pharmacy benefit managers

What patent litigation affects SOHONOS and how does it influence launch timing?

Patent litigation timing affects launch paths in two ways:

• It delays FDA approvals through injunctions or settlement
• It constrains launch design (label carveouts, restricted dosing, or limited populations)

Litigation signals to track

• Case filings and case schedules
• Markman hearings and claim construction outcomes
• Settlement press releases that disclose launch dates or carve-outs
• Court outcomes that either preserve brand protection or open the door earlier

How does SOHONOS manufacturing and supply stability affect financial results?

Supply disruptions are a direct revenue risk:

• Missed refills and delayed patient access reduce persistence-linked revenue
• Specialty pharmacy fill rates affect patient continuity and payer trust
• Cost of goods can shift margins through expedited shipping, higher raw material costs, or production inefficiencies

Operational metrics that correlate with revenue

• Fill rate and days of supply availability
• Backorder frequency and duration
• Gross-to-net volatility linked to supply lot-level variations
• Contractual penalties tied to service-level agreements

What is the revenue exposure of SOHONOS under different market scenarios?

The revenue exposure framework for investors is typically modeled across three dimensions:

1. Demand volume: eligible patient starts and refill persistence
2. Net price: payer mix and rebate intensity
3. Duration: exclusivity and competitive displacement curve

Scenario grid (directional)

• Base: continued formulary expansion and stable persistence, modest pricing pressure
• Upside: faster payer inclusion, broader prescriber adoption, and reduced discontinuation
• Downside: heightened payer restrictions, faster switch to competitors, and margin compression from cost of goods or discounting

Key takeaways

• SOHONOS revenue trajectory is driven mainly by payer access, net price realization, persistence, and supply stability after the initial launch ramp.
• Exclusivity and patent estate structure determine the timing and probability of generic substitution and label-based erosion.
• Litigation outcomes, if any, can materially shift commercialization timing and expected earnings by altering launch or entry design.
• Competitive pressure is likely to be managed through formulary contracting, PA simplification, and payer confidence in tolerability and real-world effectiveness.

FAQs

1. How does prior authorization impact SOHONOS net revenue and monthly new starts?
2. What metrics best predict SOHONOS persistence and long-term revenue beyond launch?
3. How should SOHONOS exclusivity be modeled across patent expiry versus regulatory exclusivity?
4. What settlement terms most influence generic launch timing for SOHONOS?
5. How do specialty pharmacy fill-rate and supply constraints translate into financial guidance changes for SOHONOS?

References

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