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 eight 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:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	153
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 eight 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	215559-005	Aug 16, 2023		RX	Yes	Yes	11,622,959
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-004	Aug 16, 2023		RX	Yes	No	10,864,194
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
Brazil	112018075422
European Patent Office	3721880
China	111773213	用于肌肉修复和再生的组合物和方法 (COMPOSITION AND METHOD FOR MUSCLE REPAIR AND REGENERATION)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SOHONOS

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape is characterized by rapid innovation, stringent regulatory pathways, and evolving market demands. SOHONOS, a promising therapeutic agent, is emerging within this complex ecosystem, driven by its unique pharmacological profile and strategic development plans. This analysis explores the key market dynamics shaping SOHONOS's trajectory and projects its anticipated financial performance, drawing on current industry trends, regulatory considerations, and competitive positioning.

Overview of SOHONOS

SOHONOS is a novel drug candidate targeting [specific therapeutic area, e.g., rare genetic disorders, oncology, infectious diseases]. Its mechanism of action involves [brief mechanism description, e.g., selective enzyme inhibition, receptor modulation], potentially offering substantial benefits over existing therapies, including improved efficacy, safety profile, and dosing convenience.

The drug originated from [name of the developer, e.g., pharmaceutical innovator, biotech company], which advanced it through preclinical phases before entering clinical trials. Its progression hinges on successful outcomes from Phase II and Phase III studies, and subsequent regulatory approval processes.

Market Dynamics Influencing SOHONOS

1. Competitive Landscape and Therapeutic Need

The therapeutic landscape for [target indication] is dominated by [existing major players, e.g., biologics, small molecules], which often face limitations such as [e.g., high cost, adverse effects, limited patient subpopulations]. SOHONOS’s differentiators—[novel mechanism, ease of administration, targeted delivery]—position it as a potential disruptor, especially if clinical data validate superior efficacy or safety.

The unmet medical needs in this domain—particularly for [specific patient populations, rapid-acting needs, or resistant variants]—provide fertile ground for SOHONOS’s market entry. The demand is amplified by increasing awareness and diagnosis rates, supported by technological advances in diagnostics.

2. Regulatory Environment and Approvals

Regulatory bodies, including [FDA, EMA, other regional agencies], are emphasizing expedited pathways for breakthrough therapies, orphan drugs, or medicines addressing critical unmet needs. Given its promising profile, SOHONOS could qualify for programs like Fast Track or Orphan Drug designation, reducing time to market and influencing revenue timelines.

However, regulatory hurdles remain. Demonstrating safety and efficacy convincingly is pivotal. The company’s ongoing clinical trial results, peer-reviewed publications, and data transparency will heavily influence regulatory outcomes and timelines.

3. Pricing, Reimbursement, and Market Access

Pricing strategies for SOHONOS will depend on its clinical benefits, drug manufacturing costs, and competitive positioning. Given the high costs associated with novel therapeutics, payers are demanding evidence of cost-effectiveness, especially in markets with tight healthcare budgets.

Reimbursement negotiations will be critical, particularly in regions like the U.S. and Europe, where payers’ acceptance can make or break commercial viability. Early health economic modeling and payer engagement are therefore strategic priorities for the developer.

4. Patent Life and Market Exclusivity

Innovation protection through patents is vital to securing market exclusivity and high-margin revenue streams. The patent lifespan, typically 20 years from filing, can be extended through supplementary protections such as data exclusivity or formulations patents. These exclusivities provide critical time windows for SOHONOS to establish itself and recoup R&D investments before generic or biosimilar competitors infiltrate the market.

Financial Trajectory: Revenue, Investment, and Growth Forecasts

1. Investment and Development Costs

SOHONOS’s trajectory requires significant upfront investment, including clinical trial expenses, regulatory filing costs, and manufacturing scale-up. Industry estimates place global clinical development costs for oncology or rare disease drugs at [approximately $50-$100 million, depending on scope] (Source: [2]).

Funding for early-phase trials typically involves venture capital, public offerings, or partnership agreements. Strategic partnerships are increasingly common to share costs and risks, especially in later-stage development.

2. Revenue Projections and Market Penetration

Projected revenues for SOHONOS hinge heavily on clinical success, regulatory approval, and market entry speed. Assuming successful Phase III outcomes and completion of regulatory review within [X years], revenues could initiate around $[X] million to $[Y] billion] within 3–5 years post-launch.

Market penetration rates will depend on factors including [clinical differentiation, pricing, reimbursement, physician adoption]. Early adopters and specialty centers typically lead to initial uptake, followed by broader access as payers and guidelines endorse the therapy.

3. Pricing Strategies and Payer Dynamics

Premium pricing is common for breakthrough therapies; however, value-based pricing models are gaining prominence. For SOHONOS, a potential price of $[X]–$[Y] per treatment course, aligned with its clinical benefits, could generate substantial revenues, assuming competitive advantages hold.

In countries with nationalized healthcare, reimbursement negotiations might impose discounts, impacting profitability. Strategically, alliances with healthcare providers and patient advocacy groups can facilitate favorable access terms.

4. Long-term Financial Outlook

Over a decade, if SOHONOS secures broad indications and achieves market dominance, peak sales could reach $[Z] billion] globally, especially in high-prevalence regions. Conversely, delayed approval, safety concerns, or market entry of superior competitors could attenuate expected financial gains.

Additional revenue streams may include licensing partnerships, combination therapies, and expansion into related indications, broadening SOHONOS’s market footprint.

Market Risks and Opportunities

The pathway for SOHONOS presents several risks—regulatory delays, clinical setbacks, reimbursement resistance, or emergent competitors. Conversely, opportunities include unmet medical needs, accelerated approval pathways, and strategic alliances fostering market entry.

The evolving landscape of personalized medicine and biomarker-driven treatment paradigms bolsters SOHONOS’s prospects, provided it can demonstrate consistent clinical benefits and secure regulatory and payer buy-in.

Key Takeaways

• Strategic differentiation through innovative mechanism and targeted indications provides SOHONOS a competitive edge in a crowded market.
• Regulatory pathways and designations are pivotal; early engagement with agencies can accelerate approval.
• Market access strategies, including health economic validation and payer partnerships, are essential for sustainable revenue generation.
• Investment in clinical development must be balanced with realistic timelines to optimize financial planning.
• Long-term success depends on securing patent protections, expanding indications, and establishing a strong brand within the therapeutic area.

FAQs

1. What factors most influence SOHONOS’s market entry success?
Regulatory approval timeline, clinical efficacy and safety data, market competition, pricing strategies, and payer reimbursement policies primarily determine market entry success.

2. How do regulatory designations impact SOHONOS’s financial trajectory?
Designations like Fast Track or Orphan Drug expedite development and review, reducing time-to-market, which accelerates revenue realization and enhances profitability.

3. What are the primary risks facing SOHONOS’s commercialization?
Clinical trial failures, regulatory setbacks, unfavorable reimbursement decisions, and competitive product launches pose primary risks.

4. How do market dynamics in emerging economies affect SOHONOS’s growth potential?
Emerging markets offer sizable patient populations and expanding healthcare infrastructure, but regulatory and pricing challenges require tailored strategies.

5. What strategies can maximize SOHONOS’s long-term commercial success?
Robust clinical evidence, strategic partnerships, diversified indications, patent protections, and proactive engagement with payers and healthcare providers are key.

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Sources:

1. Market research reports on pharmaceutical development costs and commercialization strategies.
2. Industry analyses on regulatory pathways and clinical trial costs.
3. Policy updates from FDA, EMA, and other regulatory agencies.
4. Reimbursement and pricing frameworks within major healthcare markets.
5. Patent law and exclusivity guidelines in pharmaceutical innovation.