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SOHONOS Drug Patent Profile

When do Sohonos patents expire, and what generic alternatives are available?

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

This drug has fifty-four patent family members in twenty-two 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:	54
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	49
Drug Prices:	Drug price information 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.

US Patents and Regulatory Information for SOHONOS

SOHONOS is protected by six 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
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-004	Aug 16, 2023		RX	Yes	No
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-005	Aug 16, 2023		RX	Yes	Yes
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-004	Aug 16, 2023		RX	Yes	No
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-001	Aug 16, 2023		RX	Yes	No

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/004867 Treatment 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
Denmark	2613776
Mexico	2013002275	COMPOSICION Y METODO PARA REPARACION Y REGENERACION MUSCULAR. (COMPOSITION AND METHOD FOR MUSCLE REPAIR AND REGENERATION.)
Denmark	3721880
Japan	5986570
Israel	224973	תכשיר להתחדשות ותיקון של שריר (Composition for muscle repair and regeneration)

SOHONOS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SOHONOS

Introduction

SOHONOS, also known as palovarotene, is a groundbreaking treatment for the ultra-rare genetic disease fibrodysplasia ossificans progressive (FOP). After a long and challenging development process, SOHONOS has finally gained FDA approval, marking a significant milestone in the treatment of this debilitating condition.

The Disease: Fibrodysplasia Ossificans Progressive (FOP)

FOP is an extremely rare disease, affecting approximately 400 people in the United States. It causes the formation of extra bone tissue, leading to loss of mobility and a significantly reduced life expectancy, with most patients requiring a wheelchair by age 30 and a life expectancy of around 56 years[4].

Development and Approval Journey

The development of SOHONOS was marked by numerous challenges. Initially developed by Roche, the drug was later acquired by Clementia Pharmaceuticals and subsequently by Ipsen in 2019 for $1 billion. Despite being referred to as a "largely de-risked" asset, SOHONOS faced multiple clinical trial holds, safety concerns, and regulatory setbacks before finally receiving FDA approval in 2023[4].

Clinical Efficacy

The pivotal phase 3 trial demonstrated that SOHONOS reduces new bone growth by 54%, providing the first effective therapy for patients with FOP. This efficacy data was crucial in securing FDA approval, despite earlier setbacks and safety flags[4].

Pricing and Cost-Effectiveness

SOHONOS is priced at $624,000 annually for a 5-mg daily dose, with the dosage adjusted based on disease severity and patient weight. This pricing has raised concerns about cost-effectiveness. According to the Canadian Agency for Drugs and Technologies in Health (CADTH), the incremental cost-effectiveness ratio (ICER) for SOHONOS plus standard of care (SoC) is $13,055,900 per quality-adjusted life-year (QALY) gained, which is not cost-effective at a $50,000 per QALY willingness-to-pay threshold. This suggests that a price reduction may be necessary for SOHONOS to be considered cost-effective[1].

Financial Impact on Healthcare Systems

The high cost of SOHONOS is expected to have a significant financial impact on healthcare systems. CADTH estimates that SOHONOS could cost public drug plans approximately $14,336,341 over the next three years based on public list prices. This financial burden highlights the need for careful consideration of pricing and reimbursement strategies[1].

Market Competition

While SOHONOS is currently the only approved treatment for FOP, it may face competition in the future. Regeneron has a pipeline drug set for FDA submission next year, which could potentially challenge SOHONOS's market position[4].

Regulatory and Safety Considerations

SOHONOS carries a boxed warning for the risk of premature closure of growth plates in children, which can cause bone deformities and stunted growth, as well as a warning for embryo-fetal toxicity. These safety concerns were significant factors in the regulatory approval process and will continue to be monitored post-approval[4].

Impact on Pharmaceutical Market Trends

The approval and pricing of SOHONOS reflect broader trends in the pharmaceutical industry. The market is characterized by growing healthcare expenditure, increased investments in research and development, and a focus on rare and orphan diseases. The use of advanced technologies such as biomarkers, next-generation biologics, and personalized medicine is also on the rise, influencing the development and pricing of new drugs[3].

Future Outlook and Challenges

Despite the challenges faced during its development, SOHONOS represents a significant advancement in the treatment of FOP. However, its high cost and potential competition from other pipeline drugs pose ongoing challenges. Ipsen must navigate these challenges while ensuring that the drug remains accessible to patients who desperately need it.

Economic and Industry Factors

The pharmaceutical industry is subject to various economic and industry factors, including general industry conditions, competition from generic products, regulatory changes, and global economic fluctuations. These factors can significantly impact the commercial success and market trajectory of drugs like SOHONOS[2].

Patient Access and Affordability

Ensuring patient access and affordability is crucial for the success of SOHONOS. Given its high cost, there may be a need for innovative pricing models, patient assistance programs, or negotiations with healthcare payers to make the drug more accessible to those who need it.

Conclusion

The market dynamics and financial trajectory of SOHONOS are complex and influenced by multiple factors, including clinical efficacy, regulatory approvals, pricing, and competition. While SOHONOS offers a groundbreaking treatment for FOP, its high cost and potential safety concerns necessitate careful management to ensure it remains a viable and accessible option for patients.

Key Takeaways

• SOHONOS is the first FDA-approved treatment for FOP, reducing new bone growth by 54%.
• The drug is priced at $624,000 annually, raising concerns about cost-effectiveness.
• SOHONOS faces potential competition from other pipeline drugs.
• Regulatory and safety considerations are critical due to the drug's boxed warnings.
• The pharmaceutical industry's broader trends, including increased R&D expenditure and a focus on rare diseases, influence SOHONOS's market position.

FAQs

Q: What is SOHONOS used to treat?

A: SOHONOS is used to treat fibrodysplasia ossificans progressive (FOP), a rare genetic disease that causes the formation of extra bone tissue.

Q: How much does SOHONOS cost?

A: SOHONOS is priced at $624,000 annually for a 5-mg daily dose, with the dosage adjusted based on disease severity and patient weight.

Q: What were the challenges in the development of SOHONOS?

A: The development of SOHONOS faced multiple clinical trial holds, safety concerns, and regulatory setbacks before finally receiving FDA approval.

Q: Is SOHONOS cost-effective?

A: According to CADTH, SOHONOS is not cost-effective at a $50,000 per QALY willingness-to-pay threshold, suggesting a price reduction may be necessary.

Q: What are the potential safety concerns associated with SOHONOS?

A: SOHONOS carries a boxed warning for the risk of premature closure of growth plates in children and a warning for embryo-fetal toxicity.

Sources

1. NCBI Bookshelf: Palovarotene (Sohonos) - NCBI Bookshelf
2. Ipsen: Ipsen provides update on palovarotene clinical programs
3. Research and Markets: Pharmaceutical Drugs Global Market Report 2024
4. FiercePharma: After much trial and error, Ipsen scores FDA nod for Sohonos