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SOHONOS Drug Patent Profile

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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 five patents protecting this drug.

This drug has fifty-one 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

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Summary for SOHONOS

International Patents:	51
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	46
Drug Prices:	Drug price information for SOHONOS
What excipients (inactive ingredients) are in SOHONOS?	SOHONOS excipients list
DailyMed Link:	SOHONOS at DailyMed

Drug patent expirations by year for SOHONOS

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

Generic Entry Date for SOHONOS^: ⤷ Try a Trial* 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.

Anatomical Therapeutic Chemical (ATC) Classes for SOHONOS

M09AX	Other drugs for disorders of the musculo-skeletal system
M09A	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M09	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M	Musculo-skeletal system

US Patents and Regulatory Information for SOHONOS

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SOHONOS is ⤷ Try a Trial.

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.

Patents protecting SOHONOS

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA

FDA Regulatory Exclusivity protecting SOHONOS

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)
Exclusivity Expiration: ⤷ Try a Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-004	Aug 16, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-005	Aug 16, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-005	Aug 16, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-001	Aug 16, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ipsen	SOHONOS	palovarotene	CAPSULE;ORAL	215559-003	Aug 16, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for SOHONOS

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for SOHONOS

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

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Country	Patent Number	Title	Estimated Expiration
Japan	2013536855		⤷ Try a Trial
Mexico	361414	COMPOSICIÓN Y MÉTODO PARA REPARACIÓN Y REGENERACIÓN MUSCULAR. (COMPOSITION AND METHOD FOR MUSCLE REPAIR AND REGENERATION.)	⤷ Try a Trial
Israel	263440	שיטות לטיפול בהתגרמות הטרוטופית (Methods for treating heterotopic ossification)	⤷ Try a Trial
Australia	2022202148	METHODS FOR TREATING HETEROTOPIC OSSIFICATION	⤷ Try a Trial
Philippines	12018502563	METHODS FOR TREATING HETEROTOPIC OSSIFICATION	⤷ Try a Trial
Colombia	6680694	Composición y método para la reparación y regeneración muscular	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration