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 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
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Questions you can ask:
- What is the 5 year forecast for SOHONOS?
- What are the global sales for SOHONOS?
- What is Average Wholesale Price for SOHONOS?
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SOHONOS
Generic Entry 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:
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SOHONOS is ⤷ Subscribe.
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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Ipsen | SOHONOS | palovarotene | CAPSULE;ORAL | 215559-004 | Aug 16, 2023 | RX | Yes | No | 9,789,074 | ⤷ Subscribe | ⤷ Subscribe | ||||
Ipsen | SOHONOS | palovarotene | CAPSULE;ORAL | 215559-005 | Aug 16, 2023 | RX | Yes | Yes | 11,622,959 | ⤷ Subscribe | ⤷ Subscribe | ||||
>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
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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 2613776 | ⤷ Subscribe | |
Mexico | 2013002275 | COMPOSICION Y METODO PARA REPARACION Y REGENERACION MUSCULAR. (COMPOSITION AND METHOD FOR MUSCLE REPAIR AND REGENERATION.) | ⤷ Subscribe |
Denmark | 3721880 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
SOHONOS Market Analysis and Financial Projection Experimental
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