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
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 |
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.
Anatomical Therapeutic Chemical (ATC) Classes for SOHONOS
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA
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
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 | ||||
>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 |
---|---|---|---|
Poland | 3721880 | ⤷ Try a Trial | |
South Korea | 102486607 | ⤷ Try a Trial | |
Brazil | 112013004685 | composição e método para reparação e regeneração muscular | ⤷ Try a Trial |
Australia | 2017276835 | Methods for treating heterotopic ossification | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |