Details for New Drug Application (NDA): 215559
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NDA 215559 describes SOHONOS, which is a drug marketed by Ipsen and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the SOHONOS profile page.
The generic ingredient in SOHONOS is palovarotene. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the palovarotene profile page.
The generic ingredient in SOHONOS is palovarotene. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the palovarotene profile page.
Summary for 215559
| Tradename: | SOHONOS |
| Applicant: | Ipsen |
| Ingredient: | palovarotene |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215559
Generic Entry Date for 215559*:
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) 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 NDA: 215559
Suppliers and Packaging for NDA: 215559
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOHONOS | palovarotene | CAPSULE;ORAL | 215559 | NDA | Ipsen Biopharmaceuticals, Inc. | 15054-0010 | 15054-0010-1 | 1 BLISTER PACK in 1 CARTON (15054-0010-1) / 14 CAPSULE in 1 BLISTER PACK |
| SOHONOS | palovarotene | CAPSULE;ORAL | 215559 | NDA | Ipsen Biopharmaceuticals, Inc. | 15054-0015 | 15054-0015-1 | 1 BLISTER PACK in 1 CARTON (15054-0015-1) / 14 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1MG | ||||
| Approval Date: | Aug 16, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 16, 2030 | ||||||||
| Regulatory Exclusivity Use: | 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) | ||||||||
| Regulatory Exclusivity Expiration: | Aug 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 31, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCTION OF HETEROTOPIC OSSIFICATION IN PATIENTS WITH FIBRODYSPLASIA (MYOSITIS) OSSIFICANS PROGRESSIVA | ||||||||
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