PALOVAROTENE - Generic Drug Details
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What are the generic drug sources for palovarotene and what is the scope of freedom to operate?
Palovarotene
is the generic ingredient in one branded drug marketed by Ipsen and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Palovarotene has fifty-four patent family members in twenty-two countries.
One supplier is listed for this compound.
Summary for PALOVAROTENE
| International Patents: | 54 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 51 |
| Clinical Trials: | 10 |
| Patent Applications: | 104 |
| What excipients (inactive ingredients) are in PALOVAROTENE? | PALOVAROTENE excipients list |
| DailyMed Link: | PALOVAROTENE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PALOVAROTENE
Generic Entry Date for PALOVAROTENE*:
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.
Recent Clinical Trials for PALOVAROTENE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ipsen | Phase 3 |
| Ipsen | Phase 1 |
| Clementia Pharmaceuticals Inc. | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for PALOVAROTENE
US Patents and Regulatory Information for PALOVAROTENE
| 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 | 215559-002 | Aug 16, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ipsen | SOHONOS | palovarotene | CAPSULE;ORAL | 215559-005 | Aug 16, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ipsen | SOHONOS | palovarotene | CAPSULE;ORAL | 215559-004 | Aug 16, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ipsen | SOHONOS | palovarotene | CAPSULE;ORAL | 215559-004 | Aug 16, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ipsen | SOHONOS | palovarotene | CAPSULE;ORAL | 215559-004 | Aug 16, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ipsen | SOHONOS | palovarotene | CAPSULE;ORAL | 215559-003 | Aug 16, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 PALOVAROTENE
| 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 PALOVAROTENE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 3721880 | ⤷ Sign Up | |
| Mexico | 2022001991 | METODOS PARA TRATAR LA OSIFICACION HETEROTOPICA. (METHODS FOR TREATING HETEROTOPIC OSSIFICATION.) | ⤷ Sign Up |
| Brazil | 112018075422 | métodos para tratar ossificação heterotópica | ⤷ Sign Up |
| Hungary | E059024 | ⤷ Sign Up | |
| Hungary | E051664 | ⤷ Sign Up | |
| Spain | 2975123 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
