Ponesimod - Generic Drug Details
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What are the generic sources for ponesimod and what is the scope of freedom to operate?
Ponesimod
is the generic ingredient in one branded drug marketed by Janssen Pharms and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ponesimod has one hundred and forty-one patent family members in forty countries.
One supplier is listed for this compound.
Summary for ponesimod
International Patents: | 141 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 46 |
Clinical Trials: | 9 |
Patent Applications: | 93 |
What excipients (inactive ingredients) are in ponesimod? | ponesimod excipients list |
DailyMed Link: | ponesimod at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ponesimod
Generic Entry Date for ponesimod*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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 ponesimod
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Janssen Pharmaceutica N.V., Belgium | Phase 1 |
Actelion | Phase 3 |
Actelion | Phase 1 |
Pharmacology for ponesimod
Drug Class | Sphingosine 1-phosphate Receptor Modulator |
Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
US Patents and Regulatory Information for ponesimod
EU/EMA Drug Approvals for ponesimod
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Janssen-Cilag International N.V. | Ponvory | ponesimod | EMEA/H/C/005163 Ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. |
Authorised | no | no | no | 2021-05-19 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ponesimod
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 6244497 | ⤷ Try a Trial | |
South Korea | 20110071133 | CRYSTALLINE FORMS OF (R)-5-[3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ[Z]YLIDENE]-2-([Z]-PROPYLIMINO)-3-0-TOLYL-THIAZOLIDIN-4-ONE | ⤷ Try a Trial |
Taiwan | 201022220 | Crystalline forms | ⤷ Try a Trial |
Eurasian Patent Organization | 039629 | ФАРМАЦЕВТИЧЕСКАЯ КОМБИНАЦИЯ, СОДЕРЖАЩАЯ СЕЛЕКТИВНЫЙ АГОНИСТ РЕЦЕПТОРА S1P1 (PHARMACEUTICAL COMBINATION COMPRISING A SELECTIVE S1P1 RECEPTOR AGONIST) | ⤷ Try a Trial |
Portugal | 2344465 | ⤷ Try a Trial | |
China | 117137912 | 选择性S1P1受体激动剂的给药方案 (Dosage regimen for selective S1P1 receptor agonists) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2016092042 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ponesimod
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3256125 | 122022000027 | Germany | ⤷ Try a Trial | PRODUCT NAME: PONESIMOD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1550 20210519 |
3256125 | LUC00262 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: PONESIMOD (NOM IUPAC : (R)-5-(3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ(Z)YLIDENE)-2-((Z)-PROPYLIMINO)-3-O-TOLYL-THIAZOLIDIN-4-ONE); AUTHORISATION NUMBER AND DATE: EU/1/21/1550 20210521 |
3256125 | 22C1021 | France | ⤷ Try a Trial | PRODUCT NAME: PONESIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1550 20210521 |
3256125 | CA 2022 00026 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PONESIMOD (IUPAC NAME: (R)-5-(3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ(Z)YLIDENE)-2-((Z)-PROPYLIMINO)-3-OTOLYL-; REG. NO/DATE: EU/1/21/1550 20210521 |
3256125 | PA2022505,C3256125 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PONEZIMODAS; REGISTRATION NO/DATE: EU/1/21/1550 20210519 |
3256125 | 18/2022 | Austria | ⤷ Try a Trial | PRODUCT NAME: PONESIMOD; REGISTRATION NO/DATE: EU/1/21/1550 (MITTEILUNG) 20210521 |
3256125 | PA2022505 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PONEZIMODAS; REGISTRATION NO/DATE: EU/1/21/1550 20210519 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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