PONVORY Drug Patent Profile
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When do Ponvory patents expire, and what generic alternatives are available?
Ponvory is a drug marketed by Janssen Pharms and is included in one NDA. There are five patents protecting this drug.
This drug has one hundred and thirty-nine patent family members in forty countries.
The generic ingredient in PONVORY is ponesimod. One supplier is listed for this compound. Additional details are available on the ponesimod profile page.
DrugPatentWatch® Generic Entry Outlook for Ponvory
Ponvory will be eligible for patent challenges on March 18, 2025. 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 May 6, 2032. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for PONVORY
International Patents: | 139 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 46 |
Clinical Trials: | 1 |
Patent Applications: | 42 |
Drug Prices: | Drug price information for PONVORY |
What excipients (inactive ingredients) are in PONVORY? | PONVORY excipients list |
DailyMed Link: | PONVORY at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PONVORY
Generic Entry Date for PONVORY*:
Constraining patent/regulatory exclusivity:
NDA:
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 PONVORY
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Janssen Pharmaceutica N.V., Belgium | Phase 1 |
Pharmacology for PONVORY
Drug Class | Sphingosine 1-phosphate Receptor Modulator |
Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Anatomical Therapeutic Chemical (ATC) Classes for PONVORY
US Patents and Regulatory Information for PONVORY
PONVORY is protected by five US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of PONVORY is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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 PONVORY
Dosing regimen for a selective S1P.sub.1 receptor agonist
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
Thiazolidin 4-one derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
Thiazolidin-4-one-derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
Crystalline forms of (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylim- ino)-3-0-tolyl-thiazolidin-4-one
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
Thiazolidin-4-one derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting PONVORY
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Pharms | PONVORY | ponesimod | TABLET;ORAL | 213498-007 | Mar 18, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Janssen Pharms | PONVORY | ponesimod | TABLET;ORAL | 213498-006 | Mar 18, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Pharms | PONVORY | ponesimod | TABLET;ORAL | 213498-009 | Mar 18, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 PONVORY
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 PONVORY
When does loss-of-exclusivity occur for PONVORY?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 3904
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 09305980
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0919673
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 40313
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 11000867
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2177144
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0150391
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 16118
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 44465
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 44465
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 59624
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 2351
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 08777
Estimated Expiration: ⤷ Try a Trial
Patent: 12505873
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 0703
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 11003988
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 797
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 2854
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 44465
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 44465
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 19548
Estimated Expiration: ⤷ Try a Trial
Patent: 11119898
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 44465
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1103691
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1409597
Estimated Expiration: ⤷ Try a Trial
Patent: 110071133
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 34333
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 62911
Estimated Expiration: ⤷ Try a Trial
Patent: 1022220
Estimated Expiration: ⤷ Try a Trial
United Kingdom
Patent: 19182
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering PONVORY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2545582 | DERIVES DE 5-(BENZ-(Z)-YLIDENE)-THIAZOLIDINE-4-ONE UTILISES COMME AGENT IMMUNODEPRESSEURS (5-(BENZ- (Z) -YLIDENE) -THIAZOLIDIN-4-ONE DERIVATIVES AS IMMUNOSUPPRESSANT AGENTS) | ⤷ Try a Trial |
Spain | 2909071 | ⤷ Try a Trial | |
Taiwan | I462911 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PONVORY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 2022C/515 | Belgium | ⤷ Try a Trial | PRODUCT NAME: PONESIMOD (IUPAC NAAM: (R)-5-(3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)- BENZ(Z)YLIDEEN)-2-((Z)-PROPYLIMINO)-3-O-TOLYL-THIAZOLIDIN-4-ON); AUTHORISATION NUMBER AND DATE: EU/1/21/1550 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 |