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Last Updated: April 22, 2024

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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 forty-one 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

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Summary for PONVORY
International Patents:141
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
Drug patent expirations by year for PONVORY
Drug Prices for PONVORY

See drug prices for PONVORY

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

SponsorPhase
Janssen Pharmaceutica N.V., BelgiumPhase 1

See all PONVORY clinical trials

Pharmacology 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
Janssen Pharms PONVORY ponesimod TABLET;ORAL 213498-010 Mar 18, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms PONVORY ponesimod TABLET;ORAL 213498-008 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 ⤷  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
Philippines 12017501059 DOSING REGIMEN FOR A SELECTIVE S1P1 AGONIST ⤷  Try a Trial
Taiwan 200528097 Novel thiazolidin-4-one derivatives ⤷  Try a Trial
Japan 2019011343 選択的S1P1レセプターアゴニストを含む薬学的合剤 (PHARMACEUTICAL COMBINATION COMPRISING SELECTIVE S1P1 RECEPTOR AGONIST) ⤷  Try a Trial
European Patent Office 3256125 RÉGIME POSOLOGIQUE POUR UN AGONISTE DE RÉCEPTEUR S1P1 SÉLECTIF (DOSING REGIMEN FOR A SELECTIVE S1P1 RECEPTOR AGONIST) ⤷  Try a Trial
New Zealand 768672 Dosing regimen for a selective s1p1 receptor agonist ⤷  Try a Trial
Japan 6846392 ⤷  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 C202230019 Spain ⤷  Try a Trial PRODUCT NAME: PONESIMOD: (R)-5-(3-CLORO-4-(2,3-DIHIDROXIPROPOXI)-BENZO(Z)IDEN)-2-((Z)-PROPILIMINO)-3-O-TOLIL-TIAZOLIDIN-4-ONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/21/1550; DATE OF AUTHORISATION: 20210519; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1550; DATE OF FIRST AUTHORISATION IN EEA: 20210519
3256125 301174 Netherlands ⤷  Try a Trial PRODUCT NAME: PONESIMOD (IUPAC NAAM: (R)-5-(3-CHLOOR-4-(2,3-DIHYDROXY-PROPOXY)-BENZ(Z)YLIDEEN)-2-((Z)-PROPYLIMINO)-3-O-TOLYL-THIAZOLIDIN-4-ON), DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/21/1550 20210521
3256125 122022000027 Germany ⤷  Try a Trial PRODUCT NAME: PONESIMOD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1550 20210519
3256125 2290019-5 Sweden ⤷  Try a Trial PRODUCT NAME: PONESIMOD AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT. REG. NO/DATE: EU/1/21/1550 20210521; FIRST REG.: GE EU/1/21/1550 20210521
3256125 C03256125/01 Switzerland ⤷  Try a Trial PRODUCT NAME: PONESIMOD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68114 16.11.2021
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.