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Last Updated: October 1, 2022

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-one patent family members in thirty-nine 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:131
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 40
Patent Applications: 51
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 Generic Entry Opportunity 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.

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting PONVORY

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Pharms PONVORY ponesimod TABLET;ORAL 213498-006 Mar 18, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms PONVORY ponesimod TABLET;ORAL 213498-009 Mar 18, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 09305980
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0919673
Estimated Expiration: See Plans and Pricing

Canada

Patent: 40313
Estimated Expiration: See Plans and Pricing

Chile

Patent: 11000867
Estimated Expiration: See Plans and Pricing

China

Patent: 2177144
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0150391
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16118
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 44465
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 44465
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 59624
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2351
Estimated Expiration: See Plans and Pricing

Japan

Patent: 08777
Estimated Expiration: See Plans and Pricing

Patent: 12505873
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 0703
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 11003988
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 797
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2854
Estimated Expiration: See Plans and Pricing

Poland

Patent: 44465
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 44465
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 19548
Estimated Expiration: See Plans and Pricing

Patent: 11119898
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 44465
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1103691
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1409597
Estimated Expiration: See Plans and Pricing

Patent: 110071133
Estimated Expiration: See Plans and Pricing

Spain

Patent: 34333
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 62911
Estimated Expiration: See Plans and Pricing

Patent: 1022220
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 19182
Estimated Expiration: See Plans and Pricing

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
New Zealand 547962 5-(benz-(z)-ylidene)-thiazolidin-4-one derivatices as immunosuppressant agents See Plans and Pricing
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) See Plans and Pricing
Croatia P20100714 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PONVORY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3256125 PA2022505 Lithuania See Plans and Pricing PRODUCT NAME: PONEZIMODAS; REGISTRATION NO/DATE: EU/1/21/1550 20210519
3256125 CA 2022 00026 Denmark See Plans and Pricing 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 301174 Netherlands See Plans and Pricing 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
>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.