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 Vanda Pharms Inc and is included in one NDA. There are six patents protecting this drug.
This drug has one hundred and forty-four patent family members in forty countries.
The generic ingredient in PONVORY is ponesimod. Two suppliers are 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: | 144 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 46 |
| Clinical Trials: | 1 |
| Patent Applications: | 72 |
| 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
*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 |
US Patents and Regulatory Information for PONVORY
PONVORY is protected by six US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of PONVORY is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 BEING TREATED WITH A BETA-BLOCKER OR IN ADULTS REINITIATING TREATMENT
Thiazolidin 4-one derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting PONVORY
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-006 | Mar 18, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-005 | Mar 18, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-007 | Mar 18, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-009 | Mar 18, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-007 | Mar 18, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-008 | Mar 18, 2021 | 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 |
Expired US Patents for PONVORY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-010 | Mar 18, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-001 | Mar 18, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-004 | Mar 18, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-002 | Mar 18, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-008 | Mar 18, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| Vanda Pharms Inc | PONVORY | ponesimod | TABLET;ORAL | 213498-006 | Mar 18, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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
Patent: FORMAS CRISTALINAS DE DERIVADOS DE TIAZOLIDINONA UTILES COMO INMUNOMODULADORES
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 09305980
Patent: Crystalline forms of (R) -5- [3-chloro-4- ( 2, 3-dihydroxy-propoxy) -benz [Z] ylidene] -2- ( [Z] -propylimino) -3-0-tolyl-thiazolidin-4-one
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0919673
Patent: formas cristalinas de (r)-5-[3-cloro-4-(2,3-diidróxi-propoxi)-benz[z]ilideno]-2-([z]-propilimino)-3-o-tolila-tiazolidin-4-ona
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 40313
Patent: FORMES CRISTALLINES DE LA (R)-5[3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ-[Z]-YLIDENE]-2-([Z]-PROPYLIMINO)-3-O-TOLYL-THIAZOLIDIN-4-ONE (CRYSTALLINE FORMS OF (R) -5- [3-CHLORO-4- ( 2, 3-DIHYDROXY-PROPOXY) -BENZ [Z] YLIDENE] -2- ( [Z] -PROPYLIMINO) -3-0-TOLYL-THIAZOLIDIN-4-ONE)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 11000867
Patent: Formas cristalinas da, c y ii de (r)-5-[3-cloro-4-(2,3-dihidroxi-propoxi)- benz[z]ilideno]-2- ([z]- propilimino) -3-o- totil-tiazolidin-4-ona; composicion farmaceutica; y uso en el tratamiento o prevencion de rechazo de organos trasplantados, sindrome autoinmunitarios, asma, diabetes, cancer.
Estimated Expiration: ⤷ Sign Up
China
Patent: 2177144
Patent: Crystalline forms of (R) -5- [3-chloro-4- ( 2, 3-dihydroxy-propoxy) -benz [Z] ylidene] -2- ( [Z] -propylimino) -3-0-tolyl-thiazolidin-4-one
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0150391
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 16118
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 44465
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 44465
Patent: FORMES CRISTALLINES DE LA (R)-5[3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ-[Z]-YLIDÈNE]-2-([Z]-PROPYLIMINO)-3-O-TOLYL-THIAZOLIDIN-4-ONE (CRYSTALLINE FORMS OF (R) -5- [3-CHLORO-4-( 2, 3-DIHYDROXY-PROPOXY)-BENZ [Z]YLIDENE]-2- [Z]-PROPYLIMINO) -3-O-TOLYL-THIAZOLIDIN-4-ONE)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 59624
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 2351
Patent: צורות גבישיות שאינן היגרוסקופיות של (r)-5-[3-כלורו-4-(3,2-דיהידרוקסי-פרופוקסי)-בנז [z]ילאידן]-2-([z]-פרופילאימינו)-3-o-טוליל-תיאזולידין-4-און, המכילות בין 0 ל 0.5 אקוויולנט מים לאקוויוולנט מולקולה, תכשירי רוקחות ושימושים שלהן (Non-hygroscopic crystalline forms of (r)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[z]ylidene]-2-([z]-propylimino)-3-o-tolyl-thiazolidin-4-one, containing from 0 to 0.5 equivalents of water per equivalent of compound, pharmaceutical compositions and uses thereof)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 08777
Estimated Expiration: ⤷ Sign Up
Patent: 12505873
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 0703
Patent: CRYSTALLINE FORMS OF (R) -5- [3-CHLORO-4-(2,3-DIHYDROXY) - BENZ [Z] YLIDENE] -2- ([Z]-PROPYLIMINO) -3-0-TOLYL-THIAZOLIDIN-4-ONE
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 11003988
Patent: FORMAS CRISTALINAS DE (R)-5-[3-CLORO-4-(2,3-DIHIDROXI-PROPOXI)-BEN Z[Z]ILIDENO]-2-([Z]-PROPILIMINO)-3-O-TOLIL-TIAZOLIDIN-4-ONA. (CRYSTALLINE FORMS OF (R) -5- [3-CHLORO-4- ( 2, 3-DIHYDROXY-PROPOXY) -BENZ [Z] YLIDENE] -2- ( [Z] -PROPYLIMINO) -3-0-TOLYL-THIAZOLIDIN-4-ONE.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 797
Patent: أشكال البلورية (r) -5 [3 كلورو-4- (2،3-ثنائي هيدروكسي بروبوكسي) بنز [z]-إيليدين] -2 - ([z]-بروبيليمينو)-3-o -طوليل-تيازولين-4-أون
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 2854
Patent: CRYSTALLINE FORMS OF (R)-5-[3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ[Z]YLIDENE]-2-([Z]-PROPYLIMINO)-3-O-TOLYL-THIAZOLIDIN-4-ONE
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 44465
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 44465
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 19548
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ (R)-5-[3-ХЛОР-4-(2, 3-ДИГИДРОКСИПРОПОКСИ)БЕНЗ[Z]ИЛИДЕН]-2-([Z]-ПРОПИЛИМИНО)-3-о-ТОЛИЛТИАЗОЛИДИН-4-ОНА (CRYSTALLINE FORMS OF (R)-5-[3-CHLORO-4-(2, 3-DIHYDROXYPROPOXY)BEZ[Z]ILIDEN]-2-([Z]-PROPYLIMINO)-3-o-TOLYLTHIAZOLIDIN-4-ONE)
Estimated Expiration: ⤷ Sign Up
Patent: 11119898
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ (R)-5-[3-ХЛОР-4-(2,3-ДИГИДРОКСИПРОПОКСИ)БЕНЗ[Z]ИЛИДЕН]-2-([Z]-ПРОПИЛИМИНО)-3-О-ТОЛИЛТИАЗОЛИДИН-4-ОНА
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 44465
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1103691
Patent: CRYSTALLINE FORMS OF (R)-5-[3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ[Z]YLIDENE]-2-([Z]-PROPYLIMINO)-3-0-TOLYL-THIAZOLIDIN-4-ONE
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1409597
Estimated Expiration: ⤷ Sign Up
Patent: 110071133
Patent: CRYSTALLINE FORMS OF (R)-5-[3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ[Z]YLIDENE]-2-([Z]-PROPYLIMINO)-3-0-TOLYL-THIAZOLIDIN-4-ONE
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 34333
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 62911
Estimated Expiration: ⤷ Sign Up
Patent: 1022220
Patent: Crystalline forms
Estimated Expiration: ⤷ Sign Up
United Kingdom
Patent: 19182
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Norway | 336734 | ⤷ Sign Up | |
| China | 117137912 | 选择性S1P1受体激动剂的给药方案 (Dosage regimen for selective S1P1 receptor agonists) | ⤷ Sign Up |
| Netherlands | 301174 | ⤷ Sign Up | |
| Malaysia | 160703 | CRYSTALLINE FORMS OF (R) -5- [3-CHLORO-4-(2,3-DIHYDROXY) - BENZ [Z] YLIDENE] -2- ([Z]-PROPYLIMINO) -3-0-TOLYL-THIAZOLIDIN-4-ONE | ⤷ Sign Up |
| Denmark | 3256125 | ⤷ Sign Up | |
| Serbia | 63048 | DOZNI REŽIM ZA PONESIMOD, SELEKTIVNI AGONIST RECEPTORA S1P1 (DOSING REGIMEN FOR PONESIMOD, A SELECTIVE S1P1 RECEPTOR AGONIST) | ⤷ Sign Up |
| >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 | ⤷ Sign Up | PRODUCT NAME: PONEZIMODAS; REGISTRATION NO/DATE: EU/1/21/1550 20210519 |
| 3256125 | CA 2022 00026 | Denmark | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | 18/2022 | Austria | ⤷ Sign Up | PRODUCT NAME: PONESIMOD; REGISTRATION NO/DATE: EU/1/21/1550 (MITTEILUNG) 20210521 |
| 3256125 | C202230019 | Spain | ⤷ Sign Up | 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 | PA2022505,C3256125 | Lithuania | ⤷ Sign Up | 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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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.
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