ZEPOSIA Drug Patent Profile
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Which patents cover Zeposia, and what generic alternatives are available?
Zeposia is a drug marketed by Bristol and is included in one NDA. There are five patents protecting this drug.
This drug has one hundred and sixty-two patent family members in thirty-three countries.
The generic ingredient in ZEPOSIA is ozanimod hydrochloride. One supplier is listed for this compound. Additional details are available on the ozanimod hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Zeposia
Zeposia was eligible for patent challenges on March 25, 2024.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 14, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ZEPOSIA
| International Patents: | 162 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 12 |
| Clinical Trials: | 1 |
| Patent Applications: | 8 |
| Drug Prices: | Drug price information for ZEPOSIA |
| What excipients (inactive ingredients) are in ZEPOSIA? | ZEPOSIA excipients list |
| DailyMed Link: | ZEPOSIA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZEPOSIA
*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 ZEPOSIA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| I.R.C.C.S. Fondazione Santa Lucia | Phase 4 |
Pharmacology for ZEPOSIA
| Drug Class | Sphingosine 1-phosphate Receptor Modulator |
| Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Anatomical Therapeutic Chemical (ATC) Classes for ZEPOSIA
US Patents and Regulatory Information for ZEPOSIA
ZEPOSIA is protected by six US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZEPOSIA 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 ZEPOSIA
Selective sphingosine 1 phosphate receptor modulators and methods of chiral synthesis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UC) IN ADULTS
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UC) IN ADULTS
Modulators of sphingosine phosphate receptors
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
Modulators of sphingosine phosphate receptors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Modulators of sphingosine phosphate receptors
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
FDA Regulatory Exclusivity protecting ZEPOSIA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN ADULT PATIENTS
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol | ZEPOSIA | ozanimod hydrochloride | CAPSULE;ORAL | 209899-001 | Mar 25, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol | ZEPOSIA | ozanimod hydrochloride | CAPSULE;ORAL | 209899-003 | Mar 25, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Bristol | ZEPOSIA | ozanimod hydrochloride | CAPSULE;ORAL | 209899-003 | Mar 25, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol | ZEPOSIA | ozanimod hydrochloride | CAPSULE;ORAL | 209899-001 | Mar 25, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol | ZEPOSIA | ozanimod hydrochloride | CAPSULE;ORAL | 209899-001 | Mar 25, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Bristol | ZEPOSIA | ozanimod hydrochloride | CAPSULE;ORAL | 209899-002 | Mar 25, 2020 | 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 |
International Patents for ZEPOSIA
When does loss-of-exclusivity occur for ZEPOSIA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 09258242
Estimated Expiration: ⤷ Sign Up
Patent: 15213309
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0912545
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 23904
Estimated Expiration: ⤷ Sign Up
China
Patent: 2118972
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0150982
Estimated Expiration: ⤷ Sign Up
Patent: 0201316
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 23338
Estimated Expiration: ⤷ Sign Up
Patent: 20033
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 91080
Estimated Expiration: ⤷ Sign Up
Patent: 13326
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 1672
Estimated Expiration: ⤷ Sign Up
Patent: 1001785
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 91080
Estimated Expiration: ⤷ Sign Up
Patent: 13326
Estimated Expiration: ⤷ Sign Up
Patent: 82991
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 0200037
Estimated Expiration: ⤷ Sign Up
Patent: 91080
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 25984
Estimated Expiration: ⤷ Sign Up
Patent: 50411
Estimated Expiration: ⤷ Sign Up
Patent: 000038
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9306
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 37417
Estimated Expiration: ⤷ Sign Up
Patent: 11523412
Estimated Expiration: ⤷ Sign Up
Patent: 16041736
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 291080
Estimated Expiration: ⤷ Sign Up
Patent: 2020529
Estimated Expiration: ⤷ Sign Up
Patent: 13326
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 6381
Estimated Expiration: ⤷ Sign Up
Patent: 2105
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 10012461
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 1065
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 9617
Patent: 3-(Inden-4-yl)-5-(phenyl)-1,2,4-oxadiazole and 3-(tetralin-5-yl)-5-(phenyl)-1,2,4-oxadiazole derivatives
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 91080
Estimated Expiration: ⤷ Sign Up
Patent: 13326
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 91080
Estimated Expiration: ⤷ Sign Up
Patent: 13326
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 91080
Estimated Expiration: ⤷ Sign Up
Patent: 13326
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1007804
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1582910
Estimated Expiration: ⤷ Sign Up
Patent: 110010777
Estimated Expiration: ⤷ Sign Up
Patent: 150064245
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 49761
Estimated Expiration: ⤷ Sign Up
Patent: 13368
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 ZEPOSIA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Cyprus | 1123338 | ⤷ Sign Up | |
| Australia | 2009258242 | Novel modulators of sphingosine phosphate receptors | ⤷ Sign Up |
| Cyprus | 1120427 | ⤷ Sign Up | |
| Denmark | 2498611 | ⤷ Sign Up | |
| Poland | 2498610 | ⤷ Sign Up | |
| Finland | 2291080 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZEPOSIA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2498610 | 2020/051 | Ireland | ⤷ Sign Up | PRODUCT NAME: OZANIMOD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR OZANIMOD HYDROCHLORIDE.; REGISTRATION NO/DATE: EU/1/20/1442 20200520 |
| 2498610 | PA2020533 | Lithuania | ⤷ Sign Up | PRODUCT NAME: OZANIMODAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC OZANIMODO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/20/1442 20200520 |
| 2498610 | CA 2020 00053 | Denmark | ⤷ Sign Up | PRODUCT NAME: OZANIMOD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER OZANIMODHYDROCHLORIDE; REG. NO/DATE: EU/1/20/1442 20200525 |
| 2291080 | PA2020529,C2291080 | Lithuania | ⤷ Sign Up | PRODUCT NAME: OZANIMODAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC OZANIMODO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/20/1442 20200520 |
| 2291080 | C202030049 | Spain | ⤷ Sign Up | PRODUCT NAME: OZANIMOD O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE OZANIMOD; NATIONAL AUTHORISATION NUMBER: EU/1/20/1442; DATE OF AUTHORISATION: 20200520; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1442; DATE OF FIRST AUTHORISATION IN EEA: 20200520 |
| 2291080 | PA2020529 | Lithuania | ⤷ Sign Up | PRODUCT NAME: OZANIMODAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC OZANIMODO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/20/1442 20200520 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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