Ozanimod hydrochloride - Generic Drug Details
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What are the generic sources for ozanimod hydrochloride and what is the scope of freedom to operate?
Ozanimod hydrochloride
is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ozanimod hydrochloride has one hundred and sixty-two patent family members in thirty-three countries.
One supplier is listed for this compound.
Summary for ozanimod hydrochloride
International Patents: | 162 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 12 |
Clinical Trials: | 30 |
Patent Applications: | 14 |
What excipients (inactive ingredients) are in ozanimod hydrochloride? | ozanimod hydrochloride excipients list |
DailyMed Link: | ozanimod hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ozanimod hydrochloride
Generic Entry Date for ozanimod hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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 ozanimod hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Geert D'Haens | Phase 4 |
I.R.C.C.S. Fondazione Santa Lucia | Phase 4 |
Bristol-Myers Squibb | Phase 3 |
Pharmacology for ozanimod hydrochloride
Drug Class | Sphingosine 1-phosphate Receptor Modulator |
Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Anatomical Therapeutic Chemical (ATC) Classes for ozanimod hydrochloride
US Patents and Regulatory Information for ozanimod hydrochloride
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 | 209899-003 | Mar 25, 2020 | RX | Yes | Yes | ⤷ 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 | ||||
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 | ⤷ Sign Up | ||||
Bristol | ZEPOSIA | ozanimod hydrochloride | CAPSULE;ORAL | 209899-001 | Mar 25, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ 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 ozanimod hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Malaysia | 189750 | SELECTIVE SPHINGOSINE 1 PHOSPHATE RECEPTOR MODULATORS AND METHODS OF CHIRAL SYNTHESIS | ⤷ Sign Up |
Serbia | 57253 | SELEKTIVNI MODULATORI FINGOZIN 1-FOSFAT RECEPTORA I POSTUPCI ASIMETRIČNE SINTEZE (SELECTIVE SPHINGOSINE 1 PHOSPHATE RECEPTOR MODULATORS AND METHODS OF CHIRAL SYNTHESIS) | ⤷ Sign Up |
Lithuania | C2291080 | ⤷ Sign Up | |
European Patent Office | 3470400 | FORME CRISTALLINE DE L'OZANIMOD, FORME CRISTALLINE DE SON HYDROCHLORIDE ET SON PROCÉDÉ DE PRÉPARATION (CRYSTAL FORM OF OZANIMOD, CRYSTAL FORM OF HYDROCHLORIDE THEREOF, AND PREPARATION METHOD THEREFOR) | ⤷ Sign Up |
Malaysia | 161854 | SELECTIVE SPHINGOSINE 1 PHOSPHATE RECEPTOR MODULATORS AND METHODS OF CHIRAL SYNTHESIS | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ozanimod hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2498610 | 2090047-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: OZANIMOD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR OZANIMOD HYDROCHLORIDE; REG. NO/DATE: EU/1/20/1442 20200525 |
2291080 | SPC/GB20/049 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: OZANIMOD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR OZANIMOD HYDROCHLORIDE; REGISTERED: UK EU/1/20/1442(NI) 20200520; UK PLGB 15105/0115 20200520 |
2291080 | 132020000000124 | Italy | ⤷ Sign Up | PRODUCT NAME: OZANIMOD O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE OZANIMOD CLORIDRATO(ZEPOSIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1442, 20200525 |
2291080 | 2020C/539 | Belgium | ⤷ Sign Up | PRODUCT NAME: OZANIMOD OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE CHLORHYDRATE D'OZANIMOD; AUTHORISATION NUMBER AND DATE: EU/1/20/1442 20200525 |
2291080 | 2090039-5 | Sweden | ⤷ Sign Up | PRODUCT NAME: OZANIMOD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR OZANIMOD HYDROCHLORIDE; REG. NO/DATE: EU/1/20/1442 20200525 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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