FINGOLIMOD LAURYL SULFATE - Generic Drug Details
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What are the generic sources for fingolimod lauryl sulfate and what is the scope of freedom to operate?
Fingolimod lauryl sulfate
is the generic ingredient in one branded drug marketed by Cycle and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fingolimod lauryl sulfate has seven patent family members in seven countries.
One supplier is listed for this compound.
Summary for FINGOLIMOD LAURYL SULFATE
| International Patents: | 7 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| What excipients (inactive ingredients) are in FINGOLIMOD LAURYL SULFATE? | FINGOLIMOD LAURYL SULFATE excipients list |
| DailyMed Link: | FINGOLIMOD LAURYL SULFATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FINGOLIMOD LAURYL SULFATE
*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.
Pharmacology for FINGOLIMOD LAURYL SULFATE
| Drug Class | Sphingosine 1-phosphate Receptor Modulator |
| Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Anatomical Therapeutic Chemical (ATC) Classes for FINGOLIMOD LAURYL SULFATE
US Patents and Regulatory Information for FINGOLIMOD LAURYL SULFATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle | TASCENSO ODT | fingolimod lauryl sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 214962-002 | Dec 9, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cycle | TASCENSO ODT | fingolimod lauryl sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 214962-002 | Dec 9, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Cycle | TASCENSO ODT | fingolimod lauryl sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 214962-001 | Dec 23, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Cycle | TASCENSO ODT | fingolimod lauryl sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 214962-001 | Dec 23, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Cycle | TASCENSO ODT | fingolimod lauryl sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 214962-001 | Dec 23, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cycle | TASCENSO ODT | fingolimod lauryl sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 214962-002 | Dec 9, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | 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 FINGOLIMOD LAURYL SULFATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3247341 | FORME GALÉNIQUE SOLIDE STABLE DE FINGOLIMOD (STABLE SOLID FINGOLIMOD DOSAGE FORMS) | ⤷ Sign Up |
| Japan | 2018502168 | 安定な固体フィンゴリモド剤形 | ⤷ Sign Up |
| Canada | 2974375 | FORME GALENIQUE SOLIDE STABLE DE FINGOLIMOD (STABLE SOLID FINGOLIMOD DOSAGE FORMS) | ⤷ Sign Up |
| China | 107530301 | 稳定的固体芬戈莫德剂型 (STABLE SOLID FINGOLIMOD DOSAGE FORMS) | ⤷ Sign Up |
| Australia | 2016209466 | Stable solid fingolimod dosage forms | ⤷ Sign Up |
| Taiwan | 201642842 | Stable solid FINGOLIMOD dosage forms | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FINGOLIMOD LAURYL SULFATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1613288 | CR 2011 00023 | Denmark | ⤷ Sign Up | PRODUCT NAME: FINGOLIMOD, HERUNDER FINGOLIMOD SOM HYDROCHLORID; REG. NO/DATE: EU/1/11/677/001-004 20110317 |
| 0627406 | 1190015-6 | Sweden | ⤷ Sign Up | PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317 |
| 1613288 | 122011100047 | Germany | ⤷ Sign Up | PRODUCT NAME: FINGOLIMOD ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON; NAT. REGISTRATION NO/DATE: FIRST REGISTRATION: EU EU/1/11/677/001-004 20110317EU/1/11/677/001 EU/1/11/677/002 EU/1/11/677/003 EU/1/11/677/004 20110317 |
| 1613288 | 28/2011 | Austria | ⤷ Sign Up | PRODUCT NAME: FINGOLIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/677-001-004 20110317 |
| 1613288 | PA2011010,C1613288 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FINGOLIMODUM; REGISTRATION NO/DATE: EU/1/11/677/001, 2011-03-17 EU/1/11/677/002, 2011-03-17 EU/1/11/677/003, 2011-03-17 EU/1/11/677/004 20110317 |
| 1613288 | C 2011 005 | Romania | ⤷ Sign Up | PRODUCT NAME: FINGOLIMOD SI SARURILE SALE ACCEPTABILE FARMACEUTIC INSPECIAL SARE CLORHIDRAT 2-AMINO-2[2-(4-OCTILFENIL)ETIL]PROPAN-1,3 DIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/677/001, RO EU/1/11/677/002, RO EU/1/11/677/003, RO EU/1/11/677/004; DATE OF NATIONAL AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/677/001, EMEA EU/1/11/677/002, EMEA EU/1/11/677/003, EMEA EU/1/11/677/004; DATE OF FIRST AUTHORISATION IN EEA: 20110317 |
| >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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