Fingolimod lauryl sulfate - Generic Drug Details
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What are the generic drug sources for fingolimod lauryl sulfate and what is the scope of patent protection?
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
Generic Entry Date for fingolimod lauryl sulfate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, ORALLY DISINTEGRATING;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.
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 | 214962-001 | Dec 23, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Cycle | TASCENSO ODT | fingolimod lauryl sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 214962-002 | Dec 9, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Cycle | TASCENSO ODT | fingolimod lauryl sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 214962-002 | Dec 9, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Cycle | TASCENSO ODT | fingolimod lauryl sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 214962-001 | Dec 23, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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 |
|---|---|---|---|
| Australia | 2016209466 | Stable solid fingolimod dosage forms | ⤷ Try a Trial |
| Japan | 2018502168 | 安定な固体フィンゴリモド剤形 | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2016118515 | ⤷ Try a Trial | |
| Canada | 2974375 | FORME GALENIQUE SOLIDE STABLE DE FINGOLIMOD (STABLE SOLID FINGOLIMOD DOSAGE FORMS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for fingolimod lauryl sulfate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0627406 | C300488 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FINGOLIMOD, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317 |
| 1613288 | 2011/027 | Ireland | ⤷ Try a Trial | PRODUCT NAME: GILENYA-FINGOLIMOD; NAT REGISTRATION NO/DATE: EU/1/11/677/001 20110317; FIRST REGISTRATION NO/DATE: EU/1/11/677/002 17/03/2011 IRELAND EU/1/11/677/003 17/03/2011 IRELAND EU/1/11/677/004 20110317 |
| 1613288 | 2011C/030 | Belgium | ⤷ Try a Trial | PRODUCT NAME: FINGOLIMOD; AUTHORISATION NUMBER AND DATE: EU/1/11/677/001 20110322 |
| 1613288 | C 2011 005 | Romania | ⤷ Try a Trial | 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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