Fingolimod - Generic Drug Details
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Summary for fingolimod
International Patents: | 137 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 20 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 44 |
Clinical Trials: | 52 |
Patent Applications: | 2,547 |
Drug Prices: | Drug price trends for fingolimod |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for fingolimod |
What excipients (inactive ingredients) are in fingolimod? | fingolimod excipients list |
DailyMed Link: | fingolimod at DailyMed |
Recent Clinical Trials for fingolimod
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Tang-Du Hospital | Phase 1/Phase 2 |
The Methodist Hospital Research Institute | Phase 2 |
General Hospital of Shenyang Military Region | Phase 4 |
Generic filers with tentative approvals for FINGOLIMOD
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | EQ 0.5MG BASE | CAPSULE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 0.5MG | CAPSULE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 0.5MG | CAPSULE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for fingolimod
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dr Reddys | FINGOLIMOD HYDROCHLORIDE | fingolimod hydrochloride | CAPSULE;ORAL | 208000-001 | Mar 5, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ezra Ventures | FINGOLIMOD HYDROCHLORIDE | fingolimod hydrochloride | CAPSULE;ORAL | 207945-001 | Dec 6, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hetero Labs Ltd V | FINGOLIMOD HYDROCHLORIDE | fingolimod hydrochloride | CAPSULE;ORAL | 207933-001 | May 18, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-002 | May 11, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | AB | 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 | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |