FINGOLIMOD HYDROCHLORIDE Drug Patent Profile
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When do Fingolimod Hydrochloride patents expire, and what generic alternatives are available?
Fingolimod Hydrochloride is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Biocon Ltd, Bionpharma, Chartwell Rx, Dr Reddys, Ezra Ventures, Glenmark Pharms Ltd, Hec Pharm Co Ltd, Hetero Labs Ltd V, Mylan, Prinston Inc, Sun Pharm, Teva Pharms Usa, and Zydus Pharms. and is included in eighteen NDAs.
The generic ingredient in FINGOLIMOD HYDROCHLORIDE is fingolimod hydrochloride. There are twenty-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fingolimod Hydrochloride
A generic version of FINGOLIMOD HYDROCHLORIDE was approved as fingolimod hydrochloride by BIOCON LTD on December 4th, 2019.
Summary for FINGOLIMOD HYDROCHLORIDE
Recent Clinical Trials for FINGOLIMOD HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The Methodist Hospital Research Institute | Phase 2 |
| General Hospital of Shenyang Military Region | Phase 4 |
| PPD | Phase 3 |
Pharmacology for FINGOLIMOD HYDROCHLORIDE
| Drug Class | Sphingosine 1-phosphate Receptor Modulator |
| Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Medical Subject Heading (MeSH) Categories for FINGOLIMOD HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for FINGOLIMOD HYDROCHLORIDE
Paragraph IV (Patent) Challenges for FINGOLIMOD HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| GILENYA | Capsules | fingolimod hydrochloride | 0.25 mg | 022527 | 1 | 2018-07-19 |
| GILENYA | Capsules | fingolimod hydrochloride | 0.5 mg | 022527 | 19 | 2014-09-22 |
US Patents and Regulatory Information for FINGOLIMOD HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | FINGOLIMOD HYDROCHLORIDE | fingolimod hydrochloride | CAPSULE;ORAL | 207991-001 | Oct 28, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | FINGOLIMOD HYDROCHLORIDE | fingolimod hydrochloride | CAPSULE;ORAL | 207994-001 | Oct 14, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Chartwell Rx | FINGOLIMOD HYDROCHLORIDE | fingolimod hydrochloride | CAPSULE;ORAL | 207971-001 | Jun 29, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma Ltd | FINGOLIMOD HYDROCHLORIDE | fingolimod hydrochloride | CAPSULE;ORAL | 207983-001 | Feb 28, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
