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GILENYA Drug Profile
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Which patents cover Gilenya, and what generic alternatives are available?
Gilenya is a drug marketed by Novartis and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.
This drug has two hundred and twenty-three patent family members in fifty countries.
The generic ingredient in GILENYA is fingolimod hydrochloride. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Gilenya
A generic version of GILENYA was approved as fingolimod hydrochloride by HEC PHARM CO LTD on December 4th, 2019.
Summary for GILENYA
| International Patents: | 223 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 124 |
| Clinical Trials: | 31 |
| Patent Applications: | 107 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GILENYA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GILENYA |
| DailyMed Link: | GILENYA at DailyMed |
Recent Clinical Trials for GILENYA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hikma Pharmaceuticals LLC | Phase 1 |
| Genuine Research Center, Egypt | Phase 1 |
| Wake Forest University Health Sciences | Early Phase 1 |
Pharmacology for GILENYA
| Drug Class | Sphingosine 1-phosphate Receptor Modulator |
| Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Paragraph IV (Patent) Challenges for GILENYA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| GILENYA | CAPSULE;ORAL | fingolimod hydrochloride | 022527 | 2018-07-19 |
| GILENYA | CAPSULE;ORAL | fingolimod hydrochloride | 022527 | 2018-07-18 |
| GILENYA | CAPSULE;ORAL | fingolimod hydrochloride | 022527 | 2014-09-22 |
US Patents and Regulatory Information for GILENYA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-002 | May 11, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-002 | May 11, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for GILENYA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-002 | May 11, 2018 | Start Trial | Start Trial |
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | Start Trial | Start Trial |
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GILENYA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2698154 | Start Trial |
| Belgium | 1015972 | Start Trial |
| Spain | 2556947 | Start Trial |
| United Kingdom | 0612721 | Start Trial |
| China | 102548579 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for GILENYA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1613288 | PA2011010 | Lithuania | Start Trial | 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 |
| 0627406 | C00627406/01 | Switzerland | Start Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 1613288 | C 2011 005 | Romania | Start 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 |
| 1613288 | C01613288/01 | Switzerland | Start Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 1613288 | 2011C/030 | Belgium | Start Trial | PRODUCT NAME: FINGOLIMOD; AUTHORISATION NUMBER AND DATE: EU/1/11/677/001 20110322 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
