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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Harvard Business School
Covington
Merck
Cerilliant
Novartis
Daiichi Sankyo
Queensland Health
Accenture
Citi

Generated: February 25, 2018

DrugPatentWatch Database Preview

GILENYA Drug Profile

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Which patents cover Gilenya, and when can generic versions of Gilenya launch?

Gilenya is a drug marketed by Novartis and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-six patent family members in forty-two countries.

The generic ingredient in GILENYA is fingolimod. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fingolimod profile page.
Summary for GILENYA
International Patents:136
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 45
Clinical Trials: 23
Patent Applications: 91
Drug Prices:see details
DailyMed Link:GILENYA at DailyMed
Drug patent expirations by year for GILENYA

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 CAPSULE;ORAL 022527-001 Sep 21, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis GILENYA fingolimod CAPSULE;ORAL 022527-001 Sep 21, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis GILENYA fingolimod CAPSULE;ORAL 022527-001 Sep 21, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for GILENYA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis GILENYA fingolimod CAPSULE;ORAL 022527-001 Sep 21, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for GILENYA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 0.5 mg ➤ Subscribe 9/22/2014

Non-Orange Book US Patents for GILENYA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,719,176 2-amino-1,3-propanediol compound and immunosuppressant ➤ Sign Up
5,952,316 2-amino-1,3-propanediol compound and immunosuppressant ➤ Sign Up
8,741,963 S1P receptor modulators for treating multiple sclerosis ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for GILENYA

Supplementary Protection Certificates for GILENYA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2011010 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
0627406/01 Switzerland ➤ Sign Up FORMER REPRESENTATIVE: BOHEST AG, CH
1613288/01 Switzerland ➤ Sign Up FORMER REPRESENTATIVE: BOHEST AG, CH
7 5008-2011 Slovakia ➤ Sign Up FIRST REGISTRATION NO/DATE: EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004, 20110317
2011 00023 Denmark ➤ Sign Up
867 Luxembourg ➤ Sign Up 91867, EXPIRES: 20260317
90015-6 Sweden ➤ Sign Up PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
C0021 France ➤ Sign Up PRODUCT NAME: FINGOLIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER SON CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/11/677/001 20110317
2011 00015 Denmark ➤ Sign Up
00497 Netherlands ➤ Sign Up PRODUCT NAME: FINGOLIMOD ALSMEDE FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Fuji
Chubb
Farmers Insurance
Healthtrust
Covington
Johnson and Johnson
Boehringer Ingelheim
Queensland Health

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 verifification 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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