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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Queensland Health
Citi
Fuji
Moodys
Teva
Cerilliant
Boehringer Ingelheim

Generated: July 22, 2018

DrugPatentWatch Database Preview

Ivacaftor; lumacaftor - Generic Drug Details

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What are the generic drug sources for ivacaftor; lumacaftor and what is the scope of ivacaftor; lumacaftor freedom to operate?

Ivacaftor; lumacaftor
is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in one NDA. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor; lumacaftor has two hundred and thirty-eight patent family members in thirty-two countries.

There are three drug master file entries for ivacaftor; lumacaftor. One supplier is listed for this compound.
Summary for ivacaftor; lumacaftor
International Patents:238
US Patents:16
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 3
Suppliers / Packagers: 1
Clinical Trials: 25
DailyMed Link:ivacaftor; lumacaftor at DailyMed

US Patents and Regulatory Information for ivacaftor; lumacaftor

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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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Non-Orange Book US Patents for ivacaftor; lumacaftor

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
7,659,268 Modulators of ATP-binding cassette transporters ➤ Try a Free Trial
7,741,321 Modulators of ATP-binding cassette transporters ➤ Try a Free Trial
7,754,739 Modulators of CFTR ➤ Try a Free Trial
7,956,052 Modulators of ATP-binding cassette transporters ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ivacaftor; lumacaftor

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016015 Lithuania ➤ Try a Free Trial PRODUCT NAME: LUMAKAFTORAS/IVAKAFTORAS; REGISTRATION NO/DATE: EU/1/15/1059 20151119
90018-5 Sweden ➤ Try a Free Trial PRODUCT NAME: 3-6-1-(2,2-DIFLUORO-1,3-BENZODIOXOL-5- YL)CYCLOPROPANECARBONYLAMINO-3-METHYLPYRIDIN-2-YLBENZOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR AN ESTER THEREOF.; REG. NO/DATE: EU/1/15/1059 20151124
0812 Netherlands ➤ Try a Free Trial PRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPAANCARBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOEZUUR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1059 20151124
2015028,C1773816 Lithuania ➤ Try a Free Trial PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
Express Scripts
Daiichi Sankyo
Covington
Mallinckrodt
Cipla
Fuji
Accenture

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.