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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Teva
QuintilesIMS
Cerilliant
US Army
Fuji
Healthtrust
UBS
Chubb

Generated: July 21, 2018

DrugPatentWatch Database Preview

ORKAMBI Drug Profile

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When do Orkambi patents expire, and what generic alternatives are available?

Orkambi is a drug marketed by Vertex Pharms Inc and is included in one NDA. There are sixteen patents protecting this drug.

This drug has two hundred and thirty-eight patent family members in thirty-two countries.

The generic ingredient in ORKAMBI is ivacaftor; lumacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor; lumacaftor profile page.
Summary for ORKAMBI
International Patents:238
US Patents:16
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 1
Clinical Trials: 10
Patent Applications: 1
DailyMed Link:ORKAMBI at DailyMed
Drug patent expirations by year for ORKAMBI
Generic Entry Opportunity Date for ORKAMBI
Generic Entry Date for ORKAMBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for ORKAMBI

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 206038-001 Jul 2, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 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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Non-Orange Book US Patents for ORKAMBI

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
7,754,739 Modulators of CFTR ➤ Sign Up
8,629,162 Modulators of ATP-binding cassette transporters ➤ Sign Up
8,741,925 Modulators of ATP-binding cassette transporters ➤ Sign Up
8,461,156 Modulators of ATP-binding cassette transporters ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ORKAMBI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00038 Denmark ➤ Sign Up PRODUCT NAME: IVACAFTOR, N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120723
2015000050 Germany ➤ Sign Up PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBONSAEUREAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723
0748 Netherlands ➤ Sign Up PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE (INN: IVACAFTOR) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
2016015 Lithuania ➤ Sign Up PRODUCT NAME: LUMAKAFTORAS/IVAKAFTORAS; REGISTRATION NO/DATE: EU/1/15/1059 20151119
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Healthtrust
Farmers Insurance
Express Scripts
Argus Health
US Department of Justice
McKinsey
US Army
McKesson

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