➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Johnson and Johnson
Dow
McKinsey
Baxter

Last Updated: August 14, 2020

DrugPatentWatch Database Preview

KALYDECO Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

Kalydeco is a drug marketed by Vertex Pharms Inc and Vertex Pharms and is included in two NDAs. There are ten patents protecting this drug.

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

The generic ingredient in KALYDECO is ivacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor profile page.

US ANDA Litigation and Generic Entry Outlook for Kalydeco

Kalydeco was eligible for patent challenges on January 31, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 13, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

Summary for KALYDECO
Drug patent expirations by year for KALYDECO
Drug Prices for KALYDECO

See drug prices for KALYDECO

Generic Entry Opportunity Date for KALYDECO
Generic Entry Dates for KALYDECO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULE;ORAL
Generic Entry Dates for KALYDECO*:
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.

Recent Clinical Trials for KALYDECO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2
National Heart, Lung, and Blood Institute (NHLBI)Early Phase 1
University of Alabama at BirminghamEarly Phase 1

See all KALYDECO clinical trials

US Patents and Regulatory Information for KALYDECO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vertex Pharms KALYDECO ivacaftor TABLET;ORAL 203188-002 May 20, 2019 DISCN Yes No   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-001 Mar 17, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Vertex Pharms KALYDECO ivacaftor TABLET;ORAL 203188-001 Jan 31, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-002 Mar 17, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-002 Mar 17, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for KALYDECO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1773816 CR 2015 00038 Denmark   Start Trial PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120725
1773816 1590036-8 Sweden   Start Trial PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/12/782/001 20120725
1773816 CA 2015 00038 Denmark   Start Trial 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
1773816 132016000022519 Italy   Start Trial PRODUCT NAME: IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KALYDECO); AUTHORISATION NUMBER(S) AND DATE(S): EU/12/782/001-002, 20120725
1773816 2015/036 Ireland   Start Trial PRODUCT NAME: N-(5-HYDROXYL-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
Moodys
Colorcon
Merck
Dow

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 verification 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.