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Last Updated: July 18, 2024

Ivacaftor - Generic Drug Details


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

Ivacaftor is the generic ingredient in three branded drugs marketed by Vertex Pharms Inc and Vertex Pharms, and is included in five NDAs. There are forty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor has two hundred and fifty-three patent family members in thirty-two countries.

There are three drug master file entries for ivacaftor. One supplier is listed for this compound. There is one tentative approval for this compound.

Drug Prices for ivacaftor

See drug prices for ivacaftor

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ivacaftor
Generic Entry Dates for ivacaftor*:
Constraining patent/regulatory exclusivity:
Dosage:
GRANULE;ORAL
Generic Entry Dates for ivacaftor*:
Constraining patent/regulatory exclusivity:
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 ivacaftor

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

SponsorPhase
Qanatpharma Canada LTDPhase 1
University of North Carolina, Chapel HillPhase 4
Chiesi USA, Inc.Phase 4

See all ivacaftor clinical trials

Generic filers with tentative approvals for IVACAFTOR
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up150MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for IVACAFTOR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KALYDECO Oral Granules ivacaftor 25 mg, 50 mg and 75 mg 207925 1 2022-04-13
KALYDECO Tablets ivacaftor 150 mg 203188 1 2020-06-10

US Patents and Regulatory Information for ivacaftor

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 KALYDECO ivacaftor GRANULE;ORAL 207925-001 Mar 17, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y 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 SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET;ORAL 210491-002 Jun 21, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for ivacaftor

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Vertex Pharmaceuticals (Ireland) Limited Kalydeco ivacaftor EMEA/H/C/002494
Kalydeco tablets are indicated:As monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see sections 4.4 and 5.1).In a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, and 3849+10kbC→T.In a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (CF) who have at least one F508del mutation in the CFTR gene (see section 5.1).Kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see sections 4.4 and 5.1).
Authorised no no no 2012-07-23
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ivacaftor

Country Patent Number Title Estimated Expiration
Japan 2012107069 MODULATOR OF ATP-BINDING CASSETTE TRANSPORTER ⤷  Sign Up
Israel 252421 תכשירים המכילים תפזורות מוצקות ושימושים בהם (Compositions comprising solid dispersions and uses thereof) ⤷  Sign Up
Slovenia 3345625 ⤷  Sign Up
Japan 2015511583 薬学的組成物およびその投与 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ivacaftor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1773816 132016000022519 Italy ⤷  Sign Up PRODUCT NAME: IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KALYDECO); AUTHORISATION NUMBER(S) AND DATE(S): EU/12/782/001-002, 20120725
1773816 617 Finland ⤷  Sign Up
1773816 300748 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
1773816 C20150028 00162 Estonia ⤷  Sign Up PRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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