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Last Updated: March 29, 2024

Ivacaftor - Generic Drug Details


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What are the generic sources for ivacaftor and what is the scope of patent protection?

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-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor has two hundred and fifty-one 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
Chiesi USA, Inc.Phase 4
University of North Carolina, Chapel HillPhase 4
Emory UniversityPhase 4

See all ivacaftor clinical trials

Generic filers with tentative approvals for IVACAFTOR
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial150MGTABLET; 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 ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-004 May 3, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-003 Apr 29, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Spain 2534606 ⤷  Try a Trial
Australia 2010251787 Modulators of ATP-Binding Cassette Transporters ⤷  Try a Trial
Israel 265430 תכשירי רוקחות המכילים פיזור מוצק של n-[2,4-ביס(1,1-דימטילאטיל)-5-הידרוקסיפניל]-1,4-דיהידרו-4-אוקסוקוינולין-3-קארבוקסאמיד ושימושים בהם (Pharmaceutical compositions containing a solid dispersion of n-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamode and uses thereof) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ivacaftor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1773816 C01773816/01 Switzerland ⤷  Try a Trial PRODUCT NAME: IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC 62686 13.01.2014
3170818 132020000000103 Italy ⤷  Try a Trial PRODUCT NAME: UNA COMBINAZIONE DI (A) LUMACAFTOR E (B) IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ORKAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1059, 20151124
2826776 21C1018 France ⤷  Try a Trial PRODUCT NAME: TEZACAFTOR ET IVACAFTOR, SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1306 20181106
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.