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Last Updated: December 3, 2022

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 thirty-seven 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.

Summary for ivacaftor
International Patents:253
US Patents:37
Tradenames:3
Applicants:2
NDAs:5
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 91
Clinical Trials: 122
Patent Applications: 1,678
Drug Prices: Drug price trends for ivacaftor
What excipients (inactive ingredients) are in ivacaftor?ivacaftor excipients list
DailyMed Link:ivacaftor at DailyMed
Drug Prices for ivacaftor

See drug prices for ivacaftor

Recent Clinical Trials for ivacaftor

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

SponsorPhase
Children's Hospital Medical Center, CincinnatiN/A
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2
University of MiamiEarly Phase 1

See all ivacaftor clinical trials

Generic filers with tentative approvals for IVACAFTOR
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing150mgTABLET; 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 GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-002 Mar 17, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-001 Aug 7, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Brazil PI0620960 formas sólidas de n-[2,4-bis(1,1-dimetiletil)-5-hidroxifenil]-1,4-didro-4- oxiquinolina-3- carboxamida See Plans and Pricing
European Patent Office 2532650 Modulateurs de transporteurs de cassette de liaison à l ́ATP (Modulators of ATP-binding cassette transporters) See Plans and Pricing
Hong Kong 1152707 MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS ATP- See Plans and Pricing
European Patent Office 2502911 Modulateurs de transporteurs de cassette de liaison à l ́ATP (Modulators of ATP-binding cassette transporters) See Plans and Pricing
Australia 2006332726 Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ivacaftor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1773816 1590036-8 Sweden See Plans and Pricing 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 132016000022519 Italy See Plans and Pricing PRODUCT NAME: IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KALYDECO); AUTHORISATION NUMBER(S) AND DATE(S): EU/12/782/001-002, 20120725
1773816 CR 2015 00038 Denmark See Plans and Pricing 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 35/2015 Austria See Plans and Pricing PRODUCT NAME: N-(5-HYDROXY-2,4DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001, EU/1/12/782/002 (MITTEILUNG) 20120725
3170818 132020000000103 Italy See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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