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-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ivacaftor has two hundred and fifty-two 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: | 252 |
US Patents: | 41 |
Tradenames: | 3 |
Applicants: | 2 |
NDAs: | 5 |
Drug Master File Entries: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 104 |
Clinical Trials: | 125 |
Patent Applications: | 1,473 |
Drug Prices: | Drug price trends for ivacaftor |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ivacaftor |
What excipients (inactive ingredients) are in ivacaftor? | ivacaftor excipients list |
DailyMed Link: | ivacaftor at DailyMed |
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
Sponsor | Phase |
---|---|
University of North Carolina, Chapel Hill | Phase 4 |
Chiesi USA, Inc. | Phase 4 |
The Marcus Foundation, Inc. | Phase 4 |
Generic filers with tentative approvals for IVACAFTOR
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 150MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology 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 |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2011019413 | ⤷ Try a Trial | |
Hong Kong | 1203840 | 藥物組合物及其施用 (PHARMACEUTICAL COMPOSITION AND ADMINISTRATION THEREOF) | ⤷ Try a Trial |
Slovenia | 2489659 | ⤷ Try a Trial | |
Russian Federation | 2525115 | СПОСОБ МОДУЛЯЦИИ ТРАНСПОРТЕРОВ АТФ-СВЯЗЫВАЮЩЕЙ КАССЕТЫ (METHOD OF MODULATING TRANSPORTERS OF ATP-BINDING CASSETTE) | ⤷ Try a Trial |
China | 101006076 | Modulators of ATP-binding cassette transporters | ⤷ Try a Trial |
China | 102652128 | 4 -oxo- iH -quinoline- 3 - carboxamides as modulators of ATP -binding cassette transporters | ⤷ Try a Trial |
Singapore | 178337 | PHARMACEUTICAL COMPOSITION AND ADMINISTRATIONS 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 | 122015000050 | Germany | ⤷ Try a Trial | 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 |
3170818 | C03170818/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: IVACAFTOR + LUMACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65981 02.09.2016 |
3170818 | 20C1037 | France | ⤷ Try a Trial | PRODUCT NAME: LUMACAFTOR ET IVACAFTOR DANS TOUTES SES FORMES RELEVANT DE LA PROTECTION DU BREVET DE BASE; REGISTRATION NO/DATE: EU/1/15/1059 20151124 |
2826776 | C02826776/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TEZACAFTOR UND IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66742 10.05.2019 |
2826776 | 132021000000062 | Italy | ⤷ Try a Trial | PRODUCT NAME: UNA COMBINAZIONE DI (A) TEZACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E (B) IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(SYMKEVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1306, 20181106 |
1773816 | 1590036-8 | Sweden | ⤷ Try a 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 | PA2015028,C1773816 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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