Ivacaftor - Generic Drug Details

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-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:	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

See drug prices for ivacaftor

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ivacaftor

Dosage:

GRANULE;ORAL

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
Emory University	Phase 4

See all ivacaftor clinical trials

Generic filers with tentative approvals for IVACAFTOR

Applicant	Application No.	Strength	Dosage Form
		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

Drug Class	Cystic Fibrosis Transmembrane Conductance Regulator Potentiator
Mechanism of Action	Chloride Channel Activation Potentiators Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ivacaftor

R07AX	Other respiratory system products
R07A	OTHER RESPIRATORY SYSTEM PRODUCTS
R07	OTHER RESPIRATORY SYSTEM PRODUCTS
R	Respiratory system

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	KALYDECO	ivacaftor	TABLET;ORAL	203188-001	Jan 31, 2012		RX	Yes	Yes
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-001	Mar 17, 2015		RX	Yes	No
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-002	Aug 7, 2018		RX	Yes	Yes			Y
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-005	May 3, 2023		RX	Yes	No
Vertex Pharms	KALYDECO	ivacaftor	TABLET;ORAL	203188-001	Jan 31, 2012		RX	Yes	Yes
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-002	Aug 7, 2018		RX	Yes	Yes

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

International Patents for ivacaftor

Country	Patent Number	Title	Estimated Expiration
Montenegro	02799	Modulatori ATP-vezujućih kasetnih transportera (Modulators of ATP-binding cassette transporters)
Russian Federation	2525115	СПОСОБ МОДУЛЯЦИИ ТРАНСПОРТЕРОВ АТФ-СВЯЗЫВАЮЩЕЙ КАССЕТЫ (METHOD OF MODULATING TRANSPORTERS OF ATP-BINDING CASSETTE)
Japan	2011530598
New Zealand	598393	Modulators of atp-binding cassette transporters
World Intellectual Property Organization (WIPO)	2011019413
Australia	2006332726	Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide

Supplementary Protection Certificates for ivacaftor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2826776	21C1018	France		PRODUCT NAME: TEZACAFTOR ET IVACAFTOR, SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1306 20181106
1773816	PA2015028	Lithuania		PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
1773816	C01773816/01	Switzerland		PRODUCT NAME: IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC 62686 13.01.2014
1773816	617	Finland
1773816	C300748	Netherlands		PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
1773816	C20150028 00162	Estonia		PRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012