Is there a generic for Ivacaftor?

The FDA Orange Book does not currently list an approved generic (ANDA) for Ivacaftor. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Ivacaftor?

KALYDECO (NDA 207925, VERTEX PHARMS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Ivacaftor?

The Orange Book lists 28 patents against Ivacaftor products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Ivacaftor have FDA marketing exclusivity?

Yes. The Orange Book records 32 marketing-exclusivity periods for Ivacaftor. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Ivacaftor are approved?

Ivacaftor is approved in the following dosage forms: granule, tablet.

FDA Orange Book · active-ingredient family

Ivacaftor

Ivacaftor is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:KALYDECO · NDA 207925

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · granule, tablet

Product	Applicant	Application	TE	Approved
KALYDECORLD×5	VERTEX PHARMS INC	NDA 207925	—	May 03, 2023
KALYDECORLD	VERTEX PHARMS	NDA 203188	—	Jan 31, 2012

Marketing exclusivity (32)

M-14New use / labeling-change exclusivity (3 years)
May 22, 2028
in 1 yr 11 mo
NPPNew patient population exclusivity (3 years)
May 03, 2026
2 mo ago
ODE-435Orphan-drug exclusivity (7 years)
May 03, 2030
in 3 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Nov 03, 2030
in 4 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 03, 2026
in 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 22, 2028
in 2 yr 6 mo
M-14New use / labeling-change exclusivity (3 years)
May 22, 2028
in 1 yr 11 mo
NPPNew patient population exclusivity (3 years)
May 03, 2026
2 mo ago
ODE-435Orphan-drug exclusivity (7 years)
May 03, 2030
in 3 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Nov 03, 2030
in 4 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 03, 2026
in 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 22, 2028
in 2 yr 6 mo
M-14New use / labeling-change exclusivity (3 years)
May 22, 2028
in 1 yr 11 mo
ODE-236Orphan-drug exclusivity (7 years)
Apr 29, 2026
2 mo ago
ODE-338Orphan-drug exclusivity (7 years)
Dec 21, 2027
in 1 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Oct 29, 2026
in 4 mo
PEDPediatric exclusivity (adds 6 months)
Jun 21, 2028
in 2 yr
PEDPediatric exclusivity (adds 6 months)
Nov 22, 2028
in 2 yr 6 mo
M-14New use / labeling-change exclusivity (3 years)
May 22, 2028
in 1 yr 11 mo
ODE-236Orphan-drug exclusivity (7 years)
Apr 29, 2026
2 mo ago
ODE-338Orphan-drug exclusivity (7 years)
Dec 21, 2027
in 1 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Oct 29, 2026
in 4 mo
PEDPediatric exclusivity (adds 6 months)
Jun 21, 2028
in 2 yr
PEDPediatric exclusivity (adds 6 months)
Nov 22, 2028
in 2 yr 6 mo
M-14New use / labeling-change exclusivity (3 years)
May 22, 2028
in 1 yr 11 mo
ODE-236Orphan-drug exclusivity (7 years)
Apr 29, 2026
2 mo ago
ODE-338Orphan-drug exclusivity (7 years)
Dec 21, 2027
in 1 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Oct 29, 2026
in 4 mo
PEDPediatric exclusivity (adds 6 months)
Jun 21, 2028
in 2 yr
PEDPediatric exclusivity (adds 6 months)
Nov 22, 2028
in 2 yr 6 mo
ODE-338Orphan-drug exclusivity (7 years)
Dec 21, 2027
in 1 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Jun 21, 2028
in 2 yr

Listed patents (28)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8354427	Jul 06, 2026	in 17 d	U-3608
9670163	Dec 28, 2026	in 6 mo	ProductU-3606
8754224	Dec 28, 2026	in 6 mo	SubstanceProduct
8410274	Dec 28, 2026	in 6 mo	Product
8354427*PED	Jan 06, 2027	in 7 mo
7495103	May 20, 2027	in 11 mo	SubstanceProduct
9670163*PED	Jun 28, 2027	in 1 yr
8754224*PED	Jun 28, 2027	in 1 yr
8410274*PED	Jun 28, 2027	in 1 yr
8324242	Aug 05, 2027	in 1 yr 2 mo	U-3609
7495103*PED	Nov 20, 2027	in 1 yr 5 mo
8324242*PED	Feb 05, 2028	in 1 yr 8 mo
11564916	Aug 13, 2029	in 3 yr 2 mo	U-3603
12458635	Aug 13, 2029	in 3 yr 2 mo	ProductU-4337
10646481	Aug 13, 2029	in 3 yr 2 mo	Product
11564916*PED	Feb 13, 2030	in 3 yr 9 mo
10646481*PED	Feb 13, 2030	in 3 yr 9 mo
12458635*PED	Feb 13, 2030	in 3 yr 9 mo
11147770	Feb 27, 2033	in 6 yr 10 mo	ProductU-3604
10272046	Feb 27, 2033	in 6 yr 10 mo	ProductU-3605
12214083	Feb 27, 2033	in 6 yr 10 mo	ProductU-4127
11752106	Feb 27, 2033	in 6 yr 10 mo	ProductU-3697
8883206	Feb 27, 2033	in 6 yr 10 mo	Product
11752106*PED	Aug 27, 2033	in 7 yr 4 mo
12214083*PED	Aug 27, 2033	in 7 yr 4 mo
11147770*PED	Aug 27, 2033	in 7 yr 4 mo
10272046*PED	Aug 27, 2033	in 7 yr 4 mo
8883206*PED	Aug 27, 2033	in 7 yr 4 mo

Ivacaftor — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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