Is there a generic for Elexacaftor, ivacaftor, tezacaftor; ivacaftor?

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

What is the reference-listed drug for Elexacaftor, ivacaftor, tezacaftor; ivacaftor?

TRIKAFTA (COPACKAGED) (NDA 217660, 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 Elexacaftor, ivacaftor, tezacaftor; ivacaftor?

The Orange Book lists 35 patents against Elexacaftor, ivacaftor, tezacaftor; 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 Elexacaftor, ivacaftor, tezacaftor; ivacaftor have FDA marketing exclusivity?

Yes. The Orange Book records 21 marketing-exclusivity periods for Elexacaftor, ivacaftor, tezacaftor; 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 Elexacaftor, ivacaftor, tezacaftor; ivacaftor are approved?

Elexacaftor, ivacaftor, tezacaftor; ivacaftor is approved in the following dosage forms: granule, tablet.

FDA Orange Book · active-ingredient family

Elexacaftor, ivacaftor, tezacaftor; ivacaftor

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

Reference-listed drug:TRIKAFTA (COPACKAGED) · NDA 217660

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · granule, tablet

Product	Applicant	Application	TE	Approved
TRIKAFTA (COPACKAGED)RLD×2	VERTEX PHARMS INC	NDA 217660	—	Apr 26, 2023
TRIKAFTA (COPACKAGED)RLD×2	VERTEX PHARMS INC	NDA 212273	—	Jun 08, 2021

Marketing exclusivity (21)

M-313New use / labeling-change exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
NPNew product exclusivity (3 years)
Apr 26, 2026
2 mo ago
ODE-433Orphan-drug exclusivity (7 years)
Apr 26, 2030
in 3 yr 11 mo
ODE-512Orphan-drug exclusivity (7 years)
Dec 20, 2031
in 5 yr 7 mo
ODE-543Orphan-drug exclusivity (7 years)
Mar 27, 2033
in 6 yr 10 mo
NPNew product exclusivity (3 years)
Apr 26, 2026
2 mo ago
ODE-433Orphan-drug exclusivity (7 years)
Apr 26, 2030
in 3 yr 11 mo
ODE-512Orphan-drug exclusivity (7 years)
Dec 20, 2031
in 5 yr 7 mo
ODE-543Orphan-drug exclusivity (7 years)
Mar 27, 2033
in 6 yr 10 mo
M-313New use / labeling-change exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
ODE*FDA marketing exclusivity
Oct 21, 2026
in 4 mo
ODE*FDA marketing exclusivity
Dec 21, 2027
in 1 yr 6 mo
ODE-357Orphan-drug exclusivity (7 years)
Jun 08, 2028
in 2 yr
ODE-512Orphan-drug exclusivity (7 years)
Dec 20, 2031
in 5 yr 7 mo
ODE-543Orphan-drug exclusivity (7 years)
Mar 27, 2033
in 6 yr 10 mo
M-313New use / labeling-change exclusivity (3 years)
Dec 20, 2027
in 1 yr 6 mo
ODE-275Orphan-drug exclusivity (7 years)
Oct 21, 2026
in 4 mo
ODE-323Orphan-drug exclusivity (7 years)
Dec 21, 2027
in 1 yr 6 mo
ODE-357Orphan-drug exclusivity (7 years)
Jun 08, 2028
in 2 yr
ODE-512Orphan-drug exclusivity (7 years)
Dec 20, 2031
in 5 yr 7 mo
ODE-543Orphan-drug exclusivity (7 years)
Mar 27, 2033
in 6 yr 10 mo

Listed patents (35)

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-3593
9931334	Dec 28, 2026	in 6 mo	ProductU-4068
9670163	Dec 28, 2026	in 6 mo	ProductU-4068
8410274	Dec 28, 2026	in 6 mo	Product
8754224	Dec 28, 2026	in 6 mo	SubstanceProduct
9974781	Apr 09, 2027	in 10 mo	ProductU-4066
11639347	Apr 09, 2027	in 10 mo	SubstanceProductU-3583
10239867	Apr 09, 2027	in 10 mo	SubstanceProductU-3590
10022352	Apr 09, 2027	in 10 mo	ProductU-3596
8598181	May 01, 2027	in 11 mo	U-4066
8623905	May 01, 2027	in 11 mo	SubstanceProduct
7645789	May 01, 2027	in 11 mo	SubstanceProduct
7495103	May 20, 2027	in 11 mo	SubstanceProduct
7776905	Jun 03, 2027	in 1 yr	SubstanceProduct
8324242	Aug 05, 2027	in 1 yr 2 mo	U-4066
8415387	Nov 12, 2027	in 1 yr 5 mo	U-3589
12458635	Aug 13, 2029	in 3 yr 2 mo	ProductU-4333
11564916	Aug 13, 2029	in 3 yr 2 mo	U-3585
10646481	Aug 13, 2029	in 3 yr 2 mo	Product
10081621	Mar 25, 2031	in 4 yr 10 mo	ProductU-4065
11578062	Mar 25, 2031	in 4 yr 10 mo	ProductU-3584
RE50453	Jul 10, 2031	in 5 yr 2 mo	SubstanceProduct
12214083	Feb 27, 2033	in 6 yr 10 mo	ProductU-4141
11147770	Feb 27, 2033	in 6 yr 10 mo	ProductU-3598
10272046	Feb 27, 2033	in 6 yr 10 mo	ProductU-3599
11752106	Feb 27, 2033	in 6 yr 10 mo	ProductU-3696
8883206	Feb 27, 2033	in 6 yr 10 mo	Product
9012496	Jul 15, 2033	in 7 yr 2 mo	U-3154
10758534	Oct 06, 2035	in 9 yr 5 mo	SubstanceProductU-3589
11426407	Oct 06, 2035	in 9 yr 5 mo	SubstanceProductU-3595
11517564	Dec 08, 2037	in 11 yr 8 mo	ProductU-3586
10793547	Dec 08, 2037	in 11 yr 8 mo	SubstanceProductU-3588
11179367	Dec 08, 2037	in 11 yr 8 mo	ProductU-3597
11453655	Dec 08, 2037	in 11 yr 8 mo	SubstanceProduct
12350262	Jul 17, 2038	in 12 yr 3 mo	U-4220

Elexacaftor, ivacaftor, tezacaftor; ivacaftor — frequently asked questions

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

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