cliffwatch

elexacaftor, ivacaftor, tezacaftor; ivacaftor · Vertex Pharms Inc · NDA 212273, 217660

Trikafta (Copackaged)

Earliest generic entry, as listed · earliest of 4 marketed strengths
8 Dec 2037

Other strengths are listed to 17 Jul 2038.

Blocked by patent: US 10793547, US 10793547, US 10793547, US 10793547, US 10793547, US 10793547, US 10793547, US 11179367, US 11179367, US 11179367, US 11179367, US 11179367, US 11179367, US 11453655, US 11517564, US 11517564, US 11517564, US 11517564, US 11517564, US 11517564, US 11517564.

Listed patents · 141 unexpired

PatentClaimsExpires
US 12350262use U-422217 Jul 2038
US 12350262use U-422117 Jul 2038
US 12350262use U-422017 Jul 2038
US 12350262use U-447617 Jul 2038
US 12350262use U-447517 Jul 2038
US 10793547substance, product, use U-31448 Dec 2037
US 10793547substance, product, use U-35888 Dec 2037
US 10793547substance, product, use U-30288 Dec 2037
US 10793547substance, product, use U-40668 Dec 2037
US 10793547substance, product, use U-44758 Dec 2037
US 10793547substance, product, use U-44768 Dec 2037
US 10793547substance, product, use U-40738 Dec 2037
US 11179367product, use U-40718 Dec 2037
US 11179367product, use U-44848 Dec 2037
US 11179367product, use U-35978 Dec 2037
US 11179367product, use U-44878 Dec 2037
US 11179367product, use U-32538 Dec 2037
US 11179367product, use U-40598 Dec 2037
US 11453655substance, product8 Dec 2037
US 11517564product, use U-40578 Dec 2037
US 11517564product, use U-44758 Dec 2037
US 11517564product, use U-44768 Dec 2037
US 11517564product, use U-35868 Dec 2037
US 11517564product, use U-40698 Dec 2037
US 11517564product, use U-40678 Dec 2037
US 11517564product, use U-34988 Dec 2037
US 10758534substance, product, use U-31446 Oct 2035
US 10758534substance, product, use U-35896 Oct 2035
US 10758534substance, product, use U-30286 Oct 2035
US 10758534substance, product, use U-40666 Oct 2035
US 10758534substance, product, use U-44756 Oct 2035
US 10758534substance, product, use U-40736 Oct 2035
US 10758534substance, product, use U-44766 Oct 2035
US 11426407substance, product, use U-34256 Oct 2035
US 11426407substance, product, use U-44756 Oct 2035
US 11426407substance, product, use U-40586 Oct 2035
US 11426407substance, product, use U-44766 Oct 2035
US 11426407substance, product, use U-40706 Oct 2035
US 11426407substance, product, use U-35956 Oct 2035
US 9012496use U-264915 Jul 2033
US 9012496use U-315415 Jul 2033
US 10272046product, use U-406227 Feb 2033
US 10272046product, use U-448227 Feb 2033
US 10272046product, use U-359927 Feb 2033
US 11147770product, use U-448327 Feb 2033
US 11147770product, use U-359827 Feb 2033
US 11147770product, use U-406027 Feb 2033
US 11752106product, use U-448927 Feb 2033
US 11752106product, use U-405227 Feb 2033
US 11752106product, use U-369627 Feb 2033
US 12214083product, use U-449227 Feb 2033
US 12214083product, use U-414127 Feb 2033
US 8883206product27 Feb 2033
US RE50453substance, product10 Jul 2031
US 10081621product, use U-360025 Mar 2031
US 10081621product, use U-448025 Mar 2031
US 10081621product, use U-448125 Mar 2031
US 10081621product, use U-407525 Mar 2031
US 10081621product, use U-406525 Mar 2031
US 10081621product, use U-303225 Mar 2031
US 10081621product, use U-315725 Mar 2031
US 11578062product, use U-405425 Mar 2031
US 11578062product, use U-449025 Mar 2031
US 11578062product, use U-358425 Mar 2031
US 11578062product, use U-448825 Mar 2031
US 11578062product, use U-354425 Mar 2031
US 10646481product13 Aug 2029
US 11564916use U-449113 Aug 2029
US 11564916use U-352513 Aug 2029
US 11564916use U-406313 Aug 2029
US 11564916use U-405513 Aug 2029
US 11564916use U-358513 Aug 2029
US 11564916use U-448513 Aug 2029
US 12458635product, use U-448613 Aug 2029
US 12458635product, use U-433013 Aug 2029
US 12458635product, use U-449313 Aug 2029
US 12458635product, use U-433313 Aug 2029
US 8415387use U-406612 Nov 2027
US 8415387use U-314412 Nov 2027
US 8415387use U-447612 Nov 2027
US 8415387use U-407312 Nov 2027
US 8415387use U-447512 Nov 2027
US 8415387use U-358912 Nov 2027
US 8415387use U-302812 Nov 2027
US 8324242use U-44755 Aug 2027
US 8324242use U-35895 Aug 2027
US 8324242use U-31445 Aug 2027
US 8324242use U-40665 Aug 2027
US 8324242use U-40735 Aug 2027
US 8324242use U-44765 Aug 2027
US 8324242use U-30285 Aug 2027
US 7776905substance, product3 Jun 2027
US 7495103substance, product20 May 2027
US 7645789substance, product1 May 2027
US 8598181use U-44761 May 2027
US 8598181use U-31441 May 2027
US 8598181use U-40561 May 2027
US 8598181use U-30281 May 2027
US 8598181use U-35891 May 2027
US 8598181use U-44751 May 2027
US 8598181use U-40661 May 2027
US 8623905substance, product1 May 2027
US 10022352product, use U-26519 Apr 2027
US 10022352product, use U-35969 Apr 2027
US 10022352product, use U-31569 Apr 2027
US 10239867substance, product, use U-44769 Apr 2027
US 10239867substance, product, use U-44759 Apr 2027
US 10239867substance, product, use U-30339 Apr 2027
US 10239867substance, product, use U-40539 Apr 2027
US 10239867substance, product, use U-40569 Apr 2027
US 10239867substance, product, use U-31589 Apr 2027
US 10239867substance, product, use U-35909 Apr 2027
US 11639347substance, product, use U-44769 Apr 2027
US 11639347substance, product, use U-35879 Apr 2027
US 11639347substance, product, use U-40569 Apr 2027
US 11639347substance, product, use U-35839 Apr 2027
US 11639347substance, product, use U-40539 Apr 2027
US 11639347substance, product, use U-44759 Apr 2027
US 9974781product, use U-40669 Apr 2027
US 9974781product, use U-40739 Apr 2027
US 9974781product, use U-44769 Apr 2027
US 9974781product, use U-44759 Apr 2027
US 9974781product, use U-31449 Apr 2027
US 9974781product, use U-35899 Apr 2027
US 9974781product, use U-30289 Apr 2027
US 8410274product28 Dec 2026
US 8754224substance, product28 Dec 2026
US 9670163product, use U-406828 Dec 2026
US 9670163product, use U-447828 Dec 2026
US 9670163product, use U-447728 Dec 2026
US 9670163product, use U-407828 Dec 2026
US 9670163product, use U-359128 Dec 2026
US 9670163product, use U-303128 Dec 2026
US 9670163product, use U-315528 Dec 2026
US 9931334product, use U-407828 Dec 2026
US 9931334product, use U-447928 Dec 2026
US 9931334product, use U-303128 Dec 2026
US 9931334product, use U-359128 Dec 2026
US 9931334product, use U-447828 Dec 2026
US 9931334product, use U-315528 Dec 2026
US 9931334product, use U-406828 Dec 2026

Exclusivities · 7 unexpired

ODE-543orphan drug (7 years)27 Mar 2033
ODE-512orphan drug (7 years)20 Dec 2031
ODE-433orphan drug (7 years)26 Apr 2030
ODE-357orphan drug (7 years)8 Jun 2028
ODE*21 Dec 2027
ODE-323orphan drug (7 years)21 Dec 2027
M-313miscellaneous (3 years)20 Dec 2027

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 4

NDA · productFormStrengthListed expiry
212273 · 001 · RLDtablet, oral100MG,75MG,50MG; 150MG17 Jul 2038
212273 · 002 · RLDtablet, oral50MG,37.5MG,25MG; 75MG17 Jul 2038
217660 · 001 · RLDgranule, oral80MG, 60MG, 40MG;59.5MG8 Dec 2037
217660 · 002 · RLDgranule, oral100MG, 75MG, 50MG;75MG17 Jul 2038
Expired or delisted (6)
  • US 8354427 · use U-3145 · 6 Jul 2026
  • US 8354427 · use U-3593 · 6 Jul 2026
  • US 8354427 · use U-3029 · 6 Jul 2026
  • ODE-275 · 21 Oct 2026
  • ODE* · 21 Oct 2026
  • NP · 26 Apr 2026