cliffwatch

deutivacaftor; tezacaftor; vanzacaftor calcium · Vertex Pharms Inc · NDA 218730

Alyftrek

Earliest generic entry, as listed · earliest of 2 marketed strengths
13 Aug 2040

Other strengths are listed to 10 Jan 2043.

Blocked by patent: US 11873300, US 11873300.

Listed patents · 50 unexpired

PatentClaimsExpires
US 12186306use U-446010 Jan 2043
US 12186306use U-408810 Jan 2043
US 11873300substance, product, use U-408313 Aug 2040
US 11873300substance, product, use U-446213 Aug 2040
US 11066417substance, product14 Feb 2039
US 11866450use U-446314 Feb 2039
US 11866450use U-408214 Feb 2039
US 10206877product, use U-409214 Apr 2035
US 10206877product, use U-446714 Apr 2035
US 11951212product, use U-446114 Apr 2035
US 11951212product, use U-408914 Apr 2035
US 10058546use U-421815 Jul 2033
US 9012496use U-409715 Jul 2033
US 10047053substance17 May 2032
US 8865902substance, product17 May 2032
US 9181192substance, product, use U-409417 May 2032
US 9181192substance, product, use U-447217 May 2032
US 9512079substance, product, use U-447117 May 2032
US 9512079substance, product, use U-409817 May 2032
US RE50453substance, product10 Jul 2031
US 10081621product, use U-446825 Mar 2031
US 10081621product, use U-408725 Mar 2031
US 11578062product, use U-446525 Mar 2031
US 11578062product, use U-409625 Mar 2031
US 10646481product13 Aug 2029
US 11564916use U-409513 Aug 2029
US 11564916use U-446613 Aug 2029
US 8415387use U-408212 Nov 2027
US 8415387use U-446312 Nov 2027
US 8324242use U-44645 Aug 2027
US 8324242use U-40905 Aug 2027
US 7776905substance, product3 Jun 2027
US 7495103substance, product20 May 2027
US 7645789substance, product1 May 2027
US 8598181use U-44631 May 2027
US 8598181use U-40901 May 2027
US 8623905substance, product1 May 2027
US 10022352product, use U-40819 Apr 2027
US 10239867substance, product, use U-44649 Apr 2027
US 10239867substance, product, use U-40909 Apr 2027
US 11639347substance, product, use U-44649 Apr 2027
US 11639347substance, product, use U-40909 Apr 2027
US 9974781product, use U-44639 Apr 2027
US 9974781product, use U-40829 Apr 2027
US 8410274product28 Dec 2026
US 8754224substance, product28 Dec 2026
US 9670163product, use U-447028 Dec 2026
US 9670163product, use U-408028 Dec 2026
US 9931334product, use U-408028 Dec 2026
US 9931334product, use U-446928 Dec 2026

Exclusivities · 3 unexpired

ODE-536orphan drug (7 years)27 Mar 2033
ODE-526orphan drug (7 years)20 Dec 2031
NCEnew chemical entity (5 years)20 Dec 2029

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 · 2

NDA · productFormStrengthListed expiry
218730 · 001 · RLDtablet, oral50MG;20MG;EQ 4MG BASE13 Aug 2040
218730 · 002 · RLDtablet, oral125MG;50MG;EQ 10MG BASE10 Jan 2043
Expired or delisted (1)
  • US 8354427 · use U-4091 · 6 Jul 2026