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.
Listed patents · 32 unexpired
50 Orange Book listing rows for 32 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12186306 | use U-4088, U-4460 | 10 Jan 2043 |
| US 12186306 listing row | use U-4088 | 10 Jan 2043 |
| US 12186306 listing row | use U-4460 | 10 Jan 2043 |
| US 11873300 | drug substance, drug product, use U-4083, U-4462 | 13 Aug 2040 |
| US 11873300 listing row | drug substance, drug product, use U-4083 · sets the listed date | 13 Aug 2040 |
| US 11873300 listing row | drug substance, drug product, use U-4462 · sets the listed date | 13 Aug 2040 |
| US 11066417 | drug substance, drug product | 14 Feb 2039 |
| US 11866450 | use U-4082, U-4463 | 14 Feb 2039 |
| US 11866450 listing row | use U-4082 | 14 Feb 2039 |
| US 11866450 listing row | use U-4463 | 14 Feb 2039 |
| US 10206877 | drug product, use U-4092, U-4467 | 14 Apr 2035 |
| US 10206877 listing row | drug product, use U-4092 | 14 Apr 2035 |
| US 10206877 listing row | drug product, use U-4467 | 14 Apr 2035 |
| US 11951212 | drug product, use U-4089, U-4461 | 14 Apr 2035 |
| US 11951212 listing row | drug product, use U-4089 | 14 Apr 2035 |
| US 11951212 listing row | drug product, use U-4461 | 14 Apr 2035 |
| US 10058546 | use U-4218 | 15 Jul 2033 |
| US 9012496 | use U-4097 | 15 Jul 2033 |
| US 10047053 | drug substance | 17 May 2032 |
| US 8865902 | drug substance, drug product | 17 May 2032 |
| US 9181192 | drug substance, drug product, use U-4094, U-4472 | 17 May 2032 |
| US 9181192 listing row | drug substance, drug product, use U-4094 | 17 May 2032 |
| US 9181192 listing row | drug substance, drug product, use U-4472 | 17 May 2032 |
| US 9512079 | drug substance, drug product, use U-4098, U-4471 | 17 May 2032 |
| US 9512079 listing row | drug substance, drug product, use U-4098 | 17 May 2032 |
| US 9512079 listing row | drug substance, drug product, use U-4471 | 17 May 2032 |
| US RE50453 | drug substance, drug product | 10 Jul 2031 |
| US 10081621 | drug product, use U-4087, U-4468 | 25 Mar 2031 |
| US 10081621 listing row | drug product, use U-4087 | 25 Mar 2031 |
| US 10081621 listing row | drug product, use U-4468 | 25 Mar 2031 |
| US 11578062 | drug product, use U-4096, U-4465 | 25 Mar 2031 |
| US 11578062 listing row | drug product, use U-4096 | 25 Mar 2031 |
| US 11578062 listing row | drug product, use U-4465 | 25 Mar 2031 |
| US 10646481 | drug product | 13 Aug 2029 |
| US 11564916 | use U-4095, U-4466 | 13 Aug 2029 |
| US 11564916 listing row | use U-4095 | 13 Aug 2029 |
| US 11564916 listing row | use U-4466 | 13 Aug 2029 |
| US 8415387 | use U-4082, U-4463 | 12 Nov 2027 |
| US 8415387 listing row | use U-4082 | 12 Nov 2027 |
| US 8415387 listing row | use U-4463 | 12 Nov 2027 |
| US 8324242 | use U-4090, U-4464 | 5 Aug 2027 |
| US 8324242 listing row | use U-4090 | 5 Aug 2027 |
| US 8324242 listing row | use U-4464 | 5 Aug 2027 |
| US 7776905 | drug substance, drug product | 3 Jun 2027 |
| US 7495103 | drug substance, drug product | 20 May 2027 |
| US 7645789 | drug substance, drug product | 1 May 2027 |
| US 8598181 | use U-4090, U-4463 | 1 May 2027 |
| US 8598181 listing row | use U-4090 | 1 May 2027 |
| US 8598181 listing row | use U-4463 | 1 May 2027 |
| US 8623905 | drug substance, drug product | 1 May 2027 |
| US 10022352 | drug product, use U-4081 | 9 Apr 2027 |
| US 10239867 | drug substance, drug product, use U-4090, U-4464 | 9 Apr 2027 |
| US 10239867 listing row | drug substance, drug product, use U-4090 | 9 Apr 2027 |
| US 10239867 listing row | drug substance, drug product, use U-4464 | 9 Apr 2027 |
| US 11639347 | drug substance, drug product, use U-4090, U-4464 | 9 Apr 2027 |
| US 11639347 listing row | drug substance, drug product, use U-4090 | 9 Apr 2027 |
| US 11639347 listing row | drug substance, drug product, use U-4464 | 9 Apr 2027 |
| US 9974781 | drug product, use U-4082, U-4463 | 9 Apr 2027 |
| US 9974781 listing row | drug product, use U-4082 | 9 Apr 2027 |
| US 9974781 listing row | drug product, use U-4463 | 9 Apr 2027 |
| US 8410274 | drug product | 28 Dec 2026 |
| US 8754224 | drug substance, drug product | 28 Dec 2026 |
| US 9670163 | drug product, use U-4080, U-4470 | 28 Dec 2026 |
| US 9670163 listing row | drug product, use U-4080 | 28 Dec 2026 |
| US 9670163 listing row | drug product, use U-4470 | 28 Dec 2026 |
| US 9931334 | drug product, use U-4080, U-4469 | 28 Dec 2026 |
| US 9931334 listing row | drug product, use U-4080 | 28 Dec 2026 |
| US 9931334 listing row | drug product, use U-4469 | 28 Dec 2026 |
Exclusivities · 3 unexpired
| ODE-536 | orphan drug (7 years) | 27 Mar 2033 |
| ODE-526 | orphan drug (7 years) | 20 Dec 2031 |
| NCE | new 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 · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218730 · 001 · RLD | tablet, oral | 50MG;20MG;EQ 4MG BASE | 13 Aug 2040 |
| 218730 · 002 · RLD | tablet, oral | 125MG;50MG;EQ 10MG BASE | 10 Jan 2043 |
Expired or delisted (1)
- US 8354427 · use U-4091 · 6 Jul 2026