ivacaftor; ivacaftor, tezacaftor · Vertex Pharms Inc · NDA 210491
Symdeko (Copackaged)
Earliest generic entry, as listed · earliest of 2 marketed strengths
14 Apr 2035
Blocked by patent: US 10206877, US 11951212.
Listed patents · 25 unexpired
32 Orange Book listing rows for 25 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10206877 | drug product, use U-3026, U-3027 | 14 Apr 2035 |
| US 10206877 listing row | drug product, use U-3026 · sets the listed date | 14 Apr 2035 |
| US 10206877 listing row | drug product, use U-3027 · sets the listed date | 14 Apr 2035 |
| US 11951212 | drug product, use U-3894 · sets the listed date | 14 Apr 2035 |
| US 10058546 | use U-3022, U-3023 | 15 Jul 2033 |
| US 10058546 listing row | use U-3022 | 15 Jul 2033 |
| US 10058546 listing row | use U-3023 | 15 Jul 2033 |
| US 9012496 | use U-2248 | 15 Jul 2033 |
| US RE50453 | drug substance, drug product | 10 Jul 2031 |
| US 10081621 | drug product, use U-3024, U-3025 | 25 Mar 2031 |
| US 10081621 listing row | drug product, use U-3024 | 25 Mar 2031 |
| US 10081621 listing row | drug product, use U-3025 | 25 Mar 2031 |
| US 11578062 | drug product, use U-3545 | 25 Mar 2031 |
| US 10646481 | drug product | 13 Aug 2029 |
| US 11564916 | use U-3527 | 13 Aug 2029 |
| US 12458635 | drug product, use U-4336 | 13 Aug 2029 |
| US 8415387 | use U-2246 | 12 Nov 2027 |
| US 8324242 | use U-2246 | 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-2246 | 1 May 2027 |
| US 8623905 | drug substance, drug product | 1 May 2027 |
| US 10022352 | drug product, use U-2343, U-2573 | 9 Apr 2027 |
| US 10022352 listing row | drug product, use U-2343 | 9 Apr 2027 |
| US 10022352 listing row | drug product, use U-2573 | 9 Apr 2027 |
| US 10239867 | drug substance, drug product, use U-2512, U-2569 | 9 Apr 2027 |
| US 10239867 listing row | drug substance, drug product, use U-2512 | 9 Apr 2027 |
| US 10239867 listing row | drug substance, drug product, use U-2569 | 9 Apr 2027 |
| US 11639347 | drug substance, drug product, use U-2569 | 9 Apr 2027 |
| US 9974781 | drug product, use U-2318, U-2574 | 9 Apr 2027 |
| US 9974781 listing row | drug product, use U-2318 | 9 Apr 2027 |
| US 9974781 listing row | drug product, use U-2574 | 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-2246 | 28 Dec 2026 |
| US 9931334 | drug product, use U-2275, U-2575 | 28 Dec 2026 |
| US 9931334 listing row | drug product, use U-2275 | 28 Dec 2026 |
| US 9931334 listing row | drug product, use U-2575 | 28 Dec 2026 |
Exclusivities · 1 unexpired
| ODE-335 | orphan drug (7 years) | 21 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210491 · 001 · RLD | tablet, oral | 150MG;150MG, 100MG | 14 Apr 2035 |
| 210491 · 002 · RLD | tablet, oral | 75MG;75MG, 50MG | 14 Apr 2035 |
Expired or delisted (2)
- US 8354427 · use U-3021 · 6 Jul 2026
- ODE-247 · 21 Jun 2026