ivacaftor · Vertex Pharms · NDA 203188, 207925
Kalydeco
Earliest generic entry, as listed · earliest of 6 marketed strengths
13 Feb 2030
Other strengths are listed to 27 Aug 2033.
Blocked by patent: US 10646481 (pediatric extension), US 11564916 (pediatric extension), US 12458635 (pediatric extension).
Listed patents · 14 unexpired
42 Orange Book listing rows for 14 patents, including 14 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10272046 | drug product, use U-2531, U-2967, U-3605 | 27 Aug 2033 |
| US 10272046 listing row | drug product, use U-2531 | 27 Feb 2033 |
| US 10272046 listing row | drug product, use U-2967 | 27 Feb 2033 |
| US 10272046 listing row | drug product, use U-3605 | 27 Feb 2033 |
| US 10272046 listing row | pediatric extension | 27 Aug 2033 |
| US 11147770 | drug product, use U-3339, U-3604 | 27 Aug 2033 |
| US 11147770 listing row | drug product, use U-3339 | 27 Feb 2033 |
| US 11147770 listing row | drug product, use U-3604 | 27 Feb 2033 |
| US 11147770 listing row | pediatric extension | 27 Aug 2033 |
| US 11752106 | drug product, use U-3697 | 27 Aug 2033 |
| US 11752106 listing row | drug product, use U-3697 | 27 Feb 2033 |
| US 11752106 listing row | pediatric extension | 27 Aug 2033 |
| US 12214083 | drug product, use U-4126, U-4127, U-4128 | 27 Aug 2033 |
| US 12214083 listing row | drug product, use U-4126 | 27 Feb 2033 |
| US 12214083 listing row | drug product, use U-4127 | 27 Feb 2033 |
| US 12214083 listing row | drug product, use U-4128 | 27 Feb 2033 |
| US 12214083 listing row | pediatric extension | 27 Aug 2033 |
| US 8883206 | drug product | 27 Aug 2033 |
| US 8883206 listing row | drug product | 27 Feb 2033 |
| US 8883206 listing row | pediatric extension | 27 Aug 2033 |
| US 10646481 | drug product | 13 Feb 2030 |
| US 10646481 listing row | drug product | 13 Aug 2029 |
| US 10646481 listing row | pediatric extension · sets the listed date | 13 Feb 2030 |
| US 11564916 | use U-3528, U-3530, U-3603 | 13 Feb 2030 |
| US 11564916 listing row | use U-3528 | 13 Aug 2029 |
| US 11564916 listing row | use U-3530 | 13 Aug 2029 |
| US 11564916 listing row | use U-3603 | 13 Aug 2029 |
| US 11564916 listing row | pediatric extension · sets the listed date | 13 Feb 2030 |
| US 12458635 | drug product, use U-4337, U-4339 | 13 Feb 2030 |
| US 12458635 listing row | drug product, use U-4337 | 13 Aug 2029 |
| US 12458635 listing row | drug product, use U-4339 | 13 Aug 2029 |
| US 12458635 listing row | pediatric extension · sets the listed date | 13 Feb 2030 |
| US 8324242 | use U-1311, U-1906, U-2527, U-2963, U-3609 | 5 Feb 2028 |
| US 8324242 listing row | use U-1311 | 5 Aug 2027 |
| US 8324242 listing row | use U-1906 | 5 Aug 2027 |
| US 8324242 listing row | use U-2527 | 5 Aug 2027 |
| US 8324242 listing row | use U-2963 | 5 Aug 2027 |
| US 8324242 listing row | use U-3609 | 5 Aug 2027 |
| US 8324242 listing row | pediatric extension | 5 Feb 2028 |
| US 7495103 | drug substance, drug product | 20 Nov 2027 |
| US 7495103 listing row | drug substance, drug product | 20 May 2027 |
| US 7495103 listing row | pediatric extension | 20 Nov 2027 |
| US 8410274 | drug product | 28 Jun 2027 |
| US 8410274 listing row | drug product | 28 Dec 2026 |
| US 8410274 listing row | pediatric extension | 28 Jun 2027 |
| US 8754224 | drug substance, drug product | 28 Jun 2027 |
| US 8754224 listing row | drug substance, drug product | 28 Dec 2026 |
| US 8754224 listing row | pediatric extension | 28 Jun 2027 |
| US 9670163 | drug product, use U-1311, U-2530, U-2966, U-3606 | 28 Jun 2027 |
| US 9670163 listing row | drug product, use U-1311 | 28 Dec 2026 |
| US 9670163 listing row | drug product, use U-2530 | 28 Dec 2026 |
| US 9670163 listing row | drug product, use U-2966 | 28 Dec 2026 |
| US 9670163 listing row | drug product, use U-3606 | 28 Dec 2026 |
| US 9670163 listing row | pediatric extension | 28 Jun 2027 |
| US 8354427 | pediatric extension | 6 Jan 2027 |
Exclusivities · 4 unexpired
| PED | pediatric (6 months added) | 3 Nov 2030 |
| ODE-435 | orphan drug (7 years) | 3 May 2030 |
| PED | pediatric (6 months added) | 22 Nov 2028 |
| PED | pediatric (6 months added) | 21 Jun 2028 |
| M-14 | miscellaneous (3 years) | 22 May 2028 |
| ODE-338 | orphan drug (7 years) | 21 Dec 2027 |
| PED | pediatric (6 months added) | 3 Nov 2026 |
| PED | pediatric (6 months added) | 29 Oct 2026 |
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
- Exclusivity expires within 90 days PED · 207925-002Exclusivity expires 29 Oct 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 207925-001Exclusivity expires 29 Oct 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 207925-003Exclusivity expires 29 Oct 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 207925-005Exclusivity expires 3 Nov 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 207925-004Exclusivity expires 3 Nov 2026Detected 24 Oct 2026
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203188 · 001 · RLD | tablet, oral | 150MG | 13 Feb 2030 |
| 207925 · 001 · RLD | granule, oral | 50MG/PACKET | 27 Aug 2033 |
| 207925 · 002 · RLD | granule, oral | 75MG/PACKET | 27 Aug 2033 |
| 207925 · 003 · RLD | granule, oral | 25MG/PACKET | 27 Aug 2033 |
| 207925 · 004 · RLD | granule, oral | 5.8MG/PACKET | 27 Aug 2033 |
| 207925 · 005 · RLD | granule, oral | 13.4MG/PACKET | 27 Aug 2033 |
Expired or delisted (7)
- US 8354427 · use U-2528 · 6 Jul 2026
- US 8354427 · use U-1905 · 6 Jul 2026
- US 8354427 · use U-1311 · 6 Jul 2026
- US 8354427 · use U-3608 · 6 Jul 2026
- US 8354427 · use U-2964 · 6 Jul 2026
- NPP · 3 May 2026
- ODE-236 · 29 Apr 2026