ivacaftor; lumacaftor · Vertex Pharms Inc · NDA 206038, 211358

Orkambi

Earliest generic entry, as listed · earliest of 5 marketed strengths

11 Jun 2031

Blocked by patent: US 8993600 (pediatric extension).

Listed patents · 23 unexpired

73 Orange Book listing rows for 23 patents, including 23 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 8993600	drug product	11 Jun 2031	2 listing rows
US 8993600 listing row	drug product	11 Dec 2030	5 strengths · listed 22 Jul 2015
US 8993600 listing row	pediatric extension · sets the listed date	11 Jun 2031	5 strengths
US 8507534	drug substance, drug product	20 Mar 2031	2 listing rows
US 8507534 listing row	drug substance, drug product	20 Sep 2030	5 strengths · listed 22 Jul 2015
US 8507534 listing row	pediatric extension	20 Mar 2031	5 strengths
US 8716338	drug product, use U-1718, U-1910, U-2396, U-3426	20 Mar 2031	5 listing rows
US 8716338 listing row	drug product, use U-1718	20 Sep 2030	listed 22 Jul 2015
US 8716338 listing row	drug product, use U-1910	20 Sep 2030	2 strengths · listed 22 Jul 2015
US 8716338 listing row	drug product, use U-2396	20 Sep 2030	2 strengths · listed 6 Sep 2018
US 8716338 listing row	drug product, use U-3426	20 Sep 2030	listed 26 Sep 2022
US 8716338 listing row	pediatric extension	20 Mar 2031	5 strengths
US 9192606	drug product, use U-1912, U-2397, U-3428	29 Mar 2030	4 listing rows
US 9192606 listing row	drug product, use U-1912	29 Sep 2029	2 strengths · listed 21 Oct 2016
US 9192606 listing row	drug product, use U-2397	29 Sep 2029	2 strengths · listed 6 Sep 2018
US 9192606 listing row	drug product, use U-3428	29 Sep 2029	listed 26 Sep 2022
US 9192606 listing row	pediatric extension	29 Mar 2030	5 strengths
US 10646481	drug product	13 Feb 2030	2 listing rows
US 10646481 listing row	drug product	13 Aug 2029	5 strengths · listed 11 Jun 2020
US 10646481 listing row	pediatric extension	13 Feb 2030	5 strengths
US 11564916	use U-3526, U-3529	13 Feb 2030	3 listing rows
US 11564916 listing row	use U-3526	13 Aug 2029	3 strengths · listed 28 Feb 2023
US 11564916 listing row	use U-3529	13 Aug 2029	2 strengths · listed 28 Feb 2023
US 11564916 listing row	pediatric extension	13 Feb 2030	5 strengths
US 12458635	drug product, use U-4335, U-4338	13 Feb 2030	3 listing rows
US 12458635 listing row	drug product, use U-4335	13 Aug 2029	3 strengths · listed 26 Nov 2025
US 12458635 listing row	drug product, use U-4338	13 Aug 2029	2 strengths · listed 26 Nov 2025
US 12458635 listing row	pediatric extension	13 Feb 2030	5 strengths
US 8846718	use U-1717, U-1908, U-2375, U-3427	2 Jan 2030	5 listing rows
US 8846718 listing row	use U-1717	2 Jul 2029	listed 22 Jul 2015
US 8846718 listing row	use U-1908	2 Jul 2029	2 strengths · listed 22 Jul 2015
US 8846718 listing row	use U-2375	2 Jul 2029	2 strengths · listed 6 Sep 2018
US 8846718 listing row	use U-3427	2 Jul 2029	listed 26 Sep 2022
US 8846718 listing row	pediatric extension	2 Jan 2030	5 strengths
US 10076513	drug product, use U-2411	4 Jun 2029	2 listing rows
US 10076513 listing row	drug product, use U-2411	4 Dec 2028	listed 18 Oct 2018
US 10076513 listing row	pediatric extension	4 Jun 2029
US 10597384	drug substance, drug product, use U-2777, U-2778, U-3430	4 Jun 2029	4 listing rows
US 10597384 listing row	drug substance, drug product, use U-2777	4 Dec 2028	2 strengths · listed 23 Apr 2020
US 10597384 listing row	drug substance, drug product, use U-2778	4 Dec 2028	2 strengths · listed 23 Apr 2020
US 10597384 listing row	drug substance, drug product, use U-3430	4 Dec 2028	listed 26 Sep 2022
US 10597384 listing row	pediatric extension	4 Jun 2029	5 strengths
US 11052075	drug product, use U-3181	4 Jun 2029	2 listing rows
US 11052075 listing row	drug product, use U-3181	4 Dec 2028	2 strengths · listed 4 Aug 2021
US 11052075 listing row	pediatric extension	4 Jun 2029	2 strengths
US 12065432	use U-3983, U-3984	4 Jun 2029	3 listing rows
US 12065432 listing row	use U-3983	4 Dec 2028	3 strengths · listed 18 Sep 2024
US 12065432 listing row	use U-3984	4 Dec 2028	2 strengths · listed 18 Sep 2024
US 12065432 listing row	pediatric extension	4 Jun 2029	5 strengths
US 8653103	drug product	4 Jun 2029	2 listing rows
US 8653103 listing row	drug product	4 Dec 2028	5 strengths · listed 6 Sep 2018
US 8653103 listing row	pediatric extension	4 Jun 2029	5 strengths
US 9150552	use U-1908, U-2375, U-3427	4 Jun 2029	4 listing rows
US 9150552 listing row	use U-1908	4 Dec 2028	2 strengths · listed 21 Oct 2016
US 9150552 listing row	use U-2375	4 Dec 2028	2 strengths · listed 6 Sep 2018
US 9150552 listing row	use U-3427	4 Dec 2028	listed 26 Sep 2022
US 9150552 listing row	pediatric extension	4 Jun 2029	5 strengths
US 8324242	use U-1311, U-1911, U-2374, U-3424	5 Feb 2028	5 listing rows
US 8324242 listing row	use U-1311	5 Aug 2027	listed 22 Jul 2015
US 8324242 listing row	use U-1911	5 Aug 2027	2 strengths · listed 22 Jul 2015
US 8324242 listing row	use U-2374	5 Aug 2027	2 strengths · listed 6 Sep 2018
US 8324242 listing row	use U-3424	5 Aug 2027	listed 26 Sep 2022
US 8324242 listing row	pediatric extension	5 Feb 2028	5 strengths
US 7495103	drug substance, drug product	20 Nov 2027	2 listing rows
US 7495103 listing row	drug substance, drug product	20 May 2027	5 strengths · listed 26 Sep 2022
US 7495103 listing row	pediatric extension	20 Nov 2027	5 strengths
US 8410274	drug product	28 Jun 2027	2 listing rows
US 8410274 listing row	drug product	28 Dec 2026	5 strengths · listed 21 Oct 2016
US 8410274 listing row	pediatric extension	28 Jun 2027	5 strengths
US 8754224	drug substance, drug product	28 Jun 2027	2 listing rows
US 8754224 listing row	drug substance, drug product	28 Dec 2026	5 strengths · listed 6 Sep 2018
US 8754224 listing row	pediatric extension	28 Jun 2027	5 strengths
US 9670163	drug product, use U-1911, U-2376, U-3429	28 Jun 2027	4 listing rows
US 9670163 listing row	drug product, use U-1911	28 Dec 2026	2 strengths · listed 5 Jul 2017
US 9670163 listing row	drug product, use U-2376	28 Dec 2026	2 strengths · listed 6 Sep 2018
US 9670163 listing row	drug product, use U-3429	28 Dec 2026	listed 26 Sep 2022
US 9670163 listing row	pediatric extension	28 Jun 2027	5 strengths
US 9931334	drug product, use U-2276, U-2376, U-3429	28 Jun 2027	4 listing rows
US 9931334 listing row	drug product, use U-2276	28 Dec 2026	2 strengths · listed 2 May 2018
US 9931334 listing row	drug product, use U-2376	28 Dec 2026	2 strengths · listed 6 Sep 2018
US 9931334 listing row	drug product, use U-3429	28 Dec 2026	listed 26 Sep 2022
US 9931334 listing row	pediatric extension	28 Jun 2027	5 strengths
US 7973038	use U-1973, U-2374, U-3424	8 May 2027	4 listing rows
US 7973038 listing row	use U-1973	8 Nov 2026	2 strengths · listed 21 Oct 2016
US 7973038 listing row	use U-2374	8 Nov 2026	2 strengths · listed 6 Sep 2018
US 7973038 listing row	use U-3424	8 Nov 2026	listed 26 Sep 2022
US 7973038 listing row	pediatric extension	8 May 2027	5 strengths
US 8741933	use U-1717, U-1909, U-2374, U-3424	8 May 2027	5 listing rows
US 8741933 listing row	use U-1717	8 Nov 2026	listed 22 Jul 2015
US 8741933 listing row	use U-1909	8 Nov 2026	2 strengths · listed 22 Jul 2015
US 8741933 listing row	use U-2374	8 Nov 2026	2 strengths · listed 6 Sep 2018
US 8741933 listing row	use U-3424	8 Nov 2026	listed 26 Sep 2022
US 8741933 listing row	pediatric extension	8 May 2027	5 strengths
US 9216969	drug substance, drug product	8 May 2027	2 listing rows
US 9216969 listing row	drug substance, drug product	8 Nov 2026	5 strengths · listed 15 Mar 2016
US 9216969 listing row	pediatric extension	8 May 2027	5 strengths

Exclusivities · 3 unexpired

PED	pediatric (6 months added)	2 Mar 2030
ODE-408	orphan drug (7 years)	2 Sep 2029
PED	pediatric (6 months added)	13 Jun 2028
M-14	miscellaneous (3 years)	13 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 · 5

NDA · product	Form	Strength	Approved	Listed expiry
206038 · 001 · RLD	tablet, oral	125MG;200MG	2 Jul 2015	11 Jun 2031
206038 · 002 · RLD	tablet, oral	125MG;100MG	28 Sep 2016	11 Jun 2031
211358 · 001 · RLD	granule, oral	125MG/PACKET;100MG/PACKET	7 Aug 2018	11 Jun 2031
211358 · 002 · RLD	granule, oral	188MG/PACKET;150MG/PACKET	7 Aug 2018	11 Jun 2031
211358 · 003 · RLD	granule, oral	94MG/PACKET;75MG/PACKET	2 Sep 2022	11 Jun 2031