carfilzomib · Onyx Pharms Amgen · NDA 202714

Kyprolis

Earliest generic entry, as listed · earliest of 3 marketed strengths

29 Oct 2041

Blocked by patent: US 12636340 (pediatric extension).

FDA has approved 1 generic application (ANDA) for Kyprolis, though its earliest generic-entry date is 29 Oct 2041 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 5 unexpired

9 Orange Book listing rows for 5 patents, including 5 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 12636340	use U-4551	29 Oct 2041	2 listing rows
US 12636340 listing row	use U-4551	29 Apr 2041	3 strengths · listed 23 Jun 2026
US 12636340 listing row	pediatric extension · sets the listed date	29 Oct 2041	3 strengths
US 9493582	drug product	27 Aug 2033	2 listing rows
US 9493582 listing row	drug product	27 Feb 2033	3 strengths · listed 20 Jun 2018
US 9493582 listing row	pediatric extension	27 Aug 2033	3 strengths
US RE47954	use U-3449	21 Apr 2030	2 listing rows
US RE47954 listing row	use U-3449	21 Oct 2029	3 strengths · listed 18 Oct 2022
US RE47954 listing row	pediatric extension	21 Apr 2030	3 strengths
US 7737112	drug product	7 Jun 2028	2 listing rows
US 7737112 listing row	drug product	7 Dec 2027	3 strengths · listed 15 Aug 2016
US 7737112 listing row	pediatric extension	7 Jun 2028	3 strengths
US 7417042	pediatric extension	20 Jan 2027	3 strengths

Exclusivities · 2 unexpired

PED	pediatric (6 months added)	22 Nov 2028
M-14	miscellaneous (3 years)	22 May 2028

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

Generic tentatively approved · ANDA 219276, Hainan Poly Pharm. Co., Ltd. · 202714-001Tentative approval 7 Nov 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 209526, Msn · 202714-001Approved 20 Jul 2026Detected 25 Oct 2026Historical import

Products covered · 3

NDA · product	Form	Strength	Approved	Listed expiry
202714 · 001 · RLD	powder, intravenous	60MG/VIAL	20 Jul 2012	29 Oct 2041
202714 · 002 · RLD	powder, intravenous	30MG/VIAL	3 Jun 2016	29 Oct 2041
202714 · 003 · RLD	powder, intravenous	10MG/VIAL	7 Jun 2018	29 Oct 2041

Expired or delisted (1)

US 7417042 · substance, product · 20 Jul 2026