Drybench Patent.
CARFILZOMIB, NDA 202714
The patents and exclusivities FDA's Orange Book lists for NDA 202714 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.
FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.
- Orange Book captured
- 14 October 2026
- Paragraph IV list captured
- 17 October 2026
- Last checked
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.
Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.
Listed protection
Listed dates run from 20 Jul 2026 to 29 Oct 2041, each by its own rule; no one date stands for this product.
- Earliest listed date
- 20 Jul 2026US 7,417,042, substance and product patentRule R1 · Products 001, 002, 003 · patent.txt lines 3,139, 3,149, 3,159
- Latest listed date
- 29 Oct 2041US 12,636,340 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 3,136, 3,146, 3,156
- Latest substance patent
- 20 Jan 2027US 7,417,042 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 3,138, 3,148, 3,158
- Latest listed patent
- 29 Oct 2041US 12,636,340 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 3,136, 3,146, 3,156
- Latest exclusivity
- 22 Nov 2028PED exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 281, 283, 285
6 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 202714, as listed. The sections below name products by these numbers.
Product 001 · KYPROLIS
- Dosage form; route
- POWDER;INTRAVENOUS
- Strength
- 60MG/VIAL
- Approval date as listed
- 20 Jul 2012
- Type as listed
- RX
- Applicant as listed
- ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC
Product 002 · KYPROLIS
- Dosage form; route
- POWDER;INTRAVENOUS
- Strength
- 30MG/VIAL
- Approval date as listed
- 3 Jun 2016
- Type as listed
- RX
- Applicant as listed
- ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC
Product 003 · KYPROLIS
- Dosage form; route
- POWDER;INTRAVENOUS
- Strength
- 10MG/VIAL
- Approval date as listed
- 7 Jun 2018
- Type as listed
- RX
- Applicant as listed
- ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC
Listed patents
Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.
10 entries from 30 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 7,417,042, substance and product patent
patent.txt lines 3,139, 3,149, 3,159- Expiry as listed
- 20 Jul 2026
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003
US 7,417,042 with pediatric exclusivity, as listed
patent.txt lines 3,138, 3,148, 3,158- Expiry as listed
- 20 Jan 2027
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 7,737,112, product patent
patent.txt lines 3,141, 3,151, 3,161- Expiry as listed
- 7 Dec 2027
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 7,737,112 with pediatric exclusivity, as listed
patent.txt lines 3,140, 3,150, 3,160- Expiry as listed
- 7 Jun 2028
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US RE47954, use patent
patent.txt lines 3,145, 3,155, 3,165- Expiry as listed
- 21 Oct 2029
- Rule
- R1
- Flags
- use code U-3449
- Product numbers
- 001, 002, 003
US RE47954 with pediatric exclusivity, as listed
patent.txt lines 3,144, 3,154, 3,164- Expiry as listed
- 21 Apr 2030
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 9,493,582, product patent
patent.txt lines 3,143, 3,153, 3,163- Expiry as listed
- 27 Feb 2033
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 9,493,582 with pediatric exclusivity, as listed
patent.txt lines 3,142, 3,152, 3,162- Expiry as listed
- 27 Aug 2033
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
US 12,636,340, use patent
patent.txt lines 3,137, 3,147, 3,157- Expiry as listed
- 29 Apr 2041
- Rule
- R1
- Flags
- use code U-4551
- Product numbers
- 001, 002, 003
US 12,636,340 with pediatric exclusivity, as listed
patent.txt lines 3,136, 3,146, 3,156- Expiry as listed
- 29 Oct 2041
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
Listed exclusivities
Each exclusivity FDA lists for NDA 202714, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
M-14 exclusivity
exclusivity.txt lines 280, 282, 284- Date
- 22 May 2028
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
PED exclusivity
exclusivity.txt lines 281, 283, 285- Date
- 22 Nov 2028
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
Paragraph IV list rows giving NDA 202714
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 202714, each cell as listed.
FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.
The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.
Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.
Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 202714
Carfilzomib · For Injection · 10 mg/vial
RLD/NDA as listed: Kyprolis 202714- First PIV submission
- 28 Nov 2018
- ANDAs
- 1
- 180-day status
- Non-Forfeiture Deferred
- Decision posted
- 8/3/2026 7/13/2021
- First applicant approval
- 11 Jun 2021
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 27 Feb 2033
Carfilzomib · For Injection · 30 mg/vial
RLD/NDA as listed: Kyprolis 202714- First PIV submission
- 5 Oct 2017
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 25 Jul 2022
- First applicant approval
- 20 Mar 2020
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 27 Feb 2033
Carfilzomib · For Injection · 60 mg/vial
RLD/NDA as listed: Kyprolis 202714- First PIV submission
- 20 Jul 2016
- ANDAs
- 9
- 180-day status
- Eligible
- Decision posted
- 13 Jul 2021
- First applicant approval
- 9 Sep 2019
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 7 Dec 2027
Notes from the trace
- R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.
Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week