Drybench Patent.
FERRIC CARBOXYMALTOSE, NDA 203565
The patents and exclusivities FDA's Orange Book lists for NDA 203565 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 31 May 2026 to 15 Feb 2028, each by its own rule; no one date stands for this product.
- Earliest listed date
- 31 May 2026I-915 exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 336–339
- Latest listed date
- 15 Feb 2028US 7,754,702, use patentRule R1 · Products 002, 003 · patent.txt lines 4,030, 4,055
- Latest substance patent
- 5 Feb 2027US 7,612,109, substance and product patentRule R1 · Products 001, 002, 003, 004 · patent.txt lines 4,006, 4,027, 4,052, 4,077
- Latest listed patent
- 15 Feb 2028US 7,754,702, use patentRule R1 · Products 002, 003 · patent.txt lines 4,030, 4,055
- Latest exclusivity
- 31 May 2026I-915 exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 336–339
86 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 203565, as listed. The sections below name products by these numbers.
Product 001 · INJECTAFER
- Dosage form; route
- SOLUTION;INTRAVENOUS
- Strength
- 750MG IRON/15ML (50MG IRON/ML)
- Approval date as listed
- 25 Jul 2013
- Type as listed
- RX
- Applicant as listed
- AMERICAN REGENT INC
Product 002 · INJECTAFER
- Dosage form; route
- SOLUTION;INTRAVENOUS
- Strength
- 500MG IRON/10ML (50MG IRON/ML)
- Approval date as listed
- 8 Oct 2020
- Type as listed
- RX
- Applicant as listed
- AMERICAN REGENT INC
Product 003 · INJECTAFER
- Dosage form; route
- SOLUTION;INTRAVENOUS
- Strength
- 1GM IRON/20ML (50MG IRON/ML)
- Approval date as listed
- 28 Apr 2021
- Type as listed
- RX
- Applicant as listed
- AMERICAN REGENT INC
Product 004 · INJECTAFER
- Dosage form; route
- SOLUTION;INTRAVENOUS
- Strength
- 100MG IRON/2ML (50MG IRON/ML)
- Approval date as listed
- 4 Feb 2022
- Type as listed
- RX
- Applicant as listed
- AMERICAN REGENT 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.
26 entries from 90 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 11,364,260, use patent
patent.txt lines 3,997, 4,018, 4,043, 4,068- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3637
- Product numbers
- 001, 002, 003, 004
US 11,433,091, use patent
patent.txt lines 3,998, 4,019, 4,044, 4,069- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3435
- Product numbers
- 001, 002, 003, 004
US 11,433,091, use patent
patent.txt lines 3,999, 4,020, 4,045, 4,070- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3436
- Product numbers
- 001, 002, 003, 004
US 11,433,091, use patent
patent.txt lines 4,000, 4,021, 4,046, 4,071- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3437
- Product numbers
- 001, 002, 003, 004
US 11,433,091, use patent
patent.txt lines 4,001, 4,022, 4,047, 4,072- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3438
- Product numbers
- 001, 002, 003, 004
US 11,433,091, use patent
patent.txt lines 4,002, 4,023, 4,048, 4,073- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3634
- Product numbers
- 001, 002, 003, 004
US 11,478,502, use patent
patent.txt lines 4,003, 4,024, 4,049, 4,074- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3472
- Product numbers
- 001, 002, 003, 004
US 11,478,502, use patent
patent.txt lines 4,004, 4,025, 4,050, 4,075- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3473
- Product numbers
- 001, 002, 003, 004
US 11,478,502, use patent
patent.txt lines 4,005, 4,026, 4,051, 4,076- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3474
- Product numbers
- 001, 002, 003, 004
US 8,895,612, use patent
patent.txt lines 4,012, 4,035, 4,060- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-1620
- Product numbers
- 001, 002, 003
US 8,895,612, use patent
patent.txt lines 4,013, 4,038, 4,063, 4,082- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3115
- Product numbers
- 001, 002, 003, 004
US 8,895,612, use patent
patent.txt lines 4,014, 4,039, 4,064, 4,083- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3116
- Product numbers
- 001, 002, 003, 004
US 8,895,612, use patent
patent.txt lines 4,015, 4,040, 4,065, 4,084- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3315
- Product numbers
- 001, 002, 003, 004
US 8,895,612, use patent
patent.txt lines 4,016, 4,041, 4,066, 4,085- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3316
- Product numbers
- 001, 002, 003, 004
US 8,895,612, use patent
patent.txt lines 4,017, 4,042, 4,067, 4,086- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3635
- Product numbers
- 001, 002, 003, 004
US 8,895,612, use patent
patent.txt lines 4,036, 4,061- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3050
- Product numbers
- 002, 003
US 8,895,612, use patent
patent.txt lines 4,037, 4,062- Expiry as listed
- 8 Jan 2027
- Rule
- R1
- Flags
- use code U-3051
- Product numbers
- 002, 003
US 7,612,109, substance and product patent
patent.txt lines 4,006, 4,027, 4,052, 4,077- Expiry as listed
- 5 Feb 2027
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003, 004
US 7,754,702, use patent
patent.txt line 4,007- Expiry as listed
- 15 Feb 2028
- Rule
- R1
- Flags
- use code U-1432
- Product numbers
- 001
US 7,754,702, use patent
patent.txt lines 4,008, 4,031, 4,056, 4,078- Expiry as listed
- 15 Feb 2028
- Rule
- R1
- Flags
- use code U-3312
- Product numbers
- 001, 002, 003, 004
US 7,754,702, use patent
patent.txt lines 4,009, 4,032, 4,057, 4,079- Expiry as listed
- 15 Feb 2028
- Rule
- R1
- Flags
- use code U-3313
- Product numbers
- 001, 002, 003, 004
US 7,754,702, use patent
patent.txt lines 4,010, 4,033, 4,058, 4,080- Expiry as listed
- 15 Feb 2028
- Rule
- R1
- Flags
- use code U-3314
- Product numbers
- 001, 002, 003, 004
US 7,754,702, use patent
patent.txt lines 4,011, 4,034, 4,059, 4,081- Expiry as listed
- 15 Feb 2028
- Rule
- R1
- Flags
- use code U-3636
- Product numbers
- 001, 002, 003, 004
US 7,754,702, use patent
patent.txt lines 4,028, 4,053- Expiry as listed
- 15 Feb 2028
- Rule
- R1
- Flags
- use code U-2555
- Product numbers
- 002, 003
US 7,754,702, use patent
patent.txt lines 4,029, 4,054- Expiry as listed
- 15 Feb 2028
- Rule
- R1
- Flags
- use code U-2556
- Product numbers
- 002, 003
US 7,754,702, use patent
patent.txt lines 4,030, 4,055- Expiry as listed
- 15 Feb 2028
- Rule
- R1
- Flags
- use code U-2557
- Product numbers
- 002, 003
Listed exclusivities
Each exclusivity FDA lists for NDA 203565, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
I-915 exclusivity
exclusivity.txt lines 336–339- Date
- 31 May 2026
- Rule
- R3
- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
Paragraph IV list rows giving NDA 203565
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 203565, 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 203565
Ferric Carboxymaltose · Injection · 1 g/20 mL
RLD/NDA as listed: Injectafer 203565- First PIV submission
- 15 Feb 2022
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 15 Jul 2026
- First applicant approval
- 25 Jun 2026
- First marketing
- 31 Aug 2026
- Last qualifying patent expiry (as listed by FDA)
- 15 Feb 2028
Ferric Carboxymaltose · Injection · 100 mg/2 mL
RLD/NDA as listed: Injectafer 203565- First PIV submission
- 23 Sep 2022
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 15 Jul 2026
- First applicant approval
- 25 Jun 2026
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 15 Feb 2028
Ferric Carboxymaltose · Injection · 500 mg/10 mL
RLD/NDA as listed: Injectafer 203565- First PIV submission
- 22 Feb 2024
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 15 Feb 2028
Ferric Carboxymaltose · Injection · 750 mg/15 mL
RLD/NDA as listed: Injectafer 203565- First PIV submission
- 27 Mar 2019
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 15 Jul 2026
- First applicant approval
- 25 Jun 2026
- First marketing
- 1 Jul 2026
- Last qualifying patent expiry (as listed by FDA)
- 15 Feb 2028
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