cliffwatch

ferric carboxymaltose · Am Regent · NDA 203565

Injectafer

Earliest generic entry, as listed · earliest of 4 marketed strengths
15 Feb 2028

Blocked by patent: US 7754702. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

FDA has approved 3 generic applications (ANDAs) for Injectafer, though its earliest generic-entry date is 15 Feb 2028 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 · 6 unexpired

26 Orange Book listing rows for 6 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 7754702use U-1432, U-2555, U-2556, U-2557, U-3312, U-3313, U-3314, U-363615 Feb 2028
US 7754702 listing rowuse U-1432 · sets the listed date15 Feb 2028
US 7754702 listing rowuse U-2555 · sets the listed date15 Feb 2028
US 7754702 listing rowuse U-2556 · sets the listed date15 Feb 2028
US 7754702 listing rowuse U-2557 · sets the listed date15 Feb 2028
US 7754702 listing rowuse U-3312 · sets the listed date15 Feb 2028
US 7754702 listing rowuse U-3313 · sets the listed date15 Feb 2028
US 7754702 listing rowuse U-3314 · sets the listed date15 Feb 2028
US 7754702 listing rowuse U-3636 · sets the listed date15 Feb 2028
US 7612109drug substance, drug product5 Feb 2027
US 11364260use U-36378 Jan 2027
US 11433091use U-3435, U-3436, U-3437, U-3438, U-36348 Jan 2027
US 11433091 listing rowuse U-34358 Jan 2027
US 11433091 listing rowuse U-34368 Jan 2027
US 11433091 listing rowuse U-34378 Jan 2027
US 11433091 listing rowuse U-34388 Jan 2027
US 11433091 listing rowuse U-36348 Jan 2027
US 11478502use U-3472, U-3473, U-34748 Jan 2027
US 11478502 listing rowuse U-34728 Jan 2027
US 11478502 listing rowuse U-34738 Jan 2027
US 11478502 listing rowuse U-34748 Jan 2027
US 8895612use U-1620, U-3050, U-3051, U-3115, U-3116, U-3315, U-3316, U-36358 Jan 2027
US 8895612 listing rowuse U-16208 Jan 2027
US 8895612 listing rowuse U-30508 Jan 2027
US 8895612 listing rowuse U-30518 Jan 2027
US 8895612 listing rowuse U-31158 Jan 2027
US 8895612 listing rowuse U-31168 Jan 2027
US 8895612 listing rowuse U-33158 Jan 2027
US 8895612 listing rowuse U-33168 Jan 2027
US 8895612 listing rowuse U-36358 Jan 2027

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

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

  • First generic approved · ANDA 217076, Mylan · 203565-001Approved 25 Jun 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 217076, Mylan · 203565-001Approved 25 Jun 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 212572, Mylan Labs Ltd · 203565-001Approved 25 Jun 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 212572, Mylan Labs Ltd · 203565-001Approved 25 Jun 2026Detected 25 Oct 2026Historical import
  • First generic approved · ANDA 217769, Mylan · 203565-001Approved 25 Jun 2026Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 217769, Mylan · 203565-001Approved 25 Jun 2026Detected 25 Oct 2026Historical import

Products covered · 4

NDA · productFormStrengthListed expiry
203565 · 001 · RLDsolution, intravenous750MG IRON/15ML (50MG IRON/ML)15 Feb 2028
203565 · 002 · RLDsolution, intravenous500MG IRON/10ML (50MG IRON/ML)15 Feb 2028
203565 · 003 · RLDsolution, intravenous1GM IRON/20ML (50MG IRON/ML)15 Feb 2028
203565 · 004 · RLDsolution, intravenous100MG IRON/2ML (50MG IRON/ML)15 Feb 2028
Expired or delisted (1)
  • I-915 · 31 May 2026