Product profile · United States

INJECTAFER

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IngredientFERRIC CARBOXYMALTOSE

Application typeNDA

Application203565

Product002

Dosage formSOLUTION

RouteINTRAVENOUS

Strength500MG IRON/10ML (50MG IRON/ML)

Approval date2020-10-08

Marketing statusPrescription

Status event—

ApplicantAM REGENT

Product source

Current GenericRadar decision

Year2027

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typeTRUE_DS_PATENT

Anchor date2027-02-05

Patent anchor2027-02-05

Exclusivity anchor—

Protection date2028-02-15

First Final ANDA—

Status event—

ANCHOR_WITH_TAIL; US:NDA:203565:002; exact Final ANDA not verified; not proof of generic absence

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
11364260	2027-01-08	U U-3637	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
11364260	2027-01-08	ORANGE_BOOK U-3637	N	N	U English description not available.	—	—	—
11433091	2027-01-08	U U-3435	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
11433091	2027-01-08	U U-3438	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
11433091	2027-01-08	U U-3436	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
11433091	2027-01-08	U U-3437	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
11433091	2027-01-08	U U-3634	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
11433091	2027-01-08	ORANGE_BOOK U-3435;U-3436;U-3437;U-3438;U-3634	N	N	U English description not available.	—	—	—
11478502	2027-01-08	U U-3473	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
11478502	2027-01-08	U U-3474	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
11478502	2027-01-08	U U-3472	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
11478502	2027-01-08	ORANGE_BOOK U-3472;U-3473;U-3474	N	N	U English description not available.	—	—	—
8895612	2027-01-08	U U-3635	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
8895612	2027-01-08	U U-3316	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
8895612	2027-01-08	U U-3315	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
8895612	2027-01-08	U U-3051	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
8895612	2027-01-08	U U-3116	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
8895612	2027-01-08	U U-3050	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
8895612	2027-01-08	U U-1620	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
8895612	2027-01-08	U U-3115	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
8895612	2027-01-08	ORANGE_BOOK U-1620;U-3050;U-3051;U-3115;U-3116;U-3315;U-3316;U-3635	N	N	U English description not available.	—	—	—
7612109	2027-02-05	DS/DP —	Y	N	TRUE_DS \| B1C03 issued-claim review2026-10-15: TRUE_DS	—	—	—
7612109	2027-02-05	ORANGE_BOOK —	Y	N	TRUE_DS English description not available.	—	—	—
7754702	2028-02-15	U U-3636	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
7754702	2028-02-15	U U-3314	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
7754702	2028-02-15	U U-2556	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
7754702	2028-02-15	U U-3313	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
7754702	2028-02-15	U U-3312	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
7754702	2028-02-15	U U-2557	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
7754702	2028-02-15	U U-2555	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
7754702	2028-02-15	ORANGE_BOOK U-2555;U-2556;U-2557;U-3312;U-3313;U-3314;U-3636	N	N	U English description not available.	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NPP	2021-11-19	2024-11-19	English description not available.	N	N	—		Source
I-915	2023-05-31	2026-05-31	English description not available.	N	N	—	—	Source
I-915	2023-05-31	2026-05-31	English description not available.	N	N	—		Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
No generic approval facts are linked to this product.

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / product	Applicant	Event / status	First marketed	Product mapping	Source	Last verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 0 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last verified
No final-approval records are linked to this product.

Decision evidence (9)

Type	Date	Role	Basis	Source
PATENT	2027-01-08	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-01-08	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-01-08	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-01-08	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-02-05	CANONICAL_ANCHOR	English description not available.	Source
PATENT	2028-02-15	FTO_TAIL	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	REGULATORY_SCOPE_CONTEXT	English description not available.	Source
REGULATORY_STATUS	2027-02-05	CANONICAL_DECISION	ANCHOR_WITH_TAIL; US:NDA:203565:002; exact Final ANDA not verified; not proof of generic absence	Source

Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.