Product profile · United States

CYTALUX

· Patent Litigation & Settlement History ↓

IngredientPAFOLACIANINE SODIUM

Application typeNDA

Application214907

Product001

Dosage formSOLUTION

RouteINTRAVENOUS

StrengthEQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)

Approval date2021-11-29

Marketing statusPrescription

Status event—

ApplicantON TARGET LABS

Product source

Current GenericRadar decision

Year2021

SelectionEXCLUDED

ReviewFINAL

Anchor typeAPPROVAL_DATE

Anchor date2021-11-29

Patent anchor2035-11-29

Exclusivity anchor2028-11-29

Protection date2035-11-29

First Final ANDA—

Status event—

GNR judgment: EXCLUDED. Reference year: 2021. Anchor type: APPROVAL_DATE. Patent anchor: 2035-11-29. Exclusivity anchor: 2028-11-29. Anchor date: 2021-11-29. Patent tail: no. Exclusivity tail: no. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
10881747	2033-08-26	DS/DP/U U-3291	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
10881747	2033-08-26	ORANGE_BOOK U-3291	N	N	U English description not available.	—	—	—
9333270	2033-08-26	DS/DP/U U-3291	N	Y	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
9333270	2033-08-26	ORANGE_BOOK U-3291	N	Y	U English description not available.	—	—	—
9341629	2033-08-26	DS/DP —	N	N	DP \| B1C03 issued-claim review2026-10-15: DP	—	—	—
9341629	2033-08-26	ORANGE_BOOK —	N	N	DP English description not available.	—	—	—
9789208	2033-08-26	DS/DP/U U-3291	N	N	U \| B1C03 issued-claim review2026-10-15: U	—	—	—
9789208	2033-08-26	ORANGE_BOOK U-3291	N	N	U English description not available.	—	—	—
9254341	2033-10-04	DS/DP —	N	N	OTHER \| B1C03 issued-claim review2026-10-15: OTHER	—	—	—
9254341	2033-10-04	ORANGE_BOOK —	N	N	OTHER English description not available.	—	—	—
9061057	2035-11-29	DS/DP/U U-3291	Y	N	TRUE_DS \| B1C03 issued-claim review2026-10-15: TRUE_DS	—	—	—
9061057	2035-11-29	ORANGE_BOOK U-3291	Y	N	TRUE_DS English description not available.	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
I-905	2022-12-16	2025-12-16	English description not available.	N	N	—	I-905 + ODE-390 Full coverage date: —	Source
NCE	2021-11-29	2026-11-29	English description not available.	Y	Y	2026-11-29	—	Source
NCE	2021-11-29	2026-11-29	English description not available.	Y	Y	2026-11-29	I-905 + ODE-390 Full coverage date: 2026-11-29	Source
ODE-390	2021-11-29	2028-11-29	English description not available.	N	N	—	—	Source
ODE-390	2021-11-29	2028-11-29	English description not available.	N	N	—	I-905 + ODE-390 Full coverage date: —	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 (10)

Type	Date	Role	Basis	Source
PATENT	2033-08-26	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2033-08-26	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2033-08-26	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2033-08-26	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2033-10-04	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2035-11-29	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_STATUS	2021-11-29	TERMINAL_STATUS	English description not available.	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.