Product profile · United States

FABHALTA

· Patent Litigation & Settlement History ↓

IngredientIPTACOPAN HYDROCHLORIDE

Application typeNDA

Application218276

Product001

Dosage formCAPSULE

RouteORAL

StrengthEQ 200MG BASE

Approval date2023-12-05

Marketing statusPrescription

Status event—

ApplicantNOVARTIS

Product source

Current GenericRadar decision

Year2034

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typeTRUE_DS_PATENT

Anchor date2034-07-14

Patent anchor2034-07-14

Exclusivity anchor2028-12-05

Protection date2041-07-15

First Final ANDA—

Status event—

US9682968 c17 named iptacopan. PNH/IgAN/C3G portfolio and hydrate tails retained; no automatic DS promotion.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
10093663	2034-07-14	U U-4161	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
10093663	2034-07-14	U U-3980	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
10093663	2034-07-14	ORANGE_BOOK U-3980;U-4161	N	N	U English description not available.	—	—	—
9682968	2034-07-14	DS/DP —	Y	N	TRUE_DS \| B1C03P8 issued-claim review2026-10-15: TRUE_DS	—	—	—
9682968	2034-07-14	ORANGE_BOOK —	Y	N	TRUE_DS English description not available.	—	—	—
11723901	2038-08-30	U U-3980	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
11723901	2038-08-30	ORANGE_BOOK U-3980	N	N	U English description not available.	—	—	—
12285422	2038-08-30	U U-4181	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
12285422	2038-08-30	ORANGE_BOOK U-4181	N	N	U English description not available.	—	—	—
12384758	2041-05-17	U U-4161	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
12384758	2041-05-17	U U-3980	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
12384758	2041-05-17	ORANGE_BOOK U-3980;U-4161	N	N	U English description not available.	—	—	—
11603363	2041-05-25	DS/DP —	N	N	DP \| B1C03P8 issued-claim review2026-10-15: DP	—	—	—
11603363	2041-05-25	ORANGE_BOOK —	N	N	DP English description not available.	—	—	—
11951101	2041-07-15	U U-3895	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
11951101	2041-07-15	ORANGE_BOOK U-3895	N	N	U English description not available.	—	—	—
12453726	2041-07-15	U U-4300	N	N	U \| B1C03P8 issued-claim review2026-10-15: U	—	—	—
12453726	2041-07-15	ORANGE_BOOK U-4300	N	N	U English description not available.	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
I-949	2024-08-07	2027-08-07	English description not available.	N	N	—	—	Source
I-949	2024-08-07	2027-08-07	English description not available.	N	N	—	NCE Full coverage date: —	Source
I-963	2025-03-20	2028-03-20	English description not available.	N	N	—	—	Source
I-963	2025-03-20	2028-03-20	English description not available.	N	N	—	NCE Full coverage date: —	Source
NCE	2023-12-05	2028-12-05	English description not available.	Y	Y	2028-12-05	—	Source
NCE	2023-12-05	2028-12-05	English description not available.	Y	Y	2028-12-05	NCE Full coverage date: 2028-12-05	Source
ODE-456	2023-12-05	2030-12-05	English description not available.	N	N	—	—	Source
ODE-456	2023-12-05	2030-12-05	English description not available.	N	N	—	NCE Full coverage date: —	Source
ODE-524	2025-03-20	2032-03-20	English description not available.	N	N	—	—	Source
ODE-524	2025-03-20	2032-03-20	English description not available.	N	N	—	NCE 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 (1)

Type	Date	Role	Basis	Source
ANNUAL_DECISION_RECHECK	—	ANCHOR_AND_TAIL	US9682968 c17 named iptacopan. PNH/IgAN/C3G portfolio and hydrate tails retained; no automatic DS promotion.	Source

Decision history

Current	Year	Status	Review	Anchor	Judged
Y	2034	DEEP_REVIEW	FINAL	2034-07-14	2026-10-17 20:32:21
N	2034	DEEP_REVIEW	FINAL	2034-07-14	2026-10-15 03:06:32

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.