Product profile · United States

TAFINLAR

· Patent Litigation & Settlement History ↓

IngredientDABRAFENIB MESYLATE

Application typeNDA

Application202806

Product001

Dosage formCAPSULE

RouteORAL

StrengthEQ 50MG BASE

Approval date2013-05-29

Marketing statusPrescription

Status event—

ApplicantNOVARTIS

Product source

Current GenericRadar decision

Year2030

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typeTRUE_DS_PATENT

Anchor date2030-07-20

Patent anchor2030-07-20

Exclusivity anchor—

Protection date2034-02-28

First Final ANDA—

Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2030. Anchor type: TRUE_DS_PATENT. Patent anchor: 2030-07-20. Exclusivity anchor: not recorded. Anchor date: 2030-07-20. Patent tail: yes. Exclusivity tail: yes. 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
9233956	2029-05-04	U U-1811	—	—	—	—	—	—
9233956	2029-05-04	U U-2031	—	—	—	—	—	—
9233956	2029-05-04	U U-2296	—	—	—	—	—	—
9233956	2029-05-04	U U-2032	—	—	—	—	—	—
9233956	2029-11-04	— —	—	—	—	—	2029-11-04	—
9233956	2029-11-04	ORANGE_BOOK U-1811,U-2031,U-2032,U-2296	N	N	U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	—	2029-11-04	—
7994185	2030-01-20	DS/DP/U U-1406	—	—	—	—	—	—
7994185	2030-01-20	DS/DP/U U-2296	—	—	—	—	—	—
7994185	2030-01-20	DS/DP/U U-2032	—	—	—	—	—	—
7994185	2030-01-20	DS/DP/U U-2031	—	—	—	—	—	—
8415345	2030-01-20	DS/DP/U U-2296	—	—	—	—	—	—
8415345	2030-01-20	DS/DP/U U-2032	—	—	—	—	—	—
8415345	2030-01-20	DS/DP/U U-2031	—	—	—	—	—	—
8415345	2030-01-20	DS/DP/U U-1406	—	—	—	—	—	—
7994185	2030-07-20	— —	—	—	—	—	2030-07-20	—
7994185	2030-07-20	ORANGE_BOOK U-1406,U-2031,U-2032,U-2296	Y	N	TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	—	2030-07-20	—
8415345	2030-07-20	— —	—	—	—	—	2030-07-20	—
8415345	2030-07-20	ORANGE_BOOK U-1406,U-2031,U-2032,U-2296	Y	N	TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	—	2030-07-20	—
8703781	2030-10-15	DS/DP/U U-2032	—	—	—	—	—	—
8703781	2030-10-15	DS/DP/U U-1713	—	—	—	—	—	—
8703781	2030-10-15	DS/DP/U U-2296	—	—	—	—	—	—
8703781	2030-10-15	DS/DP/U U-2298	—	—	—	—	—	—
8952018	2030-10-15	U U-2027	—	—	—	—	—	—
8703781	2031-04-15	— —	—	—	—	—	2031-04-15	—
8703781	2031-04-15	ORANGE_BOOK U-1713,U-2032,U-2296,U-2298	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2031-04-15	—
8952018	2031-04-15	— —	—	—	—	—	2031-04-15	—
8952018	2031-04-15	ORANGE_BOOK U-2027	N	N	U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	—	2031-04-15	—
10869869	2033-08-30	U U-3185	—	—	—	—	—	—
10869869	2034-02-28	— —	—	—	—	—	2034-02-28	—
10869869	2034-02-28	ORANGE_BOOK U-3185	N	N	U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	—	2034-02-28	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
I-908	—	2026-03-16		—	—	—	—	Source
I-908	—	2026-03-16	FDA posted date collected; scope not independently certified; preserved as context/tail.	—	—	—	—	Source
PED	—	2026-09-16		—	—	—	—	Source
PED	—	2026-09-16	FDA posted date collected; scope not independently certified; preserved as context/tail.	—	—	—	—	Source
ODE-428	—	2030-03-16		—	—	—	—	Source
ODE-428	—	2030-03-16	FDA posted date collected; scope not independently certified; preserved as context/tail.	—	—	—	—	Source
PED	—	2030-09-16		—	—	—	—	Source
PED	—	2030-09-16	FDA posted date collected; scope not independently certified; preserved as context/tail.	—	—	—	—	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 (7)

Type	Date	Role	Basis	Source
PATENT	2029-11-04	HISTORICAL_CONTEXT	Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	Source
PATENT	2030-07-20	CANONICAL_ANCHOR	Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	Source
PATENT	2030-07-20	CANONICAL_ANCHOR	Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	Source
PATENT	2031-04-15	FTO_TAIL	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2031-04-15	FTO_TAIL	Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	Source
PATENT	2034-02-28	FTO_TAIL	Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	Source
REGULATORY_STATUS	2030-07-20	CANONICAL_DECISION	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.