Product profile · United States

MEKINIST

· Patent Litigation & Settlement History ↓

IngredientTRAMETINIB DIMETHYL SULFOXIDE

Application typeNDA

Application204114

Product002

Dosage formTABLET

RouteORAL

StrengthEQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval date2013-05-29

Marketing statusDiscontinued

Status event—

ApplicantNOVARTIS

Product source

Current GenericRadar decision

Year2017

SelectionDISQUALIFIED

ReviewFINAL

Anchor typeFDA_DISCONTINUATION

Anchor date—

Patent anchor—

Exclusivity anchor—

Protection date2034-02-28

First Final ANDA—

Status event—

FDA July 2017 changes list: NDA204114/002 EQ1MG moved to non-marketed list; Jul DISC. Status event month 2017-07; exact day not stated.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
7378423	2027-05-29	DS/DP —	—	—	—	—	—	—
7378423	2027-11-29	— —	—	—	—	—	2027-11-29	—
7378423	2027-11-29	ORANGE_BOOK —	Y	N	TRUE_DS Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	—	2027-11-29	—
8703781	2030-10-15	DS/DP/U U-1712	—	—	—	—	—	—
8703781	2030-10-15	DS/DP/U U-2305	—	—	—	—	—	—
8703781	2030-10-15	DS/DP/U U-2020	—	—	—	—	—	—
8703781	2030-10-15	DS/DP/U U-2302	—	—	—	—	—	—
8703781	2030-10-15	DS/DP/U U-2037	—	—	—	—	—	—
8952018	2030-10-15	U U-2020	—	—	—	—	—	—
8703781	2031-04-15	— —	—	—	—	—	2031-04-15	—
8703781	2031-04-15	ORANGE_BOOK U-1712,U-2020,U-2037,U-2302,U-2305	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-2020	N	N	U Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	—	2031-04-15	—
8580304	2032-01-28	DP —	—	—	—	—	—	—
9155706	2032-01-28	DP —	—	—	—	—	—	—
9271941	2032-01-28	DP —	—	—	—	—	—	—
9399021	2032-01-28	DP —	—	—	—	—	—	—
8580304	2032-07-28	— —	—	—	—	—	2032-07-28	—
8580304	2032-07-28	ORANGE_BOOK —	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2032-07-28	—
9155706	2032-07-28	— —	—	—	—	—	2032-07-28	—
9155706	2032-07-28	ORANGE_BOOK —	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2032-07-28	—
9271941	2032-07-28	— —	—	—	—	—	2032-07-28	—
9271941	2032-07-28	ORANGE_BOOK —	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2032-07-28	—
9399021	2032-07-28	— —	—	—	—	—	2032-07-28	—
9399021	2032-07-28	ORANGE_BOOK —	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2032-07-28	—
10869869	2033-08-30	U U-3184	—	—	—	—	—	—
10869869	2034-02-28	— —	—	—	—	—	2034-02-28	—
10869869	2034-02-28	ORANGE_BOOK U-3184	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 (9)

Type	Date	Role	Basis	Source
PATENT	2027-11-29	HISTORICAL_CONTEXT	Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.	Source
PATENT	2031-04-15	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2031-04-15	HISTORICAL_CONTEXT	Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	Source
PATENT	2032-07-28	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2032-07-28	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2032-07-28	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2032-07-28	HISTORICAL_CONTEXT	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2034-02-28	HISTORICAL_CONTEXT	Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.	Source
REGULATORY_STATUS	—	TERMINAL_STATUS	FDA July 2017 changes list: NDA204114/002 EQ1MG moved to non-marketed list; Jul DISC. Status event month 2017-07; exact day not stated.	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.