Product profile · United States

GILENYA

· Patent Litigation & Settlement History ↓

IngredientFINGOLIMOD HYDROCHLORIDE

Application typeNDA

Application022527

Product002

Dosage formCAPSULE

RouteORAL

StrengthEQ 0.25MG BASE

Approval date2018-05-11

Marketing statusPrescription

Status event—

ApplicantNOVARTIS

Product source

Current GenericRadar decision

Year—

SelectionEXISTING_GENERIC

ReviewCOMPLETED

Anchor type—

Anchor date—

Patent anchor—

Exclusivity anchor—

Protection date—

First Final ANDA2021-11-12

Status event—

ANDA 212152/001 Final 2021-11-12; FDA RLD brand source candidate. Earliest exact-product Final ANDA and explicit product correspondence still require independent confirmation.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
9592208	2032-03-30	DP/U U-2315	—	—	—	—	—	—
9592208	2032-09-30	— —	—	—	—	—	2032-09-30	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
No exclusivity facts are recorded in this product snapshot.

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

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
212152 / 001	FINAL_APPROVAL · FINAL_APPROVED	2021-11-12	—	TEVA PHARMACEUTICALS USA INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source

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 1 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
212152 / 001	TEVA PHARMACEUTICALS USA INC	FINAL_APPROVAL · FINAL_APPROVED	2021-11-12	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	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.