Product profile · United States

XADAGO

· Patent Litigation & Settlement History ↓

IngredientSAFINAMIDE MESYLATE

Application typeNDA

Application207145

Product002

Dosage formTABLET

RouteORAL

StrengthEQ 100MG BASE

Approval date2017-03-21

Marketing statusPrescription

Status event—

ApplicantMDD US

Product source

Current GenericRadar decision

Year2023

SelectionEXISTING_GENERIC

ReviewDISQUALIFIED

Anchor typeFINAL_ANDA

Anchor date2023-06-14

Patent anchor—

Exclusivity anchor—

Protection date—

First Final ANDA2023-06-14

Status event—

Exact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
8278485	2027-06-08	DS/U U-1993	—	—	—	—	—	—
8076515	2028-12-10	DS/DP/U U-1993	—	—	—	—	—	—
8283380	2031-03-21	U U-1993	—	—	—	—	—	—

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
215902 / 002	FINAL_APPROVAL · FINAL_APPROVED	2023-06-14	—	AUROBINDO PHARMA LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
215739 / 002	FINAL_APPROVAL · FINAL_APPROVED	2024-04-25	—	PRINSTON PHARMACEUTICAL INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
215978 / 002	FINAL_APPROVAL · FINAL_APPROVED	2024-12-31	—	MSN LABORATORIES PRIVATE LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
215913 / 002	FINAL_APPROVAL · FINAL_APPROVED	2025-06-13	—	ZENARA PHARMA PRIVATE LTD	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 4 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
215902 / 002	AUROBINDO PHARMA LTD	FINAL_APPROVAL · FINAL_APPROVED	2023-06-14	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
215739 / 002	PRINSTON PHARMACEUTICAL INC	FINAL_APPROVAL · FINAL_APPROVED	2024-04-25	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
215978 / 002	MSN LABORATORIES PRIVATE LTD	FINAL_APPROVAL · FINAL_APPROVED	2024-12-31	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
215913 / 002	ZENARA PHARMA PRIVATE LTD	FINAL_APPROVAL · FINAL_APPROVED	2025-06-13	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—

Decision evidence (1)

Type	Date	Role	Basis	Source
GENERIC	2023-06-14	TERMINAL_GENERIC_BASIS	Exact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted.	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.

Event date	Party	Event	Licensed entry	Evidence	Source
Not disclosed	Generic manufacturers named in private settlement agreements (individual parties not specified in this source)	SETTLEMENT Brand-level record; strength scope not established	2027-12-01	SOURCE_CONFIRMED	Source
Newron 2025 Annual Report: US generic safinamide launch is not permitted before 2027-12-01 under settlement agreements. Supernus 2025 Form 10-K: sales may begin December 2027 or sooner under specified conditions. This is a contractual entry threshold, not a verified commercial launch. Brand-level record: do not infer a separate strength-specific licence, individual generic applicant, or actual launch.