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XADAGO

NDA

SAFINAMIDE MESYLATE | N207145 | MDD US OPERATIONS LLC

2 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Expiring < 1yr (1)Active (2)Today

2027

2028

2029

2030

2031

Today

8076515

Dec. 10, 2028

8278485

Jun. 8, 2027

8283380

Mar. 21, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Newron Pharmaceuticals S.p.A et al v. MSN Laboratories Private Limited et al 1:2021cv00843 3 patentsANDA 215902, 215978, 216020, 215739, 215945, 215913safinamide	D. Del.	2021-06-10	Terminated 2023-11-22	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

16 trials from ClinicalTrials.gov, 13 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist NCT00643045	Phase 3	Completed	Newron Pharmaceuticals SPA	269	2004-12 → 2007-07
Effect of Safinamide on Parkinson's Disease Related Chronic Pain NCT03841604	Phase 4	Completed	Zambon SpA	94	2019-04-09 → 2021-05-03
Overnight Switch From Rasagiline To Safinamide NCT03843944	Phase 4	Completed	IRCCS San Raffaele Roma	20	2018-05-01 → 2019-05-31
Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects NCT01113320	Phase 2	Completed	Newron Pharmaceuticals SPA	26	2010-04 → 2012-01
Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease NCT01187966	Phase 3	Completed	Newron Pharmaceuticals SPA	669	2007-01 → 2009-02
Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)NCT00642889	Phase 3	Completed	Newron Pharmaceuticals SPA	227	2005-06 → 2007-07
Safinamide for Multiple System Atrophy (MSA)NCT03753763	Phase 2	Completed	Zambon SpA	49	2019-10-29 → 2021-01-05
A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics NCT01026428	Phase 1/2	Completed	Newron Pharmaceuticals SPA	24	2009-09
18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD NCT01286935	Phase 3	Completed	Newron Pharmaceuticals SPA	544	2007-08 → 2010-08
MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist NCT00605683	Phase 3	Completed	Newron Pharmaceuticals SPA	679	2007-11 → 2012-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$36.41

per ea

Lowest NADAC/Unit

$36.31

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
27505011030XADAGO 50 MG TABLET	$36.41	EA	Brand	—	2026-01-21
27505011130XADAGO 100 MG TABLET	$36.31	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$852.95

Highest Price

$1099.87

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
27505-0110-30XADAGO 50MG TAB	$1099.87	FSS	Supernus Pharmaceuticals, Inc.	09/14/2027
27505-0110-30XADAGO 50MG TAB	$852.95	Big4	Supernus Pharmaceuticals, Inc.	09/14/2027
27505-0111-30XADAGO 100MG TAB	$1099.87	FSS	Supernus Pharmaceuticals, Inc.	09/14/2027
27505-0111-30XADAGO 100MG TAB	$852.95	Big4	Supernus Pharmaceuticals, Inc.	09/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Xadago (2024)

Total Spending

$7.7M

Total Claims

4,385

Beneficiaries

759

Avg Cost/Unit

$37.32

Spending Trend

$8.8M(2019)→$10.5M(2020)→$10.9M(2021)→$10.6M(2022)→$9.9M(2023)→$7.7M(2024)

YoY Change:-5.7%

5yr CAGR:+6.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs

9 active API suppliers hold Drug Master Files for this ingredient.

FIS FABBRICA ITALIANA SINTETICI SPASAFINAMIDE

DMF 322252018

MSN LIFE SCIENCES PRIVATE LTDSAFINAMIDE MESYLATE

DMF 337252019

APICORE PHARMACEUTICALS PRIVATE LTDSAFINAMIDE MESYLATE

DMF 343992020

MSN LIFE SCIENCES PRIVATE LTDSAFINAMIDE MESYLATE (PROCESS-2)

DMF 346282020

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDSAFINAMIDE MESYLATE

DMF 350962020

OPTIMUS DRUGS PRIVATE LTDSAFINAMIDE MESYLATE

DMF 351382020

APITORIA PHARMA PRIVATE LTDSAFINAMIDE MESYLATE

DMF 351792020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDSAFINAMIDE MESYLATE

DMF 352012020

SOLARA ACTIVE PHARMA SCIENCES LTDSAFINAMIDE MESYLATE

DMF 357192021

HOSTER LABS PRIVATE LTDSAFINAMIDE MESYLATE

DMF 401102024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Aug 10, 2021	SUPPL -6	View Letter (PDF)
Nov 27, 2019	SUPPL -5	View Letter (PDF)
Jun 20, 2017	SUPPL -1	View Letter (PDF)
Mar 28, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 50MG BASE

RLDAB

3 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 21, 2017

Patents (3) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8076515	Dec 10, 2028	—	Yes	Yes	—
8278485	Jun 8, 2027	—	Yes	—	—
8283380	Mar 21, 2031	—	—	—	—

#002 — EQ 100MG BASE

RLDAB

3 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 21, 2017