Viewing data from:

PONVORY

NDA

PONESIMOD | N213498 | VANDA PHARMACEUTICALS INC

10 strengths5 unique patents1 unique exclusivity

Patent Timeline

5 unique patents, 1 exclusivity by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

Nov. 16, 2029

May. 6, 2032

Dec. 10, 2035

Oct. 10, 2042

Dec. 10, 2035

NCE

Mar. 18, 2026

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Kaylin Bower FDA-2026-P-0775 · 2 docket documents Kaylin Bower filed this citizen petition with the FDA on January 24, 2026, requesting that the agency correct or remove misleading statements in FDA approval tables for multiple sclerosis drugs including Kesimpta, Aubagio, Ponvory, Gilenya, Mayzent, and Zeposia that present relative risk reductions	Other	2026-01-27	Open	Kaylin Bower

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

9 trials from ClinicalTrials.gov, 1 active, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial NCT03500328	N/A	Active	Johns Hopkins University	900	2018-05-02 → 2026-08-01
A Study of Ponesimod in Healthy Adult Participants Receiving Propranolol at Steady State NCT03882255	Phase 1	Completed	Janssen Pharmaceutica N.V., Belgium	52	2019-03-20 → 2019-08-26
Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis NCT02425644	Phase 3	Completed	Actelion	1,133	2015-06-04 → 2019-05-16
Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis NCT01093326	Phase 2	Completed	Actelion	353	2010-05-12 → 2023-09-06
Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis NCT03232073	Phase 3	Completed	Actelion	877	2017-07-05 → 2024-01-16
Study to Investigate the Absolute Bioavailability of a Single Oral Dose of Ponesimod in Healthy Male Subjects NCT02068235	Phase 1	Completed	Actelion	17	2014-08 → 2014-11
Study of the Electrocardiographic Effects of Ponesimod in Healthy Male and Female Subjects NCT02136888	Phase 1	Completed	Actelion	116	2011-08 → 2012-02
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHD NCT02461134	Phase 2	Terminated	Actelion	1	2016-09-29 → 2017-03-03
Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)NCT02907177	Phase 3	Terminated	Actelion	136	2017-03-30 → 2020-03-26

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

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$3393.05

Highest Price

$9711.71

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50458-0707-14PONVORY 14-DAY STARTER PACK	$4532.13	FSS	Vanda Pharmaceuticals, Inc.	08/31/2029
50458-0707-14PONVORY 14-DAY STARTER PACK	$3393.05	Big4	Vanda Pharmaceuticals, Inc.	08/31/2029
50458-0720-30PONVORY 20MG TAB,ORAL	$9711.71	FSS	Vanda Pharmaceuticals, Inc.	08/31/2029
50458-0720-30PONVORY 20MG TAB,ORAL	$6936.82	Big4	Vanda Pharmaceuticals, Inc.	08/31/2029
43068-0610-09PONVORY 14-DAY STARTER PACK	$4532.13	FSS	Vanda Pharmaceuticals, Inc.	08/31/2029
43068-0610-09PONVORY 14-DAY STARTER PACK	$3393.05	Big4	Vanda Pharmaceuticals, Inc.	08/31/2029
43068-0620-01PONVORY 20MG TAB,ORAL	$9711.71	FSS	Vanda Pharmaceuticals, Inc.	08/31/2029
43068-0620-01PONVORY 20MG TAB,ORAL	$6936.82	Big4	Vanda Pharmaceuticals, Inc.	08/31/2029

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

Medicare Part D Spending

CMS annual spending data for Ponvory (2024)

Total Spending

$6.4M

Total Claims

528

Beneficiaries

Avg Cost/Unit

$313.15

Spending Trend

$569K(2021)→$4.6M(2022)→$8.3M(2023)→$6.4M(2024)

YoY Change:-4.0%

5yr CAGR:+3.6%

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2024	SUPPL -5	View Letter (PDF)
Jul 2, 2024	SUPPL -6	View Letter (PDF)
Aug 11, 2023	SUPPL -4	View Letter (PDF)
Oct 29, 2021	SUPPL -1	View Letter (PDF)
Mar 19, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (10)

Sort:

#001 — 2MG

RLD

5 patents1 exclusivity▴

TABLET;ORAL | Approved: Mar 18, 2021

Patents (5) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE43728	Nov 16, 2029	—	Yes	Yes	—	—
9062014	May 6, 2032	—	Yes	Yes		—
10220023	Dec 10, 2035	—	—	—		—
11951097	Oct 10, 2042	—	—	—		—
12336980	Dec 10, 2035	—	—	—		—

Exclusivities (1)

Code	Date	Status
NCE	Mar 18, 2026	Expired

#002 — 3MG

RLD

5 patents1 exclusivity▾

TABLET;ORAL | Approved: Mar 18, 2021

#003 — 4MG

RLD

5 patents1 exclusivity▾

TABLET;ORAL | Approved: Mar 18, 2021

#004 — 5MG

RLD

5 patents1 exclusivity▾

TABLET;ORAL | Approved: Mar 18, 2021

#005 — 6MG

RLD

5 patents1 exclusivity▾

TABLET;ORAL | Approved: Mar 18, 2021

#006 — 7MG

RLD

5 patents1 exclusivity▾

TABLET;ORAL | Approved: Mar 18, 2021

#007 — 8MG

RLD

5 patents1 exclusivity▾

TABLET;ORAL | Approved: Mar 18, 2021

#008 — 9MG

RLD

5 patents1 exclusivity▾

TABLET;ORAL | Approved: Mar 18, 2021

#009 — 10MG

RLD

5 patents1 exclusivity▾

TABLET;ORAL | Approved: Mar 18, 2021

#010 — 20MG

RLD

5 patents1 exclusivity▾

TABLET;ORAL | Approved: Mar 18, 2021