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NEREUS

NDA

TRADIPITANT | N220152 | VANDA PHARMACEUTICALS INC

1 strength4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

2027

2028

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2030

2031

2032

2033

2034

2035

2036

2037

Today

Mar. 4, 2036

Mar. 4, 2036

Mar. 4, 2036

Aug. 9, 2036

NCE

Dec. 30, 2030

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 Carolyn Denise Tilton, et al. FDA-2024-P-4410 · 5 docket documents Carolyn Denise Tilton and other gastroparesis patients filed this citizen petition requesting that the FDA approve Vanda Pharmaceutical Inc.'s New Drug Application No. 218489 for tradipitant to treat gastroparesis symptoms, and requesting that the agency convene an advisory committee with gastropare	Other	2024-09-19	Open	Carolyn Denise Tilton, et al.

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

Clinical Trials

8 trials from ClinicalTrials.gov — 1 recruiting, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection NCT04326426	Phase 3	By Invitation	Vanda Pharmaceuticals	300	2020-04-13 → 2020-08-31
Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis NCT02651714	Phase 2	Completed	Vanda Pharmaceuticals	168	2016-01-19 → 2017-08-04
Study to Assess the Effect of Multiple Doses of Tradipitant on CYP3A4 Using Midazolam as a Substrate in Healthy Subjects NCT02621385	Phase 1	Completed	Vanda Pharmaceuticals	24	2015-11
Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis NCT04028492	Phase 3	Completed	Vanda Pharmaceuticals	992	2019-08-20 → 2025-02-21
Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE)NCT03568331	Phase 3	Completed	Vanda Pharmaceuticals	375	2018-07-09 → 2019-12-27
Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness NCT03772340	Phase 2	Completed	Vanda Pharmaceuticals	126	2018-12-20 → 2019-06-27
Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness NCT04327661	Phase 3	Completed	Vanda Pharmaceuticals	366	2021-11-15 → 2023-04-12
Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2)NCT04140695	Phase 3	Terminated	Vanda Pharmaceuticals	87	2019-10-21 → 2020-10-14

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 31, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 85MG

RLD

4 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Dec 30, 2025

Patents (4) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
10772880	Mar 4, 2036	—	—	—	—
10821099	Mar 4, 2036	—	—	—	—
11324735	Mar 4, 2036	—	—	—	—
12318375	Aug 9, 2036	—	—	—	—

Exclusivities (1)

Code	Date	Status
NCE	Dec 30, 2030	Active