Viewing data from:

VYKAT XR

NDA

DIAZOXIDE CHOLINE | N216665 | SOLENO THERAPEUTICS INC

3 strengths6 unique patents2 unique exclusivities

Patent Timeline

6 unique patents, 2 exclusivities by expiration date

Expiring < 1yr (1)Active (5)TodayExclusivityIPRPTAB Challenge

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Dec. 20, 2026

Mar. 5, 2029

Nov. 12, 2035

Nov. 12, 2035

Nov. 12, 2035

Nov. 12, 2035PGR

Mar. 26, 2028

ODE-532

May. 26, 2032

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
PGR2026-00034	12419895	PGR	APOTEX INC. et al.	Pending	2026-04-21	—

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MSN LABORATORIES PRIVATE LTDDIAZOXIDE CHOLINE

DMF 415342025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 28, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

RLD

6 patents2 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Mar 26, 2025

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7572789	Dec 20, 2026	—	Yes	Yes	—	—
7799777	Mar 5, 2029	—	Yes	—	—	—
9757384	Nov 12, 2035	—	—	—		—
12178823	Nov 12, 2035	—	—	—		—
12343348	Nov 12, 2035	—	—	—		—
12419895	Nov 12, 2035	—	—	—		—

Exclusivities (2)

Code	Date	Status
NP	Mar 26, 2028	Active
ODE-532	May 26, 2032	Active

#002 — 75MG

RLD

6 patents2 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Mar 26, 2025

#003 — 150MG

RLD

6 patents2 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Mar 26, 2025

Change History (3)

Recent changes detected for this application.

ADDED7/1/2026

Soleno Therapeutics added orphan drug exclusivity for Vykat XR (diazoxide choline) under NDA 216665, supplement 002, effective through ODE-532.

New: New record

ADDED7/1/2026

New: New record

ADDED7/1/2026

Soleno Therapeutics' Vykat XR (diazoxide choline) gained orphan drug exclusivity for NDA 216665, providing seven years of regulatory exclusivity from FDA approval.

New: New record