Viewing data from:

DIACOMIT

NDA

STIRIPENTOL | N206709 | BIOCODEX SA

2 strengths0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

2027

2028

2029

Today

ODE-403

Jul. 14, 2029

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Diacomit (2023)

Total Spending

$1.2M

Total Claims

229

Beneficiaries

Avg Cost/Unit

$37.64

Spending Trend

$469K(2021)→$854K(2022)→$1.2M(2023)

YoY Change:+10.1%

5yr CAGR:+1.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs

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

SS PHARMA LLCSTIRIPENTOL

DMF 332522019

MSN LIFE SCIENCES PRIVATE LTDSTIRIPENTOL

DMF 343282019

ALP PHARM BEIJING CO LTDSTIRIPENTOL

DMF 358172021

METROCHEM API PRIVATE LTDSTIRIPENTOL

DMF 380972023

TORRENT PHARMACEUTICALS LTDSTIRIPENTOL

DMF 392562023

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Apr 16, 2026	SUPPL -6	View Letter (PDF)
Jul 15, 2022	SUPPL -3	View Letter (PDF)
Aug 27, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MG

RLD

0 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Aug 20, 2018

Exclusivities (1)

Code	Date	Status
ODE-403	Jul 14, 2029	Active

#002 — 500MG

RLD

0 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Aug 20, 2018