Viewing data from:

DIPENTUM

NDA

OLSALAZINE SODIUM | N019715 | MYLAN SPECIALTY LP A VIATRIS CO

1 strength0 unique patents0 unique exclusivities

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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis NCT00004288	Phase 2	Completed	National Center for Research Resources (NCRR)	4	1996-05 → 1999-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$15.70

per ea

Lowest NADAC/Unit

$15.70

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00037686010DIPENTUM 250 MG CAPSULE	$15.70	EA	Brand	—	2026-01-01

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$1100.82

Highest Price

$1100.82

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00037-6860-10DIPENTUM 250MG CAP	$1100.82	FSS	Mylan Specialty L.P.	01/14/2027
00037-6860-10DIPENTUM 250MG CAP	$1100.82	Big4	Mylan Specialty L.P.	01/14/2027

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

Medicare Part D Spending

CMS annual spending data for Dipentum (2024)

Total Spending

$2.9M

Total Claims

1,345

Beneficiaries

194

Avg Cost/Unit

$14.55

Spending Trend

$4.1M(2019)→$3.8M(2020)→$3.1M(2021)→$3.0M(2022)→$2.9M(2023)→$2.9M(2024)

YoY Change:+1.3%

5yr CAGR:+2.4%

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

API Supply Chain3 active DMFs3 inactive

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

DOTTIKON EXCLUSIVE SYNTHESIS AGOLSALAZINE SODIUM

DMF 176772004

EMCURE PHARMACEUTICALS LTDOLSALAZINE SODIUM (PROCESS II)

DMF 276182013

MATRIX PHARMACORP PRIVATE LTDOLSALAZINE SODIUM

DMF 392692023

PHARMACIA AND UPJOHNInactiveOLSALAZINE SODIUM

DMF 64431986

EMCURE PHARMACEUTICALS LTDInactiveOLSALAZINE SODIUM

DMF 216332008

CORDEN PHARMA BERGAMO SPAInactiveOLSALAZINE SODIUM

DMF 219812008

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Jul 31, 2024	SUPPL -35	View Letter (PDF)
Oct 25, 2023	SUPPL -33	View Letter (PDF)
Nov 17, 2022	SUPPL -32	View Letter (PDF)
Nov 2, 2021	SUPPL -30	View Letter (PDF)
Jun 29, 2021	SUPPL -29	View Letter (PDF)
Oct 8, 2020	SUPPL -28	View Letter (PDF)
Nov 12, 2009	SUPPL -27	View Letter (PDF)
Jul 16, 2007	SUPPL -25	View Letter (PDF)
Aug 9, 2002	SUPPL -21	View Letter (PDF)
Jan 18, 2002	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jul 31, 1990

No patent or exclusivity listings for this strength.