DIPENTUM Drug Patent Profile

When do Dipentum patents expire, and when can generic versions of Dipentum launch?

Dipentum is a drug marketed by Mylan Spclt Viatris and is included in one NDA.

The generic ingredient in DIPENTUM is olsalazine sodium. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olsalazine sodium profile page.

Summary for DIPENTUM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Drug Prices:	Drug price information for DIPENTUM
What excipients (inactive ingredients) are in DIPENTUM?	DIPENTUM excipients list
DailyMed Link:	DIPENTUM at DailyMed

See drug prices for DIPENTUM

Pharmacology for DIPENTUM

Drug Class

Aminosalicylate

US Patents and Regulatory Information for DIPENTUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Spclt Viatris	DIPENTUM	olsalazine sodium	CAPSULE;ORAL	019715-001	Jul 31, 1990		RX	Yes	Yes

Expired US Patents for DIPENTUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Spclt Viatris	DIPENTUM	olsalazine sodium	CAPSULE;ORAL	019715-001	Jul 31, 1990	4,559,330

International Patents for DIPENTUM

See the table below for patents covering DIPENTUM around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	8002322
Germany	3161216
Japan	S56154417	USE OF 3,3'-AZOBIS -(6-HYDROXYBENZOIC ACID) AS DRUG AND PHARMACEUTICAL COMPOSITION CONTAINING IT
Japan	H0148247

Summary
DIPENTUM (mesalamine) is a pharmaceutical drug approved for ulcerative colitis treatment. Its market dynamics depend on competition, patent status, regulatory landscape, and clinical positioning. Financial trajectory is influenced by manufacturing costs, pricing strategies, and market penetration, with potential growth tied to expanding indications and geographic expansion.

Market Overview and Competitive Position

Last updated: February 14, 2026

• Dipentum is a delayed-release oral formulation of mesalamine (5-aminosalicylic acid), marketed primarily for ulcerative colitis.
• Approved in the United States in 1999 by Otsuka Pharmaceutical (for US), it has faced competition from products such as Rowasa (enema), Asacol HD, and Lialda (both from Alkermes and other firms), which also deliver mesalamine.
• The global ulcerative colitis market was valued at approximately $3.4 billion in 2022, with mesalamine drugs accounting for about 60% of the market share.[1]
• DIPENTUM holds a niche, with limited but steady market share; its exact volume depends on prescriber preference and formulary inclusion.

Patent and Regulatory Landscape

• DIPENTUM’s patent protection in the US expired in 2018, exposing it to generic competition.
• The drug’s exclusivity in other markets varies, influencing potential for market expansion.
• The FDA approval process for new formulations or biosimilars targeting similar indications could impact sales.

Pricing and Reimbursement

• DIPENTUM’s pricing ranged from approximately $600 to $1,200 per month, depending on dosage and formulations, during patent exclusivity.
• The entry of generics reduces prices, leading to potential declines in revenue unless the brand maintains a strong patient base or expands indications.
• Reimbursement dynamics vary by payer and geographic region, affecting net sales.

Market Penetration and Adoption

• Prescriber preference favors formulations with proven efficacy, safety, and patient compliance.
• DIPENTUM’s delayed-release capsule formulation offers convenience over rectal steroids, but competition from similar oral options has limited growth.
• Insurance formulary inclusion remains vital for market penetration, with some payers favoring generic options.

Financial Trajectory

• Without patent protection, revenues for DIPENTUM are under pressure.
• Historical sales data from monetized products suggest annual US sales in the low hundreds of millions dollar range pre-generic entry.
• Future revenue depends on:
  • Development of new formulations or combination therapies.
  • Geographic expansion into less penetrated markets.
  • Possible repositioning for other inflammatory bowel disease indications.

Parameter	2022 Data	Comments
Global ulcerative colitis market	$3.4 billion	Growing at 4.5% CAGR through 2027
Market share of mesalamine drugs	60%	Dominates oral UC segment
DIPENTUM’s US revenue	Low hundreds of millions	Pre-generic competition
Patent expiry	2018 (US)	Generic entry increased price competition

Key Factors Influencing Future Growth

• Patent cliff and emergence of generics challenge revenue streams.
• Expansion into new global markets remains a primary growth driver.
• Development of improved formulations or combination therapies could revitalize sales.
• Clinical trials exploring new indications or improved delivery systems could present new revenue streams.

Key Takeaways

• DIPENTUM faces significant generic competition post-2018, pressuring its revenue.
• The drug maintains niche positioning in ulcerative colitis treatment, with limited growth outside its established market.
• Market expansion relies on geographic penetration and developing new therapeutic formulations.
• Pricing pressures from generics influence profitability; cost management and patent strategies are critical.
• Innovation and diversification into other inflammatory bowel disease indications could impact its long-term trajectory.

FAQs

1. How does DIPENTUM compare to other mesalamine products?
   It is a delayed-release capsule versus other formulations like enemas or delayed-release tablets, which influences prescriber and patient preference.

2. What is the potential for DIPENTUM in developing markets?
   Expanding into markets with less generic competition or differing regulatory pathways may offer growth, contingent on pricing and reimbursement strategies.

3. Are there ongoing clinical trials for DIPENTUM?
   Current data does not indicate significant new trials; future development focus may shift to formulations or combination therapies rather than new indications.

4. How does patent expiration affect DIPEUM’s market share?
   Patent expiry typically leads to price reductions and a switch to generics, reducing revenue unless brand loyalty or new uses can sustain sales.

5. What are risks to DIPENTUM’s financial outlook?
   Risks include aggressive price competition, regulatory hurdles for new formulations, and shifting prescriber preferences favoring newer agents.

Citations
[1] Grand View Research, 2022. Market Size and Forecast for Ulcerative Colitis Drugs. [2] FDA, 2018. Patent expiration dates for mesalamine formulations. [3] IQVIA, 2022. Pharmaceutical sales data.