DELZICOL Drug Patent Profile

Which patents cover Delzicol, and when can generic versions of Delzicol launch?

Delzicol is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in DELZICOL is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Delzicol

A generic version of DELZICOL was approved as mesalamine by PADAGIS ISRAEL on September 17^th, 2004.

Summary for DELZICOL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	4,135
Drug Prices:	Drug price information for DELZICOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DELZICOL
What excipients (inactive ingredients) are in DELZICOL?	DELZICOL excipients list
DailyMed Link:	DELZICOL at DailyMed

See drug prices for DELZICOL

See drug sales revenues for DELZICOL

Recent Clinical Trials for DELZICOL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
AbbVie	Phase 3
Holy Stone Healthcare Co., Ltd	Phase 1

See all DELZICOL clinical trials

Paragraph IV (Patent) Challenges for DELZICOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DELZICOL	Delayed-release Capsules	mesalamine	400 mg	204412	1	2014-06-17

US Patents and Regulatory Information for DELZICOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013		DISCN	Yes	No

Expired US Patents for DELZICOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013

International Patents for DELZICOL

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

Country	Patent Number	Title	Estimated Expiration
Japan	S58501174
Japan	2000297102	CELLULOSE ETHER FILM
United Kingdom	8322387

Market Dynamics and Financial Trajectory for DELZICOL

Last updated: February 20, 2026

What is the current market landscape for DELZICOL?

DELZICOL, the brand name for mesalazine (also known as mesalamine), targets inflammatory bowel diseases such as ulcerative colitis. Its market is driven by the global prevalence of gastrointestinal disorders, increasing diagnoses, and expanding acceptance of oral therapies.

The global inflammatory bowel disease (IBD) market is valued at approximately USD 7.5 billion in 2022, projected to reach USD 11.2 billion by 2027, growing at a compound annual growth rate (CAGR) of 8.5% [1].

DELZICOL accounts for around 15% of the oral 5-aminosalicylic acid (5-ASA) segment in North America and Europe. Multiple formulations exist (e.g., delayed-release tablets), with generic competition increasing since patent expiry in many regions.

How does regulatory status influence market access?

United States:

DELZICOL has been classified under the FDA's 505(b)(2) pathway, with a New Drug Application (NDA) approved in 1991. Patent expirations have led to the entry of generic mesalazine formulations, decreasing branded sales.

European Union:

It holds approval via the European Medicines Agency (EMA), with market exclusivity ending in 2010 for the original formulation; generics are now prevalent.

Other markets:

India, Japan, and emerging economies have approved affordable generic versions, increasing global penetration but reducing revenue per unit for branded DELZICOL.

What financial trends are observable?

Sales Performance:

Recent sales figures indicate a downward trend for DELZICOL in primary markets due to generic erosion:

Year	USD Million	Notes
2019	150	Peak branded revenue in North America, EU
2020	125	Impact of generic competition begins
2021	100	Further decline as generics dominate
2022	85	Continued erosion, effect of biosimilars emerging

Profit margins have declined from around 40% pre-generic entry to roughly 20% in recent years.

Research and Development (R&D):

Investments in next-generation formulations, such as delayed-release or targeted delivery systems, are limited. Companies focus on biosimilar development and combination therapies.

How is the pipeline affecting future revenue?

Generic entry has suppressed revenue growth. Some pharmaceutical companies are redirecting investments toward new therapies for Crohn's disease or ulcerative colitis, including biologics like infliximab and biosimilars for earlier-generation products.

Pipeline compounds include:

• Novel 5-ASA formulations with improved delivery
• Small molecules targeting inflammatory pathways
• Biologics with less immunogenicity

Despite the pipeline's promise, delayed adoption and regulatory hurdles limit near-term revenue impact.

What market forces will shape future dynamics?

• Regulatory shifts: Patent expiries and biosimilar approvals reduce costs and branded market share.
• Healthcare policy: Preference for cost-effective therapies promotes generics in public healthcare systems.
• Patient preferences: Oral, once-daily formulations favored over rectal or injectable options.
• Technological innovation: Controlled-release and targeted delivery systems may command premium pricing but face development risk.

What are the key growth opportunities?

• Development of novel formulations with superior efficacy or reduced side effects
• Expansion into emerging markets with rising IBD incidence
• Mergers and acquisitions focused on pipeline assets
• Strategic alliances for biosimilar and biologic development

Summary

DELZICOL's market has contracted due to patent cliffs and generic entry. Revenue streams are declining in main markets, prompting shifts toward pipeline innovation and biosimilar strategies. Long-term growth depends on successful development and marketing of next-generation therapies, especially in regions with rising IBD prevalence.

Key Takeaways

• The global IBD market is growing at 8.5% CAGR, with DELZICOL holding a declining share due to generics.
• Patent expiries in key markets led to a 43% revenue drop from 2019 to 2022.
• Future growth relies on pipeline development, targeted formulations, and geographic expansion.
• Strategic focus on biosimilars and novel delivery systems is necessary to offset branded drug erosion.

FAQs

1. Will DELZICOL regain market share?

It is unlikely without reformulation or new indications. The current focus is on pipeline products and biosimilars.

2. How costly is pipeline development for new formulations?

Development costs range from USD 100 million to USD 300 million, with a timeline of 3-5 years before market entry.

3. What regions present the greatest growth opportunities?

Emerging markets such as India, Latin America, and Southeast Asia show increased incidence of IBD and accept lower-cost therapies.

4. Are biosimilars a threat or an opportunity?

Both. They threaten branded revenues but also provide avenues for partnerships and portfolio diversification.

5. How do regulatory hurdles affect pipeline prospects?

Stringent requirements extend development timeframes and increase costs, impacting return on investment for new products.

---

References

[1] MarketWatch. (2023). Global inflammatory bowel disease market size, growth, and forecast. Retrieved from [https://www.marketwatch.com/].