ASACOL HD Drug Patent Profile

Which patents cover Asacol Hd, and what generic alternatives are available?

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Asacol Hd

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

Summary for ASACOL HD

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	181
Clinical Trials:	35
Patent Applications:	4,186
Drug Prices:	Drug price information for ASACOL HD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ASACOL HD
What excipients (inactive ingredients) are in ASACOL HD?	ASACOL HD excipients list
DailyMed Link:	ASACOL HD at DailyMed

See drug prices for ASACOL HD

See drug sales revenues for ASACOL HD

Recent Clinical Trials for ASACOL HD

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

Sponsor	Phase
Shiraz University of Medical Sciences	Phase 1/Phase 2
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 3
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 3

See all ASACOL HD clinical trials

Paragraph IV (Patent) Challenges for ASACOL HD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ASACOL HD	Delayed-release Tablets	mesalamine	800 mg	021830	1	2011-07-13

US Patents and Regulatory Information for ASACOL HD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008		DISCN	Yes	No

Expired US Patents for ASACOL HD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	9,089,492
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	5,541,170
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	8,580,302
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	6,893,662

International Patents for ASACOL HD

See the table below for patents covering ASACOL HD around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2123695	ORALLY ADMINISTRABLE PHARMACEUTICAL COMPOSITIONS
Israel	161628	תכשיר רוקחות למתן פומי המכיל עטיפה פנימית ועטיפה חיצונית שונה המתמוססת באופן תלוי ph (Pharmaceutical composition for oral administration comprising an inner coating and a different outer coating dissolving in a ph-dependent manner)
European Patent Office	1453487	FORME DE DOSE PHARMACEUTIQUE A FILMS MULTIPLES (PHARMACEUTICAL DOSAGE FORM WITH MULTIPLE COATINGS)
Canada	1172570	COMPOSES PHARMACEUTIQUES ADMINISTRES PAR VOIE ORALE (ORALLY ADMINISTRABLE PHARMACEUTICAL COMPOSITIONS)

ASACOL HD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Asacol HD

Introduction to Asacol HD

Asacol HD is a medication containing mesalamine, used primarily for the treatment of ulcerative colitis, a type of inflammatory bowel disease (IBD). It is distinguished by its 800mg dosage and a dual-layer coating, which differentiates it from its predecessor, Asacol 400mg[3].

Market Drivers

The demand for Asacol HD is driven by several key factors:

Increasing Prevalence of Ulcerative Colitis

The rising cases of ulcerative colitis, particularly in regions like North America, significantly drive the demand for Asacol HD. The U.S. has one of the highest age-standardized prevalence rates for IBD, with ulcerative colitis being three times more common than Crohn's disease in this region[1].

Anti-Inflammatory Properties

Mesalamine, the active ingredient in Asacol HD, is known for its anti-inflammatory, antioxidative, and anticancer properties. This makes it an effective treatment for reducing inflammation, pain, and associated symptoms of ulcerative colitis[1].

Convenience and Tolerability

Asacol HD tablets are well tolerated and start showing effective results within 2 to 4 weeks of proper usage. They are available in different concentrations and can be taken in varied time and dose divided intake methods, making them convenient for patients[1].

Historical Context and Patent Expiration

Asacol HD was launched on July 7, 2009, by Procter & Gamble (P&G), and later acquired by Warner Chilcott in October 2009. The patents associated with Asacol HD were set to expire on November 15, 2021. Despite efforts to transition patients from Asacol 400mg to Asacol HD before the patent expiration of the former in 2013, only about 22% of prescriptions were successfully transitioned by 2011[3].

Impact of Patent Expiration

The expiration of patents for Asacol HD in 2021 has opened the market to generic competition. Companies like Zydus Lifesciences have capitalized on this by launching generic versions of mesalamine, which has contributed to their revenue growth. For instance, Zydus Lifesciences saw an 8% quarter-on-quarter growth in their U.S. revenue driven by volume growth of mesalamine products[5].

Financial Performance and Projections

Revenue Growth

The global mesalamine market, which includes Asacol HD and its generic versions, is expected to register a rapid revenue CAGR over the forecast period. This growth is driven by the increasing use of mesalamine for treating ulcerative colitis and other inflammatory bowel diseases[1].

Company Performance

Zydus Lifesciences, a key player in the mesalamine market, reported robust financial results in FY 2024, with consolidated revenues up by 13% year-over-year. Their U.S. Formulations business, which includes mesalamine products, accounted for 47% of the consolidated revenues and delivered a 37% sequential growth. The company expects to maintain high double-digit growth and EBITDA margins of around 27.5% in FY 2025, despite anticipated competition in the Asacol HD market[2].

Regional Market Dynamics

North American Market

The North American region, particularly the U.S., is a significant market for Asacol HD due to the high prevalence of IBD. This region is expected to account for a steady revenue CAGR over the forecast period, driven by the need for effective treatments for ulcerative colitis[1].

Competitive Landscape

The mesalamine market is becoming increasingly competitive with the entry of generic versions post-patent expiration. Companies like Zydus Lifesciences are leveraging this opportunity to expand their market share through volume growth and new product launches[2][5].

Challenges and Opportunities

Generic Competition

The expiration of patents for Asacol HD has introduced significant generic competition, which can impact the market share of branded products. However, this also presents opportunities for companies to innovate and offer more affordable treatment options[3].

Product Innovation

The versatility in the preparation and administration of mesalamine products, such as the ability to modify stock solutions and store them at low temperatures, adds to their advantages. This innovation can drive demand and differentiate products in a competitive market[1].

Key Takeaways

• Increasing Demand: Rising cases of ulcerative colitis drive the demand for Asacol HD and its generic versions.
• Patent Expiration: The expiration of patents has opened the market to generic competition.
• Financial Growth: Companies like Zydus Lifesciences are experiencing robust revenue growth driven by mesalamine products.
• Regional Significance: The North American region is crucial due to the high prevalence of IBD.
• Competitive Landscape: The market is becoming increasingly competitive with the entry of generic versions.

FAQs

What is Asacol HD used for?

Asacol HD is used primarily for the treatment of ulcerative colitis, an inflammatory bowel disease.

What are the key drivers of the Asacol HD market?

The market is driven by the increasing prevalence of ulcerative colitis, the anti-inflammatory properties of mesalamine, and the convenience and tolerability of the tablets.

How has the patent expiration of Asacol HD impacted the market?

The patent expiration has led to the entry of generic competition, which has contributed to revenue growth for companies like Zydus Lifesciences.

Which region is most significant for the Asacol HD market?

The North American region, particularly the U.S., is the most significant due to the high prevalence of IBD.

What are the future projections for the mesalamine market?

The global mesalamine market is expected to register a rapid revenue CAGR over the forecast period, driven by increasing demand for treatments of ulcerative colitis and other IBDs.

Cited Sources

1. Reports and Data: Mesalamine Market Size, Growth, and Industry Development by 2030.
2. Alpha Spread: ZYDUSLIFE Q4-2024 Earnings Call.
3. Casetext: In re Asacol Antitrust Litig., 323 F.R.D. 451.
4. The Insight Partners: Mesalamine Market SWOT Analysis by 2031.
5. Zydus Lifesciences: Q1 FY 23 Post Results Earnings Call Transcript.