PENTASA Drug Patent Profile

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

Pentasa is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in PENTASA 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 Pentasa

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

Summary for PENTASA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	181
Clinical Trials:	25
Patent Applications:	4,147
Drug Prices:	Drug price information for PENTASA
Drug Sales Revenues:	Drug sales revenues for PENTASA
What excipients (inactive ingredients) are in PENTASA?	PENTASA excipients list
DailyMed Link:	PENTASA at DailyMed

See drug prices for PENTASA

See drug sales revenues for PENTASA

Recent Clinical Trials for PENTASA

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

Sponsor	Phase
Bogomolets National Medical University	N/A
Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine	N/A
AIDS Healthcare Foundation	Phase 1/Phase 2

See all PENTASA clinical trials

Pharmacology for PENTASA

Drug Class

Aminosalicylate

US Patents and Regulatory Information for PENTASA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-001	May 10, 1993		RX	Yes	No
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-002	Jul 8, 2004	AB	RX	Yes	Yes

Expired US Patents for PENTASA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-001	May 10, 1993
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-001	May 10, 1993

International Patents for PENTASA

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

Country	Patent Number	Title	Estimated Expiration
Japan	S57500432
World Intellectual Property Organization (WIPO)	8102671

PENTASA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PENTASA (Mesalamine)

Introduction

PENTASA, a brand name for the drug mesalamine, is a crucial medication in the treatment of ulcerative colitis (UC) and other inflammatory bowel diseases. Here, we delve into the market dynamics and financial trajectory of PENTASA, highlighting key factors influencing its market performance.

Market Size and Growth

The global mesalamine market, which includes PENTASA, has been growing steadily. As of 2021, the global mesalamine market size was valued at USD 156.5 million, and it is projected to reach USD 220.21 million by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 5.3% during this period[1][4].

Driving Factors

Several factors are driving the growth of the mesalamine market, including:

Increasing Incidence of IBD

The rising prevalence of inflammatory bowel diseases such as ulcerative colitis is a significant driver. Ulcerative colitis affects a substantial number of people worldwide, with 9 to 20 cases per lakh population reported annually[3].

Awareness and Diagnostic Methods

Increased patient awareness about medical treatments and advancements in diagnostic methods are also contributing to the market growth. Improved diagnostics enable earlier and more accurate detection of UC, leading to higher demand for treatments like PENTASA[1].

Technological Developments

Technological advancements in drug delivery systems, such as controlled-release formulations, enhance the efficacy and patient compliance of mesalamine treatments. These innovations are crucial in maintaining the market's growth trajectory[4].

Regional Market Performance

The mesalamine market is segmented into several geographical regions:

North America

North America is the largest market for mesalamine due to the presence of major pharmaceutical companies and significant government funding for developing new therapeutics. This region continues to drive the market forward[4].

Europe

Europe also holds a substantial share of the market, driven by the increasing prevalence of bowel diseases and higher healthcare spending in the region[3][4].

Emerging Markets

Regions such as Eastern Europe, South America, Africa, and Asia are experiencing a sharp increase in UC cases, primarily due to factors like increased use of antibiotics, westernized diets, and higher exposure to pollutants. These emerging markets offer significant growth opportunities for mesalamine treatments[3].

Competitive Landscape

The mesalamine market is competitive, with several key players:

Major Companies

Companies such as Ferring, Ethypharm Pharmaceutical, Shanghai Pharmaceutical, Tillotts Pharma, and others are prominent in the market. These companies invest heavily in research and development to improve treatment options and expand their market share[1][4].

Financial Performance

The financial performance of PENTASA is closely tied to the overall mesalamine market:

Revenue Projections

The global mesalamine market is expected to grow from USD 156.5 million in 2021 to USD 220.21 million by 2032. This growth is driven by the increasing demand for effective UC treatments and the expanding patient base[1].

CAGR

The market is projected to exhibit a CAGR of 5.3% during the forecast period, indicating a steady and consistent growth trajectory[1].

Challenges and Restraints

Despite the positive growth outlook, there are several challenges that could impact the market:

Side Effects

Mesalamine treatments, including PENTASA, can have side effects such as nausea, vomiting, headache, stomach and abdominal pain, and rash. These side effects can limit patient compliance and affect market growth[4][5].

COVID-19 Impact

The COVID-19 pandemic has had a significant impact on various industries, including pharmaceuticals. The halt in production and supply chain disruptions during the pandemic affected the demand for mesalamine, although the market is recovering as normal operations resume[4].

Clinical Efficacy and Safety

PENTASA has been shown to be effective in inducing remission and treating mildly to moderately active ulcerative colitis. Clinical trials have demonstrated improvements in primary efficacy parameters such as frequency of trips to the toilet, stool consistency, rectal bleeding, abdominal/rectal pain, and urgency[2].

Regulatory Considerations

PENTASA is indicated for specific uses and comes with certain contraindications and precautions. For instance, caution is advised when administering PENTASA to patients with impaired renal function due to the risk of nephrotic syndrome and interstitial nephritis[2].

Key Takeaways

• The global mesalamine market, including PENTASA, is projected to grow from USD 156.5 million in 2021 to USD 220.21 million by 2032.
• The market is driven by increasing incidence of IBD, improved diagnostic methods, and technological advancements.
• North America and Europe are key regions driving the market growth.
• Major pharmaceutical companies are investing in research and development to enhance treatment options.
• Side effects and the impact of the COVID-19 pandemic are significant restraints on the market.

FAQs

What is the projected market size of the global mesalamine market by 2032?

The global mesalamine market is expected to reach USD 220.21 million by 2032[1].

What is the CAGR of the mesalamine market from 2021 to 2032?

The mesalamine market is expected to exhibit a CAGR of 5.3% during this period[1].

What are the primary drivers of the mesalamine market growth?

The primary drivers include the increasing incidence of IBD, improved diagnostic methods, and growing awareness among patients about medical treatments[1].

Which regions are expected to show significant growth in the mesalamine market?

North America and Europe are expected to be key regions, with emerging markets in Eastern Europe, South America, Africa, and Asia also showing significant growth potential[3][4].

What are the common side effects associated with PENTASA?

Common side effects include nausea, vomiting, headache, stomach and abdominal pain, and rash[5].

Sources

1. Business Research Insights: Mesalamine (Lialda) Market Size, Share | Global Report 2032
2. FDA: PENTASA® (mesalamine) Controlled-Release Capsules 250 mg
3. Future Market Insights: Ulcerative Colitis Treatment Market - Report, Size, Analysis
4. MarketStatsville: Mesalamine Market Share Size Value Analysis and Forecast 2027
5. RxList: Pentasa (Mesalamine): Side Effects, Uses, Dosage, Interactions