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. Forty 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
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	181
Clinical Trials:	2
Patent Applications:	4,142
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

Pharmacology for DELZICOL

Drug Class

Aminosalicylate

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	AB	RX	Yes	Yes

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	5,541,170
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013	6,649,180
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013	5,541,171

International Patents for DELZICOL

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2123695	ORALLY ADMINISTRABLE PHARMACEUTICAL COMPOSITIONS
Canada	1172570	COMPOSES PHARMACEUTIQUES ADMINISTRES PAR VOIE ORALE (ORALLY ADMINISTRABLE PHARMACEUTICAL COMPOSITIONS)
Japan	S58501174
Finland	85216

DELZICOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Delzicol (Mesalamine) Delayed-Release Capsules

Introduction

Delzicol, a generic version of mesalamine delayed-release capsules, is a significant player in the treatment of ulcerative colitis. Here, we delve into the market dynamics and financial trajectory of this medication, exploring its indications, market presence, and financial performance.

Indications and Usage

Delzicol is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older, as well as for the maintenance of remission of ulcerative colitis in adults[1][4].

Market Presence

Launch and Competition

Teva Pharmaceutical Industries Ltd. launched a generic version of Delzicol in the U.S. in 2019, expanding its comprehensive portfolio of gastrointestinal treatments. This move was significant, given Teva's leading position in the generic market, with nearly 500 FDA-approved generic products and over 100 pending first-to-file opportunities in the U.S.[1].

Sales Performance

Delzicol delayed-release capsules have substantial annual sales, approximately $130 million in the U.S. as of February 2019, according to IMS data. This figure highlights the drug's market demand and financial viability[1].

Financial Trajectory

Revenue and Market Share

The launch of Teva's generic version of Delzicol has contributed to the company's robust financial performance. With one in eight generic prescriptions in the U.S. filled with a Teva product, the company's market share is considerable. The revenue from Delzicol, along with other generic products, has been a key driver of Teva's financial growth[1].

Pricing Dynamics

The pharmaceutical market, including drugs like Delzicol, is subject to pricing pressures. While generic drugs generally offer cost savings compared to their branded counterparts, the overall trend in the pharmaceutical sector has seen rising drug prices. However, generic versions like Teva's Delzicol help mitigate these costs, providing more affordable treatment options for patients[3].

Market Growth and Projections

The pharmaceutical sector, particularly the generic market, is expected to see steady growth. Projections indicate that the number of ANDA approvals and launches will remain consistent, contributing to incremental revenue. For instance, the U.S. sales for generic products, excluding certain brands, are projected to grow from $1,340 million in FY21 to $1,760 million in FY24, with a steady number of ANDA approvals and launches[2].

Competitive Landscape

Generic Competition

The generic market is highly competitive, with multiple players vying for market share. Companies like Teva, Amneal, and Aurobindo are active in this space, with frequent divestitures and acquisitions shaping the landscape. For example, Amneal divested its UK business to Zentiva, and Actavis was acquired by Aurobindo, indicating the dynamic nature of the industry[2].

Patent and Exclusivity Issues

The pharmaceutical industry is heavily influenced by patent and exclusivity issues. The launch of generic versions like Delzicol often follows the expiration of patents on branded drugs. This transition can significantly impact the financial trajectory of both the branded and generic versions, as seen in the case of Delzicol, which replaced Asacol 400 mg tablets after their removal from the U.S. market[4].

Safety and Regulatory Considerations

Adverse Reactions and Safety Profile

Delzicol, like other mesalamine products, has a well-documented safety profile. It is associated with potential adverse reactions such as renal impairment, acute intolerance syndrome, hypersensitivity reactions, and hepatic failure. These safety considerations are crucial for both regulatory approval and patient safety[4].

Regulatory Approvals

Delzicol was approved by the FDA in February 2013 as a new phthalate-free formulation of Asacol. Regulatory approvals and subsequent labeling changes are critical for the drug's market presence and patient access[4].

Financial Performance Metrics

Revenue Growth

The revenue from Delzicol contributes to Teva's overall financial performance. The company's generic segment, which includes Delzicol, has seen steady revenue growth, driven by the launch of new products and the expansion of its generic portfolio[1].

EBITDA and Profit Margins

Teva's financial performance is also reflected in its EBITDA and profit margins. The company's EBITDA margin has remained stable, around 21%, indicating efficient operations and cost management. This stability is crucial for maintaining profitability in a competitive market[2].

Conclusion

Delzicol, as a generic version of mesalamine delayed-release capsules, plays a vital role in the treatment of ulcerative colitis. Its market dynamics are influenced by competitive pressures, regulatory approvals, and financial performance metrics. The drug's substantial sales and contribution to Teva's revenue highlight its importance in the pharmaceutical market.

Key Takeaways

• Market Presence: Delzicol is a significant player in the treatment of ulcerative colitis, with annual sales of approximately $130 million in the U.S.
• Financial Performance: The drug contributes to Teva's robust financial performance, with steady revenue growth and stable EBITDA margins.
• Competitive Landscape: The generic market is highly competitive, with frequent divestitures and acquisitions shaping the industry.
• Regulatory Considerations: Delzicol's safety profile and regulatory approvals are critical for its market presence.
• Pricing Dynamics: Generic versions like Delzicol help mitigate rising drug prices, providing more affordable treatment options.

FAQs

What is Delzicol used for?

Delzicol is used for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older, and for the maintenance of remission of ulcerative colitis in adults.

Who launched the generic version of Delzicol?

Teva Pharmaceutical Industries Ltd. launched the generic version of Delzicol in the U.S. in 2019.

What are the annual sales of Delzicol in the U.S.?

The annual sales of Delzicol delayed-release capsules in the U.S. are approximately $130 million as of February 2019.

What are the potential adverse reactions associated with Delzicol?

Delzicol is associated with potential adverse reactions such as renal impairment, acute intolerance syndrome, hypersensitivity reactions, and hepatic failure.

How does Delzicol fit into Teva's financial performance?

Delzicol contributes to Teva's revenue growth and stable EBITDA margins, making it a significant part of the company's financial performance.

Sources

1. Teva Announces the Launch of a Generic Version of Delzicol® (mesalamine) Delayed-Release Capsules in the United States - Teva Pharmaceutical Industries Ltd.
2. Sector Update Pharmaceutical Sector - Nirmal Bang Institutional Equities Research
3. May your drug price be evergreen - Oxford Academic
4. Pediatric Focused Safety Review: Asacol, Asacol HD and Delzicol - FDA
5. In re Asacol Antitrust Litig. - Casetext