SIMULECT Drug Profile

Summary for Tradename: SIMULECT

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for SIMULECT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SIMULECT

Recent Clinical Trials for SIMULECT

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University Hospital, Tours	Phase 4
City of Hope Medical Center	Phase 2
National Cancer Institute (NCI)	Phase 2

See all SIMULECT clinical trials

Recent Litigation for SIMULECT

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29
AbbVie Inc. v. Alvotech hf.	2021-05-28
Alvotech USA Inc. v. Abbvie Inc	2021-05-11

See all SIMULECT litigation

PTAB Litigation

Petitioner	Date
	2017-12-20
	2012-09-25

See all SIMULECT litigation

Pharmacology for SIMULECT

Mechanism of Action	Interleukin 2 Receptor Antagonists Interleukin 2 Receptor-directed Antibody Interactions
Established Pharmacologic Class	Interleukin-2 Receptor Blocking Antibody

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for SIMULECT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for SIMULECT Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for SIMULECT Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	10,064,938	2036-03-11	Patent claims search
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	10,086,046	2028-05-08	Patent claims search
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	10,111,968	2032-02-15	Patent claims search

SIMULECT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: SIMULECT

Introduction

SIMULECT (basiliximab) is a biologic drug used for the prophylaxis of acute organ rejection in patients receiving renal transplantation. To understand its market dynamics and financial trajectory, it is essential to delve into the broader context of biologics, their market trends, and specific data related to SIMULECT.

Biologics Market Overview

Biologics have become a significant segment of the pharmaceutical market, growing substantially over the past few years. As of 2019, biologics represented 42% of the total medicines market, up from 30% in 2014. This growth is driven by the increasing use of biologics across various therapy areas, including those traditionally dominated by small molecules[1].

Market Exclusivity and Competition

Unlike small molecules, which are subject to generic competition once their patents expire, biologics face competition from biosimilars. By the end of 2019, 17% of the biologics market was accessible to biosimilars, with biosimilars achieving a 20% share of the market where they were approved and launched. This trend is expected to continue, with up to 50% of biologic market sales potentially facing biosimilar competition in the future[1].

SIMULECT: Specific Market Dynamics

SIMULECT, developed by Novartis, is indicated for the prevention of acute organ rejection in renal transplant patients. Here are some key points regarding its market dynamics:

Indication and Efficacy

SIMULECT has shown significant efficacy in reducing the incidence of biopsy-confirmed acute rejection episodes in renal transplant patients. Clinical trials have demonstrated that patients receiving SIMULECT experienced a lower incidence of acute rejection compared to those receiving a placebo[5].

Market Position

As a biologic used in a specialized area (renal transplantation), SIMULECT operates in a niche market. The global organ transplant immunosuppressants market, while declining at a CAGR of 6.5% due to various factors such as high procedure costs and unfavorable reimbursement policies, still presents opportunities for drugs like SIMULECT that offer high efficacy[4].

Financial Performance

While specific financial data for SIMULECT is not readily available in the public domain, it is part of the broader biologics market that has seen significant cumulative sales. The top 10 biologics, including those in similar therapeutic areas, have each achieved cumulative sales of over $40 billion since their launch. Given its specialized use and efficacy, SIMULECT likely contributes to Novartis's revenue stream, although its exact financial impact would need to be derived from Novartis's financial reports[1].

Competitive Landscape

The market for immunosuppressants is competitive, with several drugs available for preventing organ rejection. However, SIMULECT's specific indication and proven efficacy help it maintain a strong position. The adoption of biosimilars in the future could pose a competitive threat, but as of now, SIMULECT remains a key player in its niche[5].

Financial Trajectory

Revenue Trends

Biologics, including those used in organ transplantation, have seen substantial revenue growth. The cumulative sales of top biologics indicate a robust financial performance, and while SIMULECT's specific revenue figures are not detailed, it is likely to follow this trend given its importance in renal transplantation.

Cost and Pricing

The cost of goods (COGs) for biologics, including antibodies, ranges between $95 and $200 per gram, but they are priced at a significant markup, often 100 times the COGs. This pricing strategy allows for high profit margins despite potential future price drops due to biosimilar competition[3].

Future Outlook

The future financial trajectory of SIMULECT will be influenced by several factors:

• Biosimilar Competition: As more biosimilars enter the market, there could be a price drop, affecting revenue.
• Market Expansion: Growing demand for organ transplants, especially in regions with developing healthcare infrastructure, could increase the market size for SIMULECT.
• Regulatory Environment: Changes in regulatory policies and reimbursement practices will also impact the financial performance of SIMULECT[1][3].

Key Takeaways

• Market Growth: Biologics, including SIMULECT, are a growing segment of the pharmaceutical market.
• Efficacy and Market Position: SIMULECT's proven efficacy in preventing acute organ rejection maintains its strong market position.
• Financial Performance: While specific figures are not available, SIMULECT contributes to the robust financial performance of biologics.
• Future Outlook: The financial trajectory will be influenced by biosimilar competition, market expansion, and regulatory changes.

FAQs

What is SIMULECT used for?

SIMULECT (basiliximab) is used for the prophylaxis of acute organ rejection in patients receiving renal transplantation.

How effective is SIMULECT in preventing acute rejection?

Clinical trials have shown that SIMULECT significantly reduces the incidence of biopsy-confirmed acute rejection episodes in renal transplant patients[5].

What is the current market trend for biologics like SIMULECT?

Biologics are a growing segment of the pharmaceutical market, representing 42% of the total medicines market as of 2019[1].

How does the emergence of biosimilars affect SIMULECT?

The emergence of biosimilars could lead to a price drop and increased competition, potentially affecting SIMULECT's revenue and market share[1][3].

What are the key factors influencing the financial trajectory of SIMULECT?

The financial trajectory of SIMULECT will be influenced by biosimilar competition, market expansion, and changes in the regulatory environment[1][3].

Sources

1. Biologics Market Dynamics: Setting the Stage for Biosimilars - FDA/FTC Workshop on a Competitive Marketplace for Biosimilars, March 9, 2020.
2. US securities & Exchange commission form 20-F 2013 - Novartis.
3. The Coming of Age of Biosimilars: A Personal Perspective - MDPI.
4. Global Organ Transplant Immunosuppressants Market - iHealthcareAnalyst.
5. Simulect® (basiliximab) For Injection - Novartis.