TOPROL-XL Drug Patent Profile

When do Toprol-xl patents expire, and when can generic versions of Toprol-xl launch?

Toprol-xl is a drug marketed by Toprol and is included in one NDA.

The generic ingredient in TOPROL-XL is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Toprol-xl

A generic version of TOPROL-XL was approved as metoprolol succinate by ACTAVIS LABS FL INC on August 3^rd, 2009.

Summary for TOPROL-XL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	22
Patent Applications:	4,359
DailyMed Link:	TOPROL-XL at DailyMed

Recent Clinical Trials for TOPROL-XL

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

Sponsor	Phase
AgoneX Biopharmaceuticals, Inc.	Phase 2
BioHealthonomics Inc.	Phase 2
ARCA Biopharma, Inc.	Phase 2

See all TOPROL-XL clinical trials

Pharmacology for TOPROL-XL

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

US Patents and Regulatory Information for TOPROL-XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-004	Feb 5, 2001	AB	RX	Yes	No
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992	AB	RX	Yes	Yes
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-001	Jan 10, 1992	AB	RX	Yes	Yes
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-002	Jan 10, 1992	AB	RX	Yes	No

Expired US Patents for TOPROL-XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-001	Jan 10, 1992
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-002	Jan 10, 1992
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992
Toprol	TOPROL-XL	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	019962-003	Jan 10, 1992

International Patents for TOPROL-XL

See the table below for patents covering TOPROL-XL around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	T47843
Germany	3572767
Germany	2106209
European Patent Office	0293347	METOPROLOL SUCCINATE AND PHARMACEUTICAL COMPOSITION CONTAINING IT
South Korea	940000100

TOPROL-XL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TOPROL-XL (Metoprolol Succinate)

Introduction

TOPROL-XL, a cardioselective beta-blocker, has been a significant player in the cardiovascular disease treatment market since its FDA approval in 1992. This article delves into the market dynamics and financial trajectory of TOPROL-XL, highlighting key milestones, ownership changes, and financial performances.

Market Indications and Usage

TOPROL-XL is indicated for the treatment of hypertension, either alone or in combination with other antihypertensives, the long-term treatment of angina pectoris, and the treatment of stable, symptomatic (NYHA class II or III) heart failure of specific origins[1][3].

Ownership and Licensing Agreements

AstraZeneca to Aralez Pharmaceuticals

In 2016, AstraZeneca entered into an agreement with Aralez Pharmaceuticals to transfer the rights to TOPROL-XL in the U.S. Aralez paid $175 million upfront and agreed to pay up to $48 million in milestone and sales-related payments, along with mid-teen percentage royalties on sales. AstraZeneca continued to manufacture and supply TOPROL-XL and its authorized generic to Aralez[3].

Aralez to Melinta Therapeutics

In April 2022, Melinta Therapeutics acquired the U.S. rights to TOPROL-XL and its Authorized Generic (AG) from New American Therapeutics, marking another significant shift in ownership. This acquisition was part of Melinta's strategy to expand and diversify its portfolio, aiming to accelerate long-term growth and enhance profitability[1].

Financial Performance

Revenue and Sales

In 2015, U.S. product sales for TOPROL-XL and the AstraZeneca share from the sale of the authorized generic medicine totaled $89 million[3].

Under Aralez, the revenue from TOPROL-XL was significant. For instance, in 2017, the net revenues from TOPROL-XL contributed substantially to Aralez's overall revenue, which would have been approximately $138 million if recorded using the 2018 accounting treatment[2].

Financial Impact on Companies

The acquisition by Aralez in 2016 was part of a broader strategy to strengthen its position in cardiovascular disease treatments. The deal included significant upfront and milestone payments, which were reflected in AstraZeneca's financial statements as Externalisation Revenue[3].

For Melinta Therapeutics, the acquisition of TOPROL-XL in 2022 was seen as a strategic move to expand its portfolio and enhance profitability. The integration of TOPROL-XL into Melinta's existing production, distribution, and commercialization structure was aimed at ensuring continuous availability of the medication without interruption[1].

Market Dynamics

Competitive Landscape

The antihypertensive drugs market is highly competitive, with various classes of drugs such as diuretics, ACE inhibitors, calcium channel blockers, and beta-blockers like TOPROL-XL. The market is driven by the increasing prevalence of hypertension and other cardiovascular diseases, as well as advancements in drug formulations and delivery systems[5].

Market Trends

The antihypertensive drugs market is expected to grow due to rising healthcare expenditures, an aging population, and increasing awareness about cardiovascular health. Fixed-dose combinations and innovative formulations are trending, offering better patient compliance and therapeutic outcomes[5].

Financial Trajectory

Revenue Projections

The financial performance of TOPROL-XL has been significant over the years. Despite changes in ownership, the drug has maintained a steady revenue stream. For instance, Aralez forecasted revenues between $140-$160 million in 2018, with adjusted EBITDA in the range of $35-$55 million[2].

Cost Structure

The cost structure associated with TOPROL-XL includes manufacturing, distribution, and commercialization costs. Aralez experienced increased costs related to the U.S. sales force, promotional activities, facility and infrastructure, and professional fees. However, these costs were managed within the context of overall revenue growth[2].

Key Takeaways

• Ownership Changes: TOPROL-XL has changed hands from AstraZeneca to Aralez Pharmaceuticals and then to Melinta Therapeutics, each transaction reflecting strategic moves to enhance market presence and profitability.
• Financial Performance: The drug has generated significant revenue, contributing substantially to the financial performance of its owners.
• Market Dynamics: The antihypertensive drugs market is competitive and growing, driven by increasing prevalence of cardiovascular diseases and advancements in drug formulations.
• Integration and Supply Chain: Ensuring continuous supply and distribution has been a key focus for each owner, highlighting the importance of a robust supply chain in maintaining market presence.

FAQs

What is TOPROL-XL used for?

TOPROL-XL is used for the treatment of hypertension, long-term treatment of angina pectoris, and the treatment of stable, symptomatic heart failure.

Who currently owns the U.S. rights to TOPROL-XL?

Melinta Therapeutics currently owns the U.S. rights to TOPROL-XL, having acquired them from New American Therapeutics in 2022.

How much did Aralez pay to acquire the rights to TOPROL-XL from AstraZeneca?

Aralez paid $175 million upfront and agreed to pay up to $48 million in milestone and sales-related payments, along with mid-teen percentage royalties on sales.

What was the revenue from TOPROL-XL in 2015?

In 2015, U.S. product sales for TOPROL-XL and the AstraZeneca share from the sale of the authorized generic medicine totaled $89 million.

How does the ownership change impact the supply of TOPROL-XL?

Each ownership change has included measures to ensure the continuous supply and distribution of TOPROL-XL, with the current owner, Melinta Therapeutics, integrating the drug into its existing production and distribution structure.

Sources

1. Melinta Therapeutics Acquires U.S. Rights to TOPROL-XL® (metoprolol succinate) from New American Therapeutics - Melinta Therapeutics.
2. Zacks Small-Cap Research - Zacks Investment Research.
3. AstraZeneca enters agreement with Aralez for beta-blocker medicine in the US - AstraZeneca.
4. AstraZeneca H1 and Q2 2024 results - AstraZeneca.
5. Antihypertensive Drugs Market and Forecast 2024-2031 - iHealthcareAnalyst.