ANTARA (MICRONIZED) Drug Patent Profile

When do Antara (micronized) patents expire, and when can generic versions of Antara (micronized) launch?

Antara (micronized) is a drug marketed by Lupin and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has two patent family members in two countries.

The generic ingredient in ANTARA (MICRONIZED) is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Antara (micronized)

A generic version of ANTARA (MICRONIZED) was approved as fenofibrate by RHODES PHARMS on May 13^th, 2005.

Summary for ANTARA (MICRONIZED)

International Patents:	2
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	138
Patent Applications:	5,091
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ANTARA (MICRONIZED)
DailyMed Link:	ANTARA (MICRONIZED) at DailyMed

Pharmacology for ANTARA (MICRONIZED)

Drug Class

Peroxisome Proliferator Receptor alpha Agonist

Paragraph IV (Patent) Challenges for ANTARA (MICRONIZED)

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ANTARA (MICRONIZED)	Capsules	fenofibrate	43 mg and 130 mg	021695	1	2008-09-15

US Patents and Regulatory Information for ANTARA (MICRONIZED)

ANTARA (MICRONIZED) is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	AB	RX	Yes	No
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	Nov 30, 2004		DISCN	No	No
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	AB	RX	Yes	Yes
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-004	Oct 18, 2013		DISCN	Yes	No	8,026,281
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-005	Oct 18, 2013		DISCN	Yes	No	8,026,281
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-005	Oct 18, 2013		DISCN	Yes	No	9,314,447		Y

Expired US Patents for ANTARA (MICRONIZED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	Nov 30, 2004	7,863,331
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	4,800,079
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	7,101,574
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-004	Oct 18, 2013	8,026,281
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-005	Oct 18, 2013	8,026,281
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	Nov 30, 2004	4,800,079
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	7,863,331

International Patents for ANTARA (MICRONIZED)

See the table below for patents covering ANTARA (MICRONIZED) around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2004277757	Pharmaceutical composition containing fenofibrate and method for the preparation thereof
Bulgaria	65504
Croatia	P20020111	PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND PREPARATION METHOD
Mexico	PA02000324	COMPOSICION FARMACEUTICA QUE CONTIENE FENOFIBRATO Y UN METODO PARA LA PREPARACION DE LA MISMA. (PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND PREPARATION METHOD.)
Poland	1667666
Slovenia	1667666
South Africa	200200169	Pharmaceutical composition containing fenofibrate and method for the preparation thereof.

Market Dynamics and Financial Trajectory for ANTARA (Micronized)

Introduction

ANTARA, a micronized form of fenofibrate, is a lipid-regulating agent used to manage elevated cholesterol and triglyceride levels. Understanding its market dynamics and financial trajectory involves examining its indications, market competition, pricing, and the broader pharmaceutical industry trends.

Indications and Usage

ANTARA is indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, triglycerides, and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. It is also used to reduce triglyceride levels in patients with severe hypertriglyceridemia[2][5].

Market Competition

The market for lipid-regulating agents is highly competitive, with several other fibrate drugs and statins available. ANTARA competes with other fenofibrate formulations such as TRICOR and TRIGLIDE, as well as other classes of lipid-lowering drugs. The competition is driven by the need for effective and safe treatments for hyperlipidemia, a common condition associated with cardiovascular disease[2][4].

Pricing and Market Status

ANTARA is available in capsule form with strengths of 43 mg and 130 mg. The pricing of ANTARA can vary based on the region, insurance coverage, and pharmacy. Generally, prescription drugs like ANTARA are priced competitively to ensure market share, but they also need to reflect the costs associated with research, development, and marketing.

Pharmaceutical Industry Trends

The pharmaceutical industry has seen significant changes in recent years, including shorter periods of marketing exclusivity for new drugs. This trend has increased competition, as follow-on drugs can enter the market more quickly. For example, the period of marketing exclusivity for breakthrough drugs has fallen dramatically from a median of 10.2 years in the 1970s to 1.2 years in the late 1990s[3].

Financial Trajectory

Research and Development Costs

The development of ANTARA, like other pharmaceuticals, involves substantial research and development costs. These costs include clinical trials, regulatory approvals, and manufacturing setup. The financial trajectory of ANTARA is influenced by these initial investments, which are typically recouped through sales once the drug is approved and marketed.

Sales Performance

The sales performance of ANTARA is influenced by its efficacy, safety profile, and market acceptance. Fenofibrate, the active ingredient in ANTARA, has been shown to be effective in reducing triglycerides and improving lipid profiles. However, its impact on coronary heart disease morbidity and mortality has not been established, which could affect long-term sales[2][5].

Pricing Strategies

Pricing strategies for ANTARA are crucial in maintaining market share. The drug is priced to balance profitability with affordability and competitiveness. Given the presence of generic and branded competitors, the pricing of ANTARA must be strategic to attract and retain patients.

Regulatory Environment

Approvals and Indications

ANTARA was initially approved in 1993, and its indications have been expanded over time. Regulatory approvals and updates play a significant role in the financial trajectory of the drug. Changes in regulatory guidelines or new clinical data can impact the drug's market position[1][2].

Safety and Efficacy Monitoring

The regulatory environment also includes ongoing monitoring of the drug's safety and efficacy. ANTARA is associated with potential side effects such as hepatotoxicity, myopathy, and rhabdomyolysis, particularly when used with other medications like statins. Regular monitoring and reporting of these adverse effects are essential to maintain regulatory approval and patient trust[5].

Market Impact of Adverse Effects

The occurrence of serious adverse effects, such as liver injury and muscle toxicity, can significantly impact the financial trajectory of ANTARA. These events can lead to increased monitoring costs, potential lawsuits, and a decrease in patient confidence, all of which can affect sales and profitability[5].

Patient and Physician Preferences

Patient and physician preferences also play a crucial role in the market dynamics of ANTARA. The drug's ease of use (it can be taken without regard to meals), its efficacy in reducing triglycerides, and its safety profile relative to other options influence its adoption and retention rates[1][2].

Economic Considerations

Cost-Benefit Analysis

From an economic perspective, the use of ANTARA must be justified through a cost-benefit analysis. This involves comparing the costs of the drug with the benefits of reduced cardiovascular events and improved patient outcomes. Studies have shown that while fenofibrate does not significantly reduce coronary heart disease morbidity and mortality, it does provide other lipid-lowering benefits that can be economically justifiable[1][2].

Insurance Coverage

Insurance coverage is another critical factor in the financial trajectory of ANTARA. The extent to which insurance plans cover the drug can significantly impact its sales. In regions with comprehensive coverage, ANTARA is more likely to be prescribed and used, contributing to higher sales figures.

Conclusion

The market dynamics and financial trajectory of ANTARA (micronized) are influenced by a complex interplay of factors including its indications, market competition, pricing strategies, regulatory environment, and economic considerations. While ANTARA has established itself as an effective lipid-regulating agent, its long-term financial success will depend on ongoing safety and efficacy monitoring, strategic pricing, and favorable regulatory and insurance environments.

Key Takeaways

• Indications and Usage: ANTARA is used to manage hyperlipidemia and reduce triglyceride levels.
• Market Competition: ANTARA competes with other fenofibrate formulations and lipid-lowering drugs.
• Pricing and Market Status: Pricing is competitive, and the drug is available in prescription form.
• Pharmaceutical Industry Trends: Shorter marketing exclusivity periods increase competition.
• Financial Trajectory: Influenced by R&D costs, sales performance, pricing strategies, and regulatory environment.
• Regulatory Environment: Ongoing safety and efficacy monitoring is crucial.
• Market Impact of Adverse Effects: Serious side effects can affect sales and profitability.
• Patient and Physician Preferences: Ease of use and safety profile influence adoption rates.
• Economic Considerations: Cost-benefit analysis and insurance coverage are critical.

FAQs

What are the primary indications for ANTARA?

ANTARA is indicated to reduce elevated LDL-C, Total-C, triglycerides, and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia, and to reduce triglyceride levels in patients with severe hypertriglyceridemia[2][5].

How does ANTARA compare to other lipid-lowering drugs?

ANTARA competes with other fenofibrate formulations like TRICOR and TRIGLIDE, as well as other classes of lipid-lowering agents. Its efficacy and safety profile are key differentiators[2][4].

What are the potential side effects of ANTARA?

ANTARA can cause serious side effects such as hepatotoxicity, myopathy, and rhabdomyolysis, particularly when used with other medications like statins[5].

How does the regulatory environment impact ANTARA?

The regulatory environment, including ongoing safety and efficacy monitoring, plays a crucial role in maintaining ANTARA's market position and ensuring patient safety[5].

What economic factors influence the use of ANTARA?

The economic viability of ANTARA is influenced by cost-benefit analysis, insurance coverage, and the overall healthcare budget of patients and healthcare systems[1][2].

Can ANTARA be used in patients with renal or hepatic impairment?

ANTARA is contraindicated in patients with severe renal dysfunction and active liver disease. Dose adjustments are necessary for patients with mild to moderate renal impairment[1][2].

How does ANTARA affect cardiovascular outcomes?

The effect of ANTARA on coronary heart disease morbidity and mortality has not been established, although it does provide other lipid-lowering benefits[1][2].

Sources

1. Antara Label - accessdata.fda.gov
2. Antara® (fenofibrate) Capsules - DailyMed
3. The economics of follow-on drug research and development - PubMed
4. Antara (micronized) - PharmaCompass
5. Label: ANTARA- fenofibrate capsule - DailyMed