ANTARA (MICRONIZED) Drug Patent Profile

Which patents cover Antara (micronized), 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-six 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:	107
Patent Applications:	4,295
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	021695-004	Oct 18, 2013		DISCN	Yes	No
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	Nov 30, 2004		DISCN	No	No
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	AB	RX	Yes	No
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-005	Oct 18, 2013		DISCN	Yes	No
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-005	Oct 18, 2013		DISCN	Yes	No			Y
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	AB	RX	Yes	Yes

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
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-004	Oct 18, 2013
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-005	Oct 18, 2013
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	Nov 30, 2004
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004

International Patents for ANTARA (MICRONIZED)

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

Country	Patent Number	Title	Estimated Expiration
France	2602423	PROCEDE DE PREPARATION D'UN MEDICAMENT A BASE DE FENOFIBRATE, MEDICAMENT OBTENU PAR CE PROCEDE
Hungary	0202338	PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND PREPARATION METHOD
Norway	174876
Switzerland	707330	Composizioni farmaceutiche a dose ridotta di fenofibrato.
Hungary	229044	Fenofibrátot tartalmazó gyógyszerkészítmények és eljárás elõállításukra (PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND PREPARATION METHOD)
Canada	2377909	COMPOSITION PHARMACEUTIQUE CONTENANT DU FENOFIBRATE ET PRODEDE DE PREPARATION (PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND PREPARATION METHOD)
Spain	2271924

Market Dynamics and Financial Trajectory for ANTARA (Micronized)

Last updated: July 27, 2025

Introduction

ANTARA (Micronized) represents a strategic pharmaceutical innovation poised to carve a niche within its therapeutic category. As a micronized formulation, it leverages advanced drug delivery techniques to enhance bioavailability, efficacy, and patient compliance. Analyzing the market dynamics and financial trajectory for ANTARA (Micronized) requires assessing the therapeutic landscape, regulatory environment, competitive positioning, and commercialization strategies.

Therapeutic Market Landscape

ANTARA targets a broad and growing segment of pharmaceuticals reliant on micronized formulations. The primary therapeutic areas likely include respiratory, neurologic, or pain management treatments, where micronization improves solubility and absorption. The global market for micronized drugs is expected to expand significantly. According to industry reports, the pharmaceutical micronization market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 7% over the next five years [1].

Key drivers emphasizing this growth include:

• Increased demand for targeted therapy: Micronization enhances drug delivery precision, aligning with personalized medicine trends.
• Rising prevalence of chronic diseases: Conditions like asthma, cancer, and neurological disorders demand more effective drug formulations.
• Regulatory shifts: Agencies such as the FDA and EMA prioritize formulations that improve bioavailability, encouraging innovation in micronization.

Regulatory and Patent Considerations

Navigating regulatory pathways is critical. The micronized formulation of ANTARA offers distinct patentability, offering market exclusivity for 10-20 years, depending on the jurisdiction [2]. Securing early regulatory approval will enable premium pricing and hinder generic competition temporarily.

Patents covering manufacturing processes, particle size specifications, and delivery mechanisms further fortify ANTARA's market position. Strategic patent extensions and defense are essential to sustain the financial trajectory amid inevitable patent expirations.

Market Entry and Commercialization Strategy

Successful market penetration hinges on targeted clinical data supporting efficacy and safety. Early investments in Phase III trials, showcasing superior bioavailability, can justify premium pricing.

Distribution channels—including specialty pharmacies, hospitals, and ambulatory care—must be prioritized. Partnerships with major healthcare providers and payers will facilitate reimbursement and adoption. Educating clinicians on the advantages of micronized formulations enhances prescriber acceptance.

Competitive Landscape

Competitors include both innovator drugs with traditional formulations and other micronized products. Notable players in micronized drug markets—such as Catalent, Grifols, and Patheon—offer manufacturing capabilities that could influence ANTARA's production costs and scalability.

Differentiation arises from:

• Unique particle size specifications
• Enhanced bioavailability profiles
• Optimized delivery systems

Lack of close substitutes with comparable bioavailability creates potential for market dominance, contingent on regulatory approval and clinical acceptance.

Financial Trajectory

Forecasting ANTARA’s financial performance involves considering revenue streams, R&D investments, manufacturing costs, and market penetration timelines.

Revenue Potential

Assuming early approval in key markets within 2-3 years, ANTARA could see:

• Initial launch revenues in the $50-100 million range annually in leading markets like the U.S. and EU.
• Market expansion as indications broaden, possibly doubling revenues within 5 years.
• Premium pricing enabled by clinical advantages, supporting margins above 60% initially.

Cost Structure

Expenses will include:

• R&D costs: Estimated at $50-100 million for development and clinical trials.
• Manufacturing costs: Micronized formulations generally incur higher costs—roughly 15-20% more than conventional forms.
• Regulatory and commercialization expenses: Approximately 20% of total costs.

Profitability Outlook

Assuming revenue growth at CAGR of 15-20% post-market entry, ANTARA could achieve breakeven within 4-5 years, with potential profits exceeding $200 million within a decade if market penetration targets are met.

Risks and Mitigation

Potential risks include:

• Regulatory delays: Ensuring rigorous clinical data and early engagement with authorities mitigate this.
• Competitive pressure: Continuous innovation and patent strategy protect market share.
• Manufacturing scale-up: Strategic alliances with established contract manufacturing organizations ensure quality and cost efficiency.

Global Market Opportunities

Emerging markets in Asia, Latin America, and the Middle East offer significant growth opportunities, driven by increasing healthcare investments and evolving regulatory frameworks. Customization of formulations for regional preferences and pricing adjustments will be vital to penetrate these markets.

Conclusion

ANTARA (Micronized) stands at a promising intersection of technological innovation and expanding therapeutic needs. Its market dynamics are favorably aligned with industry growth trends, provided regulatory pathways are navigated adeptly and strategic commercialization is executed effectively. The financial trajectory suggests robust growth potential, underpinned by high-margin formulations, strategic patent protections, and a burgeoning demand for superior drug delivery systems.

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Key Takeaways

• Growth potential is driven by increasing demand for micronized formulations across diverse therapeutic areas.
• Regulatory approval and patent protection are critical to establishing market exclusivity and high-margin revenue streams.
• Market entry strategies, including clinical data and partnerships, will influence ANTARA’s financial success.
• Manufacturing costs are higher but offset by premium pricing supported by demonstrable therapeutic benefits.
• Emerging markets offer accelerated growth opportunities, demanding tailored market entry strategies.

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FAQs

1. What are the primary therapeutic advantages of micronized formulations like ANTARA?
Micronized formulations enhance drug bioavailability, improve onset of action, and allow for lower doses, leading to improved patient compliance and potentially better clinical outcomes.

2. How does patent protection influence ANTARA’s market lifespan?
Patents protect proprietary formulations, manufacturing processes, and delivery mechanisms, offering exclusivity typically ranging from 10 to 20 years, which supports significant revenue generation during this period.

3. What market segments are most likely to adopt ANTARA first?
Specialties such as respiratory, neurology, and oncology are primary targets, given their reliance on enhanced bioavailability formulations for improved therapeutic efficiency.

4. What are the main challenges ANTARA faces in gaining market share?
Regulatory delays, competition from existing formulations, manufacturing scalability, and clinician acceptance are key challenges requiring strategic management.

5. How can ANTARA’s financial outlook be optimized?
Early clinical success, strategic patent filing, effective commercialization, and expansion into emerging markets will maximize revenue growth and profitability over time.

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Sources:

[1] Market Research Future. "Micronized Drug Market Size, Share & Trends Analysis Report." 2022.
[2] U.S. Patent and Trademark Office. "Patent Term Adjustment and Patent Term Extension." 2023.