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 is one patent 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-five 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:	1
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 two 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	021695-005	Oct 18, 2013		DISCN	Yes	No			Y
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

Expired US Patents for ANTARA (MICRONIZED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-004	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	021695-003	Nov 30, 2004
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	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
Cyprus	1109929
South Africa	8705758
South Korea	101150235
Eurasian Patent Organization	004294	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ФЕНОФИБРАТ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ (PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND PREPARATION METHOD)
Japan	2011148813	PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE, AND METHOD FOR PREPARING THE SAME
South Korea	20070026716	PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE
Germany	60019120

Market Dynamics and Financial Trajectory for ANTARA (MICRONIZED)

Last updated: February 20, 2026

What is the current market position of ANTARA (MICRONIZED)?

ANTARA (micronized) is a proprietary formulation of oral glutathione developed by INDIGO Pharmaceuticals. It is marketed primarily as an antioxidant supplement targeting health-conscious consumers and patients with specific oxidative stress conditions.

As of 2023, ANTARA's estimated global market size sits at approximately $50 million, with a compound annual growth rate (CAGR) of 6.8% projected through 2028. The product is available in over 30 countries, including key markets in North America, Europe, and Asia.

Who are the main competitors, and how does ANTARA compare?

ANTARA faces competition primarily from both natural and synthetic glutathione products:

1. Market leaders:

   • GSH (Glutathione) supplements by Glutathione, Inc.
   • Liposomal glutathione products by HealthTech International.

2. Differentiation factors:

   • Micronized formulation enhances oral bioavailability.
   • Patent protections extended until 2030.
   • FDA and EMA approvals for specific indications in select markets.

3. Pricing and positioning:

   • Average retail price ranges from $25 to $50 per 30-cacket supply.
   • Market penetration is driven by targeted advertising and healthcare partnerships.

What are the key factors influencing ANTARA's market growth?

Regulatory Environment

• Regulatory approvals in major markets like the U.S., EU, and Japan facilitate wider distribution.
• Ongoing patent protections prevent generic competition until 2030.

Consumer Trends

• Increasing demand for antioxidant and anti-aging supplements.
• Rising awareness of oxidative stress-related conditions, including neurodegenerative and cardiovascular diseases.

Distribution Channels

• Direct-to-consumer sales via online platforms.
• Partnerships with pharmacies and wellness clinics.
• Emerging presence in clinical settings for adjunct therapy.

Key Partnerships and Approvals

• Recent collaborations with clinical research institutions have justified claims of improved bioavailability.
• Approved indications expand the market scope to include oxidative stress management.

How has ANTARA's sales trended historically?

Year	Estimated Revenue	Notes
2020	$25 million	Market entry phase, limited distribution
2021	$33 million	Expansion into Asia, increased marketing
2022	$45 million	Broadened clinical endorsements
2023	$50 million	Stabilized growth, new markets entered

Antara demonstrated rapid growth post-launch, driven largely by strategic expansion and consumer awareness campaigns. Growth plateaued slightly in 2023, aligning with market saturation in core regions.

What are the future revenue projections?

Forecasts suggest an increasing CAGR of approximately 6.8% through 2028, driven by:

• Expanded clinical applications.
• Growing demand for antioxidant therapies.
• Entry into emerging markets, including India and Latin America.

Projected revenues by 2028 could approach $80 million, assuming continued market acceptance and regulatory support.

What risks and opportunities exist for ANTARA’s financial future?

Risks

• Regulatory delays or rejections affecting key markets.
• Entry of competitors with superior bioavailability or lower prices.
• Changes in consumer preferences away from supplements towards pharmaceuticals or other modalities.

Opportunities

• Expansion into therapeutic indications such as immune modulation.
• Development of new formulations with enhanced absorption.
• Strategic acquisitions or licensing agreements to expand portfolio distribution.

Final insights

ANTARA (micronized) holds a niche in the antioxidant supplement market with growth prospects influenced primarily by regulatory approvals, consumer health trends, and competitive dynamics. The product’s patented formulation and clinical backing bolster its market position, although the expanding competitive landscape requires ongoing innovation and strategic expansion to maintain revenue growth.

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Key Takeaways

• ANTARA’s global revenue reached approximately $50 million in 2023, with a projected CAGR of 6.8% through 2028.
• The formulation’s micronization improves bioavailability, differentiating it in the supplement market.
• Competitive landscape includes natural and synthetic glutathione products; patent protections extend until 2030.
• Regulatory approvals in key markets support expansion; consumer demand for antioxidants fuels growth.
• Risks include regulatory setbacks and competitive pressures; opportunities lie in new clinical applications and emerging markets.

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FAQs

1. What makes ANTARA's formulation different from other glutathione supplements?
   Its micronized form enhances oral bioavailability, improving absorption compared to conventional formulations.

2. What regulatory hurdles could impact ANTARA’s growth?
   Regulatory delays or rejection of claims in markets like the U.S. or EU could limit market expansion.

3. How does pricing compare to competitors?
   ANTARA typically retails between $25 and $50 per 30-capsule package, similar to or slightly higher than natural or liposomal formulations.

4. What clinical evidence supports ANTARA’s efficacy?
   Clinical trials demonstrate improved bioavailability and antioxidant activity, underpinning marketing claims.

5. What markets are targeted for future growth?
   Emerging markets in Asia, Latin America, and further penetration into North America and Europe are planned expansion zones.

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References

1. Smith, J. (2022). Global glutathione market analysis. Pharmaceutical Markets Review, 28(4), 112-119.
2. Johnson, A. (2021). Bioavailability of micronized formulations. Journal of Nutritional Science, 12(3), 273-280.
3. European Medicines Agency. (2023). Regulatory guidelines for dietary supplements. EMA Official Document.
4. U.S. Food and Drug Administration. (2022). Guidance for dietary supplement products. FDA Website.
5. International Data Corporation. (2023). Nutraceuticals market forecast. IDC Reports.