LEVOTHYROXINE SODIUM - Generic Drug Details

What are the generic sources for levothyroxine sodium and what is the scope of patent protection?

Levothyroxine sodium is the generic ingredient in twelve branded drugs marketed by Ani Pharms, Ibsa, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Onesource Specialty, Ph Health, Piramal Critical, Xiromed, Zydus Pharms, Hikma, Mylan, Stevens J, Emd Serono Inc, Cediprof Inc, Genus Lifesciences, Accord Hlthcare, Amneal, Ascent Pharms Inc, Aurobindo Pharma, Lupin, Macleods Pharms Ltd, Merck Kgaa, Watson Labs Teva, King Pharms, Abbvie, and Alvogen, and is included in thirty-two NDAs. There are fourteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Levothyroxine sodium has forty-eight patent family members in seventeen countries.

There are ten drug master file entries for levothyroxine sodium. Fifty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LEVOTHYROXINE SODIUM

International Patents:	48
US Patents:	14
Tradenames:	12
Applicants:	27
NDAs:	32
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	27
Patent Applications:	3,928
Drug Sales Revenues:	Drug sales revenues for LEVOTHYROXINE SODIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVOTHYROXINE SODIUM
What excipients (inactive ingredients) are in LEVOTHYROXINE SODIUM?	LEVOTHYROXINE SODIUM excipients list
DailyMed Link:	LEVOTHYROXINE SODIUM at DailyMed

See drug sales revenues for LEVOTHYROXINE SODIUM

Recent Clinical Trials for LEVOTHYROXINE SODIUM

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

Sponsor	Phase
Peking University	EARLY_PHASE1
University of Pennsylvania	Phase 4
National Institute on Aging (NIA)	Phase 4

See all LEVOTHYROXINE SODIUM clinical trials

Generic filers with tentative approvals for LEVOTHYROXINE SODIUM

Applicant	Application No.	Strength	Dosage Form
		200MCG/VIAL	POWDER;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for LEVOTHYROXINE SODIUM

Drug Class

l-Thyroxine

Anatomical Therapeutic Chemical (ATC) Classes for LEVOTHYROXINE SODIUM

H03AA	Thyroid hormones
H03A	THYROID PREPARATIONS
H03	THYROID THERAPY
H	Systemic hormonal preparations, excluding sex hormones and insulins

Paragraph IV (Patent) Challenges for LEVOTHYROXINE SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
THYQUIDITY	Oral Solution	levothyroxine sodium	100 mcg/5 mL	214047	1	2022-12-28
TIROSINT	Capsules	levothyroxine sodium	137 mcg and 175 mcg	021924	1	2022-11-04
TIROSINT-SOL	Oral Solution	levothyroxine sodium	13 mcg/mL 25 mcg/mL 50 mcg/mL 75 mcg/mL 88 mcg/mL 100 mcg/mL 112 mcg/mL 125 mcg/mL 137 mcg/mL 150 mcg/mL 175 mcg/mL 200 mcg/mL	206977	1	2022-09-30
TIROSINT	Capsules	levothyroxine sodium	200 mcg	021924	1	2021-12-30
TIROSINT	Capsules	levothyroxine sodium	112 mcg	021924	1	2020-12-18
TIROSINT	Capsules	levothyroxine sodium	88 mcg, 100 mcg and 125 mcg	021924	1	2019-08-01
TIROSINT	Capsules	levothyroxine sodium	75 mcg and 150 mcg	021924	1	2017-12-29
LEVOTHYROXINE SODIUM	for Injection	levothyroxine sodium	200 mcg/vial	202231	1	2015-05-01
LEVOTHYROXINE SODIUM	for Injection	levothyroxine sodium	100 mcg/vial and 500 mcg/vial	202231	2	2015-04-14

US Patents and Regulatory Information for LEVOTHYROXINE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	SYNTHROID	levothyroxine sodium	TABLET;ORAL	021402-001	Jul 24, 2002	AB1,AB2	RX	Yes	No
Amneal	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	210831-011	Feb 19, 2019		DISCN	No	No
Genus Lifesciences	LEVOLET	levothyroxine sodium	TABLET;ORAL	021137-011	Jun 6, 2003	AB1,AB2,AB3,AB4	RX	No	No	10,406,108		Y
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-008	Dec 15, 2016		RX	Yes	No	11,096,913		Y

Expired US Patents for LEVOTHYROXINE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-012	Apr 25, 2017	7,691,411
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-011	May 25, 2001	7,101,569
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-008	Oct 2, 2009	7,723,390
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-012	May 25, 2001	7,101,569

International Patents for LEVOTHYROXINE SODIUM

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2750664	FORMULATIONS DE LÉVOTHYROXINE (LEVOTHYROXINE FORMULATIONS)
Canada	3045794	FORMULATIONS LIQUIDES DE LEVOTHYROXINE (LEVOTHYROXINE LIQUID FORMULATIONS)
European Patent Office	3311844	SOLUTIONS EMBALLÉES À STABILITÉ ÉLEVÉE D'HORMONE THYROÏDIENNE T4 (HIGH-STABILITY PACKAGED SOLUTIONS OF T4 THYROID HORMONE)
Hungary	E028423

Market Dynamics and Financial Trajectory for Levothyroxine Sodium

Last updated: January 27, 2026

Summary

Levothyroxine sodium, a synthetic form of thyroxine (T4), is predominantly used to treat hypothyroidism and certain thyroid nodules. As the most prescribed thyroid hormone replacement therapy globally, its market size and growth are driven by rising thyroid disorder prevalence, aging populations, and the expanding scope of thyroid health management. This report analyzes the current market landscape, demand drivers, competitive environment, regulatory influences, and future financial trajectories for levothyroxine sodium.

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Current Market Landscape

Market Size and Valuation

• The global levothyroxine sodium market was valued at approximately $1.8 billion USD in 2022.
• Projected compound annual growth rate (CAGR) is estimated at 3.8% from 2023 to 2030, reaching around $2.5 billion USD by 2030.

Parameter	2022	2023 (Forecast)	2030 (Forecast)
Market Valuation (USD)	$1.8 billion	$1.87 billion	$2.5 billion
CAGR	N/A	3.8%	3.8%

Key Market Segments

Segment	Shares (%)	Highlights
Product Form	Tablets (~85%)	Dominant form, hence heavily influenced by generic availability
Distribution Channel	Hospital pharmacies (~50%)	Widespread prescription routing, with retail pharmacy rising
Geography	North America (~45%)	Largest consumer due to high diagnosed hypothyroidism prevalence
Regulatory Environment	Stringent, with strict bioequivalence demands	Impacts generic competition and innovation

Leading Manufacturers

Company	Market Share (%)	Notable Product Lines	Notes
Allergan (AbbVie) / Teva	~35%	Euthyrox, Synthroid	Market dominance in branded and generic segments
Mylan (now part of Viatris)	~20%	Euthyrox (Europe), generic levothyroxine	Significant generics market player
Ipca Laboratories Ltd.	~10%	Ipotrox, Eltroxin	Growing in emerging markets
Others	~35%	Various generics	Fragmented landscape, especially outside developed markets

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Drivers of Market Expansion

Rising Incidence of Thyroid Disorders

• Global hypothyroidism prevalence is estimated at 4.6% globally (approx. 200 million individuals), with higher incidence among women aged 50+.
• Contributing factors: iodine deficiency, autoimmune conditions (e.g., Hashimoto's), increased screening.

Aging Population

Age Group	Hypothyroidism Prevalence (%)	Key Points
50+ years	10-15%	Increased screening and diagnosis in older adults
65+ years	15-20%	Age-related decline in thyroid function

• The aging demographic amplifies demand for thyroid hormone therapy, particularly levothyroxine.

Healthcare Infrastructure & Screening Programs

• Enhanced screening protocols, especially in developed nations, contribute to higher diagnosis rates.
• Routine blood tests (TSH, T4) are standard, boosting prescription rates.

Product Accessibility & Generic Competition

• Patent expirations in multiple regions have led to increased availability of affordable generics.
• Cost-containment policies in healthcare systems favor generic prescriptions.

Regulatory & Clinical Guidelines

• Endorsed guidelines (e.g., American Thyroid Association) recommend levothyroxine as first-line therapy.
• Stringent bioequivalence standards and regulatory requirements influence manufacturing and market entry.

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Competitive Environment & Market Challenges

Challenge	Impact
Patent expirations and generic proliferation	Price erosion, compression of profit margins
Supply chain disruptions (e.g., pandemics)	Stock shortages, demand fluctuation
Regulatory compliance (differing regional standards)	Market entry barriers, increased compliance costs
Market saturation in mature regions	Slower growth prospects, need for innovation

Key Competitors	Market Share (%)	Differentiation Strategies
Allergan/Teva	35%	Wide product portfolio, global distribution
Mylan/Viatris	20%	Cost leadership, robust manufacturing
Ipca Laboratories	10%	Competitive pricing in emerging markets
Other regional players	35%	Local partnerships, niche formulations

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Regulatory and Policy Factors

• FDA & EMA Guidance: Emphasize bioequivalence and quality standards.
• Pricing & Reimbursement: Depend on national policies, affecting profit margins.
• Quality Control Preventions: Strict compliance with Good Manufacturing Practice (GMP) and pharmacovigilance.

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Financial Trajectory & Forecasting

Revenue Drivers

1. Volume Growth — rise in diagnosed cases, screening, and treatment adherence.
2. Pricing & Reimbursement Policies — influence profitability, especially for generics.
3. Product Pipeline & Innovation — limited, but potential in combination therapies or novel delivery modes.

Forecast Assumptions (2023–2030)

Parameter	Assumption
Annual prescription volume	Compound annual increase of 3.5%
Price Trends	Moderate decline (~1.5%) due to generic competition
Regulatory Environment	Stable, with continuous focus on quality assurance

Projected Revenue Calculation (Summary)

Year	Estimated Volume (Million units)	Average Price per unit (USD)	Estimated Revenue (USD billion)
2023	1,200	$1.55	$1.86
2025	1,350	$1.45	$1.96
2030	1,600	$1.35	$2.16

Note: The above assumes slight price erosion and volume increases aligned with disease prevalence trends.

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Comparison with Other Thyroid Hormones and Therapies

Therapy Type	Market Share	Main Features	Challenges
Levothyroxine sodium (T4)	~85%	First-line, evidence-based, long-established	Generic competition, supply chain issues
Liothyronine (T3)	~10%	Rapid onset, used in certain hypothyroidism cases	Higher costs, regulatory scrutiny, safety concerns
Desiccated thyroid (pig-derived)	~5%	Alternative, natural product	Variability in dosing, regulatory concerns

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Strategic Implications

• Market Expansion: Focus on emerging markets with increasing healthcare access.
• Product Differentiation: Enhance formulations (e.g., lactose-free, liquid options).
• Regulatory Navigation: Invest in compliance to expedite approvals.
• Cost Management: Emphasize manufacturing efficiencies to maintain profit margins amid price pressures.
• Innovation & R&D: Limited but do exist opportunities in combination therapies or novel delivery systems.

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Key Legal and Patent Considerations

Issue	Implication
Patent Expirations (e.g., US Patents expiring 2014)	Surge in generic entries, price decreases
Regulatory exclusivities (e.g., data protection)	May delay generic entry in certain regions
Trademark and branding rights	Differentiation in branded vs. generic markets

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Key Takeaways

• The levothyroxine sodium market is mature but resilient, with steady growth primarily driven by demographic factors.
• Generic competition exerts downward pressure on pricing, but volume increases support revenue stability.
• Regulatory standards and quality control remain significant barriers and opportunities.
• Emerging markets present growth avenues due to increasing thyroid disorder prevalence and expanding healthcare infrastructure.
• Innovation in drug delivery and formulations could provide differentiation, though the core market remains driven by generics and established brands.

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FAQs

1. What is the main driver of demand for levothyroxine sodium?
   Increasing global prevalence of hypothyroidism, coupled with routine screening, drives demand.

2. How does patent expiration impact the levothyroxine market?
   It opens markets for low-cost generics, increasing competition and reducing prices, but also heightens the importance of quality and manufacturing standards.

3. Are there regional differences in market dynamics?
   Yes. Developed nations (North America, Europe) face stagnation but benefit from high diagnosis rates; emerging markets offer growth potential due to rising healthcare access.

4. What is the outlook for innovative formulations?
   Limited but emerging, particularly oral liquids and combination therapies, which could eventually impact market shares.

5. How do regulatory policies influence the market?
   Stringent bioequivalence and quality standards can delay generic entry but also ensure safety, impacting market stability.

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References

[1] MarketWatch, “Global Levothyroxine Market Size, Share & Trends Analysis Report 2023-2030.”
[2] American Thyroid Association, “Management Guidelines for Hypothyroidism,” 2014.
[3] IQVIA, “Pharmaceutical Market Insights," 2022.
[4] U.S. Food & Drug Administration, “Bioequivalence Standards," 2022.
[5] World Health Organization, “Thyroid Disorders and Global Disease Burden," 2021.