LEVOTHYROXINE SODIUM Drug Patent Profile

Which patents cover Levothyroxine Sodium, and when can generic versions of Levothyroxine Sodium launch?

Levothyroxine Sodium is a drug marketed by Teva Pharms Usa Inc, Dr Reddys, Endo Operations, Fresenius Kabi Usa, Maia Pharms Inc, Piramal Critical, Steriscience, Xiromed, Zydus Pharms, Hikma, Accord Hlthcare, Amneal, Ascent Pharms Inc, Aurobindo Pharma, Lupin, Macleods Pharms Ltd, Merck Kgaa, Mylan, and Watson Labs Teva. and is included in twenty-one NDAs. There are seven patents protecting this drug and two Paragraph IV challenges.

This drug has five patent family members in three countries.

The generic ingredient in LEVOTHYROXINE SODIUM is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Levothyroxine Sodium

A generic version of LEVOTHYROXINE SODIUM was approved as levothyroxine sodium by MYLAN on June 5^th, 2002.

Summary for LEVOTHYROXINE SODIUM

International Patents:	5
US Patents:	7
Applicants:	19
NDAs:	21
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	190
Clinical Trials:	25
Patent Applications:	4,198
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
University of Pennsylvania	Phase 4
National Institute on Aging (NIA)	Phase 4
Xeris Pharmaceuticals	Phase 2

See all LEVOTHYROXINE SODIUM clinical trials

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

LEVOTHYROXINE SODIUM is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ascent Pharms Inc	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	215259-006	Jan 18, 2023	AB4	RX	No	No
Macleods Pharms Ltd	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	211417-006	Dec 21, 2022	AB1,AB2,AB3,AB4	RX	No	No
Fresenius Kabi Usa	LEVOTHYROXINE SODIUM	levothyroxine sodium	SOLUTION;INTRAVENOUS	210632-003	Apr 11, 2019		RX	Yes	Yes	10,398,669		Y
Zydus Pharms	LEVOTHYROXINE SODIUM	levothyroxine sodium	POWDER;INTRAVENOUS	217066-003	Mar 24, 2023	AP	RX	No	No
Lupin	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	209713-003	Jan 18, 2019	AB1,AB2,AB3	RX	No	No

International Patents for LEVOTHYROXINE SODIUM

See the table below for patents covering LEVOTHYROXINE SODIUM around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	3045794	FORMULATIONS LIQUIDES DE LEVOTHYROXINE (LEVOTHYROXINE LIQUID FORMULATIONS)
European Patent Office	2750664	FORMULATIONS DE LÉVOTHYROXINE (LEVOTHYROXINE FORMULATIONS)
World Intellectual Property Organization (WIPO)	2013033194
World Intellectual Property Organization (WIPO)	2017013591
World Intellectual Property Organization (WIPO)	2018102145

Market Dynamics and Financial Trajectory for Levothyroxine Sodium

Introduction to Levothyroxine Sodium

Levothyroxine sodium is a synthetic form of the thyroid hormone thyroxine (T4), widely used for the treatment of hypothyroidism, a condition characterized by an underactive thyroid gland. The market for levothyroxine sodium is driven by several key factors, including the increasing prevalence of thyroid disorders, advancements in healthcare infrastructure, and the growing demand for thyroid hormone replacement therapies.

Market Size and Growth

The global levothyroxine sodium market has been experiencing steady growth. In 2023, the market size was valued at approximately $3.73 billion and is expected to reach $3.90 billion in 2024, with a compound annual growth rate (CAGR) of 4.4%[3].

By 2030, the market is projected to grow further, reaching $4.65 billion at a CAGR of 4.5%[3]. In the longer term, the market is anticipated to touch $4.02 billion by 2032, exhibiting a CAGR of 3.1%[4].

Segmentation of the Market

The levothyroxine sodium market is segmented based on several criteria:

By Type

• The market is segmented into oral and injection forms. Oral formulations are the most common, while injection forms are used in specific clinical scenarios[4].

By Application

• The market is classified into hospitals, pharmacies, and other healthcare settings. The demand from hospitals and pharmacies is particularly high due to the widespread use of levothyroxine sodium in these settings[4].

By Region

• Geographically, the market is dominated by North America, which was the largest region in 2023. However, the Asia-Pacific region is expected to be the fastest-growing region in the forecast period[3].

Driving Factors

Several factors are driving the growth of the levothyroxine sodium market:

Increasing Prevalence of Thyroid Disorders

• The rising incidence of hypothyroidism and other thyroid disorders is a significant driver. According to the American Cancer Society, approximately 44,020 new cases of thyroid cancer are predicted in the US by 2024, highlighting the growing need for thyroid hormone replacement treatments[3].

Advancements in Diagnostic Tools and Healthcare Infrastructure

• Improvements in diagnostic tools and healthcare infrastructure have led to earlier detection of thyroid problems, increasing the demand for levothyroxine sodium[1].

Demographic Changes

• The aging population is a key demographic factor. Thyroid conditions, particularly hypothyroidism, are more common among the elderly, driving the demand for levothyroxine sodium formulations in developed nations[1].

Regulatory Approvals and Generic Formulations

• The availability of generic levothyroxine formulations has increased competition and access to thyroid drugs. Regulatory approvals for these generic variants support market growth[1].

Lifestyle Factors

• Changing lifestyles, including increased stress and sedentary habits, contribute to the risk of hypothyroidism, further driving the demand for levothyroxine sodium[1].

Market Trends

Several trends are expected to shape the levothyroxine sodium market in the forecast period:

Sustainable Healthcare Practices

• There is an increasing focus on sustainable healthcare practices, which may impact the production, distribution, and disposal of levothyroxine sodium products[3].

Advancements in Research and Development

• Continued investment in research and development is expected to lead to innovations in laboratory formulations and new product introductions[3].

Telemedicine and E-Pharmacy Services

• The growing adoption of telemedicine and e-pharmacy services is likely to enhance access to levothyroxine sodium, particularly in regions with limited healthcare infrastructure[3].

Competitive Landscape

The levothyroxine sodium market is competitive, with several key players:

• Novartis
• Abbvie
• Mylan Pharma
• Merck
• Pfizer
• Lannett Company
• Fresenius Kabi
• IBSA
• Piramal Critical Care
• Abbott
• Azico Biophore India
• Excella GmbH & Co.
• Peptido GmbH
• China Associate Pharma[1][4].

These companies are focusing on improving API purity and consistency, expanding production capacities, and introducing new formulations to meet the growing demand.

Financial Trajectory

The financial trajectory of the levothyroxine sodium market is positive, driven by the factors mentioned above. Here are some key financial metrics:

• Market Size in 2023: $3.73 billion[3]
• Forecasted Market Size in 2024: $3.90 billion[3]
• Forecasted Market Size in 2030: $4.65 billion[3]
• Forecasted Market Size in 2032: $4.02 billion[4]
• CAGR (2024-2030): 4.5%[1][3]
• CAGR (2023-2032): 3.1%[4]

Regional Performance

• North America: Currently the largest region in the levothyroxine sodium market[3].
• Asia-Pacific: Expected to be the fastest-growing region in the forecast period[3].

Impact of External Factors

The market is also influenced by external factors such as:

COVID-19 Pandemic

• The pandemic has had a continued but declining impact on supply chains and consumption patterns[3].

Economic Factors

• Higher inflation and resulting interest rate spikes in many countries have affected macro-economic parameters and, consequently, the market[3].

Geopolitical Events

• The Russian-Ukraine war has impacted supply chains and consumption patterns, particularly in the Eastern European region[3].

Key Takeaways

• The levothyroxine sodium market is growing steadily due to the increasing prevalence of thyroid disorders and advancements in healthcare infrastructure.
• The market is driven by demographic changes, regulatory approvals, and the introduction of generic formulations.
• Key players are focusing on improving API purity and expanding production capacities.
• The market is expected to reach $4.65 billion by 2030 and $4.02 billion by 2032.
• North America is the largest region, while the Asia-Pacific region is expected to be the fastest-growing.

Frequently Asked Questions

Q: What is the expected market size of levothyroxine sodium by 2032? A: The global levothyroxine sodium market is projected to touch $4.02 billion by 2032[4].

Q: What is the CAGR of the levothyroxine sodium market from 2023 to 2032? A: The levothyroxine sodium market is expected to exhibit a CAGR of 3.1% from 2023 to 2032[4].

Q: Which regions are expected to dominate the levothyroxine sodium market? A: North America is currently the largest region, while the Asia-Pacific region is expected to be the fastest-growing in the forecast period[3].

Q: What are the main types of levothyroxine sodium formulations? A: The market is segmented into oral and injection forms[4].

Q: Who are the key players in the levothyroxine sodium market? A: Key players include Novartis, Abbvie, Mylan Pharma, Merck, Pfizer, and others[1][4].

Sources

1. Global Levothyroxine Sodium API Market Research Report 2024 - Valuates Reports
2. Levothyroxine Sodium Global Market Report 2024 - Research and Markets
3. Levothyroxine Sodium Global Market Report 2024 - GII Research
4. Levothyroxine Sodium Market Size, Share & Forecast, 2032 - Business Research Insights
5. Levothyroxine Sodium Sales Market Size, Scope And Forecast Report - Market Research Intellect

Last updated: 2024-12-16