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 Teva Pharms Usa Inc, Ibsa, Dr Reddys, Endo Operations, Fresenius Kabi Usa, Maia Pharms Inc, Piramal Critical, Zydus Pharms, Hikma, Mylan, Azurity, Provell, Cediprof Inc, Genus Lifesciences, Accord Hlthcare, Amneal, Ascent Pharms Inc, Aurobindo Pharma, Lupin, Macleods Pharms Ltd, Merck Kgaa, Watson Labs Teva, King Pharms, Abbvie, Alvogen, and Stevens J, and is included in thirty NDAs. There are sixteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Levothyroxine sodium has sixty-four patent family members in twenty 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:	64
US Patents:	16
Tradenames:	12
Applicants:	26
NDAs:	30
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	190
Clinical Trials:	25
Patent Applications:	6,580
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

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
Aurobindo Pharma	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	216414-003	Jul 16, 2024	AB2	RX	No	No
Abbvie	SYNTHROID	levothyroxine sodium	TABLET;ORAL	021402-012	Jul 24, 2002	AB1,AB2	RX	Yes	No
Genus Lifesciences	LEVOLET	levothyroxine sodium	TABLET;ORAL	021137-012	Jun 6, 2003	AB1,AB2,AB3,AB4	RX	No	No			Y
Stevens J	UNITHROID	levothyroxine sodium	TABLET;ORAL	021210-007	Aug 21, 2000	AB1,AB2,AB3	RX	Yes	No
Alvogen	THYRO-TABS	levothyroxine sodium	TABLET;ORAL	021116-010	Oct 24, 2002	AB1,AB2,AB3,AB4	RX	Yes	No
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-015	Jun 22, 2022		RX	Yes	No

Expired US Patents for LEVOTHYROXINE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-007	May 25, 2001
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-012	Apr 25, 2017
King Pharms	LEVOXYL	levothyroxine sodium	TABLET;ORAL	021301-012	May 25, 2001
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-012	Apr 25, 2017
Cediprof Inc	LEVO-T	levothyroxine sodium	TABLET;ORAL	021342-002	Mar 1, 2002
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-003	Oct 13, 2006

International Patents for LEVOTHYROXINE SODIUM

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016137969
Italy	MI20011401
Montenegro	03810	TEKUĆE FORMULACIJE LEVOTIROKSINA (LIQUID LEVOTHYROXINE FORMULATIONS)
Russian Federation	2019106889	ВЫСОКОСТАБИЛЬНЫЕ УПАКОВАННЫЕ РАСТВОРЫ ТИРЕОИДНОГО ГОРМОНА Т4
China	109789213	T4甲状腺激素的高稳定性包装解决方案 (HIGH-STABILITY PACKAGED SOLUTIONS OF T4 THYROID HORMONE)
Portugal	3528847

Supplementary Protection Certificates for LEVOTHYROXINE SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1291021	132012902104794	Italy		PRODUCT NAME: LEVOTIROXINA SODICA(ALIASINT); AUTHORISATION NUMBER(S) AND DATE(S): RVG 106848; 106850-106860, 20110407;DA 041528011/M A 041528365/M, 20120808

LEVOTHYROXINE SODIUM Market Analysis and Financial Projection Experimental

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