You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

UNITHROID Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Unithroid is a drug marketed by Stevens J and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Unithroid

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

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for UNITHROID?
  • What are the global sales for UNITHROID?
  • What is Average Wholesale Price for UNITHROID?
Drug patent expirations by year for UNITHROID
Drug Prices for UNITHROID

See drug prices for UNITHROID

Drug Sales Revenue Trends for UNITHROID

See drug sales revenues for UNITHROID

Recent Clinical Trials for UNITHROID

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

SponsorPhase
Children's Hospital of PhiladelphiaN/A
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)N/A
Brigham and Women's HospitalN/A

See all UNITHROID clinical trials

Pharmacology for UNITHROID
Drug Classl-Thyroxine

US Patents and Regulatory Information for UNITHROID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Stevens J UNITHROID levothyroxine sodium TABLET;ORAL 021210-001 Aug 21, 2000 AB1,AB2,AB3 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Stevens J UNITHROID levothyroxine sodium TABLET;ORAL 021210-007 Aug 21, 2000 AB1,AB2,AB3 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Stevens J UNITHROID levothyroxine sodium TABLET;ORAL 021210-004 Aug 21, 2000 AB1,AB2,AB3 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Stevens J UNITHROID levothyroxine sodium TABLET;ORAL 021210-011 Aug 21, 2000 AB1,AB2,AB3 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Stevens J UNITHROID levothyroxine sodium TABLET;ORAL 021210-012 Feb 8, 2008 AB1,AB2,AB3 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Stevens J UNITHROID levothyroxine sodium TABLET;ORAL 021210-002 Aug 21, 2000 AB1,AB2,AB3 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

UNITHROID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Unithroid and the Thyroid Medication Market

Introduction to Unithroid and Thyroid Medications

Unithroid, a brand of levothyroxine, is a crucial medication in the treatment of hypothyroidism and other thyroid-related disorders. Levothyroxine, in both its brand and generic forms, dominates the thyroid medication market. Here, we will delve into the market dynamics and financial trajectory of Unithroid and the broader thyroid medication market.

Market Size and Growth

The global thyroid gland disorders treatment market, which includes medications like Unithroid, was valued at USD 2.37 billion in 2022 and is projected to grow to USD 3.14 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 3.17% during the forecast period of 2024-2031[3].

Segment Analysis

The medication segment, which includes levothyroxine and other thyroid medications, is the largest segment in the thyroid gland disorders treatment market. This segment is relatively stable and tends to grow steadily due to the increasing prevalence of thyroid disorders[3].

Unithroid Performance

Unithroid, specifically, has shown strong performance in recent quarters. In Amneal Pharmaceuticals' Q2 2023 earnings call, it was reported that Unithroid revenue grew 17% sequentially and 24% compared to the prior year. This growth indicates a robust demand for the medication and reflects the company's strong commercial execution[2].

Market Drivers

Several factors drive the growth of the thyroid medication market, including:

Increasing Prevalence of Thyroid Disorders

Thyroid conditions such as hyperthyroidism and hypothyroidism are becoming more common globally, contributing to the market's growth[3].

Aging Population

The expanding aging population is another significant driver, as thyroid disorders are more prevalent among older individuals[3].

Advances in Medical Technology

Improved medical technology and diagnostic tools have enhanced the detection and treatment of thyroid disorders, further boosting the market[3].

Telehealth and Remote Monitoring

The increased use of telemedicine and remote monitoring solutions, especially for endocrinology consultations and medication management, has improved access to thyroid care, particularly in areas with limited specialist availability[3].

Financial Trajectory of Amneal Pharmaceuticals

Amneal Pharmaceuticals, the company behind Unithroid, has demonstrated a strong financial performance in recent years.

Revenue Growth

In 2023, Amneal reported total net revenue of $2.4 billion, marking an 8% increase from the previous year. The company raised its financial guidance twice during the year and effectively met these targets, reflecting strong operational capabilities and market confidence[5].

Adjusted EBITDA and EPS

The adjusted EBITDA for 2023 increased by 9%, and the adjusted EPS guidance was raised to $0.45 to $0.55, indicating improved profitability and financial health[2].

Debt Reduction

Amneal has also focused on reducing its debt, with net leverage decreasing from 7.4x in 2019 to 4.9x in Q2 2023. The company aims to reduce its net leverage below 4x by the end of 2025[2].

Competitive Landscape

The thyroid medication market is highly competitive, with both brand and generic products vying for market share.

Generic Market Dominance

Generic drugs, including generic levothyroxine, now comprise approximately 90% of all prescription drug purchases in the United States, while accounting for only 20% of all prescription drug spending. This dominance is due to the FDA's streamlined oversight and the cost-effectiveness of generic medications[4].

Licensing and Supply Agreements

Companies like Amneal often enter into long-term licensing and supply agreements to secure their market position. For example, Amneal's 10-year agreement with Jerome Stevens Pharmaceuticals for Levothyroxine sodium tablets highlights the strategic importance of such partnerships in maintaining market share and ensuring continuous supply[1].

Challenges and Risks

Despite the positive growth trajectory, the market faces several challenges:

Limited Diagnostic Facilities

In some regions, limited diagnostic facilities and awareness of thyroid disorders can hinder market growth[3].

High Treatment Costs

The high cost of therapies for thyroid disorders can pose a significant barrier to market expansion, especially in emerging economies[3].

Regulatory Changes

Changes in regulatory environments, including FDA product approval requirements and healthcare reforms, can impact the market dynamics and profitability of companies involved[1].

Key Takeaways

  • Market Growth: The global thyroid gland disorders treatment market is expected to grow from USD 2.45 billion in 2023 to USD 3.14 billion by 2031.
  • Unithroid Performance: Unithroid has shown significant revenue growth, with a 17% sequential increase and a 24% increase compared to the prior year.
  • Financial Health: Amneal Pharmaceuticals has demonstrated strong financial performance, with revenue growth, improved adjusted EBITDA, and a reduction in net leverage.
  • Market Drivers: Increasing prevalence of thyroid disorders, aging population, advances in medical technology, and telehealth solutions drive the market.
  • Challenges: Limited diagnostic facilities, high treatment costs, and regulatory changes are potential risks.

FAQs

Q: What is the current market size of the global thyroid gland disorders treatment market? A: The global thyroid gland disorders treatment market was valued at USD 2.37 billion in 2022[3].

Q: How is Unithroid performing in the market? A: Unithroid revenue grew 17% sequentially and 24% compared to the prior year in Q2 2023, indicating strong demand and commercial execution[2].

Q: What are the main drivers of the thyroid medication market? A: The main drivers include the increasing prevalence of thyroid disorders, an aging population, advances in medical technology, and the use of telehealth solutions[3].

Q: How has Amneal Pharmaceuticals' financial performance been in recent years? A: Amneal reported total net revenue of $2.4 billion in 2023, with an 8% increase in revenues and a 9% increase in adjusted EBITDA. The company has also reduced its net leverage significantly[5].

Q: What are some of the challenges facing the thyroid medication market? A: Challenges include limited diagnostic facilities, high treatment costs, and potential changes in regulatory environments[3].

Sources

  1. Amneal Announces 10-Year Licensing and Supply Agreement with Jerome Stevens Pharmaceuticals Inc for Levothyroxine. Investors.Amneal.com.
  2. AMRX Q2-2023 Earnings Call. AlphaSpread.
  3. Thyroid Gland Disorders Treatment Market Size, Share, Growth. SkyQuestT.
  4. Real-World Case Study of Levothyroxine Use And Generic Switching. FDA.gov.
  5. Earnings call: Amneal Pharmaceuticals sees growth and diversification in 2023. Investing.com.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.