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Last Updated: December 26, 2024

LEVOLET Drug Patent Profile


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When do Levolet patents expire, and when can generic versions of Levolet launch?

Levolet is a drug marketed by Genus Lifesciences and is included in one NDA. There are two patents protecting this drug.

The generic ingredient in LEVOLET 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 Levolet

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

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Summary for LEVOLET
Drug patent expirations by year for LEVOLET
Recent Clinical Trials for LEVOLET

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

SponsorPhase
Dr. Reddy's Laboratories LimitedPhase 4
Dr. Reddy's Laboratories Limited

See all LEVOLET clinical trials

US Patents and Regulatory Information for LEVOLET

LEVOLET 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
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-001 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-010 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No 10,406,108 ⤷  Subscribe Y ⤷  Subscribe
Genus Lifesciences LEVOLET levothyroxine sodium TABLET;ORAL 021137-005 Jun 6, 2003 AB1,AB2,AB3,AB4 RX No No 10,231,931 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

LEVOLET Market Analysis and Financial Projection Experimental

Levofloxacin Market Dynamics and Financial Trajectory: A Comprehensive Overview

Market Overview

The global Levofloxacin market, which includes the brand Levofloxacin and its generic versions like Levolet, has been witnessing significant growth driven by several key factors. Here is a detailed look at the market dynamics and financial trajectory of Levofloxacin.

Market Size and Growth

As of 2022, the global Levofloxacin market was valued at USD 1.44 billion. It is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 5.41% from 2023 to 2028, indicating robust growth in the forecast period[1].

Key Drivers

Increasing Prevalence of Bacterial Infections

The rising prevalence of bacterial infections worldwide is a major driver of the Levofloxacin market. Levofloxacin's effectiveness against a wide range of bacterial strains, including those resistant to other antibiotics, makes it a crucial medication in combating these infections[1].

Rising Awareness of Antibiotic Importance

Public awareness campaigns, educational initiatives, and healthcare provider training programs have increased the awareness of the importance of antibiotics and their judicious use. This has contributed to the sustained demand for Levofloxacin, a powerful fluoroquinolone antibiotic[1].

Expansion of Healthcare Infrastructure

The expansion of healthcare infrastructure in emerging economies has also driven the demand for Levofloxacin. Improved healthcare facilities and increased access to medications in developing regions have boosted the market[1].

Market Segmentation

Product Type

The Levofloxacin market is segmented by product type, including 250 mg, 500 mg, and 750 mg tablets. These different dosages cater to various treatment needs and patient populations[3].

Distribution Channel

The market is also segmented by distribution channels such as hospital pharmacies, retail pharmacies, and online pharmacies. Retail pharmacies, in particular, play a significant role in ensuring patients receive the appropriate dosage and guidance on its use[3].

Application

Levofloxacin is used to treat a variety of bacterial infections, including pneumonia, skin infections, kidney infections, and bladder infections. Pneumonia is the fastest-growing segment due to the high efficacy of Levofloxacin in treating this condition[1][3].

Regional Insights

North America

North America, particularly the United States, holds the largest market share in the global Levofloxacin market. The region's well-developed healthcare infrastructure, substantial healthcare expenditure, and significant burden of bacterial infections contribute to its dominant position[1].

Challenges and Regulatory Scrutiny

Potential Side Effects and Adverse Reactions

Concerns regarding potential side effects and adverse reactions associated with fluoroquinolone antibiotics, including Levofloxacin, have led to regulatory scrutiny and restrictions in some regions. This has prompted pharmaceutical companies to invest in the development of safer alternatives and promote responsible antibiotic use[1].

Recent Developments

Divestment of Brands

In February 2022, Dr. Reddy's divested its antibiotic brands Ciprolet and Levolet in Russia and CIS countries to Binnopharm Group. This move allowed Dr. Reddy's to focus its resources on key therapy areas such as gastroenterology, pain management, and oncology[2].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the Levofloxacin market. While it has led to increased investments in the pharmaceutical sector and drug discovery, it has also highlighted the need for rapid testing and point-of-care diagnosis, which in turn has fueled the demand for medications like Levofloxacin[3].

Financial Trajectory

The financial trajectory of the Levofloxacin market is positive, with a projected CAGR of 5.41% from 2023 to 2028. The market's growth is supported by increasing healthcare expenditures, expanding healthcare infrastructure, and the ongoing need for effective antibiotic treatments.

Key Takeaways

  • The global Levofloxacin market is valued at USD 1.44 billion as of 2022 and is expected to grow at a CAGR of 5.41% until 2028.
  • The increasing prevalence of bacterial infections and rising awareness of antibiotic importance are key drivers.
  • North America holds the largest market share due to its well-developed healthcare infrastructure and significant healthcare expenditure.
  • Regulatory scrutiny due to potential side effects is a challenge, prompting the development of safer alternatives.
  • Recent divestments by companies like Dr. Reddy's reflect strategic shifts in the market.

FAQs

What is the current market size of the global Levofloxacin market?

The global Levofloxacin market was valued at USD 1.44 billion in 2022[1].

What is the projected CAGR for the global Levofloxacin market from 2023 to 2028?

The global Levofloxacin market is anticipated to grow at a CAGR of 5.41% from 2023 to 2028[1].

Which region holds the largest market share in the global Levofloxacin market?

North America, particularly the United States, holds the largest market share in the global Levofloxacin market[1].

What are the primary drivers of the Levofloxacin market?

The primary drivers include the increasing prevalence of bacterial infections and the rising awareness of the importance of antibiotics[1].

What challenges does the Levofloxacin market face?

The market faces challenges related to potential side effects and adverse reactions associated with fluoroquinolone antibiotics, leading to regulatory scrutiny and restrictions[1].

How has the COVID-19 pandemic impacted the Levofloxacin market?

The pandemic has led to increased investments in the pharmaceutical sector, highlighted the need for rapid testing and point-of-care diagnosis, and fueled the demand for medications like Levofloxacin[3].

Sources

  1. TechSci Research: Levofloxacin Market By Size, Share and Forecast 2028
  2. The Economic Times: Dr Reddy's divests two antibiotic brands Ciprolet and Levolet in Russia & CIS countries
  3. Biospace: Levofloxacin Tablets Market Analysis, Statistics, Revenue, Demand and Trend Analysis Research Report by 2028

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