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

Last Updated: December 22, 2024

GEMCITABINE HYDROCHLORIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Gemcitabine Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Inc, Actavis Totowa, Am Regent, Apotex, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hameln Rds Gmbh, Hikma, Hikma Intl Pharms, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Norvium Bioscience, Novast Labs, Sagent Pharms, Sagent Pharms Inc, Shilpa, Sun Pharm, Teva Pharms, and Teyro Labs. and is included in thirty NDAs.

The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Gemcitabine Hydrochloride

A generic version of GEMCITABINE HYDROCHLORIDE was approved as gemcitabine hydrochloride by HOSPIRA INC on November 15th, 2010.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for GEMCITABINE HYDROCHLORIDE?
  • What are the global sales for GEMCITABINE HYDROCHLORIDE?
  • What is Average Wholesale Price for GEMCITABINE HYDROCHLORIDE?
Drug patent expirations by year for GEMCITABINE HYDROCHLORIDE
Recent Clinical Trials for GEMCITABINE HYDROCHLORIDE

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

SponsorPhase
Lee Ocuin, MDPhase 2
Merck Sharp & Dohme LLCPhase 2
State University of New York - Downstate Medical CenterPhase 1/Phase 2

See all GEMCITABINE HYDROCHLORIDE clinical trials

Pharmacology for GEMCITABINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for GEMCITABINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for GEMCITABINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GEMZAR For Injection gemcitabine hydrochloride 1g/vial 020509 1 2005-11-14
GEMZAR For Injection gemcitabine hydrochloride 200 mg/vial 020509 1 2005-11-01

US Patents and Regulatory Information for GEMCITABINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride SOLUTION;INTRAVENOUS 209604-001 Aug 3, 2017 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Meitheal GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 212129-002 Dec 11, 2020 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma Intl Pharms GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 206617-001 Jun 25, 2021 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 200145-001 Jul 25, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Shilpa GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 210991-003 Oct 4, 2019 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan Labs Ltd GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 205242-003 Dec 6, 2017 AP RX No 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

GEMCITABINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Gemcitabine Hydrochloride Market Dynamics and Financial Trajectory

Market Overview

The gemcitabine hydrochloride market is poised for significant growth, driven by several key factors. This market analysis will delve into the current state, growth drivers, and financial projections of the gemcitabine hydrochloride market.

Growth Drivers

Increasing Prevalence of Cancer

The global burden of cancer is a major driver of the gemcitabine hydrochloride market. According to the World Health Organization, in 2021, an estimated 1.9 million new cancer cases were diagnosed in the United States alone, and approximately 400,000 children develop cancer globally each year[3][4].

Combination Therapies and Efficacy

Gemcitabine hydrochloride is widely used in combination with other chemotherapeutic agents, which enhances its efficacy in treating various types of cancers, including pancreatic, ovarian, and lung cancers. This versatility and effectiveness in combination therapies are significant growth drivers[2][4].

COVID-19 Pandemic Impact

The COVID-19 pandemic highlighted the dual anti-cancer and anti-viral properties of gemcitabine hydrochloride. Studies suggested that gemcitabine's difluoro group is essential for its antiviral action, and its combination with other antiviral medications, such as remdesivir, could be a viable alternative for treating SARS-CoV-2 infections. This increased its demand during the pandemic and is expected to sustain post-pandemic[1][3].

Research and Development

Ongoing research and development activities are expanding the therapeutic scope of gemcitabine hydrochloride. New formulations and combinations with newer agents, such as checkpoint inhibitors and targeted therapies, are improving patient outcomes and driving market growth[2][4].

Generic and Biosimilar Versions

The development of generic and biosimilar versions of gemcitabine hydrochloride is making the drug more affordable, particularly in cost-sensitive markets. This increased affordability is boosting its adoption in regions like China, India, and Brazil[4].

Healthcare Expenditure and Infrastructure

Rising healthcare expenditure in emerging economies and investments in healthcare infrastructure are enabling greater access to cancer treatments. This is creating new opportunities for the gemcitabine hydrochloride market, especially in countries with a high incidence of cancer[4].

Market Size and Forecast

Current Market Size

As of 2023, the global market for gemcitabine hydrochloride was estimated at approximately $770.4 million[4].

Forecasted Growth

The market is projected to grow at a Compound Annual Growth Rate (CAGR) of around 5.1% to 7.1% between 2023 and 2030, depending on the source. By 2030, the market is expected to reach $1.1 billion[2][4].

Regional Market Share

North America is anticipated to hold a significant share in the global gemcitabine hydrochloride market due to the high prevalence of cancer and advancements in drug formulations. The low cost of generic gemcitabine hydrochloride and reformulation strategies are also driving growth in this region[1].

Financial Trajectory

Revenue Projections

The gemcitabine hydrochloride market is forecast to increase by USD 323.8 million at a CAGR of 7.08% between 2023 and 2028, according to some estimates. This growth will be driven by the increasing demand for effective cancer treatments and the expanding patient base[2].

Market Value

By 2030, the market value is expected to reach $1.1 billion, up from $770.4 million in 2023. This significant growth underscores the market's potential and the increasing importance of gemcitabine hydrochloride in cancer treatment[4].

Key Market Trends

Increasing Acceptance of Combination Therapies

The growing acceptance of combination therapies in developed countries like the US and Europe is boosting the market. Gemcitabine hydrochloride's efficacy in these combinations is a key factor driving its adoption[2].

Focus on Early Diagnosis and Treatment

Government screening programs and awareness campaigns are leading to higher detection rates of cancer, which in turn increases the demand for effective chemotherapeutic agents like gemcitabine hydrochloride[4].

Cost Reduction Strategies

To address the high cost of cancer treatments, governments in several countries are implementing policies to reduce the cost of essential oncology drugs, including gemcitabine, through subsidies, local manufacturing, and generic production[4].

Competitive Landscape

Major Players

The market is dominated by several major players, including Abbexa, Accord Healthcare, and BioCrick BioTech. These companies are investing in research and development, forming strategic alliances, and expanding their production facilities to meet the growing demand[4].

Market Presence

The competitive landscape is characterized by strong, active, and niche players. The presence of generic and biosimilar versions is increasing competition but also expanding market accessibility[4].

Regional Analysis

North America

North America is expected to hold a significant market share due to the high prevalence of cancer and advancements in drug formulations. The region's low cost of generic gemcitabine hydrochloride and reformulation strategies are key drivers[1].

Emerging Economies

Countries like China, India, and Brazil are witnessing a surge in cancer incidence and are making significant investments in healthcare infrastructure. These regions represent substantial growth opportunities for the gemcitabine hydrochloride market[4].

Challenges and Opportunities

High Cost of Treatment

Despite the growth drivers, the high cost of cancer treatments remains a significant barrier. However, the development of generic and biosimilar versions and government policies aimed at reducing costs are addressing this challenge[4].

Expansion of Healthcare Coverage

The expansion of healthcare coverage and increased investment in cancer care infrastructure are expected to support the broader adoption of gemcitabine hydrochloride in emerging markets[4].

"The escalating burden of cancer globally, particularly lung, pancreatic, and breast cancers, is one of the most significant drivers of the Gemcitabine market. The drug's ability to effectively target rapidly dividing cells and its efficacy in combination with other chemotherapeutic agents have made it a preferred choice for many oncologists."[4]

Key Takeaways

  • The gemcitabine hydrochloride market is expected to grow significantly due to the increasing global prevalence of cancer.
  • The drug's dual anti-cancer and anti-viral properties, as well as its efficacy in combination therapies, are key growth drivers.
  • The market is forecast to reach $1.1 billion by 2030, growing at a CAGR of around 5.1% to 7.1%.
  • North America is expected to hold a significant market share, while emerging economies offer substantial growth opportunities.
  • The development of generic and biosimilar versions, along with government policies to reduce costs, is increasing market accessibility.

FAQs

What is the current market size of the gemcitabine hydrochloride market?

The current market size of the gemcitabine hydrochloride market was estimated at approximately $770.4 million in 2023[4].

What is the forecasted growth rate of the gemcitabine hydrochloride market?

The market is projected to grow at a CAGR of around 5.1% to 7.1% between 2023 and 2030[2][4].

Which regions are expected to drive the growth of the gemcitabine hydrochloride market?

North America is expected to hold a significant market share, while emerging economies like China, India, and Brazil represent substantial growth opportunities[1][4].

What are the key factors driving the demand for gemcitabine hydrochloride?

The increasing prevalence of cancer, the drug's efficacy in combination therapies, and its dual anti-cancer and anti-viral properties are key factors driving demand[1][2][4].

How is the development of generic and biosimilar versions impacting the market?

The development of generic and biosimilar versions is making gemcitabine hydrochloride more affordable, increasing its adoption, especially in cost-sensitive markets[4].

Sources

  1. Mordor Intelligence: Gemcitabine Hydrochloride Market Size & Share Analysis
  2. Technavio: Gemcitabine Hydrochloride Market Size 2024-2028
  3. Mordor Intelligence: Gemcitabine Hydrochloride Market Size
  4. GlobeNewswire: Gemcitabine Hydrochloride Strategic Industry Research Report 2023-2030

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.