GEMCITABINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for gemcitabine hydrochloride and what is the scope of patent protection?

Gemcitabine hydrochloride is the generic ingredient in three branded drugs 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, Teyro Labs, and Lilly, and is included in thirty-two NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Gemcitabine hydrochloride has seventeen patent family members in fourteen countries.

There are thirty drug master file entries for gemcitabine hydrochloride. Thirteen suppliers are listed for this compound.

Summary for GEMCITABINE HYDROCHLORIDE

International Patents:	17
US Patents:	1
Tradenames:	3
Applicants:	26
NDAs:	32
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	2,804
Patent Applications:	7,632
What excipients (inactive ingredients) are in GEMCITABINE HYDROCHLORIDE?	GEMCITABINE HYDROCHLORIDE excipients list
DailyMed Link:	GEMCITABINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for GEMCITABINE HYDROCHLORIDE

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

Sponsor	Phase
Lee Ocuin, MD	Phase 2
Merck Sharp & Dohme LLC	Phase 2
Medizinische Hochschule Hannover, Germany, Prof. Dr. Arndt Vogel	Phase 2

See all GEMCITABINE HYDROCHLORIDE clinical trials

Pharmacology for GEMCITABINE HYDROCHLORIDE

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for GEMCITABINE HYDROCHLORIDE

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Dr Reddys Labs Ltd	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	091365-002	Jul 25, 2011	AP	RX	No	No
Accord Hlthcare	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	209604-002	Aug 3, 2017		RX	Yes	Yes
Teva Pharms	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	077983-001	Jan 25, 2011		DISCN	No	No
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-002	May 15, 1996		DISCN	Yes	No

Expired US Patents for GEMCITABINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-002	May 15, 1996	4,808,614*PED
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-001	May 15, 1996	5,464,826*PED
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-001	May 15, 1996	4,808,614*PED
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-002	May 15, 1996	5,464,826*PED

International Patents for GEMCITABINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Portugal	2656848
Mexico	2014013101	SOLUCION DE GEMCITABINA LISTA PARA INFUNDIR. (READY TO BE INFUSED GEMCITABINE SOLUTION.)
Canada	2871061	SOLUTION DE GEMCITABINE PRETE A ETRE PERFUSEE (READY TO BE INFUSED GEMCITABINE SOLUTION)
South Korea	20150014438

Supplementary Protection Certificates for GEMCITABINE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0122707	96C0030	Belgium		PRODUCT NAME: CHLORHYDRATE DE GEMCITABINE EQUIVALENT EN GEMCITABINE; NAT. REGISTRATION NO/DATE: 58 IS 88 F 12 19960606; FIRST REGISTRATION: NL RVG 17854 19950327
0122707	SPC/GB95/031	United Kingdom		PRODUCT NAME: GEMCITABINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY- ACCEPTABLE SALT; REGISTERED: NL RVG17854 19950327; UK 00006/0301 19951026; UK 00006/0302 19951026

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