Gemcitabine hydrochloride - Generic Drug Details

What are the generic drug sources for gemcitabine hydrochloride and what is the scope of freedom to operate?

Gemcitabine hydrochloride is the generic ingredient in five branded drugs marketed by Accord Hlthcare, Actavis Inc, Actavis Totowa, Am Regent, Apotex, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland, Hameln Rds Gmbh, Hikma, Hikma Intl Pharms, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Novast Labs, Pharmobedient, Sagent Pharms, Sagent Pharms Inc, Shilpa, Sun Pharm, Teva Pharms, Teyro Labs, Lilly, Avyxa Holdings, and Janssen Biotech, and is included in thirty-four NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Gemcitabine hydrochloride has one hundred and fifty-six patent family members in twenty-eight countries.

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

Summary for gemcitabine hydrochloride

International Patents:	156
US Patents:	4
Tradenames:	5
Applicants:	28
NDAs:	34
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3,117
Patent Applications:	6,644
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
Lisata Therapeutics, Inc.	PHASE1
National Cancer Institute (NCI)	PHASE3
Massachusetts General Hospital	PHASE2

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
Pharmobedient	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	200145-003	Jul 25, 2011		DISCN	No	No
Actavis Inc	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	204549-001	Apr 11, 2016		DISCN	No	No
Fresenius Kabi Usa	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	090799-001	Jul 25, 2011	AP	RX	No	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
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-001	May 15, 1996
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-001	May 15, 1996

International Patents for gemcitabine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Cyprus	1124354
Lithuania	3035991
Eurasian Patent Organization	201270033	ИМПЛАНТИРУЕМЫЕ УСТРОЙСТВА ДЛЯ ДОСТАВКИ ЛЕКАРСТВ И СПОСОБЫ ИХ ИЗГОТОВЛЕНИЯ

Supplementary Protection Certificates for gemcitabine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for Gemcitabine Hydrochloride

Last updated: July 27, 2025

Introduction

Gemcitabine hydrochloride, a nucleoside analog used primarily as an antineoplastic agent, has established a critical role in the treatment of various cancers. Since its development and approval in the late 20th century, it has undergone significant market evolutions driven by clinical advancements, regulatory landscapes, and shifting healthcare priorities. This analysis examines the current market dynamics influencing gemcitabine hydrochloride and forecasts its financial trajectory, highlighting emerging trends, competitive pressures, and strategic opportunities.

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Product Overview and Clinical Significance

Gemcitabine hydrochloride (brand examples include Gemzar) functions by incorporating into DNA during replication, causing chain termination and apoptosis of cancer cells. Its broad-spectrum efficacy spans pancreatic, non-small cell lung, bladder, and ovarian cancers, underlining its importance in oncology regimens. Its favorable pharmacokinetics, manageable toxicity profile, and compatibility with combination therapies have cemented its status as a first-line or adjunct treatment.

The ongoing proliferation of cancer cases globally, coupled with a steady pipeline of clinical research improving its application, sustains its relevance. For instance, advancements in biomarkers and combination strategies are enhancing treatment outcomes, broadening gemcitabine’s clinical use.

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Market Dynamics Influencing Demand and Growth

1. Market Drivers

• Rising Global Cancer Incidence: According to WHO, approximately 19.3 million new cancer cases were diagnosed worldwide in 2020, with projections reaching 28.4 million by 2040. Pancreatic, lung, and bladder cancers constitute significant segments within this growth, all of which benefit from gemcitabine therapy [1].

• Expanded Clinical Indications: New studies and regulatory approvals have extended gemcitabine’s use into combination therapies and neoadjuvant settings. Novel combination protocols involving targeted agents and immunotherapies are demonstrating promising efficacy, thus expanding market potential.

• Advances in Oncology Diagnostics: Improved diagnostics facilitate earlier diagnosis, leading to a higher proportion of eligible patients for gemcitabine-based treatments, indirectly fueling demand.

• Generic Entry and Price Competition: The expiration of key patents has increased the availability of low-cost generics, driving volume sales but compressing profit margins for branded manufacturers.

2. Market Challenges

• Emergence of Novel Therapies: Immuno-oncology agents, targeted therapies, and biomarkers are redefining treatment paradigms. Agents such as checkpoint inhibitors (e.g., pembrolizumab) are increasingly replacing chemotherapy in certain indications, impacting gemcitabine's market share.

• Toxicity and Resistance: Tumor resistance to gemcitabine and uptake issues limit its efficacy in some patient populations, prompting clinicians to consider alternative agents.

• Regulatory and Pricing Pressures: Healthcare payers and regulatory bodies are imposing cost-containment measures, especially in high-volume markets like the U.S. and EU.

3. Geographic Market Trends

• Developed Markets: The U.S. and Western Europe account for significant portions of global sales, driven by established healthcare infrastructure, high prevalence of target cancers, and robust clinical adoption.

• Emerging Markets: Countries such as China, India, and Brazil present substantial growth opportunities owing to expanding healthcare coverage, increasing cancer burden, and rising penetration of generics.

4. Competitive Landscape

The market is characterized by several key players, including Eli Lilly (Gemzar), Teva, Dr. Reddy’s, and others offering branded and generic versions.

• Patent Expirations: Several patents have expired or are nearing expiration, resulting in increased generic penetration and price erosion.

• Pipeline and Research: Efforts are ongoing to develop improved formulations and combination regimens, aiming to optimize efficacy and reduce resistance.

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Financial Trajectory and Market Outlook

Historical Market Performance

Over the past decade, global sales of gemcitabine have exhibited moderate growth, supported by steady clinical adoption and expanding indications. The biosimilar and generic markets significantly influence pricing strategies, reducing per-unit costs but boosting volume sales.

For instance, the global market size was valued at approximately US$1.2 billion in 2019, with a compound annual growth rate (CAGR) around 4-6% projected through 2025 [2].

Forecasted Trends

• Market Growth Rate: Projected CAGR between 5% and 7% over the next five years, driven by increasing cancer prevalence, expanding therapeutic options, and market penetration in emerging economies.

• Revenue Streams:

  • Brand-Name Sales: Initial high-margin sales decline post-patent expiry; however, specialty formulations and combination regimens sustain revenue.

  • Generic and Biosimilar Sales: Rapid growth expected as patents expire, with prices converging towards commodity levels, resulting in volume-driven revenues.

• Emerging Markets: Expected to outpace mature markets in growth, supported by healthcare infrastructure investments and policy reforms.

• Market Challenges on Revenue: Stringent pricing controls, competition from new therapies, and resistance patterns could temper growth. Continuous innovation and strategic licensing will be critical to sustain revenues.

Impact of Competitive Innovations

The introduction of targeted agents and immunotherapies targeting specific molecular pathways may displace gemcitabine in some indications. However, economic considerations and existing infrastructure for chemotherapy delivery suggest that gemcitabine will remain part of standard protocols in many regions, especially in combination regimens where it complements targeted therapies.

Strategic Opportunities

• Formulation and Delivery: Developing more effective or less toxic formulations could extend patient eligibility and adherence.

• Combination Regimens: Investing in clinical testing for combinations with immunotherapies or targeted agents enhances market relevance.

• Geographic Expansion: Focusing on low- and middle-income countries can secure growth in emerging markets.

• Partnerships and Licensing: Collaborations with biotech firms and biosimilar manufacturers can optimize market positioning and mitigate patent expiry impacts.

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Regulatory and Reimbursement Landscape

Regulatory agencies, such as the FDA and EMA, continue to approve new indications based on ongoing clinical research, supporting sustained market activity. Reimbursement policies favor cost-effective options, favoring generics, which benefits volume sales but pressure profitability.

Patent protections in key markets have led to a proliferation of biosimilars and generics, which can dilute pricing but promote widespread access to therapies.

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Key Takeaways

• Growing Cancer Burden: The increasing global incidence of cancers susceptible to gemcitabine sustains steady demand, particularly in resource-limited settings.

• Market Transition to Generics: Patent expirations have shifted revenue streams toward volume sales of generic formulations, compressing margins but expanding accessibility.

• Innovation and Combination Therapy: Ongoing research into novel combination regimens incorporating gemcitabine offers avenues to maintain relevance and commercial viability.

• Competitive and Regulatory Pressures: Price sensitivity, emerging therapies, and evolving regulatory frameworks necessitate continuous strategic adaptation.

• Emerging Markets as Growth Catalysts: Brazil, China, India, and Southeast Asian markets are poised for rapid growth due to improving healthcare infrastructure and rising cancer prevalence.

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Conclusion

The financial trajectory of gemcitabine hydrochloride is characterized by moderate growth, reinforced by expanding indications and global cancer trends. However, market saturation due to patent expiries and the advent of novel therapies necessitate strategic innovation and diversification. Companies that leverage emerging markets, optimize combination regimens, and develop enhanced formulations will position themselves favorably in this evolving landscape.

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References

[1] World Health Organization. (2020). Global Cancer Statistics 2020.

[2] IQVIA. (2021). Global Oncology Market Analysis Report.