GEMZAR Drug Patent Profile

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

Gemzar is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in GEMZAR 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 Gemzar

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

Summary for GEMZAR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	710
Patent Applications:	7,558
Drug Prices:	Drug price information for GEMZAR
What excipients (inactive ingredients) are in GEMZAR?	GEMZAR excipients list
DailyMed Link:	GEMZAR at DailyMed

See drug prices for GEMZAR

Recent Clinical Trials for GEMZAR

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

Sponsor	Phase
Shantou Central Hospital	Phase 2
First Affiliated Hospital, Sun Yat-Sen University	Phase 2
Merck Sharp & Dohme LLC	Phase 2

See all GEMZAR clinical trials

Paragraph IV (Patent) Challenges for GEMZAR

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 GEMZAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-002	May 15, 1996		DISCN	Yes	No
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-001	May 15, 1996		DISCN	Yes	No

Expired US Patents for GEMZAR

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

International Patents for GEMZAR

See the table below for patents covering GEMZAR around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H0637394
Cyprus	1806	Improvements in the treatment of tumors in mammals
Austria	92499

Supplementary Protection Certificates for GEMZAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0122707	SPC/GB95/03	United Kingdom		SPC/GB95/03: 20040306, EXPIRES: 20090305
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

GEMZAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gemcitabine (GEMZAR)

Introduction to Gemcitabine (GEMZAR)

Gemcitabine, marketed under the brand name GEMZAR, is a chemotherapeutic agent used primarily in the treatment of various types of cancer, including lung, pancreatic, and breast cancers. Here, we delve into the market dynamics and financial trajectory of this crucial oncology drug.

Global Market Size and Growth

The global market for Gemcitabine Hydrochloride is experiencing significant growth. As of 2023, the market was valued at approximately $770.4 million and is projected to reach $1.1 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.1% during this period[1].

Key Drivers of Market Growth

Rising Prevalence of Cancer

The escalating burden of cancer globally, particularly in types such as lung, pancreatic, and breast cancers, is a major driver of the Gemcitabine market. The increasing incidence of these cancers necessitates more treatments, thereby boosting the demand for effective chemotherapeutic agents like Gemcitabine[1].

Advancements in Drug Formulations

Advancements in drug formulations and the increasing acceptance of combination therapies are also driving the market. Gemcitabine's efficacy in combination with other chemotherapeutic agents, as well as newer agents like checkpoint inhibitors and targeted therapies, is expanding its therapeutic scope and offering improved patient outcomes[1].

Generic and Biosimilar Versions

The development of generic and biosimilar versions of Gemcitabine is making the drug more affordable, especially in cost-sensitive markets. This increased affordability is leading to higher adoption rates, particularly in emerging economies[1].

Healthcare Expenditure in Emerging Economies

Rising healthcare expenditure in countries like China and India, which are witnessing a surge in cancer incidence, is enabling greater access to cancer treatments. This increased investment in healthcare infrastructure and oncology care is creating new opportunities for the Gemcitabine Hydrochloride market[1].

Market Opportunities and Trends

Increased Clinical Studies and Government Initiatives

There is a rising awareness and investment in clinical studies and government initiatives aimed at improving cancer treatments. These studies and initiatives are likely to drive market growth by identifying new uses and improving the efficacy of Gemcitabine[4].

Multi-Channel Engagement

The launch of new digital channels has significantly changed how pharmaceutical companies engage with healthcare professionals and expand their reach. This multi-channel engagement is helping to maintain contact with HCPs and increase the overall market reach of Gemcitabine[4].

Retail Pharmacies Demand

The increasing demand for retail pharmacies is another opportunity for the Gemcitabine market. As more patients seek convenient and accessible healthcare services, retail pharmacies are becoming key distribution channels for oncology drugs like Gemcitabine[4].

Financial Assistance and Access

Financial Assistance Programs

For patients facing financial challenges, various financial assistance programs are available. For example, Pfizer's Oncology Together program offers co-pay savings, free medicine through the Pfizer Patient Assistance Program, and assistance with out-of-pocket costs for eligible patients. These programs help make Gemcitabine and other oncology medicines more accessible to those in need[2].

Healthcare Insurance and Reimbursement

Navigating healthcare insurance and reimbursement can be complex, especially for cancer patients. Resources like the ACCC Financial Assistance Toolkit provide tools to assess benefits, estimate costs of chemotherapy care plans, and track patient assistance programs. These resources help patients and healthcare providers manage the financial aspects of cancer care more effectively[5].

Competitive Landscape

The oncology drugs market, including Gemcitabine, is highly competitive and dynamic. The global oncology drugs market is projected to grow from $231.56 billion in 2024 to $532.91 billion by 2031, with a CAGR of 12.6%. This growth is driven by the adoption of targeted therapies and immunotherapies, among other factors[3].

Regional Market Dynamics

North America, Europe, and Asia Pacific

The market for Gemcitabine is distributed across various regions, with North America, Europe, and the Asia Pacific being key markets. The Asia Pacific region, particularly countries like China and India, is seeing significant growth due to increasing healthcare expenditure and a rising incidence of cancer[1][3].

Challenges and Limitations

High Development Costs

Despite the growth opportunities, the development of oncology drugs like Gemcitabine comes with high costs. These costs can be a barrier to entry for new market players and can impact the pricing and affordability of the drug[3].

Stringent Government Regulations

Stringent government regulations are another challenge faced by the Gemcitabine market. These regulations can slow down the approval process for new formulations and combinations, affecting market growth[3].

Key Takeaways

• The global Gemcitabine Hydrochloride market is projected to reach $1.1 billion by 2030, growing at a CAGR of 5.1% from 2023 to 2030.
• The market is driven by the rising prevalence of cancer, advancements in drug formulations, and increasing acceptance of combination therapies.
• Generic and biosimilar versions are making the drug more affordable, especially in emerging economies.
• Financial assistance programs and healthcare insurance resources are crucial for making Gemcitabine accessible to patients.
• The market faces challenges such as high development costs and stringent government regulations.

FAQs

Q: What is the current market size of Gemcitabine Hydrochloride?

A: As of 2023, the global market for Gemcitabine Hydrochloride was valued at approximately $770.4 million[1].

Q: What is the projected growth rate of the Gemcitabine Hydrochloride market?

A: The market is projected to grow at a CAGR of 5.1% from 2023 to 2030[1].

Q: What are the key drivers of the Gemcitabine market growth?

A: Key drivers include the rising prevalence of cancer, advancements in drug formulations, and the increasing acceptance of combination therapies[1].

Q: Are there financial assistance programs available for patients using Gemcitabine?

A: Yes, programs like Pfizer's Oncology Together offer co-pay savings, free medicine, and assistance with out-of-pocket costs for eligible patients[2].

Q: What are the challenges faced by the Gemcitabine market?

A: High development costs and stringent government regulations are significant challenges faced by the market[3].

Sources

1. Gemcitabine Hydrochloride Strategic Industry Research Report 2023-2030. GlobeNewswire.
2. Financial Assistance | Pfizer Oncology Together | Patient. Pfizer Oncology Together.
3. Oncology Drugs Market to Reach USD 532.91 Billion by 2031. BioSpace.
4. Global Gemcitabine HCl Market – Industry Trends and Forecast to .... Data Bridge Market Research.
5. Financial Assistance Toolkit. Association of Community Cancer Centers (ACCC).