GOSERELIN ACETATE - Generic Drug Details

What are the generic drug sources for goserelin acetate and what is the scope of patent protection?

Goserelin acetate is the generic ingredient in one branded drug marketed by Tersera and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for goserelin acetate. One supplier is listed for this compound.

Summary for GOSERELIN ACETATE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	122
Patent Applications:	7,042
What excipients (inactive ingredients) are in GOSERELIN ACETATE?	GOSERELIN ACETATE excipients list
DailyMed Link:	GOSERELIN ACETATE at DailyMed

Recent Clinical Trials for GOSERELIN ACETATE

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

Sponsor	Phase
Sohag University	Phase 1
Seoul National University	Phase 2
Gangnam Severance Hospital	Phase 2

See all GOSERELIN ACETATE clinical trials

Pharmacology for GOSERELIN ACETATE

Drug Class	Gonadotropin Releasing Hormone Receptor Agonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for GOSERELIN ACETATE

Antineoplastic Agents, Hormonal

Anatomical Therapeutic Chemical (ATC) Classes for GOSERELIN ACETATE

L02AE	Gonadotropin releasing hormone analogues
L02A	HORMONES AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for GOSERELIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726-001	Dec 29, 1989		RX	Yes	Yes
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578-001	Jan 11, 1996		RX	Yes	Yes

Expired US Patents for GOSERELIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578-001	Jan 11, 1996
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726-001	Dec 29, 1989
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578-001	Jan 11, 1996
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726-001	Dec 29, 1989
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578-001	Jan 11, 1996

GOSERELIN ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Goserelin Acetate

Introduction

Goserelin acetate, a luteinizing hormone-releasing hormone (LHRH) agonist, is widely used in the treatment of hormone-sensitive cancers such as prostate cancer, breast cancer, and certain benign gynecological disorders. This article delves into the market dynamics and financial trajectory of goserelin acetate, highlighting key players, market trends, and financial performance.

Key Players in the Goserelin Acetate Market

The goserelin acetate market is dominated by several key players, each contributing significantly to its growth and development.

• AstraZeneca: AstraZeneca is one of the primary manufacturers and marketers of goserelin acetate, sold under the brand name Zoladex. The company has a global presence and continues to commercialize Zoladex in markets outside the US and Canada[5].
• TerSera Therapeutics: TerSera Therapeutics acquired the commercial rights to Zoladex in the US and Canada from AstraZeneca in 2017. This agreement includes upfront payments, milestone payments, and recurring sales-based payments to AstraZeneca[5].
• Luye Pharma: Luye Pharma is another significant player, known for its innovative and international strategies. While not exclusively focused on goserelin acetate, Luye Pharma's portfolio includes various oncology and CNS products that compete in similar therapeutic areas[2].
• Alvogen and Apino Pharma: These companies also play a role in the market, though their specific contributions and market share may vary compared to the larger players like AstraZeneca and TerSera Therapeutics[1].

Market Segmentation

The goserelin acetate market can be segmented based on type and application.

Types of Goserelin Acetate Implants

• 3.6mg and 10.8mg Implants: These are the most common dosages available in the market. The choice between these dosages depends on the specific treatment protocol and patient needs[1].

Applications of Goserelin Acetate

• Prostate Cancer: Goserelin acetate is widely used in the treatment of prostate cancer to reduce testosterone levels, thereby slowing the growth of cancer cells.
• Breast Cancer: It is also used in the treatment of hormone-receptor-positive breast cancer.
• Endometriosis and Other Conditions: Additionally, goserelin acetate is used to treat endometriosis and other benign gynecological disorders[1].

Market Trends and Growth

The market for goserelin acetate is influenced by several trends and factors.

Increasing Prevalence of Hormone-Related Cancers

The rising incidence of hormone-related cancers such as prostate and breast cancer is a significant driver for the goserelin acetate market. As the global population ages, the demand for effective treatments for these cancers is expected to increase[4].

Technological Advancements and New Product Launches

Companies like Luye Pharma are focusing on innovation and internationalization, which includes the launch of new products and the expansion of existing product lines. This strategic approach helps in diversifying revenue sources and reducing dependence on individual products[2].

Regulatory and Policy Factors

Regulatory changes, such as volume-based procurement (VBP) and health insurance policies, can impact the market. However, companies like Luye Pharma have managed to mitigate these impacts through growing medical evidence and stable cash flows from their products[2].

Financial Performance

The financial performance of goserelin acetate is closely tied to the overall performance of its key players.

AstraZeneca's Financial Performance

AstraZeneca reported strong financial performance in 2022, with total revenue increasing by 25% to $44.351 billion. The company's oncology segment, which includes Zoladex, saw a significant increase in revenue, contributing to the overall growth. AstraZeneca expects to continue this growth trajectory through 2025 and beyond, driven by its robust pipeline and recent launches[3].

TerSera Therapeutics' Agreement with AstraZeneca

The agreement between TerSera Therapeutics and AstraZeneca for the commercial rights of Zoladex in the US and Canada included an upfront payment of $250 million and potential milestone payments of up to $70 million. This deal ensures a sustainable income stream for AstraZeneca from the US and Canadian markets[5].

Luye Pharma's Financial Growth

Luye Pharma reported a 15% year-on-year increase in revenue to RMB 5.982 billion in 2022, along with a 101.8% increase in normalized net profit. The company's focus on innovation and internationalization has driven its financial growth and positioned it for further expansion in the global market[2].

Regional Market Dynamics

The market for goserelin acetate varies by region, influenced by local healthcare policies, market demand, and competition.

North American Market

The North American market, particularly the US and Canada, is significant for goserelin acetate. TerSera Therapeutics' acquisition of commercial rights for Zoladex in these regions has helped in expanding the product's reach and ensuring continued patient access[5].

Emerging Markets

Emerging markets, including those in Asia, are also crucial for the growth of goserelin acetate. Companies like Luye Pharma are leveraging their global development, manufacturing, and marketing capabilities to tap into these markets[2].

Future Outlook

The future outlook for the goserelin acetate market is promising, driven by several factors.

Increasing Demand for Cancer Treatments

The rising incidence of cancer and the need for effective treatments will continue to drive the demand for goserelin acetate. The global zoladex market, for instance, is expected to reach USD 1.28 billion by 2032, growing at a CAGR of 2.3%[4].

Innovations and New Product Launches

Companies are continuously innovating and launching new products, which will help in maintaining market growth. Luye Pharma's strategy of launching new products and diversifying revenue sources is a prime example of this trend[2].

Regulatory Support

Regulatory support, such as the inclusion of products like Lipusu® (paclitaxel liposome for injection) in national reimbursement drug lists, will also contribute to the stable growth of the market[2].

Key Takeaways

• Dominant Players: AstraZeneca, TerSera Therapeutics, Luye Pharma, Alvogen, and Apino Pharma are key players in the goserelin acetate market.
• Market Segmentation: The market is segmented by type (3.6mg and 10.8mg implants) and application (prostate cancer, breast cancer, endometriosis).
• Growth Drivers: Increasing prevalence of hormone-related cancers, technological advancements, and new product launches drive market growth.
• Financial Performance: Strong financial performance by key players, including AstraZeneca and Luye Pharma, underpins market growth.
• Regional Dynamics: North American and emerging markets are crucial for the product's growth.

FAQs

Q: What are the primary applications of goserelin acetate?

• Goserelin acetate is primarily used in the treatment of prostate cancer, breast cancer, and certain benign gynecological disorders like endometriosis[1].

Q: Who are the key players in the goserelin acetate market?

• The key players include AstraZeneca, TerSera Therapeutics, Luye Pharma, Alvogen, and Apino Pharma[1].

Q: What is the expected growth of the global zoladex market by 2032?

• The global zoladex market is expected to reach USD 1.28 billion by 2032, growing at a CAGR of 2.3%[4].

Q: How does the agreement between AstraZeneca and TerSera Therapeutics impact the market?

• The agreement ensures continued patient access to Zoladex in the US and Canada, while providing AstraZeneca with a sustainable income stream through upfront, milestone, and sales-based payments[5].

Q: What are the driving factors for the goserelin acetate market?

• The driving factors include the increasing prevalence of hormone-related cancers, technological advancements, and the rising elderly population[4].

Sources

1. Goserelin Acetate Sustained Release Implant Market - Valuates Reports
2. Luye Pharma Announces 2022 Financial Results - Luye Pharma
3. Full year and Q4 2022 results - AstraZeneca
4. Zoladex Market Size, Share, Growth, Trends Statistics Report, 2032 - Business Research Insights
5. AstraZeneca enters agreement with TerSera Therapeutics for Zoladex in the US and Canada - AstraZeneca