Ganirelix acetate - Generic Drug Details

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

Ganirelix acetate is the generic ingredient in two branded drugs marketed by Sun Pharm, Amphastar Pharms Inc, Gland Pharma Ltd, Lupin Ltd, Meitheal, and Organon Usa Organon, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for ganirelix acetate. Eight suppliers are listed for this compound.

Summary for ganirelix acetate

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	22
Patent Applications:	295
Drug Prices:	Drug price trends for ganirelix acetate
What excipients (inactive ingredients) are in ganirelix acetate?	ganirelix acetate excipients list
DailyMed Link:	ganirelix acetate at DailyMed

See drug prices for ganirelix acetate

Recent Clinical Trials for ganirelix acetate

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

Sponsor	Phase
Instituto Bernabeu	Phase 4
Jiangsu HengRui Medicine Co., Ltd.	Phase 3
Yale University	N/A

See all ganirelix acetate clinical trials

Pharmacology for ganirelix acetate

Drug Class	Gonadotropin Releasing Hormone Receptor Antagonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Antagonists
Physiological Effect	Decreased GnRH Secretion

Anatomical Therapeutic Chemical (ATC) Classes for ganirelix acetate

H01CC	Anti-gonadotropin-releasing hormones
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

Paragraph IV (Patent) Challenges for GANIRELIX ACETATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GANIRELIX ACETATE	Injection	ganirelix acetate	250 mcg/0.5 mL, 1 mL PFS	021057	1	2012-03-30

US Patents and Regulatory Information for ganirelix acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	216075-001	Nov 16, 2023	AP	RX	No	No
Meitheal	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	214996-001	Jun 6, 2022	AP	RX	No	No
Sun Pharm	FYREMADEL	ganirelix acetate	INJECTABLE;INJECTION	204246-001	Nov 30, 2018	AP	RX	No	No
Gland Pharma Ltd	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	215658-001	Feb 28, 2023	AP	RX	No	No
Organon Usa Organon	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	021057-001	Jul 29, 1999	AP	RX	Yes	Yes
Amphastar Pharms Inc	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	212613-001	Apr 7, 2022	AP	RX	No	No

Expired US Patents for ganirelix acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Organon	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	021057-001	Jul 29, 1999	4,801,577
Organon Usa Organon	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	021057-001	Jul 29, 1999	6,653,286
Organon Usa Organon	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	021057-001	Jul 29, 1999	5,767,082

Ganirelix acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ganirelix Acetate

Introduction to Ganirelix Acetate

Ganirelix acetate is an injectable gonadotropin-releasing hormone (GnRH) antagonist, primarily used in fertility treatments to prevent premature ovulation during controlled ovarian stimulation. It is marketed under brand names such as Orgalutran and Antagon[2].

Market Size and Growth

The global Ganirelix acetate market has been experiencing significant growth. As of 2023, the market was valued at a substantial amount, and it is projected to continue growing at a notable Compound Annual Growth Rate (CAGR) until 2030. For instance, the Ganirelix API market, a crucial component of the overall Ganirelix acetate market, was valued at US$ 642 million in 2023 and is anticipated to reach US$ 920 million by 2030, with a CAGR of 5.3% during the forecast period[4].

Market Drivers

Several factors are driving the growth of the Ganirelix acetate market:

Increasing Demand for Fertility Treatments

The rising demand for assisted reproductive technologies (ART) and fertility treatments is a significant driver. As more individuals and couples seek fertility treatments, the demand for Ganirelix acetate increases[2].

Technological Advancements

Advancements in medical technology and the development of more effective GnRH antagonists contribute to market growth. These advancements improve the efficacy and safety of fertility treatments, making them more appealing to patients[1].

Government Incentives and Policies

Government incentives and supportive policies for fertility treatments and reproductive health also play a crucial role. These policies can include subsidies, insurance coverage, and regulatory support, which help in expanding the market[1].

Emerging Markets

The Asia-Pacific region, in particular, is emerging as a key player due to rapid industrialization, infrastructure development, and increasing healthcare spending. This region offers significant growth opportunities for the Ganirelix acetate market[4].

Market Segmentation

The Ganirelix acetate market is segmented in various ways:

By Type

The market can be segmented based on the purity levels of the API, such as >95% and >99% purity[4].

By Application

Ganirelix acetate is used in both original drugs and generic drugs. The generic segment is expected to grow significantly due to its cost-effectiveness and wider availability[4].

By Region

The market is segmented geographically into regions such as North America, Europe, Asia-Pacific, and emerging markets. Each region has its own set of drivers and challenges that influence market growth[1][4].

Competitive Landscape

The competitive landscape of the Ganirelix acetate market is characterized by several key players:

Major Market Players

Companies such as Sun Pharma, ASPEN OSS BV, BCN Peptides, ChemWerth, LGM Pharma, Apicore, and Aurobindo Pharma Limited are among the top market leaders. These companies are involved in the production and distribution of Ganirelix acetate and its API[4].

Market Strategies

These players employ various strategies to maintain their market share, including product innovation, strategic partnerships, and expansion into new markets. For example, Gland Pharma Limited has successfully launched new molecules, including Ganirelix acetate, and has seen significant revenue growth from these efforts[3].

Financial Performance

The financial performance of the Ganirelix acetate market is robust and indicative of its growth potential:

Revenue Growth

The revenue from the Ganirelix API market is expected to increase from US$ 642 million in 2023 to US$ 920 million by 2030. This growth is driven by consistent performance across markets, increased shipment volumes, and the introduction of new products[4].

EBITDA and Profit Margins

Companies involved in the production and distribution of Ganirelix acetate have seen significant increases in their EBITDA and profit margins. For instance, Gland Pharma Limited reported a 38% year-on-year increase in EBITDA and a 34% EBITDA margin in FY 2023-24[3].

Challenges and Opportunities

Challenges

Despite the growth, the market faces several challenges, including technical bottlenecks, cost limitations, and high entry barriers. Additionally, geopolitical tensions and economic fluctuations can impact the supply chain and market dynamics[1][4].

Opportunities

The market presents several opportunities, such as government incentives, emerging markets, and collaborations between stakeholders. The growing consumer demand and the need for innovative solutions in fertility treatments also offer avenues for market expansion[1].

Technological Trends

Technological advancements are a key factor in the growth of the Ganirelix acetate market:

Advancements in GnRH Antagonists

The development of more effective and safer GnRH antagonists is driving the market forward. These advancements improve the efficacy of fertility treatments and reduce side effects[2].

Impact on Market Growth

These technological trends influence market growth by increasing adoption rates and consumer preferences. They also drive innovation, leading to new products and better treatment outcomes[1].

Market Challenges and Opportunities

Market Challenges

The market faces challenges such as technical bottlenecks, cost limitations, and high entry barriers. Ovarian hyperstimulation syndrome (OHSS) is a significant risk associated with the use of Ganirelix acetate, which can impact market growth[2].

Market Opportunities

Despite these challenges, the market offers several opportunities. Government incentives, emerging markets, and collaborations between stakeholders can accelerate market growth. The growing demand for fertility treatments and the need for innovative solutions also present avenues for expansion[1].

Key Takeaways

• The Ganirelix acetate market is growing significantly, driven by increasing demand for fertility treatments and technological advancements.
• The market is segmented by type, application, and region, with key players such as Sun Pharma and Gland Pharma Limited.
• Financial performance is robust, with increasing revenue and EBITDA margins.
• Challenges include technical bottlenecks and cost limitations, but opportunities such as government incentives and emerging markets are substantial.

Frequently Asked Questions (FAQs)

1. What is Ganirelix acetate used for?

Ganirelix acetate is used in fertility treatments to prevent premature ovulation during controlled ovarian stimulation[2].

2. Who are the major players in the Ganirelix acetate market?

Major players include Sun Pharma, ASPEN OSS BV, BCN Peptides, and Gland Pharma Limited[4].

3. What are the key drivers of the Ganirelix acetate market?

Key drivers include increasing demand for fertility treatments, technological advancements, and government incentives[1][4].

4. What are the common side effects of Ganirelix acetate?

Common side effects include mild nausea, stomach pain, headache, vaginal bleeding, and pain or irritation at the injection site[2].

5. How is Ganirelix acetate administered?

Ganirelix acetate is administered subcutaneously once daily during the mid-to-late follicular phase of the menstrual cycle[2].

Sources:

1. 24 Market Reports: "Ganirelix Acetate Market | Size, share, status 2024 forecast to 2030"
2. Medicover Hospitals: "Ganirelix: Uses, Side Effects, Dosage & Precautions"
3. Gland Pharma Limited: "Expanding Capabilities Accelerating Growth - Gland Pharma Limited"
4. OpenPR: "Ganirelix API Market Growth Rate at a CAGR of 5.3% 2024-2030"