FACTREL Drug Patent Profile

Which patents cover Factrel, and when can generic versions of Factrel launch?

Factrel is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in FACTREL is gonadorelin hydrochloride. There are seven drug master file entries for this compound. Additional details are available on the gonadorelin hydrochloride profile page.

Summary for FACTREL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	21
DailyMed Link:	FACTREL at DailyMed

US Patents and Regulatory Information for FACTREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982		DISCN	No	No
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-002	Sep 30, 1982		DISCN	No	No
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982		DISCN	No	No

Expired US Patents for FACTREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-002	Sep 30, 1982
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-002	Sep 30, 1982
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982

International Patents for FACTREL

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

Country	Patent Number	Title	Estimated Expiration
Israel	48514	HEXAPEPTIDE INTERMEDIATE FOR THE PREPARATION OF THE LH-AND FSH-RELEASING HORMONE
Canada	1034568
Belgium	865156
Israel	41313
Japan	S5729462
Switzerland	589608

FACTREL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Parenteral Drugs: A Comprehensive Overview

Introduction to Parenteral Drugs

Parenteral drugs are administered via injection, either intravenously, intramuscularly, or subcutaneously, bypassing the digestive system to ensure rapid and effective delivery of the medication. This method is crucial for various medical conditions, including those requiring immediate treatment or where oral administration is not feasible.

Global Market Outlook

The global parenteral drug market is poised for significant growth. As of 2024, the market is valued at US$ 595.63 billion and is projected to reach US$ 1,020.17 billion by 2034, growing at a Compound Annual Growth Rate (CAGR) of 5.5%[1].

Key Drivers of Growth

Increasing Demand for Biologic Drugs

The rising consumption of biologic drugs globally is a major driver. Many biologic drugs are available in injectable forms, increasing the count of parenteral drugs in the pipeline and generating lucrative opportunities for market players[1].

Advancements in Technology

The adoption of single-use strategies for proteins, antibodies, vaccines, cell therapy, and gene therapy is on the rise. Additionally, the FDA's recommendation for automation in pharmaceutical production is enhancing safety and efficiency, contributing to market growth[1].

Regulatory Frameworks

Intensifying regulatory frameworks, particularly the use of isolator technology to ensure patient safety, are expanding the application scope of parenteral drugs[1].

Segmental Analysis

Oncology Segment

The demand for parenteral drugs in oncology is expected to increase at a CAGR of 8.3%, reaching a market value of US$ 233.09 billion by 2034. This segment is driven by the need for targeted and effective treatments for various types of cancer[1].

Large Molecule-Based Drugs

Global sales of large molecule-based parenteral drugs are projected to rise at a CAGR of 6.5%, reaching US$ 696.42 billion by 2034. This growth is attributed to the increasing use of monoclonal antibodies and other biologic therapies[1].

Regional Market Dynamics

United States

The United States is a significant market, with a projected value of US$ 296.97 billion by 2034, growing at a CAGR of 4.9%. Biopharma and pharma companies are focusing on program development and manufacturing to meet the surging demand for parenteral products[1].

India

India's parenteral drug market is forecasted to grow at a CAGR of 9.7%, reaching US$ 77.54 billion by 2034. The adoption of new treatments and the offset of patent lifecycles are key factors driving this growth[1].

Japan

The Japanese market, though growing at a slower pace with a CAGR of 2.3%, remains a significant player in the Asia-Pacific region[1].

Competitive Landscape

Major players in the parenteral drug market include Merck & Co Inc., Pfizer Inc., Teva Pharmaceutical Industries Ltd., Novartis AG, Sanofi S.A., and Johnson & Johnson. These companies are investing heavily in research and development to expand their product portfolios and meet the increasing demand for parenteral drugs[1].

Financial Performance and Funding

Revenue and Sales

Companies like Travere Therapeutics have seen significant revenue growth from their parenteral drug products. For example, Travere's net product sales of FILSPARI (sparsentan) totaled $35.6 million in the third quarter of 2024, reflecting strong commercial performance[2].

Research and Development Expenses

Research and development expenses are a critical component of the financial trajectory for parenteral drug companies. For instance, Fractyl Health's R&D expenses increased to $38.0 million in 2023, driven by clinical, medical, and personnel-related expenditures[5].

Funding Challenges

The biotech sector faces funding challenges due to higher real interest rates and weak biotech valuations. However, positive clinical data releases and the impact of patent cliffs on key players are expected to support a positive trend in mergers and acquisitions and generate excitement in the biotech market[3].

Examples and Case Studies

FILSPARI (Sparsentan)

FILSPARI, developed by Travere Therapeutics, is a notable example of a parenteral drug that has received full FDA approval as the only non-immunosuppressive treatment for IgA Nephropathy (IgAN). Its commercial success highlights the potential for innovative parenteral drugs in addressing unmet medical needs[2].

Revita® by Fractyl Health

Fractyl Health's Revita® is another example, focused on treating type 2 diabetes and obesity. Although the commercial pilot is in its early stages, the company's progress in clinical trials and funding through an initial public offering underscores the potential for parenteral drugs in emerging therapeutic areas[5].

Challenges and Opportunities

Regulatory Compliance

Ensuring compliance with stringent regulatory frameworks is a significant challenge. However, this also presents opportunities for companies to differentiate themselves through the adoption of advanced technologies and safety protocols[1].

Generic and Biosimilar Competition

The rise of generic and biosimilar drugs poses a competitive challenge but also stimulates innovation. Companies are increasing their expenditure on developing novel medicines to stay competitive[1].

Key Takeaways

• The global parenteral drug market is projected to grow significantly, driven by increasing demand for biologic drugs and technological advancements.
• Regional markets such as the United States, India, and Japan are expected to contribute substantially to this growth.
• Major pharmaceutical companies are investing heavily in R&D to expand their product portfolios.
• Funding challenges in the biotech sector may impact short-term growth but are expected to clear as the market adjusts to new valuations.
• Innovative products like FILSPARI and Revita® highlight the potential for parenteral drugs in addressing unmet medical needs.

FAQs

1. What is the projected growth rate of the global parenteral drug market from 2024 to 2034? The global parenteral drug market is expected to grow at a CAGR of 5.5% from 2024 to 2034[1].

2. Which segment is expected to drive the most growth in the parenteral drug market? The oncology segment is expected to drive significant growth, with a projected CAGR of 8.3% and reaching a market value of US$ 233.09 billion by 2034[1].

3. What are the key drivers of growth in the parenteral drug market? Key drivers include the increasing demand for biologic drugs, advancements in technology, and intensifying regulatory frameworks[1].

4. How is the competitive landscape shaping up in the parenteral drug market? Major players such as Merck & Co Inc., Pfizer Inc., and Novartis AG are investing in R&D and expanding their product portfolios to meet the increasing demand[1].

5. What are the funding challenges faced by companies in the biotech sector? Companies face funding challenges due to higher real interest rates and weak biotech valuations, although positive clinical data and patent cliffs are expected to support a positive trend in M&As[3].

Cited Sources

1. Fact.MR: Parenteral Drug Market Size and Share | Statistics - 2034
2. Travere Therapeutics: Travere Therapeutics Reports Third Quarter 2024 Financial Results
3. PharmaVoice: PharmaVoice's Crystal Ball: Perspectives on the financial future
4. Future Market Insights: Precocious Puberty Treatment Market Size, Share
5. Fractyl Health: Fractyl Health Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update