GEREF Drug Patent Profile

When do Geref patents expire, and what generic alternatives are available?

Geref is a drug marketed by Emd Serono and Emd Serono Inc and is included in two NDAs.

The generic ingredient in GEREF is sermorelin acetate. There is one drug master file entry for this compound. Additional details are available on the sermorelin acetate profile page.

Summary for GEREF

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	25
Patent Applications:	954
DailyMed Link:	GEREF at DailyMed

US Patents and Regulatory Information for GEREF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Emd Serono	GEREF	sermorelin acetate	INJECTABLE;INJECTION	019863-001	Dec 28, 1990		DISCN	Yes	No
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-001	Sep 26, 1997		DISCN	Yes	No
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-002	Sep 26, 1997		DISCN	Yes	No

Expired US Patents for GEREF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-002	Sep 26, 1997	4,517,181
Emd Serono	GEREF	sermorelin acetate	INJECTABLE;INJECTION	019863-001	Dec 28, 1990	4,517,181
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-002	Sep 26, 1997	4,703,035

International Patents for GEREF

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

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	77185
Hungary	199508	PROCESS FOR PRODUCING GRF ANALOGUES AND PHARMACEUTICAL COMPOSITIONS COMPRISING SAME AS ACTIVE INGREDIENT
Norway	842148

GEREF Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Geref (Sermorelin Acetate)

Overview of Geref (Sermorelin Acetate)

Geref, also known as sermorelin acetate, is a synthetic analogue of the naturally occurring growth hormone-releasing hormone (GHRH). It is developed by EMD Serono, Inc. and is used to treat growth hormone deficiency, particularly in children and adults[4].

Market Context

Pharmaceutical Market Growth

The global pharmaceutical market is experiencing significant growth, projected to reach $1.4 trillion by 2028, driven by the increasing burden of chronic diseases and the need for innovative treatments[3].

Biotechnology and Specialty Drugs

The biotechnology sector, which includes drugs like Geref, is a key driver of this growth. Biotechnology products, including those for rare and chronic conditions, are gaining traction due to their efficacy and the unmet medical needs they address.

Market Dynamics for GHRH Analogues

Demand and Usage

Geref is used in specific medical conditions, such as growth hormone deficiency. The demand for such drugs is influenced by the prevalence of these conditions and the availability of healthcare resources. For instance, the increasing focus on endocrinology and the growing awareness of growth hormone deficiencies are likely to drive the demand for GHRH analogues.

Competitive Landscape

The market for GHRH analogues is relatively niche but competitive. Companies like EMD Serono, Inc. invest heavily in research and development to maintain their market position. The competitive landscape is also influenced by generic and biosimilar entries, although the complexity of biologic drugs often limits the immediate impact of generics[5].

Regulatory Environment

Regulatory approvals and designations play a crucial role in the market dynamics of drugs like Geref. Orphan drug designations, for example, can provide exclusive market rights for a period, which can significantly impact the financial trajectory of a drug. However, the misuse of orphan drug designations to extend market exclusivity, as seen with other drugs, is a regulatory concern[2].

Financial Trajectory

Revenue Projections

While specific revenue projections for Geref are not widely available, the overall market for biotechnology and specialty drugs is expected to grow significantly. The global biotechnology market, for instance, is projected to grow from $1.54 trillion in 2023 to $5.68 trillion by 2033, at a CAGR of 13.95%[1].

Pricing and Market Exclusivity

The pricing of Geref and similar biologic drugs is often high due to the complexity of their development and the limited competition from generics. Market exclusivity, whether through patents or regulatory designations, can help maintain high prices and revenue streams. However, as seen with other biologics, the eventual entry of biosimilars can reduce prices and market share over time[5].

Research and Development Investments

Pharmaceutical companies, including those developing GHRH analogues, invest heavily in research and development. These investments are crucial for maintaining market position and addressing unmet medical needs. For Geref, ongoing research and clinical trials are essential for expanding its indications and maintaining its competitive edge[3].

Key Factors Influencing Market Dynamics

Healthcare Spending and Access

The growth of the pharmerging markets, which include countries like India, China, and Brazil, is driven by increasing healthcare spending and access to healthcare services. This trend is likely to benefit drugs like Geref, especially if they are approved for use in these markets[1].

Technological Advancements

Technological advancements in biotechnology and pharmaceutical research are driving innovation and efficiency in drug development. For Geref, advancements in delivery systems and formulations could enhance its efficacy and patient compliance.

Government Policies and Regulations

Government policies, particularly those promoting localization and generic drug use, can impact the market dynamics of specialty drugs. However, for biologics like Geref, regulatory support and incentives for innovation are more likely to influence their financial trajectory[1].

Illustrative Statistics

• The global biotechnology market is projected to grow from $1.54 trillion in 2023 to $5.68 trillion by 2033, at a CAGR of 13.95%[1].
• The pharmaceutical market revenue is projected to exceed $1.4 trillion by 2028, driven by the escalating global burden of chronic diseases[3].

Quotes from Industry Experts

"Our goal is to try to get it right," said Rao, referring to the FDA's efforts to ensure that orphan drug designations are used appropriately. "There are over 7,000 rare diseases, likely more, the vast majority of which have nothing … I want to ensure that we continue to keep our eye on that prize."[2]

Examples and Analogies

The strategy of extending market exclusivity through multiple orphan drug designations, as seen with drugs like Humira, highlights the complexities and opportunities in the biologic drug market. For Geref, similar strategies could be employed to maximize its market presence, though this would need to align with regulatory guidelines and ethical considerations[2].

Key Takeaways

• Market Growth: The global pharmaceutical and biotechnology markets are experiencing significant growth, driven by chronic diseases and innovative treatments.
• Regulatory Environment: Regulatory approvals and designations are crucial for the financial trajectory of drugs like Geref.
• Competitive Landscape: The market for GHRH analogues is competitive, with a focus on innovation and regulatory support.
• Healthcare Spending: Increasing healthcare spending and access in pharmerging markets can drive demand for specialty drugs.
• Technological Advancements: Innovations in biotechnology and pharmaceutical research are key drivers of market dynamics.

FAQs

Q: What is Geref (sermorelin acetate) used for? A: Geref is used to treat growth hormone deficiency, particularly in children and adults.

Q: How does the global pharmaceutical market impact Geref? A: The growing global pharmaceutical market, driven by chronic diseases and innovative treatments, creates a favorable environment for drugs like Geref.

Q: What role do regulatory approvals play in the market dynamics of Geref? A: Regulatory approvals and designations, such as orphan drug designations, can significantly impact the market exclusivity and revenue of Geref.

Q: How does the competitive landscape affect Geref? A: The competitive landscape for GHRH analogues is influenced by innovation, regulatory support, and the entry of generics or biosimilars.

Q: What are the key factors driving the financial trajectory of Geref? A: Key factors include healthcare spending, technological advancements, government policies, and regulatory environment.

Sources

1. Pharmerging Market Size to Hit Around USD 4.13 Trillion by 2033 - Biospace
2. Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies - KFF Health News
3. Investment Trends in Pharmaceutical Research - DrugBank Blog
4. Sermorelin acetate - University of Maryland, Baltimore
5. The Effect on Federal Spending of Legislation Creating a Regulatory Pathway for Follow-on Biologics - Duke University Economics Department