HISTRELIN ACETATE - Generic Drug Details

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

Histrelin acetate is the generic ingredient in three branded drugs marketed by Endo Operations and Shire, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Histrelin acetate has three patent family members in three countries.

There is one drug master file entry for histrelin acetate. One supplier is listed for this compound.

Summary for HISTRELIN ACETATE

International Patents:	3
US Patents:	1
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	5
Patent Applications:	6,655
What excipients (inactive ingredients) are in HISTRELIN ACETATE?	HISTRELIN ACETATE excipients list
DailyMed Link:	HISTRELIN ACETATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for HISTRELIN ACETATE

Dosage:

IMPLANT;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for HISTRELIN ACETATE

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

Sponsor	Phase
NRG Oncology	Phase 3
Southwest Oncology Group	Phase 3
National Cancer Institute (NCI)	Phase 3

See all HISTRELIN ACETATE clinical trials

Pharmacology for HISTRELIN ACETATE

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

Anatomical Therapeutic Chemical (ATC) Classes for HISTRELIN 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 HISTRELIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-002	Dec 24, 1991		DISCN	No	No
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-003	Dec 24, 1991		DISCN	No	No
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058-001	May 3, 2007		RX	Yes	Yes
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-001	Dec 24, 1991		DISCN	No	No

Expired US Patents for HISTRELIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-001	Dec 24, 1991
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058-001	May 3, 2007
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-003	Dec 24, 1991
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-002	Dec 24, 1991

International Patents for HISTRELIN ACETATE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006009801
Canada	2570960	COMPOSITIONS ET METHODES DE TRAITEMENT DE LA PUBERTE CENTRALE PRECOCE (COMPOSITIONS AND METHODS FOR TREATING CENTRAL PRECOCIOUS PUBERTY)
European Patent Office	1773293	COMPOSITIONS ET METHODES DE TRAITEMENT DE LA PUBERTE CENTRALE PRECOCE (COMPOSITIONS AND METHODS FOR TREATING CENTRAL PRECOCIOUS PUBERTY)

HISTRELIN ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Histrelin Acetate

Introduction

Histrelin acetate, a synthetic nonapeptide analog of gonadotropin-releasing hormone (GnRH), is a crucial treatment for central precocious puberty (CPP) and other conditions. This article delves into the market dynamics and financial trajectory of histrelin acetate, highlighting key factors influencing its growth and usage.

Market Size and Growth

The global central precocious puberty market, which includes histrelin acetate, is projected to exhibit significant growth. As of 2022, the market was valued at US$ 1,595.2 million and is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.9% from 2022 to 2030, reaching a value of US$ 2,926.2 million by 2030[1].

Key Drivers of Market Growth

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

Increasing Product Approvals

The approval of new drugs and formulations is a significant driver. For instance, Tolmar Pharmaceuticals received FDA approval for FENSOLVI (leuprolide acetate) in 2020, which, although not histrelin acetate, indicates a favorable regulatory environment for GnRH agonists[1].

Partnerships and Agreements

Market players are engaging in strategic partnerships and agreements to enhance market presence. Debiopharm International SA's exclusive distribution agreement with Arbor Pharmaceuticals for triptorelin 22.5 mg is an example of such collaborations that can boost the market for GnRH agonists, including histrelin acetate[1].

Increasing Availability of Drugs

The commercial availability of drugs like Triptodur in the U.S. for CPP treatment has expanded the market. Histrelin acetate, being another key player, benefits from this increased availability and acceptance of GnRH agonists[1].

Competitive Landscape

The competitive landscape for histrelin acetate is marked by several key players:

Market Players

Companies such as Endo Pharmaceuticals Inc., which manufactures the SUPPRELIN LA implant, are major players. Other notable companies include Teva Pharmaceutical Industries Ltd., AbbVie Inc., Pfizer Inc., and Ipsen Pharma[1].

Product Differentiation

Histrelin acetate, marketed as SUPPRELIN LA, differentiates itself through its unique delivery system—a subcutaneous implant that provides continuous release of histrelin acetate for 12 months. This convenience and efficacy contribute to its market position[2][4].

Treatment Patterns and Efficacy

Clinical Outcomes

Studies have shown that patients treated with histrelin acetate have a longer duration of treatment and lower rates of treatment discontinuation compared to those treated with leuprolide. Additionally, histrelin acetate is associated with lower annual treatment costs[3].

Dosage and Administration

The recommended dose of SUPPRELIN LA is one implant every 12 months, containing 50 mg of histrelin acetate, which delivers approximately 65 mcg of histrelin acetate per day. This continuous release helps in suppressing gonadal steroids effectively[2][4].

Financial Implications

Treatment Costs

The median annual total treatment costs for histrelin acetate are slightly lower compared to leuprolide, with costs ranging from $16,833 to $31,050 per year. This cost-effectiveness can attract more patients and healthcare providers to opt for histrelin acetate[3].

Market Share

While specific market share figures for histrelin acetate are not provided, the overall growth of the CPP market and the increasing adoption of GnRH agonists suggest a positive financial trajectory for histrelin acetate[1].

Regional Market Dynamics

Dominant Regions

North America, particularly the U.S., is expected to hold a dominant position in the global central precocious puberty market due to the increasing availability and approval of drugs for CPP treatment[1].

Challenges and Restraints

COVID-19 Impact

The COVID-19 pandemic has had a limiting effect on the growth of the global central precocious puberty market, including histrelin acetate, due to supply chain disruptions and decreased availability of raw materials and pharmaceutical drugs[1].

Adverse Reactions and Contraindications

Histrelin acetate, like other GnRH agonists, can cause initial transient increases in sex steroids, leading to temporary worsening of symptoms. Additionally, it is contraindicated in patients with hypersensitivity to GnRH or GnRH analogs and in pregnant females due to potential fetal harm[2][4].

Key Takeaways

• Market Growth: The global central precocious puberty market, including histrelin acetate, is projected to grow at a CAGR of 7.9% from 2022 to 2030.
• Product Approvals: Increasing product approvals and regulatory clearances are driving market growth.
• Partnerships: Strategic partnerships among market players are enhancing the market presence of GnRH agonists.
• Efficacy and Cost: Histrelin acetate offers longer treatment durations and lower treatment costs compared to other GnRH agonists.
• Regional Dynamics: North America is expected to dominate the market due to increased drug availability and approvals.
• Challenges: The COVID-19 pandemic and potential adverse reactions are restraints to market growth.

FAQs

What is histrelin acetate used for?

Histrelin acetate is used for the treatment of central precocious puberty (CPP) and for the palliative treatment of advanced prostate cancer.

How is histrelin acetate administered?

Histrelin acetate is administered via a subcutaneous implant that provides continuous release of the drug for 12 months.

What are the common adverse reactions to histrelin acetate?

Common adverse reactions include implant site reactions, initial transient increases in sex steroids, and potential worsening of symptoms during the first few weeks of treatment.

How does histrelin acetate compare to other GnRH agonists in terms of treatment duration and costs?

Histrelin acetate has a longer treatment duration and lower annual treatment costs compared to leuprolide.

What are the contraindications for histrelin acetate?

Histrelin acetate is contraindicated in patients with hypersensitivity to GnRH or GnRH analogs and in pregnant females due to potential fetal harm.

Sources

1. Coherent Market Insights: Central Precocious Puberty Market Size and Forecast to 2030.
2. FDA: SUPPRELIN LA (histrelin acetate) label.
3. PubMed: Clinical characteristics and treatment patterns with histrelin acetate.
4. Elsevier Healthcare Hub: Histrelin - Elsevier healthcare hub.
5. Minnesota.gov: GnRH agonists for pubertal suppression.