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TRELSTAR Drug Patent Profile

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

Trelstar is a drug marketed by Verity and is included in three NDAs. There is one patent protecting this drug.

This drug has forty-six patent family members in thirty-one countries.

The generic ingredient in TRELSTAR is triptorelin pamoate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the triptorelin pamoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Trelstar

Trelstar was eligible for patent challenges on June 15, 2004.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 30, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TRELSTAR

International Patents:	46
US Patents:	1
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	11
Patent Applications:	5,251
Drug Prices:	Drug price information for TRELSTAR
What excipients (inactive ingredients) are in TRELSTAR?	TRELSTAR excipients list
DailyMed Link:	TRELSTAR at DailyMed

See drug prices for TRELSTAR

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

Constraining patent/regulatory exclusivity:

10,166,181

NDA:

022437

Dosage:

INJECTABLE;INTRAMUSCULAR

^*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 TRELSTAR

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

Sponsor	Phase
Prostate Cancer Foundation	Phase 2
Panbela Therapeutics	Phase 2
Bristol-Myers Squibb	Phase 2

See all TRELSTAR clinical trials

US Patents and Regulatory Information for TRELSTAR

TRELSTAR is protected by one US patents.

This potential generic entry date is based on patent 10,166,181.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000		RX	Yes	Yes
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001		RX	Yes	Yes
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	022437-001	Mar 10, 2010		RX	Yes	Yes	10,166,181		Y

Expired US Patents for TRELSTAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001	5,776,885
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000	5,134,122
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001	5,225,205

International Patents for TRELSTAR

When does loss-of-exclusivity occur for TRELSTAR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRELSTAR around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2209937	WATER INSOLUBLE POLYPEPTIDES
Italy	1225148	LIBERAZIONE PROLUNGATA E CONTROLLATA DI PEPTIDI INSOLUBILI IN ACQUA
Australia	619996

TRELSTAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TRELSTAR (Triptorelin)

Overview of TRELSTAR

TRELSTAR, also known as triptorelin, is a synthetic analogue of the naturally occurring hormone gonadotropin-releasing hormone (GnRH). It is used primarily in the treatment of hormone-dependent conditions such as prostate cancer, endometriosis, and central precocious puberty. Here’s a detailed look at the market dynamics and financial trajectory of TRELSTAR.

Market Size and Growth

The global triptorelin market, which includes TRELSTAR, is projected to experience significant growth. As of 2023, the market is valued at approximately $955.50 million and is expected to grow to $1,556.41 million by 2033, with a Compound Annual Growth Rate (CAGR) of 5% during this period[1].

Key Drivers of Market Growth

Several factors are driving the growth of the triptorelin market:

Increasing Prevalence of Endocrine Disorders

The rising incidence of endocrine disorders, such as prostate cancer and endometriosis, is a major driver. For instance, in South Africa, nearly 14,000 men were newly diagnosed with prostate cancer in 2020, highlighting the growing need for effective treatments[4].

Government Initiatives and Awareness

Government initiatives to raise awareness about endocrine disorders are also contributing to market expansion. Increased awareness leads to higher demand for treatments like TRELSTAR[1].

Expanding Healthcare Infrastructure

The growing number of hospitals and pharmacies, particularly in emerging markets, is facilitating greater access to triptorelin therapies[1].

Research and Development

Ongoing research and development by private producers and research institutions are exploring new therapeutic indications for triptorelin, such as breast cancer and HIV. This expanded use is expected to further boost market growth[1].

Therapeutic Indications

TRELSTAR is used in various therapeutic areas:

Prostate Cancer

TRELSTAR works by reducing testosterone levels, which are essential for the growth of hormone-dependent prostate cancer. This reduction in testosterone can stop the growth of tumors and alleviate symptoms such as painful bones, weight loss, and difficulty urinating[2][4].

Endometriosis

TRELSTAR is used to treat endometriosis by reducing the production of gonadotropins, thereby decreasing estrogen levels and alleviating pain associated with the condition[5].

Central Precocious Puberty

It is also effective in treating central precocious puberty by reducing the secretion of gonadotropins, thus delaying premature puberty[1].

Market Challenges

Despite the growth potential, there are several challenges facing the triptorelin market:

High Cost of Therapy

The high cost of TRELSTAR therapy is a significant barrier to market growth. This cost can be prohibitive for many patients, especially in regions with limited healthcare resources[1].

Side Effects

TRELSTAR is associated with several side effects, including hot flashes, muscle aches, loss of appetite, and decreased sexual drive. These side effects can limit patient compliance and impact market growth[2].

Geographical Market

North America

North America holds the largest market share for triptorelin, driven by advanced healthcare infrastructure and higher awareness of endocrine disorders[1].

Emerging Markets

Partnerships between pharmaceutical companies and local players in regions like South Africa are expanding the market reach. For example, Debiopharm's partnership with Aspen to launch TRELSTAR in South Africa is expected to increase access to this treatment in the region[4].

Competitive Landscape

The triptorelin market is competitive, with several key players:

Debiopharm

Debiopharm, the developer of TRELSTAR, has been active in forming partnerships to expand the drug's reach. Their agreement with Aspen to launch TRELSTAR in South Africa is a notable example[4].

Amneal Pharmaceuticals

Amneal Pharmaceuticals has entered into a long-term partnership with Orion Corporation to commercialize complex generic medications, including triptorelin, in various regions[1].

Financial Assistance and Access

To address the high cost of therapy, several financial assistance programs are available:

Copay Assistance

Programs like AmeriPharma Specialty Care offer copay assistance, reducing out-of-pocket expenses for patients. These programs help in making TRELSTAR more accessible to those in need[2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of TRELSTAR:

Government Policies

Government policies regarding the use of triptorelin vary by country and can significantly impact the market. Continuous monitoring of the political climate is necessary to anticipate changes in the regulatory framework[1].

Economic Factors

Economic factors such as GDP growth, inflation, and currency exchange rates can influence the cost of production and distribution, thereby affecting the market pricing of TRELSTAR[1].

Technological Advancements

Technological advancements are crucial for the triptorelin market:

Production Costs

Advances in technology can lower production costs and enhance the efficacy and safety of the drug. This can make TRELSTAR more competitive in the market[1].

Marketing and Distribution

Technology also aids in the marketing and distribution of the drug, improving its reach and accessibility[1].

Key Takeaways

• The global triptorelin market, including TRELSTAR, is projected to grow from $955.50 million in 2023 to $1,556.41 million by 2033 at a CAGR of 5%.
• The market is driven by the increasing prevalence of endocrine disorders, government initiatives, and expanding healthcare infrastructure.
• TRELSTAR is used in treating prostate cancer, endometriosis, and central precocious puberty.
• High costs and side effects are significant challenges to market growth.
• North America holds the largest market share, with emerging markets showing potential for growth through partnerships.
• Financial assistance programs and technological advancements are crucial for improving access and reducing costs.

FAQs

What is TRELSTAR used for?

TRELSTAR (triptorelin) is used primarily for the treatment of hormone-dependent conditions such as prostate cancer, endometriosis, and central precocious puberty.

What are the side effects of TRELSTAR?

Common side effects include hot flashes, muscle aches, loss of appetite, decreased sexual drive, and various other symptoms related to the reduction of testosterone levels.

How does TRELSTAR work in treating prostate cancer?

TRELSTAR works by reducing blood testosterone levels, which are essential for the growth of hormone-dependent prostate cancer, thereby stopping the growth of tumors and alleviating symptoms.

What are the market challenges for TRELSTAR?

The high cost of therapy and associated side effects are significant challenges to market growth.

Are there financial assistance programs available for TRELSTAR?

Yes, several copay assistance programs and financial aid options are available to help reduce the financial burden of TRELSTAR therapy.

Sources

1. Future Market Insights: Triptorelin Market Size, Growth, Trends & Forecast 2033
2. AmeriPharma Specialty Care: Trelstar Copay Assistance
3. Lantern Pharma Inc.: Annual Reports
4. Debiopharm: Press Release - Debiopharm and Aspen Partner to Launch Prostate Cancer Drug Trelstar in South Africa
5. Johns Hopkins Medicine: TRELSTAR (triptorelin pamoate) Criteria