TRINALIN Drug Patent Profile

Which patents cover Trinalin, and what generic alternatives are available?

Trinalin is a drug marketed by Schering and is included in one NDA.

The generic ingredient in TRINALIN is azatadine maleate; pseudoephedrine sulfate. There are two drug master file entries for this compound. Additional details are available on the azatadine maleate; pseudoephedrine sulfate profile page.

Summary for TRINALIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	49
DailyMed Link:	TRINALIN at DailyMed

US Patents and Regulatory Information for TRINALIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	TRINALIN	azatadine maleate; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	018506-001	Mar 23, 1982		DISCN	No	No

Expired US Patents for TRINALIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	TRINALIN	azatadine maleate; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	018506-001	Mar 23, 1982	3,419,565
Schering	TRINALIN	azatadine maleate; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	018506-001	Mar 23, 1982	3,717,647

International Patents for TRINALIN

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

Country	Patent Number	Title	Estimated Expiration
Switzerland	537929	Verfahren zur Herstellung von 5-Substituierten Aza-dibenzo-cycloheptenen (Cpds. of general formulae I and II, and intermediates of general formula III where A = H or one or more of the following:- halogen, lower alkyl, -CF)
Germany	1795745	ARZNEIMITTEL, ENTHALTEND 5-SUBSTITUIERTE 4-AZA-DIBENZOCYCLOHEPTENE
Germany	1695853	4-AZADIBENZOCYCLOHEPTENDERIVATE UND VERFAHREN ZU IHRER HERSTELLUNG
Austria	258906
Switzerland	533115	Verfahren zur Herstellung von 5-substituierten Aza-dibenzo-cycloheptenen

TRINALIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Triptorelin (TRINALIN)

Market Overview

Triptorelin, often marketed under the brand name TRINALIN, is a synthetic decapeptide analog of the naturally occurring gonadotropin-releasing hormone (GnRH). It is widely used in the treatment of various conditions, including prostate cancer, central precocious puberty, endometriosis, and uterine fibroids.

Market Size and Growth

The triptorelin market is anticipated to experience significant growth over the coming years. As of 2023, the market was valued at approximately $955.50 million and is projected to reach $1,556.41 million by 2033, growing at a Compound Annual Growth Rate (CAGR) of 5% during this period[1][4].

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 endometriosis, prostate cancer, and central precocious puberty is a major driver. The growing awareness about these conditions and the available treatment options is also contributing to market expansion[1][4].

Government Initiatives

Government initiatives aimed at raising awareness about endocrine disorders are further fueling market growth. These initiatives help in early diagnosis and treatment, thereby increasing the demand for triptorelin[1].

Research and Development

Ongoing research and development by private producers and research groups are expanding the potential therapeutic indications of triptorelin. Clinical trials investigating its use in breast cancer and HIV are underway, which could open new avenues for the drug[1].

Technological Advancements

Advancements in technology are expected to lower production costs and enhance the efficacy and safety of triptorelin. These advancements also aid in better marketing and distribution strategies[1].

Restraints on Market Growth

Despite the positive outlook, there are several factors that could limit market growth:

High Cost of Therapy

The high cost associated with triptorelin therapy is a significant restraint. This cost can be prohibitive for many patients, especially in regions with limited healthcare resources[1].

Side Effects

The negative side effects associated with triptorelin use are another constraint. Increasing public awareness of these side effects could lead to a preference for alternative treatments[1].

Market Segmentation

The triptorelin market can be segmented based on various factors:

Therapeutic Indications

• Prostate Cancer: Triptorelin is widely used in the treatment of prostate cancer, and this segment is expected to drive significant market growth.
• Central Precocious Puberty: The growing prevalence of central precocious puberty among children is another key driver.
• Endometriosis and Uterine Fibroids: Triptorelin is also used in treating these conditions, contributing to market expansion[1][4].

Distribution Channels

• Hospital Pharmacies: These are the primary distribution channels for triptorelin, given the need for medical supervision.
• Online Pharmacies: Online pharmacies are also gaining traction, especially in regions with high demand for hormone therapy[4].

Geographical Regions

• North America: This region is expected to have the highest gain by the end of the forecast period, driven by growing demand for hormone therapy and a high number of transgender individuals seeking hormone treatment[4].
• Asia-Pacific: This region is projected for rapid expansion due to a large patient pool and streamlined procedures, making it an attractive location for clinical trials and treatment[4].

Competitive Landscape

The triptorelin market is competitive, with several key players:

Key Competitors

Pharmaceutical manufacturers are upgrading their product portfolios through inorganic expansion techniques to maintain their market position. Companies are also focusing on expanding their presence in various geographical areas[1].

Market Strategies

Companies are adopting strategies such as partnerships, collaborations, and technological advancements to stay competitive. For instance, the integration of virtual services in clinical trials is becoming more prevalent[3].

Financial Trajectory

The financial performance of the triptorelin market is robust and is expected to continue growing:

Revenue Projections

• 2023: The market was valued at $955.50 million.
• 2033: The market is projected to reach $1,556.41 million[1].

CAGR

The market is expected to grow at a CAGR of 5% from 2023 to 2033[1].

Economic Factors

Economic factors such as GDP growth, inflation, and currency exchange rates can impact the market. The cost of production and distribution affects the pricing of the drug, which in turn influences market dynamics[1].

Regulatory Landscape

The regulatory environment plays a crucial role in the triptorelin market:

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 identify potential changes in the regulatory framework[1].

Compliance and Approval

Clinical trials and regulatory approvals are critical for the expansion of triptorelin's therapeutic indications. Compliance with regulatory standards is essential for market growth[3].

Key Takeaways

• The triptorelin market is expected to grow significantly, driven by increasing prevalence of endocrine disorders and government initiatives.
• Technological advancements and ongoing research are expanding the drug's therapeutic indications.
• High costs and side effects are potential restraints on market growth.
• North America and the Asia-Pacific region are key markets due to their large patient pools and streamlined procedures.
• The competitive landscape is characterized by key players upgrading their product portfolios and expanding geographically.

FAQs

What is the projected market size of triptorelin by 2033?

The triptorelin market is projected to reach $1,556.41 million by 2033[1].

What are the primary drivers of the triptorelin market?

The primary drivers include the increasing prevalence of endocrine disorders, government initiatives, and ongoing research and development[1].

Which regions are expected to dominate the triptorelin market?

North America and the Asia-Pacific region are expected to be the dominant markets due to high demand and favorable regulatory environments[4].

What are the main therapeutic indications for triptorelin?

Triptorelin is primarily used in the treatment of prostate cancer, central precocious puberty, endometriosis, and uterine fibroids[1][4].

How does the regulatory landscape impact the triptorelin market?

Government policies and regulatory frameworks significantly impact the market. Continuous monitoring of these factors is necessary to identify potential changes that could influence market dynamics[1].

Sources

1. Future Market Insights: Triptorelin Market Size, Growth, Trends & Forecast 2033
2. Trinseo: Trinseo Reports Fourth Quarter and Full-Year 2023 Financial Results
3. GlobeNewswire: Clinical Trials Market Value to Reach USD 887.0 Billion by 2032
4. Research Nester: Triptorelin Market Size & Share, Growth Forecast 2024-2036