TRIPTORELIN PAMOATE - Generic Drug Details

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

Triptorelin pamoate is the generic ingredient in two branded drugs marketed by Azurity and Verity, and is included in four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Triptorelin pamoate has forty-six patent family members in thirty-one countries.

There are two drug master file entries for triptorelin pamoate. Two suppliers are listed for this compound.

Summary for TRIPTORELIN PAMOATE

International Patents:	46
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	17
Patent Applications:	6,823
What excipients (inactive ingredients) are in TRIPTORELIN PAMOATE?	TRIPTORELIN PAMOATE excipients list
DailyMed Link:	TRIPTORELIN PAMOATE at DailyMed

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

Constraining patent/regulatory exclusivity:

10,166,181

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 TRIPTORELIN PAMOATE

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

Sponsor	Phase
Cancer Research Antwerp	Phase 2
Janssen Pharmaceutica	Phase 2
National Cancer Institute (NCI)	Phase 1/Phase 2

See all TRIPTORELIN PAMOATE clinical trials

Medical Subject Heading (MeSH) Categories for TRIPTORELIN PAMOATE

Antineoplastic Agents, Hormonal

Luteolytic Agents

Anatomical Therapeutic Chemical (ATC) Classes for TRIPTORELIN PAMOATE

L02AE	Gonadotropin releasing hormone analogues
L02A	HORMONES AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for TRIPTORELIN PAMOATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	TRIPTODUR KIT	triptorelin pamoate	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	208956-001	Jun 29, 2017		RX	Yes	Yes
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000		RX	Yes	Yes
Azurity	TRIPTODUR KIT	triptorelin pamoate	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	208956-001	Jun 29, 2017		RX	Yes	Yes	10,166,181		Y
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	022437-001	Mar 10, 2010		RX	Yes	Yes	10,166,181		Y

Expired US Patents for TRIPTORELIN PAMOATE

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
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	022437-001	Mar 10, 2010	5,776,885

International Patents for TRIPTORELIN PAMOATE

Country	Patent Number	Title	Estimated Expiration
Cyprus	1120891
Japan	5419169
Denmark	2164467
Japan	2010529106

TRIPTORELIN PAMOATE Market Analysis and Financial Projection Experimental

Global Triptorelin Market: Dynamics and Financial Trajectory

Introduction to Triptorelin Pamoate

Triptorelin pamoate, a synthetic decapeptide agonist analog of gonadotropin-releasing hormone (GnRH), is a pivotal drug in the treatment of various hormone-sensitive conditions. It works by initially stimulating the pituitary gland to release luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which temporarily increases testosterone levels. However, with continued use, the pituitary gland reduces the production of LH and FSH, leading to a decrease in testosterone levels, thereby slowing or stopping the growth of testosterone-dependent cancer cells[2].

Market Size and Growth Projections

The global triptorelin market is poised for significant growth, with projections indicating a rise from approximately USD 955.50 million in 2023 to USD 1556.41 million by 2033. This growth is expected to occur at a compound annual growth rate (CAGR) of 5% over the next decade[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Endometriosis

One of the primary drivers behind the surge in triptorelin demand is the increasing prevalence of endometriosis among women worldwide. Endometriosis, a condition affecting millions, has made triptorelin a preferred treatment option due to its efficacy in reducing estrogen levels[1][4].

Rise in Central Precocious Puberty

The market is also seeing an increase in cases of central precocious puberty, a condition characterized by the early onset of puberty in children under the age of nine. This condition is linked with a higher risk of developing cancers such as salivary gland cancer and prostate cancer, further driving the demand for triptorelin[1].

Growing Incidence of Cancer

The rising incidence of cancer, particularly prostate cancer, is another significant factor contributing to the market's expansion. In 2023, the cancer category accounted for more than 25% of the total triptorelin industry share[1].

Regional Outlook

North America

North America, particularly the United States, is expected to dominate the triptorelin market due to the increased incidence of prostate cancer and the rising demand for hormone therapy among men[1].

Europe

Europe, with Germany and France as key contributors, is anticipated to be a significant market. Government initiatives for cancer awareness and early diagnosis, along with increasing healthcare costs, are driving growth in this region[1].

Latin America

Latin America, led by Brazil and Mexico, is seeing growth due to government programs for cancer awareness and early diagnosis, as well as rising healthcare costs[1].

Asia Pacific and Middle East & Africa

The Asia Pacific and Middle East & Africa regions are experiencing growth driven by the increasing frequency of endocrine disorders and the expansion of hospitals and pharmacies. Growing awareness about available treatment options is also a key factor[1].

Market Segmentation

Route of Administration

The triptorelin market share from the intradermal sector is expected to increase at a CAGR of about 4.5% from 2023 to 2033. The triptorelin embonate segment is also projected to grow, with a CAGR of more than 5% over the same period[1].

Therapeutic Applications

Triptorelin is primarily used in the treatment of prostate cancer, endometriosis, and central precocious puberty. Its use in other types of cancer, such as breast cancer and salivary gland cancer, is also being explored through ongoing clinical trials[1][4].

Competitive Landscape

The triptorelin market is characterized by a dynamic competitive environment, with key players such as LGM Pharma, Ipsen Pharma, BACHEM, Ferring B.V., Merck & Co., Inc., and Dr. Reddy’s Laboratories Ltd. These companies are focusing on partnerships and collaborations to enhance their market influence[1].

Novel Innovations and Advancements

Several clinical trials are underway to investigate the potential future use of triptorelin in conditions like breast cancer and human immunodeficiency virus (HIV). Technological advancements are also expected to lower production costs and improve the drug's efficacy and safety[4].

Economic and Regulatory Factors

Economic factors such as GDP growth, inflation, and currency exchange rates can impact the supply and demand of triptorelin, affecting its pricing and market dynamics. The political climate and regulatory policies in various countries also play a significant role in shaping the market[4].

Challenges and Limitations

Despite the growth prospects, the triptorelin market faces challenges such as the high cost of therapy and the adverse effects associated with its use. These factors are projected to limit market growth during the forecast period[4].

Key Takeaways

• Market Growth: The global triptorelin market is expected to grow from USD 955.50 million in 2023 to USD 1556.41 million by 2033 at a CAGR of 5%.
• Regional Dominance: North America, particularly the United States, is expected to dominate the market, followed by Europe and other regions.
• Therapeutic Applications: Triptorelin is primarily used in treating prostate cancer, endometriosis, and central precocious puberty.
• Competitive Landscape: Key players are focusing on partnerships and collaborations to enhance their market position.
• Challenges: High therapy costs and adverse effects are potential limitations to market growth.

FAQs

What is the primary mechanism of action of triptorelin pamoate?

Triptorelin pamoate works by initially stimulating the pituitary gland to release LH and FSH, which temporarily increases testosterone levels. With continued use, it reduces the production of LH and FSH, leading to lower testosterone levels[2].

Which regions are expected to drive the growth of the triptorelin market?

North America, Europe, Latin America, and the Asia Pacific and Middle East & Africa regions are expected to drive the growth of the triptorelin market, each with their unique drivers such as increasing cancer incidence, government initiatives, and expanding healthcare infrastructure[1].

What are the main therapeutic applications of triptorelin?

Triptorelin is primarily used in the treatment of prostate cancer, endometriosis, and central precocious puberty. It is also being studied for use in other types of cancer like breast cancer and salivary gland cancer[1][4].

Who are the key players in the triptorelin market?

Key players include LGM Pharma, Ipsen Pharma, BACHEM, Ferring B.V., Merck & Co., Inc., and Dr. Reddy’s Laboratories Ltd. These companies are focusing on partnerships and collaborations to enhance their market influence[1].

What are the potential challenges facing the triptorelin market?

The high cost of therapy and the adverse effects associated with its use are projected to limit market growth during the forecast period[4].

How is the regulatory environment impacting the triptorelin market?

The regulatory environment, including government policies and awareness programs, significantly impacts the triptorelin market. Continuous monitoring of the political climate is necessary to identify potential changes in the regulatory framework[4].