Carboprost tromethamine - Generic Drug Details

What are the generic sources for carboprost tromethamine and what is the scope of patent protection?

Carboprost tromethamine is the generic ingredient in two branded drugs marketed by Alembic, Amneal, Ani Pharms, Caplin, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Long Grove Pharms, Micro Labs, Sola Pharms, Steriscience Speclts, Sunny, and Pfizer, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for carboprost tromethamine. Eighteen suppliers are listed for this compound.

Summary for carboprost tromethamine

US Patents:	0
Tradenames:	2
Applicants:	13
NDAs:	13
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	3
Patent Applications:	369
What excipients (inactive ingredients) are in carboprost tromethamine?	carboprost tromethamine excipients list
DailyMed Link:	carboprost tromethamine at DailyMed

Recent Clinical Trials for carboprost tromethamine

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

Sponsor	Phase
Northwestern University	Early Phase 1
C.R.Darnall Army Medical Center	N/A
American University of Beirut Medical Center	N/A

See all carboprost tromethamine clinical trials

Pharmacology for carboprost tromethamine

Drug Class

Prostaglandin Analog

Medical Subject Heading (MeSH) Categories for carboprost tromethamine

Abortifacient Agents, Nonsteroidal

Oxytocics

Anatomical Therapeutic Chemical (ATC) Classes for carboprost tromethamine

G02AD	Prostaglandins
G02A	UTEROTONICS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for carboprost tromethamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Caplin	CARBOPROST TROMETHAMINE	carboprost tromethamine	INJECTABLE;INJECTION	216882-001	Feb 13, 2023	AP	RX	No	No
Pfizer	HEMABATE	carboprost tromethamine	INJECTABLE;INJECTION	017989-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Dr Reddys	CARBOPROST TROMETHAMINE	carboprost tromethamine	INJECTABLE;INJECTION	211941-001	Jul 2, 2019	AP	RX	No	No
Alembic	CARBOPROST TROMETHAMINE	carboprost tromethamine	INJECTABLE;INJECTION	217198-001	Jun 15, 2023	AP	RX	No	No
Gland Pharma Ltd	CARBOPROST TROMETHAMINE	carboprost tromethamine	INJECTABLE;INJECTION	217657-001	Aug 7, 2023	AP	RX	No	No
Micro Labs	CARBOPROST TROMETHAMINE	carboprost tromethamine	INJECTABLE;INJECTION	218013-001	Apr 3, 2024	AP	RX	No	No
Sunny	CARBOPROST TROMETHAMINE	carboprost tromethamine	INJECTABLE;INJECTION	213118-001	Mar 25, 2021	AP	RX	No	No

Expired US Patents for carboprost tromethamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	HEMABATE	carboprost tromethamine	INJECTABLE;INJECTION	017989-001	Approved Prior to Jan 1, 1982	3,728,382

Carboprost tromethamine Market Analysis and Financial Projection Experimental

Carboprost Tromethamine Market Dynamics and Financial Trajectory

Market Overview

Carboprost tromethamine, a prostaglandin analog, is a crucial drug in the treatment of postpartum hemorrhage and in inducing abortion. The market for this drug is experiencing significant growth driven by several key factors.

Market Size and Growth Rate

As of 2023, the global carboprost tromethamine market was valued at approximately USD 1,518.71 million[4][5].

• The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.7% from 2024 to 2032, reaching a value of USD 2,100.63 million by 2032[4].
• Another estimate suggests the market could reach USD 1,850 million by 2030, with a CAGR of 3.06%[5].

Geographical Distribution

North America

• This region holds the largest market share due to a strong healthcare framework and high awareness of maternal health in countries like the United States and Canada[4].
• The United States, in particular, has a high rate of unintended pregnancies, which contributes to the demand for carboprost tromethamine. For instance, in 2021, the United States had approximately 30.6% of unintended pregnancies[1].

Asia-Pacific

• This region is expected to be the fastest-growing market for carboprost tromethamine, driven by increasing healthcare infrastructure and growing awareness of maternal health issues[1].

Application Segments

Postpartum Hemorrhage Treatment

• The effectiveness of carboprost tromethamine in treating postpartum hemorrhage, with a reported efficacy of 84.0-96.0%, is a significant driver for its demand[1].
• The escalating cases of postpartum hemorrhage globally are pushing the need for reliable and effective treatments, thereby boosting the market.

Pregnancy Abortion

• The pregnancy abortion segment has seen a sharp rise due to changing social perspectives on family planning and reproductive options. Government policies and the accessibility of healthcare services related to abortion also influence market growth[4].

Distribution Channels

Hospital Pharmacies

• Hospital pharmacies dominate the distribution channel segment due to the critical need for carboprost tromethamine in hospital settings where comprehensive obstetric care is provided[4].

Key Players and Market Concentration

• The carboprost tromethamine market is fragmented and competitive, with several major players such as Merck KGaA, Pfizer, Universal Biologicals, Woodward Pharma, and ChemScene[1].
• These companies are involved in various strategies including product launches, acquisitions, and partnerships to maintain their market share.

Drivers of Market Growth

Increasing Pregnancy Rates and Maternal Health Concerns

• The global increase in pregnancy rates and the growing concerns for maternal health are significant drivers for the market. The need for effective treatments for postpartum hemorrhage and abortion procedures is on the rise[4].

FDA Approvals and Regulatory Support

• The growing number of FDA approvals for carboprost tromethamine has enhanced its credibility and safety profile, further boosting market growth[4].

Improvement in Healthcare Infrastructure

• Worldwide improvements in healthcare infrastructure, especially in developing regions, have increased the accessibility of carboprost tromethamine, contributing to market expansion[4].

Challenges and Restraints

Side Effects and Healthcare Professional Requirements

• Concerns about potential side effects and the need for skilled healthcare professionals to administer the drug are challenges the market faces[4].

Accessibility and Awareness Issues

• Limited accessibility in certain regions and a lack of awareness among healthcare providers about the benefits of carboprost tromethamine also act as barriers to market growth[4].

Financial Trajectory

The financial trajectory of the carboprost tromethamine market is positive, with steady growth projected over the next decade.

• 2023: The market was valued at USD 1,518.71 million[4].
• 2024: Expected to grow to USD 1,572.02 million[4].
• 2032: Projected to reach USD 2,100.63 million with a CAGR of 3.7%[4].

Regional Landscape and Market Share

• North America: Currently holds the largest market share due to its robust healthcare system and high awareness of maternal health issues[4].
• Asia-Pacific: Expected to be the fastest-growing region, driven by improving healthcare infrastructure and increasing awareness of maternal health[1].

Key Takeaways

• The carboprost tromethamine market is driven by increasing demand for effective treatments for postpartum hemorrhage and abortion.
• North America dominates the market, while Asia-Pacific is the fastest-growing region.
• Hospital pharmacies are the primary distribution channel.
• Major players include Merck KGaA, Pfizer, and Universal Biologicals.
• The market faces challenges related to side effects and accessibility but is supported by FDA approvals and improving healthcare infrastructure.

FAQs

1. What is the current global market size for carboprost tromethamine?

• The global carboprost tromethamine market was valued at approximately USD 1,518.71 million in 2023[4].

2. Who are the key players in the global carboprost tromethamine market?

• Major players include Merck KGaA, Pfizer, Universal Biologicals, Woodward Pharma, and ChemScene[1].

3. Which region is expected to grow the fastest in the carboprost tromethamine market?

• The Asia-Pacific region is expected to be the fastest-growing market for carboprost tromethamine[1].

4. What are the primary applications of carboprost tromethamine?

• The primary applications are the treatment of postpartum hemorrhage and inducing abortion[1][4].

5. What are the major distribution channels for carboprost tromethamine?

• Hospital pharmacies dominate the distribution channel segment[4].

Cited Sources:

1. Mordor Intelligence - Carboprost Tromethamine Market Size & Share Analysis[1]
2. Polaris Market Research - Carboprost Tromethamine Market Size, Analysis Report, 2024-2032[2]
3. Research and Markets - Carboprost Tromethamine Global Market Size & Competitors[3]
4. PR Newswire - At 3.7% CAGR, Global Carboprost Tromethamine Market Size Value to Be Worth USD 2,100.63 Million by 2032[4]
5. GlobeNewswire - Global Carboprost Tromethamine Market Size Is Projected to Grow USD 1850 Million by 2030 with CAGR of 3.06%[5]