HEMABATE Drug Patent Profile

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

Hemabate is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in HEMABATE is carboprost tromethamine. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the carboprost tromethamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hemabate

A generic version of HEMABATE was approved as carboprost tromethamine by DR REDDYS on July 2^nd, 2019.

Summary for HEMABATE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	6
Patent Applications:	240
Drug Prices:	Drug price information for HEMABATE
What excipients (inactive ingredients) are in HEMABATE?	HEMABATE excipients list
DailyMed Link:	HEMABATE at DailyMed

See drug prices for HEMABATE

Recent Clinical Trials for HEMABATE

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

Sponsor	Phase
Northwestern University	Early Phase 1
West China Second University Hospital	Phase 4
Dongguan Maternity & Child Health Hospital	N/A

See all HEMABATE clinical trials

Pharmacology for HEMABATE

Drug Class

Prostaglandin Analog

US Patents and Regulatory Information for HEMABATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	HEMABATE	carboprost tromethamine	INJECTABLE;INJECTION	017989-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes

Expired US Patents for HEMABATE

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

International Patents for HEMABATE

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

Country	Patent Number	Title	Estimated Expiration
Finland	53309
Spain	390709
Switzerland	578496

HEMABATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for HEMABATE (Carboprost Tromethamine)

Introduction to HEMABATE

HEMABATE, also known as carboprost tromethamine, is a prostaglandin analog used primarily in the management of postpartum hemorrhage and severe bleeding following childbirth, as well as in the induction of abortion. This drug plays a crucial role in obstetric and gynecologic care, and its market dynamics are influenced by several key factors.

Market Size and Growth Projections

The global carboprost tromethamine market is anticipated to experience significant growth. By 2032, the market size is expected to reach USD 2,100.63 million, growing at a CAGR of 3.7% from 2024 to 2032[1][3].

Key Drivers of Market Growth

Maternal Health Concerns

The rising concern for maternal health and the increasing instances of childbirth-related complications are major drivers of the carboprost tromethamine market. The drug's efficacy in preventing and treating postpartum hemorrhage, a leading cause of maternal mortality, drives its demand[3].

Improvements in Healthcare Infrastructure

Global improvements in healthcare infrastructure, particularly in regions like Asia-Pacific, contribute to the market's growth. Initiatives by governments and healthcare entities to enhance maternal healthcare outcomes are instrumental in increasing the adoption of carboprost tromethamine[3].

Evolving Societal Attitudes and Regulatory Changes

Changing societal attitudes towards family planning and reproductive choices, along with regulatory changes and policies surrounding abortion practices, influence the market dynamics. These factors contribute to increased demand for drugs like carboprost tromethamine in managing pregnancy complications[3].

Generic and Advanced Therapeutics

The global trend of switching from traditional medications to advanced and quick therapeutics, especially post-COVID-19, is another factor driving the market growth. Recent announcements, such as Dr. Reddy’s Laboratory introducing a carboprost tromethamine injection in the U.S. market, further support this trend[4].

Market Segmentation

Application Outlook

The carboprost tromethamine market is segmented based on application, with the pregnancy abortion segment projected to grow at the highest CAGR during the forecast period. This is due to the increasing demand for safe and effective abortion methods and the drug's role in inducing abortion by facilitating uterine contractions[3].

Distribution Channel Outlook

The market is also segmented by distribution channel, with various channels such as hospitals, clinics, and pharmacies playing crucial roles in the drug's availability and accessibility. The distribution network's efficiency and reach significantly impact the market's growth[1].

Regional Outlook

Geographically, the Asia-Pacific region is expected to be the most lucrative market for carboprost tromethamine. Countries like India and China, with large female populations and high childbirth rates, drive the demand for this drug. Government initiatives aimed at reducing maternal mortality rates and enhancing maternal healthcare further boost the market in this region[3].

Challenges and Restraints

Side Effects and Adverse Reactions

Despite its benefits, carboprost tromethamine is associated with several side effects, including vomiting, diarrhea, nausea, and breast pain. These adverse reactions can hamper market growth as they may deter some patients and healthcare providers from using the drug[4][5].

Lack of Awareness and Skilled Healthcare Professionals

Lack of awareness about menstrual hygiene and reproductive health, particularly in rural and underdeveloped regions, is a significant restraint. Additionally, the absence of highly skilled healthcare professionals in some areas can limit the drug's utility, as it requires skilled administration in emergency settings[4].

Financial Trajectory

Current Market Value

As of 2023, the carboprost tromethamine market size was valued at USD 1,518.71 million. It is anticipated to grow to USD 1,572.02 million in 2024 and continue to rise to USD 2,100.63 million by 2032[3].

Revenue Projections

The revenue from the carboprost tromethamine market is expected to increase steadily over the forecast period, driven by the factors mentioned above. The North American market, in particular, is expected to witness exponential growth due to the presence of major global players and their collaborative efforts with regional players[4].

Key Market Trends

Generic Therapies and Competitive Landscape

The introduction of generic versions of carboprost tromethamine, such as the one by Dr. Reddy’s Laboratory, is a significant trend. This competition can drive down costs and increase accessibility, further propelling market growth[4].

Regional Market Focus

South and Southeast Asia, including China and India, are witnessing high sales of carboprost tromethamine due to large female populations and higher childbirth rates. In contrast, Africa is expected to see limited growth due to inadequate health infrastructure and legal and social issues[4].

Conclusion

The carboprost tromethamine market, driven by its critical role in maternal health and the management of postpartum hemorrhage and abortion, is poised for significant growth. Despite challenges such as side effects and lack of awareness, the market is expected to expand, particularly in regions with improving healthcare infrastructure and increasing demand for advanced therapeutics.

Key Takeaways

• The global carboprost tromethamine market is projected to reach USD 2,100.63 million by 2032.
• The market is driven by rising concerns for maternal health, improvements in healthcare infrastructure, and evolving societal attitudes towards reproductive choices.
• The Asia-Pacific region is expected to be the most lucrative market due to government initiatives and high childbirth rates.
• Side effects and lack of awareness are significant restraints to market growth.
• Generic therapies and competitive market dynamics are key trends influencing the market.

FAQs

Q: What is the primary use of carboprost tromethamine (HEMABATE)? A: Carboprost tromethamine is primarily used in the management of postpartum hemorrhage and severe bleeding following childbirth, as well as in the induction of abortion.

Q: What are the key drivers of the carboprost tromethamine market? A: The key drivers include rising concerns for maternal health, improvements in healthcare infrastructure, and evolving societal attitudes towards reproductive choices.

Q: Which region is expected to be the most lucrative for the carboprost tromethamine market? A: The Asia-Pacific region, particularly countries like India and China, is expected to be the most lucrative due to large female populations and government initiatives to enhance maternal healthcare.

Q: What are some of the common side effects associated with carboprost tromethamine? A: Common side effects include vomiting, diarrhea, nausea, and breast pain. Other adverse reactions can also occur, such as increased blood pressure and gastrointestinal effects.

Q: How is the competitive landscape of the carboprost tromethamine market evolving? A: The market is seeing the introduction of generic versions, such as the one by Dr. Reddy’s Laboratory, which can drive down costs and increase accessibility, further propelling market growth.

Sources

1. Polaris Market Research - "Carboprost Tromethamine Market Set $2,100.63 Mn By 2032,CAGR ..."
2. Oxford Academic - "A comprehensive digital phenotype for postpartum hemorrhage"
3. Polaris Market Research - "Carboprost Tromethamine Market Size, Analysis Report, 2024-2032"
4. Allied Market Research - "Carboprost Tromethamine Market Size, Share and Industry Analysis ..."
5. FDA - "Hemabate® carboprost tromethamine injection, USP"