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. Nineteen 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:	44
Clinical Trials:	6
Patent Applications:	252
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
Germany	2121980
Poland	81615
Netherlands	154729
Belgium	766682
Philippines	11635	15-METHYL-15(R)-PROSTAGLANDINE
Israel	45415	5-ALKYL-15(R)-PROSTAGLANDINS
U.S.S.R.	416939

Market Dynamics and Financial Trajectory for HEMABATE

Last updated: July 29, 2025

Introduction

HEMABATE (Carboprost Tromethamine) is a synthetic prostaglandin used primarily in obstetric practice for the induction of postpartum hemorrhage and termination of pregnancy. Known for its efficacy in controlling excessive bleeding, HEMABATE's market presence is shaped by evolving clinical practices, regulatory approval landscapes, and competitive pharmaceutical developments. Analyzing current market dynamics and forecasting its financial trajectory requires a comprehensive understanding of regulatory status, clinical applications, market competitors, and regional adoption trends.

Regulatory Status and Global Market Penetration

The approval and regulation of HEMABATE vary across regions, influencing its market reach. In the United States, Carboprost Tromethamine received approval from the Food and Drug Administration (FDA) in 2001, primarily for postpartum hemorrhage management [1]. Conversely, other regions such as Europe and Asia have differing approvals and usage guidelines, which in turn impact market size and growth.

Regulatory barriers, including safety concerns associated with prostaglandins—like bronchospasm and gastrointestinal side effects—have necessitated strict manufacturing and prescribing standards, sometimes limiting off-label use. Nonetheless, in many emerging markets, especially in Asia and Africa, the drug is widely adopted due to its established efficacy and cost-effectiveness.

Market Drivers

Clinical Demand and Medical Need

The global prevalence of postpartum hemorrhage (PPH)—a leading cause of maternal mortality—augments demand for effective uterotonics such as HEMABATE. According to WHO estimates, PPH accounts for approximately 27% of maternal deaths worldwide [2], positioning carboprost as an essential intervention in obstetric care.

Cost-Effectiveness

Compared to newer or more expensive uterotonics, carboprost remains a cost-efficient option, especially in resource-limited settings. Its straightforward administration and established manufacturing processes reinforce its attractiveness to healthcare providers and procurement agencies.

Advancements in Obstetric Interventions

The increasing emphasis on obstetric training and capacity building has led to improved awareness and usage of HEMABATE in managing hemorrhagic events. Additionally, a trend towards integrating uterotonics into comprehensive maternal health programs propels its adoption.

Regulatory and Patent Status

Given that carboprost has been on the market for over two decades, patent protections have generally expired, resulting in increased generic manufacturing and competitive pricing. The absence of patent barriers lowers entry costs for producers, fostering broader availability.

Market Challenges

Safety Profile and Side Effects

Prostaglandins, including carboprost, are associated with adverse effects like nausea, vomiting, fever, bronchospasm, and diarrhea. These safety concerns can constrain prescribing practices and limit use in certain patient populations.

Emergence of Alternatives

Newer uterotonics—such as oxytocin, misoprostol, and carbide oxytocin—offer comparable efficacy with better safety profiles or easier administration routes. For instance, misoprostol is favored in low-resource settings for its stability and oral delivery, which can diminish HEMABATE's market share.

Regulatory Variability

Differences in approval status, indications, and recommended dosages across jurisdictions impact global sales. Regulatory uncertainties or restrictions could slow market expansion in certain regions.

Manufacturing and Supply Chain Constraints

Supply chain disruptions, especially amid global events like the COVID-19 pandemic, threaten the consistent availability of HEMABATE. Manufacturing challenges related to maintaining quality standards also influence market stability.

Financial Trajectory and Market Outlook

Market Size and Revenue Projections

The global obstetric drug market, valued at approximately USD 3.5 billion in 2022, is expected to grow at a compound annual growth rate (CAGR) of around 5-7% through 2030 [3]. As a segment, uterotonics like HEMABATE benefit from this growth, supported by increased institutional deliveries, rising maternal healthcare investments, and expanding awareness about PPH management.

Regional Growth Dynamics

• North America and Europe: Market saturation and stringent regulations may limit rapid growth. However, ongoing training initiatives and guideline adherence sustain steady demand.

• Asia-Pacific: The fastest-growing segment due to increasing healthcare infrastructure, higher birth rates, and supportive government policies promoting maternal health.

• Africa and Latin America: Market expansion accelerated by unmet medical needs, affordability, and emphasis on reducing maternal mortality.

Competitive Landscape

The presence of generic carboprost products has led to price competition, intensifying profit margins for manufacturers. Companies that innovate in formulation, improve delivery methods (e.g., sustained-release preparations), or enhance safety profiles could capture additional market share.

Forecasting Financial Trajectory

In the near-term (2023-2028), HEMABATE's revenues are projected to grow modestly, aligned with the overall obstetric drug market. Long-term, market expansion hinges on regulatory approvals in underserved regions, improvements in safety margins, and integration into maternal health programs.

Potential revenue streams will also depend on healthcare policy shifts, government procurement strategies, and the competitive landscape involving alternative uterotonics. The entry of biosimilars or novel prostaglandin formulations could pose both challenges and opportunities.

Strategic Opportunities

• Innovation in Formulation: Developing safer, more tolerable derivatives or delivery mechanisms could reinforce HEMABATE's market position.

• Geographic Expansion: Navigating soft regulatory environments and tailoring marketing strategies in emerging markets could unlock significant growth potential.

• Partnerships and Collaborations: Engaging with global health agencies, NGOs, and local governments can facilitate distribution and acceptance.

• Education and Training: Promoting awareness among healthcare providers on HEMABATE's efficacy and safety can increase prescription rates, especially where traditional uterotonics are favored.

Regulatory and Ethical Considerations

Ensuring compliance with ongoing clinical safety surveillance and adapting to evolving regional drug approval standards are crucial. Transparency regarding side effects and contraindications maintains trust and encourages appropriate usage.

Key Takeaways

• Market demand is driven by the global burden of postpartum hemorrhage, positioning HEMABATE as a vital uterotonic in obstetric care.

• Regulatory approval status varies regionally, influencing market access and revenue opportunities; navigating local approval pathways remains essential.

• Pricing dynamics favor generics, intensifying competition but enabling wider access, especially in resource-limited settings.

• Safety concerns and emergence of alternatives like misoprostol challenge HEMABATE's market share but also create opportunities for innovation.

• Regional growth prospects are strongest in Asia-Pacific and underserved areas where maternal health initiatives are expanding.

Conclusion

The financial trajectory of HEMABATE will hinge on regulatory adaptability, safety profile improvements, regional market expansion, and competitive differentiation. While challenges persist—such as safety concerns and competing therapies—the ongoing global focus on reducing maternal mortality and improving obstetric care portends steady demand. Strategic engagement with emerging markets and ongoing product optimization will be key to maximizing HEMABATE's market potential.

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References

[1] U.S. Food and Drug Administration. (2001). FDA approval documents for Carboprost Tromethamine.

[2] World Health Organization. (2012). WHO Recommendations for the Prevention and Treatment of Postpartum Hemorrhage.

[3] MarketWatch. (2023). Global obstetric drug market overview and growth forecast.