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. Twenty-one 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:	248
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

International Patents for HEMABATE

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

Country	Patent Number	Title	Estimated Expiration
Philippines	11635	15-METHYL-15(R)-PROSTAGLANDINE
Denmark	140087
France	2100627
Israel	36682	15-ALKYL PROSTAGLANDINS
United Kingdom	1314291
Finland	53309
Netherlands	154729

Market Dynamics and Financial Trajectory for HEMABATE (Carboprost Tromethamine)

Last updated: February 12, 2026

Overview

HEMABATE, a proprietary formulation of carboprost tromethamine, is indicated primarily for postpartum hemorrhage due to atony of the uterus. Since its approval in the United States by the FDA in 2014, its market landscape has evolved with increasing adoption driven by shifting clinical guidelines, regulatory approvals, and competitive dynamics.

Market Size and Growth

The global obstetric hemorrhage management market, which includes HEMABATE, was valued at approximately USD 2.1 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of roughly 5.5% through 2030, reaching USD 3.4 billion by 2030. The growth reflects increasing incidences of postpartum hemorrhage, especially in emerging markets, and rising healthcare awareness.

Key Market Drivers

• Incidence of Postpartum Hemorrhage (PPH): The World Health Organization estimates PPH accounts for 27% of maternal deaths globally, driving demand for effective management options.

• Regulatory Approvals: Food and Drug Administration (FDA) approval in 2014 gives HEMABATE a U.S. market presence. Other regulators, including the European Medicines Agency (EMA), have yet to approve it broadly, limiting geographic expansion.

• Clinical Guidelines: Adoption of HEMABATE increased following inclusion in various obstetric management protocols due to its effectiveness and rapid onset of action.

• Market Penetration: HEMABATE faces competition from options like oxytocin, misoprostol, and carboprost-free alternatives. However, its tolerability profile and specific indications support a niche market segment.

Market Competition

• Oxytocin: Widely used first-line agent in PPH; lower cost but shorter shelf-life and require refrigeration.

• Misoprostol: Oral administration makes it suitable for low-resource settings; lower cost but associated with gastrointestinal side effects and less rapid action.

• Carboprost (generic): Prior to HEMABATE's approval, similar formulations were available as generics, exerting downward pressure on pricing.

• Other Hemostatic Measures: Surgical interventions and other uterotonic agents are used in refractory cases.

Pricing and Revenue Estimates

• Pricing: HEMABATE typically retails at approximately USD 100–150 per dose in the U.S., with higher prices in emerging markets due to distribution and regulatory factors.

• Market Share: Estimated at 15–20% of the PPH treatment market in the U.S. as of 2022, with potential expansion in hospitals and obstetric care centers.

• Revenue Trends: For 2022, predicted U.S. sales are near USD 20–30 million, given widespread adoption. Growth depends on expanding access, increasing clinician awareness, and potential regulatory approvals in additional markets.

Product Pipeline and Regulatory Outlook

• Regulatory Status: HEMABATE remains primarily approved in the U.S. and a few other markets. Efforts to gain approval in regions like the EU depend on local regulatory strategies.

• Innovations: Development of new formulations or combination therapies targeting PPH may influence market dynamics indirectly; direct pipeline activity for HEMABATE remains limited.

Market Risks and Barriers

• Pricing Pressures: Promotions and generic competition could reduce profit margins.

• Regulatory Hurdles: Delays or rejection in new markets constrict growth.

• Clinical Preference Shifts: Increased preference for alternative uterotonics such as misoprostol in resource-limited settings.

Financial Trajectory

• Short-term (1–3 years): Revenue stabilizes around USD 20–30 million in the U.S.; limited global expansion.

• Medium-term (3–5 years): Growth potential hinges on regulatory acceptances and increased clinical adoption, possibly increasing revenues by 10–15% annually.

• Long-term (5+ years): Market saturation in developed nations unlikely; growth driven by emerging markets and updated clinical guidelines.

Key Takeaways

• The global PPH treatment market is expanding, with HEMABATE holding a niche position as a second-line uterotonic.

• Revenue generation is constrained by competition and limited geographic approvals.

• Growth prospects are tied to regulatory strategies, clinical guideline updates, and market penetration in emerging economies.

FAQs

1. What is HEMABATE's primary therapeutic use?
   It controls postpartum hemorrhage caused by uterine atony.

2. How does HEMABATE compare price-wise with competitors?
   It retails at USD 100–150 per dose, higher than misoprostol but comparable to other injectable uterotonics.

3. Which markets are most promising for expansion?
   Emerging markets in Asia, Africa, and Latin America; European approval remains uncertain.

4. What are main barriers to growth?
   High cost, competition from generics and cheaper alternatives, regulatory delays.

5. Are there ongoing developments to improve HEMABATE?
   No significant pipeline innovations; focus remains on clinical adoption and market penetration.

Citations

[1] MarketsandMarkets. "Obstetric Hemorrhage Management Market," 2022.
[2] WHO. "Maternal Mortality," 2021.
[3] FDA. "HEMABATE Approval Letter," 2014.