HYDROXYPROGESTERONE CAPROATE - Generic Drug Details

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

Hydroxyprogesterone caproate is the generic ingredient in two branded drugs marketed by Allergan, Epic Pharma Llc, Bristol Myers Squibb, Aspen Global Inc, and Eugia Pharma, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for hydroxyprogesterone caproate. One supplier is listed for this compound.

Summary for HYDROXYPROGESTERONE CAPROATE

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	6
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	30
Patent Applications:	6,924
Drug Prices:	Drug price trends for HYDROXYPROGESTERONE CAPROATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HYDROXYPROGESTERONE CAPROATE
What excipients (inactive ingredients) are in HYDROXYPROGESTERONE CAPROATE?	HYDROXYPROGESTERONE CAPROATE excipients list
DailyMed Link:	HYDROXYPROGESTERONE CAPROATE at DailyMed

See drug prices for HYDROXYPROGESTERONE CAPROATE

Recent Clinical Trials for HYDROXYPROGESTERONE CAPROATE

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

Sponsor	Phase
Bezmialem Vakif University	N/A
Assiut University	Phase 4
Aswan University Hospital	N/A

See all HYDROXYPROGESTERONE CAPROATE clinical trials

Pharmacology for HYDROXYPROGESTERONE CAPROATE

Drug Class

Progestin

Anatomical Therapeutic Chemical (ATC) Classes for HYDROXYPROGESTERONE CAPROATE

G03DA	Pregnen (4) derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03DA	Pregnen (4) derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for HYDROXYPROGESTERONE CAPROATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MAKENA (AUTOINJECTOR)	Injection (Auto- injector)	hydroxyprogesterone caproate	275 mg/1.1 mL	021945	1	2020-09-28

US Patents and Regulatory Information for HYDROXYPROGESTERONE CAPROATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aspen Global Inc	HYDROXYPROGESTERONE CAPROATE	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	200271-001	Aug 24, 2015		DISCN	No	No
Epic Pharma Llc	HYDROXYPROGESTERONE CAPROATE	hydroxyprogesterone caproate	INJECTABLE;INJECTION	018004-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Eugia Pharma	HYDROXYPROGESTERONE CAPROATE	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	211142-001	May 9, 2019		DISCN	No	No
Bristol Myers Squibb	DELALUTIN	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	010347-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Bristol Myers Squibb	DELALUTIN	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	010347-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

HYDROXYPROGESTERONE CAPROATE Market Analysis and Financial Projection Experimental

Hydroxyprogesterone Caproate Injection Market: Dynamics and Financial Trajectory

Market Overview

The hydroxyprogesterone caproate (OHPC) injection market is a niche but critical segment within the pharmaceutical industry, primarily focused on preventing preterm births. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Key Drivers

The OHPC injection market is driven by several key factors:

• Increasing Prevalence of Preterm Birth: Preterm birth is a significant global health issue, and its increasing prevalence is a major driver for the OHPC injection market. The incidence of preterm birth has been rising due to factors such as delayed childbearing, assisted reproductive technologies, and underlying maternal medical conditions[1].
• FDA Approval and Clinical Evidence: The FDA approval of OHPC injection for preventing preterm birth in high-risk patients has been a significant boost to the market. Clinical evidence supporting its efficacy has further solidified its position[1].
• Growing Awareness and Maternal Health Focus: Increasing awareness about preterm birth prevention and a growing focus on maternal and child health globally are also driving the demand for OHPC injections[5].

Market Restraints

Despite the positive drivers, there are several restraints affecting the market:

• High Cost: The high cost of OHPC injections, particularly the branded version Makena, is a significant barrier. Makena costs $1,500 per injection, leading to a projected cost of $30,000 per pregnancy, which is substantially higher than the cost of compounded versions[2].
• Limited Awareness: Limited awareness about the availability and benefits of OHPC injections in some regions can hinder market growth[1].

Market Segmentation

The OHPC injection market can be segmented in several ways:

• By Distribution Channel: The market is segmented into direct sales to healthcare providers and specialty pharmacy networks. Direct sales to healthcare providers currently hold the larger market share due to Makena's established distribution network[1].
• By Application: The market is segmented into hospitals and clinics, with hospitals being the primary users of OHPC injections[5].

Regional Analysis

The global OHPC injection market is analyzed based on geographical regions:

• North America: This region, particularly the United States, dominates the market due to its high incidence of preterm birth, well-developed healthcare infrastructure, and the availability of OHPC injection as an FDA-approved treatment[1].
• Europe: Europe is another significant market, driven by countries like the UK, Germany, and France. The region's emphasis on maternal and child health and comprehensive healthcare coverage contribute to its market size[1].
• Asia-Pacific: This region is anticipated to witness the fastest growth, driven by the increasing prevalence of preterm birth, expanding healthcare infrastructure, and a rising focus on improving maternal and child health outcomes in countries like China, India, and Japan[1].
• Latin America and Middle East & Africa: These regions are smaller markets but are expected to experience moderate growth due to increasing focus on improving access to quality prenatal care and rising awareness about preterm birth prevention[1].

Competitive Landscape

The competitive landscape of the OHPC injection market is currently dominated by a single manufacturer, Makena, produced by KV Pharmaceutical. However, the potential entry of generic competitors could significantly alter the market dynamics:

• Generic Competition: The expiration of Makena's exclusivity and the approval of generic versions could introduce more competition, potentially impacting pricing and accessibility. Despite the availability of generic versions since 2018, Makena's branded autoinjector formulation has maintained a significant market share[3].
• Product Hopping: Makena’s strategy of introducing new formulations, such as the autoinjector, has helped extend its functional exclusivity period and maintain high spending on the drug[3].

Financial Trajectory

The financial trajectory of the OHPC injection market is marked by steady growth:

• Market Size: The global OHPC injection market size was estimated to be around USD 265.4 million in 2024 and is projected to reach USD 294.46 million by 2032[4].
• CAGR: The market is expected to exhibit a CAGR of approximately 1.5% by 2032[5].
• Cost and Spending: The high cost of Makena has been a significant factor in healthcare spending. For instance, state Medicaid programs reimbursed $41,872,080 for all forms of hydroxyprogesterone caproate in quarter 3 of 2020, with 73.2% of this amount being for the Makena autoinjector[3].

Integration with Digital Health Technologies

The integration of OHPC injections with digital health technologies, such as patient monitoring and telemedicine, presents opportunities for market expansion. This can enhance patient access, improve monitoring, and support the use of OHPC injections more effectively[1].

Use Trends

The use of hydroxyprogesterone caproate has seen significant changes over the years:

• Historical Use: The use of OHPC injections increased from less than 11,000 fills per quarter between 2010 and 2014 to more than 30,000 fills per quarter in quarter 1 of 2019. However, use declined following the announcement of Makena’s failed postapproval trial and the advisory committee’s recommendation to withdraw Makena from the market[3].

Challenges and Opportunities

The market faces several challenges and opportunities:

• Challenges: High costs, limited awareness, and potential regulatory changes pose challenges to the market.
• Opportunities: The integration with digital health technologies, expanding healthcare infrastructure in developing countries, and the potential entry of generic competitors offer opportunities for market growth[1].

Expert Insights

Industry experts highlight the importance of ensuring affordable access to OHPC injections:

"The price barrier to access imposed by KV Pharmaceutical actually could result in an increase in preterm deliveries over current rates. Actions are needed by the FDA, national societies, and the manufacturer to ensure that all high-risk patients continue to get the needed therapy to reduce the number of preterm births."[2]

Key Takeaways

• The OHPC injection market is driven by the increasing prevalence of preterm birth and the need for effective interventions.
• The market is dominated by Makena, but the potential entry of generic competitors could change the competitive landscape.
• High costs and limited awareness are significant restraints.
• Integration with digital health technologies and expanding healthcare infrastructure in developing countries present opportunities.
• The market is expected to grow steadily, reaching USD 294.46 million by 2032.

Frequently Asked Questions

Q: What is the projected market size of the hydroxyprogesterone caproate injection market by 2032? A: The market is projected to reach USD 294.46 million by 2032[4].

Q: What is the expected CAGR of the hydroxyprogesterone caproate market by 2032? A: The market is expected to exhibit a CAGR of approximately 1.5% by 2032[5].

Q: What are the key drivers of the hydroxyprogesterone caproate market? A: The key drivers include the increasing prevalence of preterm birth, FDA approval and clinical evidence, and growing awareness about preterm birth prevention[1][5].

Q: How does the high cost of Makena impact the market? A: The high cost of Makena acts as a significant barrier to access, potentially leading to increased preterm deliveries if affordable alternatives are not available[2].

Q: What role do generic competitors play in the market? A: Generic competitors could introduce more competition, potentially impacting pricing and accessibility, although Makena's branded autoinjector has maintained a significant market share despite generic availability[3].

Cited Sources

1. Data Horizzon Research: Hydroxyprogesterone Caproate Injection Market Size, Share ...
2. PubMed: Unjustified increase in cost of care resulting from U.S. ...
3. JAMA Network: Changes in the Use of Hydroxyprogesterone Caproate Injection ...
4. The Market Intelligence: Hydroxyprogesterone Caproate Injection Market Size 2032
5. Business Research Insights: Hydroxyprogesterone Caproate Market Size - Forecast To 2032