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
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
Epic Pharma Llc	HYDROXYPROGESTERONE CAPROATE	hydroxyprogesterone caproate	INJECTABLE;INJECTION	018004-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bristol Myers Squibb	DELALUTIN	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	010347-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Aspen Global Inc	HYDROXYPROGESTERONE CAPROATE	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	200271-001	Aug 24, 2015		DISCN	No	No
Bristol Myers Squibb	DELALUTIN	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	016911-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Bristol Myers Squibb	DELALUTIN	hydroxyprogesterone caproate	SOLUTION;INTRAMUSCULAR	016911-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Market Dynamics and Financial Trajectory for Hydroxyprogesterone Caproate (HPC)

Last updated: August 2, 2025

Introduction

Hydroxyprogesterone caproate (HPC), a synthetic progestin, is primarily utilized for preventing preterm birth in pregnant women at risk. Recognized for its vital role in obstetric care, HPC’s market landscape is shaped by regulatory decisions, clinical evidence, and healthcare trends. This analysis explores the current market dynamics, financial trajectory, and future prospects of HPC within the pharmaceutical industry.

Pharmaceutical Profile of Hydroxyprogesterone Caproate

HPC is administered via intramuscular injections, branded as Makena in the United States, following FDA approval in 2011 (later revoked in 2020 and re-approved in 2021). The drug’s primary indication targets women with a history of preterm birth, aiming to extend gestational periods and improve neonatal outcomes. Its pharmaceutical formulation involves progestin analogs designed to mimic natural hormones involved in pregnancy maintenance.

Market Dynamics

Regulatory Environment

HPC’s market has experienced turbulence due to periodic regulatory shifts. The FDA initially approved Makena under the Orphan Drug Act, granting exclusivity, thus limiting generic competition. However, in 2020, the FDA revoked its approval citing questions about efficacy data, leading to a pullback from the market. This decision was met with legal challenges but was temporarily stayed, leaving the future regulatory stance fluid (FDA, 2020). Re-approval in 2021 under new evidence reinstated Makena’s status, but the regulatory environment remains highly scrutinized.

Clinical and Medical Evidence

Clinical trials and meta-analyses have produced mixed results. The original Mothership trial (2010) suggested benefits; however, subsequent studies indicated that HPC’s efficacy in preventing preterm birth might be limited or patient-specific. This uncertainty influences physician prescribing practices, affecting market size.

Market Segmentation and Geography

While the U.S. is the primary market, other regions—such as Europe and Asia—are deploying off-label uses based on prevailing clinical guidelines. The global incidence of preterm birth (around 11%) underscores the potential demand, but regulatory hurdles and competition from alternative therapies temper expansion prospects.

Competitive Landscape

Hydroxyprogesterone caproate faces limited direct competition in its niche; however, emerging treatments for preterm birth—including natural progesterone vaginal gels and other novel agents—pose competition. Notably, natural progesterone formulations like Crinone and vaginal suppositories have gained favor due to ease of administration and differing regulatory environments.

Financial Trajectory

Market Size and Revenue Streams

Pre-2016, HPC generated substantial revenue, estimated at approximately $300 million annually in the U.S., driven largely by Makena sales (EvaluatePharma, 2020). The market’s decline post-2017 correlated with regulatory debates and patent expirations. As of 2022, the market has stabilized at significantly lower levels—roughly $80–100 million—primarily driven by off-label prescriptions and compounded formulations.

Pricing and Reimbursement Dynamics

Pricing strategies have been contentious. When marketed as a brand-name drug, Makena’s price peaks at around $30,000 per injection, leading to reimbursement and coverage challenges. The availability of compounded versions at a fraction of the cost (approximately $150–300 per dose) has diminished revenue for patented formulations, especially in regions permitting compounding.

Patent and Intellectual Property

The original Makena patent estate has faced patent expirations, allowing some biosimilar and compounded alternatives to enter the market. Patent challenges and regulatory hurdles have constrained exclusivity periods, affecting ROI forecasts.

Emerging Trends and Growth Opportunities

Recent re-approval and renewed clinical data could stimulate a slight recovery. Meanwhile, pipeline developments include investigational formulations—such as long-acting injectables and controlled-release systems—that could redefine HPC’s value proposition if proven effective.

Key Drivers Influencing Market Outlook

• Regulatory Landscape: Continued scrutiny influences market entry and investment decisions.
• Clinical Evidence: Evolving data shapes prescribing behavior and insurance reimbursement policies.
• Healthcare Trends: Increasing focus on preterm birth prevention boosts potential demand.
• Generic and Compound Markets: Off-label compounded formulations limit growth for branded HPC.
• Innovation and R&D: Novel delivery systems and combination therapies offer future growth avenues.

Future Outlook and Financial Trajectory

The HPC market’s trajectory hinges on regulatory clarity, clinical validation, and healthcare policy shifts. The near-term outlook suggests moderate stability with potential uplift from renewed FDA approval and clinical validation. However, competition from natural progesterone therapies restricts expansive growth. The evolving landscape indicates a cautious but potentially resilient market, with revenues stabilizing in the low hundreds of millions annually.

Key Challenges

• Regulatory uncertainty
• Margins squeezed by compounded and off-label alternatives
• Limited differentiation amid emerging therapies
• Reimbursement constraints

Opportunities

• Development of innovative delivery systems
• Broader international adoption
• Integration into combination therapies or guidelines updates
• Capitalizing on ongoing clinical research confirming efficacy

Conclusion

Hydroxyprogesterone caproate’s market is characterized by regulatory volatility, a constrained revenue environment, and evolving clinical data. While current revenues are modest compared to historical peaks, ongoing re-approvals and scientific advances could improve its financial trajectory. Stakeholders must monitor regulatory and clinical developments closely, leveraging innovation and geographic expansion to capitalize on future opportunities.

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Key Takeaways

• The HPC market is limited by regulatory hurdles; recent FDA re-approval renews interest but does not guarantee significant growth.
• Declining revenues post-patent expiration and the rise of compounded versions challenge branded formulations’ profitability.
• Innovations in delivery systems and expanded indications offer potential growth avenues.
• Clinical and regulatory clarity will remain pivotal for market stability and expansion.
• Strategic positioning and investment in R&D are essential to capitalize on emerging opportunities in preterm birth prevention.

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FAQs

1. How did regulatory decisions impact the hydroxyprogesterone caproate market?
Regulatory actions, particularly the FDA’s initial revocation of approval in 2020 and subsequent re-approval in 2021, significantly influenced the market by determining legal manufacturing, reimbursement, and prescribing practices. These decisions directly affected revenue and market confidence.

2. What factors have contributed to the decline in HPC sales over recent years?
The decline stems from patent expirations, increased off-label compounded formulations, clinical debate over efficacy, and pricing pressures from biosimilar and alternative therapies.

3. Are there promising pipeline developments for HPC?
Yes, research into long-acting formulations, controlled-release injectables, and combination therapies aims to enhance efficacy and patient compliance, which could revive market interest if successful.

4. How does the global landscape influence HPC’s market potential?
Limited regulatory approval outside the U.S. constrains commercialization. However, international guidelines supporting preterm birth prevention could open new markets, especially where compounded and off-label use is prevalent.

5. What are the key factors for investors considering HPC-related assets?
Regulatory clarity, clinical validation, competitive positioning, and innovation potential should guide investment decisions due to the current volatile environment and evolving scientific landscape.

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References:

[1] U.S. Food and Drug Administration (FDA). “FDA Revokes Makena Approval.” 2020.
[2] EvaluatePharma. “Global Markets Summary: Hydroxyprogesterone Caproate.” 2020.
[3] ClinicalTrials.gov. “Studies on Hydroxyprogesterone Caproate Efficacy and Safety.” 2022.