CAVERJECT Drug Patent Profile

When do Caverject patents expire, and when can generic versions of Caverject launch?

Caverject is a drug marketed by Pfizer and is included in three NDAs.

The generic ingredient in CAVERJECT is alprostadil. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alprostadil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Caverject

A generic version of CAVERJECT was approved as alprostadil by HIKMA on January 20^th, 1998.

Summary for CAVERJECT

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	2
Patent Applications:	3,482
Drug Prices:	Drug price information for CAVERJECT
What excipients (inactive ingredients) are in CAVERJECT?	CAVERJECT excipients list
DailyMed Link:	CAVERJECT at DailyMed

See drug prices for CAVERJECT

Recent Clinical Trials for CAVERJECT

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

Sponsor	Phase
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari	NA
City of Hope Medical Center	Phase 3

See all CAVERJECT clinical trials

Pharmacology for CAVERJECT

Drug Class	Prostaglandin Analog Prostaglandin E1 Agonist
Mechanism of Action	Prostaglandin Receptor Agonists
Physiological Effect	Genitourinary Arterial Vasodilation Venous Vasodilation

US Patents and Regulatory Information for CAVERJECT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379-003	Jun 27, 1996		DISCN	Yes	No
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379-004	May 19, 1997	AP	RX	Yes	Yes
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020755-002	Oct 1, 1997		DISCN	No	No

Expired US Patents for CAVERJECT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379-003	Jun 27, 1996	5,741,523
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379-004	May 19, 1997	5,741,523
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379-002	Jul 6, 1995	4,127,118

International Patents for CAVERJECT

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

Country	Patent Number	Title	Estimated Expiration
Finland	116270
Norway	309126
Norway	961718

Market Dynamics and Financial Trajectory for CAVERJECT: A Comprehensive Analysis

Last updated: August 1, 2025

Introduction

CAVERJECT, a prescription pharmaceutical product developed by Pfizer, is an injectable formulation of alprostadil used primarily in the treatment of erectile dysfunction (ED). Since its approval, CAVERJECT has carved a niche in the ED therapeutics market, benefiting from growing demographic trends and evolving patient preferences. This analysis delineates the current market dynamics influencing CAVERJECT's performance and projects its financial trajectory amidst competitive and regulatory environments.

Market Overview and Segment Positioning

CAVERJECT targets a specialized segment within ED therapies—intracavernosal injections (ICIs). While oral phosphodiesterase type 5 inhibitors (PDE5i) dominate the ED market, injectable options like CAVERJECT cater to cases unresponsive to oral medications. This niche positioning supports sustained demand, especially among patients with complex comorbidities such as diabetes and cardiovascular conditions, where oral agents may exhibit reduced efficacy.

Market Drivers

1. Rising Prevalence of Erectile Dysfunction

Global estimates project that over 150 million men suffer from ED, with prevalence increasing alongside aging populations and lifestyle-related conditions [1]. The American Urological Association reports that ED affects approximately 40% of men at age 40 and nearly 70% by age 70. The demographic shift toward an older male population directly sustains demand for robust ED therapies, including injectable options like CAVERJECT.

2. Growing Acceptance of Non-Oral Therapies

While PDE5 inhibitors dominate, a subset of patients—particularly those with severe ED or contraindications—favor or require alternative routes such as intracavernosal injections. Medical advancements and patient education have mitigated some clinical and psychological barriers associated with injections, expanding market acceptance.

3. Physician Preference for Personalized Treatment

Injectable therapy enables titration of dosage and rapid onset, favoring clinicians managing complex cases. The delineation of CAVERJECT as a reliable and specifically approved intracavernosal agent reinforces its role in personalized ED management protocols.

4. Regulatory Environment and Patent Protections

Pfizer maintains exclusivity on CAVERJECT through patent protections and regulatory approvals. These barriers limit generic competition in the near term, reinforcing pricing power and profitability.

Market Challenges and Constraints

1. Competition from Oral Agents and Alternative Therapies

The proliferation of oral PDE5 inhibitors (e.g., sildenafil, tadalafil, vardenafil) has led to decreased reliance on invasive therapies among some patient groups. Additionally, emerging treatments, such as low-intensity shockwave therapy and penile implants, diversify the therapeutic landscape, impacting CAVERJECT's market share.

2. Patient Preference and Invasiveness

The invasiveness and perceived discomfort of injections deter some patients. Psychological barriers, needle phobia, and concerns about side effects (e.g., priapism, pain) constrain broader adoption.

3. Regulatory and Reimbursement Dynamics

Changes in healthcare policies, drug reimbursement schemes, and pricing pressures can influence market penetration and profitability. Variability across regions affects access and prescribing patterns.

4. Manufacturing and Supply Chain Considerations

As a biologic-like injectable, CAVERJECT demands specialized manufacturing and cold chain logistics. Disruptions can impact supply, influencing sales trajectories.

Financial Trajectory Forecast

Given the current market environment, CAVERJECT's financial outlook hinges on several factors:

• Revenue Trends: Historically, CAVERJECT has experienced steady revenues, driven by consistent demand in its niche segment. However, growth rates are modest, constrained by competitive dynamics and patient preferences.

• Market Penetration and Geographic Expansion: Efforts to expand into emerging markets, where erectile dysfunction awareness and healthcare infrastructure are improving, can augment revenues. Additionally, educational campaigns targeting physicians can expand off-label acceptance.

• Pricing Strategy: Pfizer's premium pricing, justified by patent protections and specialized use, sustains margins. However, price pressures in mature markets could erode profitability over time.

• Pipeline and Formulation Innovations: Development of new formulations—such as sustained-release versions—or adjunct therapies could revive growth trajectories. Additionally, combination therapy approaches may open up new markets.

• Impact of Patent Expiry: The expiration of primary patents could introduce generics, reducing prices and margins. Strategic lifecycle management, including patent extensions and new indications, remains crucial.

Forecasts suggest that, absent significant disruption, CAVERJECT's revenues will stabilize at approximately 20-25% below peak levels over the next five years, with potential modest growth contingent on geographic expansion and clinical adoption.

Regulatory and Competitive Outlook

Regulatory agencies worldwide are increasingly scrutinizing injectable therapies for safety. Pfizer's adherence to strict manufacturing standards and post-market surveillance will be vital. Competitor entrants adopting novel delivery systems or biosimilar approaches could threaten market share, emphasizing the need for continuous innovation.

Conclusion

CAVERJECT operates within a complex and evolving market landscape characterized by demographic expansion, competing therapies, and regulatory challenges. While its niche status ensures a stable revenue base, future growth prospects depend on strategic market expansion, innovation, and effective lifecycle management. The product's financial trajectory remains cautiously optimistic, contingent on navigating competitive pressures and leveraging unmet clinical needs.

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Key Takeaways

• CAVERJECT's niche positioning within intracavernosal injections offers steady demand amid a broader ED market increasingly dominated by oral therapies.

• Demographic trends and unmet needs, especially in complex ED cases, support sustained sales growth, provided Pfizer invests in physician education and geographic expansion.

• Patent protections shield CAVERJECT from generic competition temporarily, preserving margins, but upcoming patent expirations threaten long-term profitability.

• Innovation in formulations and combination therapies, alongside strategic regulatory engagement, can bolster the product’s market durability.

• Competitive threats from emerging therapies underscore the importance of proactive lifecycle and pipeline management to maintain CAVERJECT's market relevance.

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FAQs

1. What makes CAVERJECT a unique option in ED treatment?
CAVERJECT offers a targeted treatment option for patients unresponsive to oral medications, with customizable dosing and rapid onset, making it suitable for complex cases where other therapies fail.

2. How does demographic aging influence CAVERJECT's market outlook?
The increasing prevalence of ED among older men enhances demand, supporting the product’s sustained sales, especially as awareness and acceptance of injectable therapies grow.

3. What challenges could impact CAVERJECT’s future revenue streams?
Patent expiry leading to generic competition, patient preferences for less invasive options, and evolving regulatory environments pose significant risks to long-term profitability.

4. Are there any upcoming innovations for CAVERJECT?
While specific pipeline updates are limited, ongoing research aims to develop sustained-release formulations and combination therapies, which could rejuvenate market interest.

5. How does Pfizer's patent protection strategy influence CAVERJECT's financial performance?
Patent protections enable premium pricing and market exclusivity, maintaining higher profit margins; however, lifecycle management strategies are needed to mitigate revenue declines post-patent expiration.

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Sources
[1] American Urological Association. Erectile Dysfunction: Epidemiology and Clinical Assessment. Journal of Urology, 2022.