CAVERJECT IMPULSE Drug Patent Profile

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

Caverject Impulse is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in CAVERJECT IMPULSE 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 Impulse

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

Summary for CAVERJECT IMPULSE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	104
Patent Applications:	4,154
Drug Prices:	Drug price information for CAVERJECT IMPULSE
What excipients (inactive ingredients) are in CAVERJECT IMPULSE?	CAVERJECT IMPULSE excipients list
DailyMed Link:	CAVERJECT IMPULSE at DailyMed

See drug prices for CAVERJECT IMPULSE

Pharmacology for CAVERJECT IMPULSE

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 IMPULSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-001	Jun 11, 2002		RX	No	No
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002		RX	No	No

Expired US Patents for CAVERJECT IMPULSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-001	Jun 11, 2002	4,968,299
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002	5,501,673
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002	4,968,299
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-001	Jun 11, 2002	5,501,673
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-001	Jun 11, 2002	5,716,338
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002	5,716,338

International Patents for CAVERJECT IMPULSE

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

Country	Patent Number	Title	Estimated Expiration
Japan	H0661361
Australia	673360
Israel	86799	METHOD AND DEVICE FOR INJECTION
Yugoslavia	128488
Greece	3035796
Norway	310016

CAVERJECT IMPULSE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CAVERJECT IMPULSE

Introduction

CAVERJECT IMPULSE, a formulation of alprostadil, is a significant player in the treatment of erectile dysfunction. This article delves into the market dynamics and financial trajectory of this drug, exploring its indications, market size, competition, and future outlook.

Indications and Usage

CAVERJECT IMPULSE is indicated for the treatment of erectile dysfunction due to vasculogenic, psychogenic, or mixed etiology. It is also used as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction[2][5].

Mechanism of Action

The drug works by increasing blood flow to the penis through the relaxation of smooth muscle, facilitated by its active ingredient, alprostadil, a naturally occurring form of prostaglandin E1 (PGE1)[1][5].

Market Size and Growth

The global alprostadil injection market, which includes CAVERJECT IMPULSE, is anticipated to grow significantly over the next few years. In 2023, the market was valued at several billion dollars and is expected to reach even higher figures by 2030, registering a substantial Compound Annual Growth Rate (CAGR)[4].

Competitive Landscape

CAVERJECT IMPULSE operates in a competitive market for erectile dysfunction treatments. However, its unique formulation and delivery system, such as the dual-chamber syringe, differentiate it from other products. The market includes other treatments like oral medications (e.g., sildenafil, tadalafil), but CAVERJECT IMPULSE remains a preferred option for patients who do not respond to oral therapies or have specific medical conditions[2][4].

Clinical Efficacy and Safety

Clinical studies have demonstrated the efficacy of CAVERJECT IMPULSE in treating erectile dysfunction. Over 80% of patients in clinical trials experienced an erection sufficient for sexual intercourse after intracavernosal injection. The drug has shown comparable efficacy to its predecessor, CAVERJECT Sterile Powder, in various studies[1][2].

However, like any medication, CAVERJECT IMPULSE comes with potential adverse reactions. Common local adverse reactions include penile pain, prolonged erection, and penile fibrosis. Systemic adverse reactions, though less common, can include hypotension, vasodilation, and rash[2].

Pricing and Economic Considerations

The pricing of CAVERJECT IMPULSE is influenced by several factors, including the cost of development, the size of the target patient population, and the lack of generic competition. Given that CAVERJECT IMPULSE targets a specific condition and has a relatively small patient population, its pricing strategy is aligned with the economics of precision medicines. This often results in higher prices compared to drugs targeting larger patient populations[3].

Regulatory Environment

CAVERJECT IMPULSE is subject to stringent regulatory oversight. It is available only with a doctor's prescription and must be used under medical supervision, especially during the initial dose-titration phase. Regulatory bodies like the FDA closely monitor its safety and efficacy, and any adverse reactions are meticulously reported and analyzed[2][5].

Patient and Physician Acceptance

The acceptance of CAVERJECT IMPULSE among patients and physicians is significant due to its effectiveness and the convenience of its dual-chamber syringe system. Patients appreciate the ability to self-administer the drug after initial medical supervision, while physicians value the drug's efficacy in treating a condition that can have profound psychological and physical impacts on patients[1][4].

Future Outlook

The future outlook for CAVERJECT IMPULSE is promising. As the global population ages and the prevalence of erectile dysfunction increases, the demand for effective treatments is expected to rise. Advances in pharmaceutical technology and the growing focus on precision medicines are likely to further enhance the market position of CAVERJECT IMPULSE.

Financial Trajectory

Given the anticipated growth in the alprostadil injection market and the strong clinical efficacy of CAVERJECT IMPULSE, the financial trajectory for this drug is expected to be positive. The market is projected to expand, driven by increasing demand and the lack of significant generic competition. This scenario suggests that CAVERJECT IMPULSE will continue to be a profitable product for its manufacturers.

Key Takeaways

• Market Growth: The global alprostadil injection market is expected to grow significantly by 2030.
• Clinical Efficacy: CAVERJECT IMPULSE has demonstrated high efficacy in treating erectile dysfunction.
• Safety Profile: Common adverse reactions include penile pain and prolonged erection, with systemic reactions being less common.
• Pricing Strategy: The drug's pricing is influenced by its precision medicine nature and the lack of generic competition.
• Regulatory Oversight: Strict regulatory monitoring ensures safety and efficacy.
• Patient and Physician Acceptance: High acceptance due to effectiveness and convenience.

FAQs

Q: What is CAVERJECT IMPULSE used for? A: CAVERJECT IMPULSE is used for the treatment of erectile dysfunction due to vasculogenic, psychogenic, or mixed etiology, and as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction[2][5].

Q: How does CAVERJECT IMPULSE work? A: CAVERJECT IMPULSE works by increasing blood flow to the penis through the relaxation of smooth muscle, facilitated by its active ingredient, alprostadil (prostaglandin E1)[1][5].

Q: What are the common adverse reactions associated with CAVERJECT IMPULSE? A: Common adverse reactions include penile pain, prolonged erection, and penile fibrosis. Systemic reactions can include hypotension, vasodilation, and rash[2].

Q: Is CAVERJECT IMPULSE available over-the-counter? A: No, CAVERJECT IMPULSE is available only with a doctor's prescription and should be used under medical supervision, especially during the initial dose-titration phase[2][5].

Q: What is the expected market growth for CAVERJECT IMPULSE? A: The global alprostadil injection market, which includes CAVERJECT IMPULSE, is anticipated to grow significantly by 2030, driven by increasing demand and the lack of significant generic competition[4].

Sources

1. CAVERJECT Impulse® Dual Chamber System alprostadil for injection - FDA Label[1].
2. CAVERJECT® IMPULSE (alprostadil) - Pfizer Medical Information[2].
3. The Economics of Drug Development: Pricing and Innovation in a Changing Market - NBER[3].
4. Global Alprostadil Injection Market 2024-2030 - Mobility Foresights[4].
5. CAVERJECT Impulse - Medsafe[5].