Alprostadil - Generic Drug Details

What are the generic sources for alprostadil and what is the scope of patent protection?

Alprostadil is the generic ingredient in six branded drugs marketed by Hikma, Meitheal, Pfizer, Endo Operations, and Mylan Speciality Lp, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for alprostadil. Five suppliers are listed for this compound.

Summary for alprostadil

US Patents:	0
Tradenames:	6
Applicants:	5
NDAs:	8
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	39
Patent Applications:	5,995
What excipients (inactive ingredients) are in alprostadil?	alprostadil excipients list
DailyMed Link:	alprostadil at DailyMed

Recent Clinical Trials for alprostadil

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

Sponsor	Phase
University Hospital, Rouen	Phase 3
Kafrelsheikh University	N/A
The First Hospital of Jilin University	Phase 4

See all alprostadil clinical trials

Pharmacology for alprostadil

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

Medical Subject Heading (MeSH) Categories for alprostadil

Platelet Aggregation Inhibitors

Urological Agents

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for alprostadil

C01EA	Prostaglandins
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for alprostadil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	EDEX	alprostadil	INJECTABLE;INJECTION	020649-003	Jun 12, 1997	AP	RX	Yes	No
Endo Operations	EDEX	alprostadil	INJECTABLE;INJECTION	020649-005	Jul 30, 1998		RX	Yes	Yes
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020755-001	Oct 31, 1997		DISCN	No	No
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-002	Nov 19, 1996		DISCN	Yes	No
Endo Operations	EDEX	alprostadil	INJECTABLE;INJECTION	020649-002	Jun 12, 1997	AP	RX	Yes	No
Endo Operations	EDEX	alprostadil	INJECTABLE;INJECTION	020649-007	Jul 30, 1998		RX	Yes	Yes

Expired US Patents for alprostadil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-003	Nov 19, 1996	5,242,391
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002	4,968,299
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-001	Nov 19, 1996	5,886,039
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-002	Nov 19, 1996	5,886,039
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-003	Nov 19, 1996	5,474,535
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-001	Nov 19, 1996	5,242,391

Alprostadil Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alprostadil

Introduction to Alprostadil

Alprostadil, a synthetic version of prostaglandin E1, has emerged as a crucial therapeutic agent in managing several critical health conditions, most notably erectile dysfunction (ED) and certain heart diseases in newborns. Here, we delve into the market dynamics and financial trajectory of alprostadil, highlighting its current status, growth drivers, and future prospects.

Therapeutic Applications of Alprostadil

Alprostadil is primarily used to treat two major conditions:

• Erectile Dysfunction (ED): Alprostadil is administered via intracavernosal injection or as a urethral suppository to enhance blood flow and facilitate erections in men who do not respond well to oral medications like Viagra, Cialis, and Levitra[1][5].
• Neonatal Heart Conditions: Alprostadil is used intravenously to manage heart defects in newborns, such as patent ductus arteriosus (PDA), by regulating blood flow and improving survival rates before corrective surgery[1].

Market Growth Drivers

Several factors are driving the growth of the alprostadil market:

Increasing Awareness and Stigma Reduction

Public awareness campaigns and educational initiatives have helped reduce the stigma associated with ED, leading to more men seeking medical help. This increased awareness is a significant driver for the alprostadil market[2][3].

Advancements in Delivery Methods

Innovations in delivery systems, such as more refined and less invasive methods, are making alprostadil treatments more accessible and appealing to patients. These advancements include new formulations and administration routes that enhance patient comfort and efficacy[1].

Growing Demand in Emerging Markets

Emerging economies, particularly in the Asia-Pacific and Latin America regions, are witnessing an increase in demand for alprostadil due to rising healthcare needs and growing awareness of ED and neonatal health issues. Pharmaceutical companies expanding into these markets are likely to experience significant growth[1].

Financial Trajectory

The financial outlook for the alprostadil market is promising:

Global Market Size and Growth Rate

The global erectile dysfunction market, which includes alprostadil, is projected to reach USD 6.1 billion by 2032, growing at a CAGR of 6.8% from 2022 to 2032. This growth is driven by the increasing prevalence of ED and the introduction of new products in the market[3].

Regional Market Performance

North America currently dominates the erectile dysfunction drugs market with a revenue share of 51.7% in 2022, due to high prevalence rates and strong healthcare infrastructure. The Asia-Pacific region is expected to grow rapidly, driven by the introduction of new products and increasing awareness[3].

Business Opportunities and Collaborations

The relatively low production cost of alprostadil, coupled with its growing demand, makes it an attractive investment opportunity for pharmaceutical companies. Strategic partnerships between pharmaceutical companies and healthcare providers are facilitating the development of new formulations and delivery methods, further expanding market reach and fostering innovation[1].

Competitive Landscape

The competitive landscape of the alprostadil market is characterized by:

Innovations and Clinical Trials

Companies like Palatin Technologies are conducting clinical trials to evaluate new treatments, such as bremelanotide (BMT) co-administered with PDE5 inhibitors, to address a broader spectrum of patient conditions. These innovations are crucial for market growth and sustainability[2].

Market Share and Distribution Channels

Retail pharmacies dominate the distribution channel with the largest revenue share, indicating a strong retail presence for alprostadil and other ED treatments. The market is also seeing collaborations between pharmaceutical companies and healthcare providers to make alprostadil more accessible[3].

Challenges and Side Effects

While alprostadil is an effective treatment, it comes with some challenges and side effects:

• Common Side Effects: Pain or swelling at the injection site, priapism (prolonged erection), and low blood pressure are common side effects. Adhering to recommended dosages is crucial to minimize these risks[1].
• Alternative Treatments: Oral medications like Viagra, Cialis, and Levitra are alternatives, but alprostadil remains a viable option for men who do not respond to these treatments[1].

Future Prospects

The future of the alprostadil market looks promising due to several factors:

Expanding Global Markets

Emerging markets in Asia-Pacific and Latin America offer significant growth opportunities as awareness of ED and neonatal health issues increases in these regions[1].

Innovations in Delivery Systems

Continual innovations in delivery methods and formulations will enhance patient outcomes and make treatments more convenient and effective[1].

Strategic Collaborations

Collaborations between pharmaceutical companies and healthcare providers will continue to drive market growth by bringing new treatments to market faster and making them more accessible to patients[1].

Key Takeaways

• Growing Demand: The demand for alprostadil is increasing due to its effectiveness in treating ED and neonatal heart conditions.
• Innovations: Advancements in delivery methods and formulations are key drivers of market growth.
• Expanding Markets: Emerging economies offer significant growth opportunities.
• Collaborations: Strategic partnerships are essential for fostering innovation and expanding market reach.
• Financial Outlook: The market is projected to grow significantly, driven by increasing prevalence and awareness.

FAQs

Q: What are the primary uses of alprostadil? A: Alprostadil is primarily used to treat erectile dysfunction (ED) and certain heart conditions in newborns, such as patent ductus arteriosus (PDA)[1].

Q: How is alprostadil administered for ED? A: Alprostadil can be administered via an intracavernosal injection or as a urethral suppository for treating ED[1].

Q: What are the common side effects of alprostadil? A: Common side effects include pain or swelling at the injection site, priapism (prolonged erection), and low blood pressure[1].

Q: What are the growth drivers for the alprostadil market? A: Key growth drivers include increasing awareness of ED, advancements in delivery methods, and growing demand in emerging markets[1][2][3].

Q: What is the projected market size for the erectile dysfunction drugs market, which includes alprostadil? A: The global erectile dysfunction drugs market is projected to reach USD 6.1 billion by 2032, growing at a CAGR of 6.8% from 2022 to 2032[3].

Sources:

1. Market Research Intellect - Enhancing Patient Outcomes: The Rise of Alprostadil Injections
2. BioSpace - Erectile Dysfunction Market to Reach USD 3.9 Billion by 2034
3. GlobeNewswire - Erectile Dysfunction Drugs Market Value to Reach USD 6.1 bn by 2032
4. Mobility Foresights - Global Alprostadil Injection Market 2024-2030
5. University of Maryland, Baltimore - Alprostadil Summary Report