PROSTIN F2 ALPHA Drug Patent Profile

When do Prostin F2 Alpha patents expire, and when can generic versions of Prostin F2 Alpha launch?

Prostin F2 Alpha is a drug marketed by Pharmacia And Upjohn and is included in one NDA.

The generic ingredient in PROSTIN F2 ALPHA is dinoprost tromethamine. There are six drug master file entries for this compound. Additional details are available on the dinoprost tromethamine profile page.

Summary for PROSTIN F2 ALPHA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	12
Patent Applications:	444
DailyMed Link:	PROSTIN F2 ALPHA at DailyMed

Recent Clinical Trials for PROSTIN F2 ALPHA

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

Sponsor	Phase
University Medical Centre Maribor	Phase 4
Aswan University Hospital	N/A
Yong Loo Lin School of Medicine	N/A

See all PROSTIN F2 ALPHA clinical trials

US Patents and Regulatory Information for PROSTIN F2 ALPHA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacia And Upjohn	PROSTIN F2 ALPHA	dinoprost tromethamine	INJECTABLE;INJECTION	017434-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for PROSTIN F2 ALPHA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmacia And Upjohn	PROSTIN F2 ALPHA	dinoprost tromethamine	INJECTABLE;INJECTION	017434-001	Approved Prior to Jan 1, 1982
Pharmacia And Upjohn	PROSTIN F2 ALPHA	dinoprost tromethamine	INJECTABLE;INJECTION	017434-001	Approved Prior to Jan 1, 1982
Pharmacia And Upjohn	PROSTIN F2 ALPHA	dinoprost tromethamine	INJECTABLE;INJECTION	017434-001	Approved Prior to Jan 1, 1982

International Patents for PROSTIN F2 ALPHA

See the table below for patents covering PROSTIN F2 ALPHA around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	60703
Australia	465150
South Africa	7203196
Germany	2126127
United Kingdom	1288174
Finland	53308

PROSTIN F2 ALPHA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prostaglandin F2 Alpha (Prostin F2 Alpha)

Introduction

Prostaglandin F2 alpha (PGF2α), also known as Prostin F2 Alpha, is a potent prostaglandin with diverse therapeutic applications, including ophthalmology, women's health, and veterinary medicine. This article delves into the market dynamics and financial trajectory of PGF2α, highlighting its current status, future prospects, and the factors influencing its market performance.

Therapeutic Applications

PGF2α has several therapeutic applications that drive its market demand:

Ophthalmology

PGF2α analogs, such as latanoprost, bimatoprost, and travoprost, are widely used in the treatment of open-angle glaucoma and ocular hypertension. These analogs are preferred due to their efficacy in lowering intraocular pressure and their low systemic side-effect profile[2].

Women's Health

PGF2α plays a crucial role in female reproductive functions, including the induction of labor and the management of premature labor (tocolysis). It is also used in the treatment of dysmenorrhea and other gynecological conditions[1][2].

Veterinary Medicine

In veterinary medicine, PGF2α is used for its luteolytic effects, particularly in horses and cattle. The drug's efficacy and the differences in its metabolic clearance between species are critical factors in its veterinary use[4].

Market Size and Growth

The market for PGF2α and its analogs is substantial and growing, driven by increasing demand in various therapeutic areas.

Current Market Size

The PGF2α receptor pipeline includes approximately 23 molecules in various stages of development, with a significant portion in advanced stages such as Phase III and Phase II. This indicates a robust pipeline that is expected to contribute to market growth[1].

Growth Prospects

The ophthalmology segment, particularly the treatment of glaucoma and ocular hypertension, is a major driver of growth. The increasing prevalence of these conditions, coupled with the efficacy of PGF2α analogs, is expected to drive market expansion. Additionally, advancements in women's health and veterinary medicine are likely to further boost the market[1][2].

Key Players and Competitive Landscape

Several pharmaceutical companies and research institutions are actively involved in the development of PGF2α targeted therapeutics.

Pharmaceutical Companies

Companies such as Pfizer, Allergan, and Novartis are key players in the development and marketing of PGF2α analogs. These companies have a strong presence in the ophthalmology and women's health markets, which are significant segments for PGF2α[1].

Research Institutions

Universities and research institutes also play a crucial role in the development of new PGF2α molecules. Their contributions to the pipeline are essential for innovation and market growth[1].

Financial Trajectory

The financial performance of PGF2α and its analogs is influenced by several factors, including market demand, competition, and regulatory approvals.

Revenue Streams

The primary revenue streams for PGF2α come from its use in ophthalmology and women's health. The sales of PGF2α analogs, such as latanoprost and bimatoprost, are significant contributors to the revenue of pharmaceutical companies involved in these markets[2].

Cost and Pricing

The cost of PGF2α and its analogs can vary depending on the formulation, dosage, and market. However, these drugs are generally priced competitively within their therapeutic categories. The pricing strategy often balances the need for profitability with the need to ensure accessibility to patients[2].

Regulatory Environment

Regulatory approvals are critical for the financial trajectory of PGF2α. Companies must navigate stringent regulatory processes to bring new products to market. Successful approvals can significantly boost revenue, while delays or rejections can have adverse financial impacts[1].

Challenges and Opportunities

The market for PGF2α faces several challenges and opportunities that shape its financial trajectory.

Challenges

• Side Effects and Tolerability: Some patients may experience side effects such as conjunctival hyperemia, surface irritation, and pigmentation changes, which can affect market acceptance[2].
• Generic Competition: The entry of generic versions of PGF2α analogs can reduce market share and revenue for branded products[2].

Opportunities

• Emerging Markets: Expanding into emerging markets can provide new revenue streams. The increasing healthcare spending in these regions presents significant opportunities for growth[1].
• New Indications: Research into new therapeutic indications for PGF2α, such as vitiligo, can open up additional market opportunities[2].

Pipeline and Development

The development pipeline for PGF2α is robust, with several molecules in various stages of clinical development.

Clinical Stages

As of 2024, the PGF2α receptor pipeline includes molecules in Pre-Registration, Phase III, Phase II, Phase I, IND/CTA Filed, Preclinical, and Discovery stages. This diverse pipeline ensures a steady stream of potential new products entering the market[1].

Mechanism of Action

PGF2α acts through the prostanoid FP receptor, which is a G-protein-coupled receptor. Understanding its mechanism of action is crucial for developing effective therapeutics and optimizing treatment outcomes[1][5].

Market Trends

Several trends are influencing the market dynamics of PGF2α:

Personalized Medicine

The trend towards personalized medicine is expected to impact the use of PGF2α, particularly in ophthalmology where genetic variations can affect treatment response[2].

Digital Health

The integration of digital health technologies can enhance patient compliance and monitoring, potentially improving the efficacy of PGF2α treatments[2].

Key Takeaways

• Therapeutic Versatility: PGF2α has diverse therapeutic applications, including ophthalmology, women's health, and veterinary medicine.
• Robust Pipeline: The development pipeline for PGF2α is strong, with several molecules in advanced stages of clinical development.
• Market Growth: The market for PGF2α is expected to grow driven by increasing demand in various therapeutic areas.
• Regulatory and Competitive Challenges: The market faces challenges from regulatory approvals and generic competition.
• Emerging Opportunities: Expanding into emerging markets and exploring new therapeutic indications present significant growth opportunities.

FAQs

What are the primary therapeutic applications of Prostaglandin F2 Alpha (PGF2α)?

PGF2α is primarily used in ophthalmology for treating open-angle glaucoma and ocular hypertension, in women's health for inducing labor and managing premature labor, and in veterinary medicine for its luteolytic effects.

Which companies are key players in the development of PGF2α targeted therapeutics?

Companies such as Pfizer, Allergan, and Novartis are key players in the development and marketing of PGF2α analogs.

What are the main challenges facing the PGF2α market?

The main challenges include side effects and tolerability issues, generic competition, and regulatory hurdles.

How does the mechanism of action of PGF2α influence its therapeutic efficacy?

PGF2α acts through the prostanoid FP receptor, a G-protein-coupled receptor, which is crucial for its therapeutic effects in various indications.

What are the growth prospects for the PGF2α market?

The market is expected to grow driven by increasing demand in ophthalmology, women's health, and emerging markets, as well as the exploration of new therapeutic indications.

How does the regulatory environment impact the financial trajectory of PGF2α?

Regulatory approvals are critical for bringing new products to market. Successful approvals can significantly boost revenue, while delays or rejections can have adverse financial impacts.

Sources

1. Pharmaceutical Technology: "Prostaglandin F2 Alpha Receptor drugs in development, 2024"
2. Taylor and Francis: "Prostaglandin F2 alpha – Knowledge and References"
3. PubMed: "Effects of prostaglandin F2 alpha on agonist-induced progesterone production"
4. Oxford Academic: "Plasma Clearance and Half-Life of Prostaglandin F2alpha"
5. Enzo: "Prostaglandin F2α"