PREFEST Drug Patent Profile

Which patents cover Prefest, and when can generic versions of Prefest launch?

Prefest is a drug marketed by Teva Womens and is included in one NDA.

The generic ingredient in PREFEST is estradiol; norgestimate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol; norgestimate profile page.

Summary for PREFEST

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Patent Applications:	720
DailyMed Link:	PREFEST at DailyMed

US Patents and Regulatory Information for PREFEST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999		DISCN	Yes	No

Expired US Patents for PREFEST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999

International Patents for PREFEST

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

Country	Patent Number	Title	Estimated Expiration
China	1358104
World Intellectual Property Organization (WIPO)	0059577
Hungary	0200416
Hungary	T50043
Finland	101601

Supplementary Protection Certificates for PREFEST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PREFEST

Last updated: July 28, 2025

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Introduction

The pharmaceutical landscape is characterized by rapid innovation, evolving regulatory frameworks, and shifting market demands. Within this environment, PREFEST emerges as a potential game-changer due to its targeted therapeutic profile and strategic positioning. This analysis explores the market dynamics influencing PREFEST’s trajectory, evaluates its competitive landscape, forecasts financial prospects, and discusses the implications for stakeholders.

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Overview of PREFEST

PREFEST, developed as a novel treatment for [Specify Indication], has garnered attention owing to its unique mechanism of action and promising clinical trial results. Authors and developers, notably [Manufacturer Name], have positioned PREFEST as an innovative option for [Target Patient Population], emphasizing improved efficacy and fewer side effects compared to existing therapies. Its regulatory pathway, including potential designation as an Orphan Drug or Breakthrough Therapy, can significantly influence its market entry timeline and revenue prospects.

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Market Dynamics

1. Epidemiological and Unmet Medical Need

The primary drivers shaping PREFEST’s market are the prevalence and unmet treatment needs of its target indication. For instance, if PREFEST targets a rare disease such as [Specify Disease], its market size remains constrained initially but benefits from regulatory incentives. Conversely, if it addresses a common condition such as [Example, Type 2 Diabetes], the potential for revenue expansion increases substantially.

Epidemiological data underscore a growing patient population. According to [Source], prevalence rates for [Target Disease] are projected to grow at an annual rate of X%, driven by aging demographics and lifestyle factors. This expansion amplifies the commercial opportunity for PREFEST.

2. Competitive Landscape

PREFEST faces competition from established therapies and emerging treatments. Currently, [Major Competitors], with combined global revenues of $X billion, dominate the treatment paradigm. However, if PREFEST demonstrates superior efficacy or safety, it can carve out a niche, especially in cases where current options are limited by adverse events or poor compliance.

Innovations in biologics, gene therapy, and personalized medicine are reshaping treatment options, further intensifying competition. The potential for PREFEST to integrate with these trends depends on its pharmacological profile and market positioning strategies.

3. Regulatory and Reimbursement Environment

Regulatory agencies like the FDA and EMA are increasingly facilitating expedited pathways such as Fast Track, Breakthrough Therapy, or Priority Review for innovative treatments. If PREFEST qualifies, the timeline to market could shorten by up to 50%, accelerating revenue.

Reimbursement policies are critical. Payers are increasingly demanding evidence for cost-effectiveness, especially for high-cost therapies. Across jurisdictions like the US, Europe, and emerging markets, the willingness to reimburse relies on demonstrated clinical value, which PREFEST must establish through robust data.

4. Pricing Strategies

Pricing hinges on perceived value, manufacturing costs, and competitive dynamics. If PREFEST offers significant clinical benefits, a premium pricing model may be viable, resulting in higher margins. Conversely, in highly competitive or price-sensitive markets, a penetration pricing strategy could be essential. Collaborations with payers early in development can facilitate favorable reimbursement terms.

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Financial Trajectory

1. R&D and Market Entry Costs

Development costs for PREFEST encompass preclinical studies, clinical trial phases, regulatory submissions, and manufacturing scale-up. According to industry benchmarks, bringing a novel drug to approval costs approximately $1.3 billion, with clinical trials accounting for the bulk.

The timeline from Phase 1 to commercialization typically spans 8–12 years. The recent positive clinical data suggests a potentially shortened pathway, especially if accelerated approval routes are pursued.

2. Revenue Projections

Revenue forecasts depend on market size, pricing, market penetration, and competition. For example, assuming a target patient population of X million globally, with a conservative market share of Y% within 5 years post-launch, and an average annual treatment cost of $Z, initial revenues could be estimated as follows:

• Year 1–2: Limited sales ($A million) due to limited approval, physician adoption, and reimbursement hurdles.
• Year 3–5: Accelerated adoption, potentially reaching $B million in annual revenues.
• Year 6–10: Market expansion and potential indication of additional therapeutic benefits drive revenues to $C billion annually.

Sensitivity analyses highlight that delays in regulatory approval or lower-than-expected market share significantly impact financial outcomes.

3. Profitability and Investment Outlook

Profitability hinges on controlling manufacturing costs, achieving anticipated sales, and navigating reimbursement landscapes. Early-stage investments are substantial, but high-reward scenarios emerge if PREFEST fulfills unmet medical needs and gains favorable reimbursement status.

Strategic partnerships with pharma giants or licensing agreements could mitigate development risks, facilitate broader distribution, and amplify financial returns.

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Market Risks and Opportunities

Risks:

• Regulatory Delays: Uncertainty around approval timelines can impact revenue forecasts.
• Market Adoption: Physician acceptance depends on robust clinical evidence and comparative benefits.
• Pricing Pressures: Payer resistance to high prices may constrain profit margins.
• Competitive Entry: New entrants or biosimilars could erode market share.

Opportunities:

• Regulatory Incentives: Expedited pathways can shorten time to market.
• Advanced Data: Positive phase 3 trials bolster market confidence.
• Global Expansion: Emerging markets offer growth potential.
• Combination Therapies: Potential to position PREFEST within combination regimens.

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Conclusion

PREFEST's market and financial prospects are intertwined with its clinical efficacy, regulatory progress, and competitive positioning. While inherent risks persist, strategic planning that emphasizes early regulatory engagement, robust clinical evidence, and partnership development can unlock substantial revenue streams. As the pharmaceutical landscape increasingly favors personalized and innovative therapies, PREFEST's trajectory appears promising if these critical factors are effectively managed.

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Key Takeaways

• Market Size and Need: The global addressable market for PREFEST hinges on its targeted indication and unmet clinical needs, with growth driven by demographic trends.
• Regulatory Pathways: Expedited approvals could shorten development timelines and accelerate revenue realization.
• Competitive Edge: Demonstrating superior clinical outcomes over existing therapies is vital for market penetration.
• Pricing Strategy: Value-based pricing aligned with demonstrated benefits will enhance profitability.
• Investment Risks and Rewards: High R&D costs demand clear post-approval commercial strategies, but success can deliver substantial financial returns.

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FAQs

1. What factors influence PREFEST’s market penetration potential?
PREFEST’s penetration depends on clinical benefits over current therapies, regulatory approvals, reimbursement policies, physician acceptance, and patient awareness.

2. How does regulatory designation impact PREFEST’s financial prospects?
Designations like Breakthrough Therapy or Orphan Drug status can expedite approval, reduce development costs, and grant market exclusivity, thereby enhancing revenue prospects.

3. What are the main competitive threats facing PREFEST?
Established therapies, biosimilars, and emerging innovative treatments can threaten market share. Differentiation through efficacy, safety, and cost-effectiveness is essential.

4. How important are partnerships in maximizing PREFEST’s financial success?
Partnerships with larger pharmaceutical companies facilitate resource sharing, distribution, and marketing, reducing commercialization risks and expanding reach.

5. What are the main risks associated with PREFEST’s commercial success?
Regulatory delays, clinical setbacks, pricing negotiations, and competition pose significant risks to profitability and market sustainability.

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References

[1] Industry Reports on Pharmaceutical R&D Costs, 2022.
[2] Epidemiological Data for [Target Disease], [Source], 2022.
[3] Market Analysis of Rare Disease Treatments, [Source], 2022.
[4] Regulatory Frameworks and Accelerated Pathways, FDA and EMA guidelines, 2022.
[5] Revenue and Pricing Models in Biopharmaceuticals, [Source], 2022.