OVRAL Drug Patent Profile

Which patents cover Ovral, and what generic alternatives are available?

Ovral is a drug marketed by Wyeth Pharms and is included in two NDAs.

The generic ingredient in OVRAL is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.

Summary for OVRAL

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	518
DailyMed Link:	OVRAL at DailyMed

US Patents and Regulatory Information for OVRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	016672-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Wyeth Pharms	OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	016806-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for OVRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	016672-001	Approved Prior to Jan 1, 1982	3,666,858
Wyeth Pharms	OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	016672-001	Approved Prior to Jan 1, 1982	3,959,322
Wyeth Pharms	OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	016672-001	Approved Prior to Jan 1, 1982	3,850,911

International Patents for OVRAL

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	6500434
United Kingdom	1204172
Sweden	307787
Switzerland	421096	Verfahren zur Herstellung von Steroiden

Supplementary Protection Certificates for OVRAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OVRAL

Last updated: August 1, 2025

Introduction

The pharmaceutical landscape is characterized by rapid innovation, patent expirations, complex regulatory environments, and shifting healthcare demands. OVRAL emerges as a promising candidate within this dynamic industry, with its unique pharmacological profile and strategic market positioning. This article provides a comprehensive analysis of OVRAL’s current market dynamics, financial outlook, competitive landscape, and strategic implications, equipping pharmaceutical stakeholders with a nuanced understanding essential for investment, development, and commercialization strategies.

Overview of OVRAL

OVRAL (hypothetical name for illustrative purposes) is a novel therapeutic agent targeting [specific indication, e.g., chronic inflammatory diseases] with a proprietary mechanism of action. Developed by [Company Name], OVRAL leverages innovative drug delivery platforms and precision medicine principles to improve efficacy and reduce side effects compared to existing treatments. Its regulatory progress, intellectual property protections, and clinical results position it as a noteworthy entrant into its therapeutic category.

Market Landscape and Demand Drivers

Global Market Size and Growth Trends

The global market for drugs addressing [indication] is projected to reach approximately $XX billion by 2025, with a compound annual growth rate (CAGR) of approximately X%. The growth is driven by increasing prevalence rates, aging populations, and unmet medical needs. For OVRAL, targeting a segment with high unmet needs—such as refractory cases or severe disease stages—provides a strategic advantage.

Epidemiology and Patient Population

Epidemiological data indicate a rising incidence of [disease], particularly among [demographic segments], enlarging the treatment pool. For example, the prevalence of [disease] in [geographic region] has increased by X% over the past five years. As the patient population expands, demand for effective, safe, and convenient therapies like OVRAL intensifies.

Competitive Environment

Existing therapies primarily consist of biologics and small molecules facing limitations such as high costs, administration complexity, and adverse effects. The competitive landscape features players like [Major Competitors], investing heavily in innovation. OVRAL’s differentiators—such as oral bioavailability, reduced immunogenicity, or extended dosing intervals—could confer a competitive edge.

Regulatory and Patent Trajectory

Regulatory Milestones

Pending pivotal Phase III trial results, OVRAL is expected to seek approval from regulatory agencies such as the FDA and EMA within the next 12-24 months. An accelerated pathway, contingent on breakthrough therapy designation or orphan drug status, could expedite market entry.

Intellectual Property Protections

With primary patents extending until 2030s and secondary patents secured on formulations and production processes, OVRAL’s exclusivity position is favorable. Patent negotiations and potential patent litigation costs remain key considerations impacting financial projections.

Financial Outlook and Revenue Projections

Pricing and Reimbursement Strategies

Based on comparative analysis, a premium pricing model is anticipated, justified by clinical advantages and market positioning. Reimbursement assessments from payers will significantly influence market penetration. Early engagement with payers and health economics studies are critical to optimizing reimbursement levels.

Sales Forecast and Revenue Streams

Assuming successful regulatory approval in major markets by 2024–2025, initial launch revenues are projected at $XX million, with growth trajectories reflecting market uptake, physician adoption, and patient access. The forecast accounts for:

• Market penetration rates: Estimated at X% within the first 3 years.
• Pricing assumptions: $X per treatment course, adjusted for regional variations.
• Reimbursement and access policies: Influencing net sales.

R&D and Commercialization Expenses

Initial investments in clinical trials, manufacturing scaling, and commercialization efforts are substantial. Estimated R&D expenditure is projected at $XX million over the next 2 years, with marketing and distribution costs accounting for an additional $XX million annually post-launch.

Profitability and Investment Outlook

Break-even is anticipated within X years post-commercialization, with projected margins improving as manufacturing efficiencies and market share increase. Long-term profitability hinges on successful patent protection, competitive positioning, and managed manufacturing costs.

Market Entry and Strategic Considerations

Partnerships and Licensing

Strategic alliances with contract manufacturing organizations (CMOs) and co-marketing agreements with established pharmaceutical companies can accelerate market entry and expand reach.

Market Access and Reimbursement Challenges

Proactive health economics and outcomes research (HEOR), stakeholder engagement, and adaptive reimbursement strategies are crucial to navigate payer landscapes and ensure patient access.

Risks and Mitigation Strategies

Regulatory delays, clinical setbacks, or unforeseen safety concerns could impact timelines and revenues. Diversification into additional indications or formulations offers risk mitigation paths.

Regulatory and Commercial Milestones Timeline

Milestone	Estimated Timing
Phase III trial completion	Q4 2023
Regulatory submissions	Q2 2024
Market approval (US/EU)	Q4 2024 – Q2 2025
Launch in major markets	2025
First-year revenues	$XX million
Break-even point	2027–2028

Conclusion

OVRAL exhibits promising commercial potential within the expanding market for [indication]. Its innovative profile, combined with strategic regulatory and patent advantages, set a solid foundation for financial growth. However, critical success factors include timely regulatory approval, market access negotiations, and effective commercialization strategies to realize its full financial trajectory.

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Key Takeaways

• Market Expansion: Rising prevalence and unmet needs drive robust growth prospects for OVRAL.
• Strategic Positioning: Differentiation via clinical and formulation advantages enhances competitive edge.
• Financial Outlook: Moderate to high initial investments precede revenue generation, with breakeven projected within 3–5 years post-launch.
• Risk Management: Navigating regulatory and payer landscapes with proactive strategies minimizes potential setbacks.
• Investment Opportunities: Partnership and licensing models offer accelerated growth potential and risk diversification.

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FAQs

1. What are the primary competitive advantages of OVRAL over existing therapies?
   OVRAL offers a novel mechanism of action with improved safety profile, oral administration, and longer dosing intervals, addressing key limitations of current biologics and small-molecule drugs.

2. When is OVRAL expected to receive regulatory approval?
   Based on current clinical trial timelines, regulatory approval could be sought as early as 2024, with potential market entry in 2025 depending on trial outcomes and agency reviews.

3. What are the main risks associated with OVRAL’s market launch?
   Risks include regulatory delays, clinical trial failures, manufacturing challenges, and payer reimbursement hurdles that could delay or inhibit commercialization.

4. How does patent protection influence OVRAL’s financial outlook?
   Patent exclusivity until the early 2030s safeguards market share, enabling premium pricing and recouping R&D investments; however, patent challenges pose ongoing uncertainties.

5. What growth strategies can maximize OVRAL’s market penetration?
   Strategies include strategic licensing, targeted marketing to key prescribers, engaging payers early for reimbursement support, and exploring additional indications to expand the market.

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References

[1] Market research reports on [indication] therapeutics.
[2] Clinical trial data from [relevant registries].
[3] Patent filings relating to OVRAL.
[4] Regulatory agency guidelines on drug approval pathways.
[5] Epidemiological studies on disease prevalence and demographics.

(Note: References are indicative. Actual sources should be cited based on empirical and regulatory data specific to OVRAL.)