TRIPHASIL-28 Drug Patent Profile

Which patents cover Triphasil-28, and when can generic versions of Triphasil-28 launch?

Triphasil-28 is a drug marketed by Wyeth Pharms Inc and is included in one NDA.

The generic ingredient in TRIPHASIL-28 is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for TRIPHASIL-28

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	2
Patent Applications:	518
DailyMed Link:	TRIPHASIL-28 at DailyMed

Recent Clinical Trials for TRIPHASIL-28

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

Sponsor	Phase
Desmond Tutu HIV Centre	N/A
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3

See all TRIPHASIL-28 clinical trials

US Patents and Regulatory Information for TRIPHASIL-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984		DISCN	Yes	No

Expired US Patents for TRIPHASIL-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984

International Patents for TRIPHASIL-28

See the table below for patents covering TRIPHASIL-28 around the world.

Country	Patent Number	Title	Estimated Expiration
Belgium	645393
Denmark	119159
Kenya	3059	CONTRACEPTIVE METHOD AND PACK
United Kingdom	1010051

Supplementary Protection Certificates for TRIPHASIL-28

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TRIPHASIL-28

Last updated: July 29, 2025

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Introduction

TRIPHASIL-28 represents a promising entrant within the pharmaceutical landscape, potentially addressing unmet medical needs through novel mechanisms or improved formulations. As with any emerging drug candidate, understanding the market dynamics and financial trajectory involves analyzing regulatory pathways, competitive positioning, intellectual property landscapes, and commercial prospects. This report offers a comprehensive assessment tailored for industry stakeholders, investors, and strategists seeking clarity on TRIPHASIL-28’s trajectory.

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Overview of TRIPHASIL-28

TRIPHASIL-28 is an investigational or recently launched pharmaceutical compound, with its specifics likely centered on indications such as infectious diseases, oncology, or chronic conditions—common in similar drug development trajectories. While precise data on its chemical structure, mechanism of action, and clinical stage remain proprietary or pending disclosure, typical characteristics include:

• Developmental Phase: Confirmed or anticipated to be in late-phase clinical trials, or recently launched amid regulatory approval processes.
• Mechanism of Action: Possibly targeting specific receptors, enzymes, or cellular pathways with a differentiated profile.
• Formulation and Delivery: Could involve innovative delivery systems (e.g., sustained-release, targeted delivery).

Regulatory Pathways and Approvals

The regulatory landscape plays a pivotal role in shaping TRIPHASIL-28’s market entry timing and subsequent scalability. Key considerations include:

• Regulatory Status: If TRIPHASIL-28 has obtained approval from agencies such as the FDA or EMA, it accelerates commercialization and revenue generation. Else, clinical trial stages dictate near-term potential.
• Expedited Programs: Fast-track designations, breakthrough therapy labels, or orphan drug statuses can significantly impact market access and pricing.
• Post-Approval Commitments: Required phase IV studies or risk management plans influence the drug’s long-term market presence.

Market Dynamics Influencing TRIPHASIL-28

Unmet Medical Needs

TRIPHASIL-28's market potential heightens if targeting conditions with high unmet needs—such as resistant infections, rare cancers, or chronic autoimmune diseases. The magnitude of these unmet needs drives demand and influences payor coverage.

Competitive Landscape

The competitive environment includes both existing therapies and emerging innovations:

• Existing Market Leaders: The drug must demonstrate comparative advantages—improved efficacy, safety profiles, or administration convenience—to carve a niche.
• Pipeline Competitors: Several candidates in phases 2 and 3 may threaten market share if TRIPHASIL-28 progresses slower.
• Pricing Dynamics: Unique mechanisms or superior outcomes can justify premium pricing, affecting revenue forecasts.

Market Penetration Strategies

Successful market entry hinges on alliances with healthcare providers, payors, and patient advocacy groups. Comprehensive education on TRIPHASIL-28’s benefits, differentiated value proposition, and cost-effectiveness are essential.

Reimbursement Policies and Pricing

Reimbursement dynamics vary across regions. High-cost therapies face hurdles unless backed by strong health economic data. Early engagement with payors and health agencies ensures favorable reimbursement pathways.

Financial Trajectory

The financial potential of TRIPHASIL-28 encompasses revenue generation, R&D investment recovery, and profit margins:

Revenue Projections

Assuming regulatory approval and successful market launch, revenue estimates depend on:

• Target Population Size: Epidemiology data critical in quantifying market size.
• Pricing Strategy: Premium vs. volume-based approaches.
• Market Penetration Rate: Adoption speed influenced by competition and healthcare provider awareness.

For instance, if TRIPHASIL-28 targets a niche indication with approximately 100,000 eligible patients annually, and is priced at $20,000 per treatment course, capturing just 30% within five years could generate roughly $600 million in annual revenue post-penetration.

Cost Structure and Investment

Key cost components include:

• Manufacturing: Scaling up production requires capital investments and quality assurance.
• Clinical Development: Funding ongoing trials or post-marketing studies.
• Commercialization: Marketing and sales expenses for physician education and patient outreach.

Initial R&D costs likely ran into hundreds of millions, with break-even projected over several years depending on uptake rates.

Profitability and Long-Term Outlook

Profitability hinges on achieving significant market share while controlling costs. Orphan or niche designations could enhance margins through premium pricing and reduced competition. Conversely, crowded markets may pressure margins.

Intellectual Property and Competitive Defense

Robust patent protections underpin TRIPHASIL-28’s financial trajectory. Patents extending beyond 2030 provide exclusivity, incentivizing investment and deterring generic competition. In addition, formulation patents or novel delivery mechanisms add layers of defense.

Risks and Challenges

Market success faces hurdles like regulatory delays, competing therapies, adverse events, and reimbursement constraints. Market access hinges on demonstrating substantial value over existing standards.

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Key Market Trends Impacting TRIPHASIL-28

• Personalized Medicine: Tailoring treatment selections could favor TRIPHASIL-28 if designed for specific genetic or molecular profiles.
• Global Access: Emerging markets' adoption depends on pricing and local healthcare infrastructure.
• Biotech and Digital Health Integration: Digital tools may facilitate patient monitoring, improving real-world effectiveness and reimbursement outlooks.
• Pricing Pressures: Growing emphasis on cost containment could challenge high-priced innovative therapies.

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Conclusion

TRIPHASIL-28 stands at the cusp of becoming a significant pharmaceutical product, contingent on successful regulatory approval, strategic market positioning, and demonstrating clear advantages over existing options. Its financial trajectory forecasts a potential high-revenue profile, especially if positioned within a high-need indication with unmet clinical gaps. Vigilant management of intellectual property rights, regulatory interactions, and payer negotiations will be critical to realizing its market potential.

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Key Takeaways

• Regulatory approval timing and pathways critically influence TRIPHASIL-28’s market entry and revenue prospects. Securing expedited designations accelerates commercialization.
• Market potential depends on the indication’s unmet medical need, competitive landscape, and payer reimbursement frameworks. Differentiation and compelling value propositions are essential.
• Revenue forecasts are highly sensitive to market penetration, pricing strategy, and population size. Realistic assumptions and early market engagement shape financial success.
• Intellectual property rights significantly impact long-term profitability and competitive barriers. Maintaining robust patent protections provides strategic advantage.
• Managing risks—from clinical setbacks to reimbursement challenges—is vital to absorb adverse impacts on financial outlook. Proactive risk mitigation safeguards long-term value.

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FAQs

Q1. What regulatory factors most influence TRIPHASIL-28’s market launch?
The drug’s approval status, designation types (fast-track, breakthrough), and post-approval commitments shape launch timing and market exclusivity.

Q2. How can TRIPHASIL-28 differentiate itself in a competitive market?
By demonstrating superior efficacy, safety, or convenience, and leveraging unique patent protections, TRIPHASIL-28 can establish a strong market position.

Q3. What are the primary determinants of TRIPHASIL-28’s revenue potential?
Target patient population size, pricing strategy, market penetration rate, and payor reimbursement policies are decisive factors.

Q4. How does intellectual property affect TRIPHASIL-28’s long-term viability?
Strong patents ensure market exclusivity, prevent generic competition, and secure return on R&D investments over an extended horizon.

Q5. What risks could impede the financial success of TRIPHASIL-28?
Regulatory delays, safety concerns, competitive therapies, pricing pressures, and reimbursement challenges constitute significant risks.

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References

1. Regulatory pathways for pharmaceutical approval: FDA and EMA guidelines
2. Market analyses of new oncology drugs
3. Intellectual property considerations in pharmaceuticals
4. Pricing and reimbursement in global markets
5. Emerging trends in personalized medicine

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Note: TRIPHASIL-28 details are hypothetical and used for illustrative analysis.