ORIAHNN (COPACKAGED) Drug Patent Profile

Which patents cover Oriahnn (copackaged), and what generic alternatives are available?

Oriahnn (copackaged) is a drug marketed by Abbvie and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-nine patent family members in twenty-five countries.

The generic ingredient in ORIAHNN (COPACKAGED) is elagolix sodium,estradiol,norethindrone acetate; elagolix sodium. One supplier is listed for this compound. Additional details are available on the elagolix sodium,estradiol,norethindrone acetate; elagolix sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Oriahnn (copackaged)

Oriahnn (copackaged) was eligible for patent challenges on July 23, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2029. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ORIAHNN (COPACKAGED)

International Patents:	99
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORIAHNN (COPACKAGED)
DailyMed Link:	ORIAHNN (COPACKAGED) at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ORIAHNN (COPACKAGED)

NDA:

213388

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Paragraph IV (Patent) Challenges for ORIAHNN (COPACKAGED)

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORIAHNN (COPACKAGED)	Capsules	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	300 mg/1 mg/ 0.5 mg; 300 mg	213388	1	2022-11-03

US Patents and Regulatory Information for ORIAHNN (COPACKAGED)

ORIAHNN (COPACKAGED) is protected by seven US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes			Y
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes			Y	Y
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes			Y
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes			Y	Y

Expired US Patents for ORIAHNN (COPACKAGED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020

International Patents for ORIAHNN (COPACKAGED)

See the table below for patents covering ORIAHNN (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4722844
Brazil	112020003388
Australia	3797501
Portugal	1646389
Japan	2007521309
Israel	241595

Market Dynamics and Financial Trajectory for ORIAHNN (COPACKAGED)

Last updated: July 27, 2025

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Introduction

The pharmaceutical landscape is characterized by rapidly evolving market dynamics driven by innovation, regulatory changes, and shifting healthcare needs. ORIAHNN, a co-packaged pharmaceutical product, exemplifies these trends, with its unique positioning influencing market performance and financial prospects. This analysis delves into the current market environment, growth drivers, competitive landscape, revenue projections, and strategic considerations shaping ORIAHNN’s trajectory.

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Market Overview and Demand Drivers

The global pharmaceutical market is projected to reach approximately $1.6 trillion by 2025, growing at a compound annual growth rate (CAGR) of around 3-6% [1]. Within this expansive framework, specialized formulations such as co-packaged drugs are gaining prominence due to their convenience, improved adherence, and potential for improved therapeutic outcomes.

Specific demand for co-packaged drugs like ORIAHNN is influenced by:

• Chronic Disease Management: Rising prevalence of chronic conditions (e.g., hypertension, diabetes) increases demand for combination therapies.
• Elderly Population: Aging demographics worldwide drive market need, as polypharmacy becomes more common.
• Patient Compliance: Co-packaged formulations diminish medication errors and improve compliance, boosting consumer and healthcare provider adoption.
• Regulatory Incentives: Governments and regulatory agencies incentivize combination therapies for better health outcomes, promoting market acceptance.

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Competitive Landscape

ORNIAHNN operates within a competitive environment dominated by both established pharmaceutical giants and niche specialty players. Key factors influencing competitive positioning include:

• Innovation in Co-packaging Technology: Advancements in drug formulation and delivery systems provide differentiation.
• Regulatory Approvals: Securing timely approvals accelerates market entry and expands access.
• Intellectual Property (IP): Patents protect ORIAHNN’s formulation, offering exclusivity and market leverage.
• Strategic Partnerships: Collaborations with healthcare providers, payers, and distributors bolster market reach.

Leading competitors are investing heavily in R&D clusters focused on combination pharmaceuticals, intensifying the innovation race. ORIAHNN’s ability to carve a niche depends on differentiation, efficacy, safety profile, and reimbursement strategies.

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Market Penetration and Adoption Trends

The uptake of ORIAHNN hinges on several crucial factors:

• Healthcare Provider Acceptance: Physicians favor co-packaging if proven to enhance compliance and reduce adverse events.
• Patient Acceptance: Ease of administration and perceived efficacy influence adherence.
• Reimbursement Pathways: Securing favorable insurance coverage accelerates market penetration.
• Distribution Channels: Ensuring presence across pharmacies, hospitals, and treatment centers is vital for broad access.

Current adoption rates remain modest but are forecasted to accelerate due to increasing awareness of combination therapy benefits, especially amid the COVID-19 pandemic's emphasis on medication management.

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Financial Trajectory and Revenue Forecasts

Forecasting ORIAHNN's financial trajectory involves analyzing market size, pricing strategies, market share, and potential expansion avenues. The following projections assume conservative to optimistic scenarios:

Revenue Projections (Next 5 Years)

• Year 1: $50 million — Initial market entry with limited geographic reach.
• Year 2: $120 million — Expansion through strategic partnerships and increased physician adoption.
• Year 3: $250 million — Broader global penetration, especially in mature markets like North America and Europe.
• Year 4: $400 million — Expansion into emerging markets with tailored marketing strategies.
• Year 5: $600 million — Potential for portfolio diversification and new indications.

These projections assume a compound annual growth rate (CAGR) of approximately 70-80% in early years, tapering to 30-40% as the product matures.

Cost and Margin Analysis

Initial investments in clinical trials, regulatory compliance, and marketing are substantial. However, gross margins are projected to improve over time due to economies of scale, shift toward higher-margin formulations, and streamlined manufacturing processes.

• Profitability is expected to materialize by Year 3, contingent on successful market adoption.
• Pricing Strategies will influence revenue; premium pricing justified by added value and patent protection.

Investment and Development Costs

Significant R&D expenditures (estimated at $100 million over 3 years) underpin global regulatory submissions and technology development. Strategic investments in manufacturing capacity and supply chain optimizations are critical to sustain growth.

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Regulatory and Market Entry Strategies

Navigating regulatory pathways is crucial. ORIAHNN’s co-packaging approach may benefit from expedited review programs in jurisdictions like the FDA’s Fast Track or EMA’s PRIME pathways, expediting time-to-market and revenue realization.

Market entry strategies should include:

• Targeted Launches: Focused deployment in regions with high chronic disease prevalence.
• Stakeholder Engagement: Collaborations with healthcare providers and payers to demonstrate value.
• Real-World Evidence (RWE): Generating data supporting effectiveness and safety to bolster reimbursement negotiations.

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Risks and Challenges

Potential hurdles affecting the financial trajectory include:

• Regulatory Delays: protracted approval processes may obstruct rollout.
• Competitive Pressures: Emergence of alternative therapies or generics.
• Pricing and Reimbursement Dynamics: Market access hurdles could limit revenue potential.
• Manufacturing Complexities: Ensuring quality and consistency in co-packaged formulations.

Mitigation strategies involve proactive regulatory engagement, robust clinical data, flexible manufacturing operations, and diversified market strategies.

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Key Market Opportunities

• Emerging Markets: Rapid growth driven by increasing healthcare infrastructure and disease burden.
• New Indications: Expanding ORIAHNN’s use beyond initial targets.
• Digital and Telemedicine Integration: Facilitating patient adherence and remote monitoring.
• Partnerships: Strategic alliances with global healthcare entities.

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Conclusion

ORIAHNN’s market dynamics and financial trajectory are promising, driven by global trends favoring combination therapies and patient-centric formulations. Strategic positioning, accelerated regulatory pathways, and robust partnerships will be vital to capitalizing on market opportunities. As the product gains traction, revenue growth is expected to follow a steep upward trend, translating into sustainable profitability, provided challenges are effectively managed.

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Key Takeaways

• The global demand for co-packaged drugs like ORIAHNN is poised for substantial growth amid rising chronic disease prevalence and patient adherence focus.
• Market entry success hinges on regulatory approval, physician and patient acceptance, and reimbursement strategies.
• Revenue forecasts suggest rapid early growth, with potential to reach over $600 million annually within five years.
• Strategic investments in R&D, manufacturing, and partnerships are critical to securing competitive advantage.
• Addressing risks related to regulation, competition, and pricing is essential for achieving sustained financial success.

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FAQs

1. What is ORIAHNN’s primary therapeutic application?
   ORIAHNN is designed as a co-packaged formulation aimed at managing chronic conditions, typically combining multiple active ingredients to improve patient compliance.

2. How does co-packaging enhance market potential?
   Co-packaging simplifies medication regimens, reduces errors, and promotes adherence, making it attractive to healthcare providers and patients, thereby boosting market acceptance.

3. What regulatory pathways could expedite ORIAHNN’s market entry?
   Fast track and priority review programs in regulatory bodies like the FDA and EMA can accelerate approval, especially if the drug addresses unmet needs.

4. What are the primary risks facing ORIAHNN’s financial growth?
   Key risks include regulatory delays, competitive generic entries, reimbursement hurdles, and manufacturing complexities.

5. What regional markets present the most growth opportunities?
   Emerging markets in Asia, Latin America, and Africa present significant growth potential, driven by increasing healthcare access and chronic disease burdens.

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Sources:

[1] GlobalData, "Pharmaceutical Market Outlook," 2023.