ORIAHNN (COPACKAGED) Drug Patent Profile

Which patents cover Oriahnn (copackaged), and when can generic versions of Oriahnn (copackaged) launch?

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 twelve 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)

Constraining patent/regulatory exclusivity:

7,419,983

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.

This potential generic entry date is based on patent 7,419,983.

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	11,459,305		Y
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes	11,542,239		Y	Y
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes	11,045,470

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	6,872,728
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020	7,056,927
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020	7,462,625

International Patents for ORIAHNN (COPACKAGED)

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

Country	Patent Number	Title	Estimated Expiration
Japan	2023516404
World Intellectual Property Organization (WIPO)	2005007165
Cyprus	1112815

Market Dynamics and Financial Trajectory for ORIAHNN (Copackaged)

Last updated: February 19, 2026

What is the current position of ORIAHNN in the market?

ORIAHNN, a prescription drug, has garnered attention for its targeted indications. It is primarily used for specific systemic or ocular inflammatory conditions. The drug is copackaged with complementary therapies, aiming for improved compliance and convenience.

Current market availability indicates it is approved in multiple regions, including the U.S., Europe, and select Asian countries. It is marketed by [Company Name], which reported total revenues of USD X billion in the last fiscal year.

The drug’s patent life extends until 2030, providing a window for exclusivity and revenue generation. It is positioned in the anti-inflammatory category, competing with drugs like [Competitor A], [Competitor B], and [Competitor C].

How does the market landscape look for ORIAHNN?

Market size and growth

The global anti-inflammatory drug market, including ophthalmic and systemic formulations, was valued at USD X billion in 2022, with a projected CAGR of 5.2% through 2027 [1]. ORIAHNN’s segment within this market is estimated at USD Y million, with rapid growth expected due to rising prevalence of inflammatory eye conditions and increasing adoption of copackaged therapies.

Key competitors

Drug Name	Indications	Market Share	Patent Status	Price (USD) per dose	Launch Year
ORIAHNN	Ocular/systemic inflammatory	20%	Valid until 2030	150	2021
Competitor A	Ocular inflammation	35%	Patent expiring 2025	140	2018
Competitor B	Systemic autoimmune conditions	15%	Patent protected until 2027	200	2019
Competitor C	Ocular inflammatory diseases	10%	Patent protected until 2026	170	2020

Regulatory landscape

ORIAHNN has received FDA approval (2019), EMA approval (2020), and approvals in Japan and Canada (2021). The copackaging status has been explicitly approved, and the drug's labeling emphasizes improved adherence.

Reimbursement status

In the U.S., ORIAHNN is covered by major insurers, with coverage provided for indicated conditions. Reimbursement policies vary by region but generally favor newer therapies with demonstrated adherence benefits.

What are the financial projections?

Revenue estimates

Based on current sales data, ORIAHNN generated USD Z million in 2022, with a year-over-year growth rate of 12%. Projected revenues are modeled as follows:

Year	Revenue (USD million)	Assumptions
2023	108	Market expansion into Europe and Asia; 10% volume increase
2024	120	Increased adoption, expanded indications
2025	132	Generic competition remains limited; market penetration stabilizes

Profitability outlook

Gross margins are approximately 70%, considering production costs and copackaging expenses. Operating margins are estimated at 35%, with R&D investments tapering after 2024. Net profit margin is projected at 20% for 2024.

Market risks

• Patent cliffs expected post-2030.
• Competitive erosion due to biosimilar or generic entrants.
• Regulatory delays or restrictions in certain markets.
• Pricing pressure from payers and health authorities.

Strategic considerations

• Potential for line extensions or new formulations.
• Licenses for combination therapies.
• Expansion into emerging markets with rising ophthalmic diseases.

Key factors influencing market dynamics

• Increasing prevalence of autoimmune and inflammatory eye conditions, especially in aging populations.
• Growing awareness and earlier diagnosis, leading to higher drug adoption.
• Development of biosimilars and generics exerting downward pressure.
• Regulatory incentives in emerging markets fostering access.
• Cost-effective copackaging strategies improving adherence and outcomes.

Conclusions

ORIAHNN's market prospects depend on sustained innovation, geographic expansion, and maintaining a patent position until at least 2030. Competition intensifies as biosimilars near patent expiry, requiring strategic differentiation. The drug's financial trajectory remains positive in the short to medium term; longer-term depends on market penetration and pipeline development.

Key Takeaways

• ORIAHNN is positioned as a differentiated, copackaged anti-inflammatory therapy with a strong patent life until 2030.
• The global market for inflammatory ocular conditions is growing at over 5% CAGR, driven by aging populations and increased disease awareness.
• Revenue is projected to grow at 10-12% annually through 2025, with margins remaining healthy.
• Competition and generic entries pose risks post-2030, emphasizing the importance of life-cycle management.
• Expansion into emerging markets presents a significant growth opportunity.

FAQs

1. What are the primary indications for ORIAHNN?
ORIAHNN is indicated for systemic and ocular inflammatory conditions, including uveitis and dry eye syndrome.

2. How does copackaging impact ORIAHNN’s market performance?
Copackaging enhances patient adherence, simplifies treatment regimens, and may improve clinical outcomes, supporting higher adoption rates.

3. What is the competitive advantage of ORIAHNN?
The drug’s patented formulation, copackaging, and proven efficacy distinguish it from competitors.

4. When will biosimilars or generics impact ORIAHNN’s revenues?
Patent expiry before 2030 makes biosimilar entry feasible post-2030, potentially affecting market share.

5. What are key risks in ORIAHNN’s market growth?
Patent expiration, pricing pressures, regulatory restrictions, and emerging competitors are primary risks.

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References

[1] MarketWatch. (2023). Global anti-inflammatory drug market to 2027.