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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 eight patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-eight 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 two 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:	98
US Patents:	8
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 eight 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	7,056,927		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
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	12,083,227		Y
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes	10,881,659

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	7,462,625
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	7,179,815

International Patents for ORIAHNN (COPACKAGED)

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

Country	Patent Number	Title	Estimated Expiration
Spain	2383954
Japan	2016513708	月経出血過多および子宮類線維腫の処置に使用するための組成物
Portugal	1646389
Japan	2003520856
South Africa	200600475	Pyrimidine-2,4-dione derivatives as gonadotripin-releasing hormone receptor antagonists
World Intellectual Property Organization (WIPO)	2009062087

ORIAHNN (COPACKAGED) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ORIAHNN (COPACKAGED)

Introduction

ORIAHNN, a copackaged drug containing elagolix, estradiol, and norethindrone acetate, was approved by the FDA in 2020 for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This article delves into the market dynamics and financial trajectory of ORIAHNN, exploring its efficacy, market positioning, and potential financial impact.

FDA Approval and Market Entry

ORIAHNN received FDA approval on May 29, 2020, marking a significant milestone in the treatment of heavy menstrual bleeding caused by uterine fibroids. This approval was based on two Phase 3 clinical trials that demonstrated the drug's efficacy in reducing menstrual blood loss[2][3].

Market Need and Target Population

Heavy menstrual bleeding associated with uterine fibroids is a common condition affecting many premenopausal women. The market need for an effective treatment is substantial, given the impact of this condition on quality of life and the limitations of existing treatments. ORIAHNN targets this specific population, offering a unique combination of a gonadotropin-releasing hormone (GnRH) antagonist, an estrogen, and a progestin[2].

Efficacy and Clinical Outcomes

Clinical trials have shown that ORIAHNN is highly effective in reducing heavy menstrual bleeding. In the trials, 68.5% to 76.5% of women treated with ORIAHNN responded to the treatment, compared to 8.7% to 10.5% of those receiving a placebo. This significant reduction in menstrual blood loss highlights the drug's potential to improve the lives of many women[2].

Market Positioning

ORIAHNN enters a market where existing treatments may have limitations, such as surgical interventions or less effective pharmacological options. Its unique mechanism of action, combining elagolix, estradiol, and norethindrone acetate, positions it as a preferred choice for managing heavy menstrual bleeding associated with uterine fibroids. The drug's ability to reduce menstrual bleeding significantly, and in some cases eliminate periods altogether, makes it an attractive option for both patients and healthcare providers[2][3].

Pricing and Cost Considerations

The cost of ORIAHNN is a critical factor in its market dynamics. While the exact pricing may vary, it is generally expected to be competitive with other treatments for uterine fibroids. The cost-benefit analysis will likely favor ORIAHNN due to its high efficacy and the potential to reduce long-term healthcare costs associated with managing heavy menstrual bleeding[2].

Side Effects and Safety Profile

Like any medication, ORIAHNN comes with potential side effects and safety concerns. Notable side effects include alopecia (hair loss), thrombotic or thromboembolic disorders, bone loss, and liver transaminase elevations. These risks, particularly the increased risk of thrombotic events in certain populations, must be carefully managed and monitored by healthcare providers[3][5].

Alopecia

A significant side effect of ORIAHNN is alopecia, which was reported by 3.5% of subjects in clinical trials compared to 1.0% in the placebo group. The FDA has requested further studies to assess the incidence, time to onset, pattern, extent, and reversibility of alopecia associated with ORIAHNN use[1].

Thrombotic and Thromboembolic Disorders

The combination of estrogen and progestin in ORIAHNN increases the risk of thrombotic or thromboembolic disorders, particularly in women over 35 years of age who smoke or have uncontrolled hypertension. This risk necessitates careful patient selection and monitoring[3][5].

Financial Trajectory

Revenue Projections

Given its efficacy and the significant market need, ORIAHNN is expected to generate substantial revenue. The drug's approval and subsequent market entry have positioned it as a major player in the treatment of heavy menstrual bleeding associated with uterine fibroids. Revenue projections are likely to be optimistic, especially as the drug gains traction and becomes a standard treatment option.

Market Share

ORIAHNN's unique mechanism of action and strong clinical outcomes are expected to help it capture a significant market share. As more healthcare providers and patients become aware of its benefits, the drug is likely to displace some existing treatments, further solidifying its market position.

Competitive Landscape

The competitive landscape for treatments of uterine fibroids is evolving, with ORIAHNN entering a space that includes surgical options, other pharmacological treatments, and emerging therapies. ORIAHNN's competitive edge lies in its efficacy, convenience of use (with two capsules taken daily), and the comprehensive approach it offers in managing heavy menstrual bleeding.

Regulatory and Post-Marketing Surveillance

The FDA has mandated post-marketing surveillance studies to further assess the safety profile of ORIAHNN, particularly regarding alopecia and other potential side effects. These studies will provide valuable data on the long-term safety and efficacy of the drug, which can influence its market dynamics and financial trajectory[1].

Patient and Provider Adoption

Patient and provider adoption are crucial for the financial success of ORIAHNN. Positive word-of-mouth, favorable clinical outcomes, and educational campaigns by the manufacturer can drive adoption rates. Additionally, reimbursement policies and insurance coverage will play a significant role in making the drug accessible to a broader patient population.

Conclusion

ORIAHNN has entered the market with strong clinical evidence supporting its efficacy in managing heavy menstrual bleeding associated with uterine fibroids. Its unique combination of active ingredients and significant reduction in menstrual blood loss position it as a preferred treatment option. While side effects and safety concerns must be carefully managed, the overall market dynamics and financial trajectory for ORIAHNN appear promising.

Key Takeaways

• Efficacy: ORIAHNN is highly effective in reducing heavy menstrual bleeding.
• Market Need: The drug addresses a significant unmet need in the treatment of uterine fibroids.
• Side Effects: Alopecia, thrombotic events, and bone loss are notable side effects.
• Financial Trajectory: Expected to generate substantial revenue and capture a significant market share.
• Regulatory Surveillance: Ongoing post-marketing studies to assess long-term safety and efficacy.

FAQs

1. What is ORIAHNN used for? ORIAHNN is used for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

2. How does ORIAHNN work? ORIAHNN works by combining a GnRH antagonist (elagolix), an estrogen (estradiol), and a progestin (norethindrone acetate) to lower sex hormone levels, thereby reducing menstrual bleeding.

3. What are the common side effects of ORIAHNN? Common side effects include alopecia (hair loss), thrombotic or thromboembolic disorders, bone loss, and liver transaminase elevations.

4. How is ORIAHNN administered? ORIAHNN is administered as two separate capsules taken daily: one in the morning containing elagolix, estradiol, and norethindrone acetate, and one in the evening containing only elagolix.

5. What are the limitations of using ORIAHNN? The use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible.

Sources

1. FDA Document: 213388Orig1s000MultidisciplineR.pdf
2. Medical News Today: Oriahnn: Side effects, dosage, uses, cost, and more
3. Rx AbbVie: Oriahnn-uspi-elagolix-estradiol-and-norethindrone-acetate
4. FDA Document: 213388Orig1s000ChemR.pdf
5. FDA Label: ORIAHNN label[5]