ORIAHNN (COPACKAGED) Drug Patent Profile

« Back to Dashboard

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.

The generic ingredient in ORIAHNN (COPACKAGED) is elagolix sodium,estradiol,norethindrone acetate; elagolix sodium. There is one drug master file entry for this compound. 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 23, 2039. This may change due to patent challenges or generic licensing.

There have been eighteen 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)

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

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)

When does loss-of-exclusivity occur for ORIAHNN (COPACKAGED)?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

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

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

Country	Patent Number	Title	Estimated Expiration
Canada	2906894	COMPOSITIONS DESTINEES A L'UTILISATION DANS LE TRAITEMENT DE SAIGNEMENTSMENSTRUELS ABONDANTS ET FIBROMES UTERINS (COMPOSITIONS FOR USE IN TREATING HEAVY MENSTRUAL BLEEDING AND UTERINE FIBROIDS)
European Patent Office	2968566	COMPOSITIONS UTILES POUR TRAITER LES RÈGLES ABONDANTES ET LES FIBROMES (COMPOSITIONS FOR USE IN TREATING HEAVY MENSTRUAL BLEEDING AND UTERINE FIBROIDS)
European Patent Office	3384930	PROCÉDÉS DE TRAITEMENT D'UN SAIGNEMENT MENSTRUEL EXCESSIF (COMPOSITIONS FOR USE IN TREATING HEAVY MENSTRUAL BLEEDING)
European Patent Office	4223298	COMPOSITIONS POUR LE TRAITEMENT DES SAIGNEMENTS MENSTRUELS LOURDS (COMPOSITIONS FOR USE IN TREATING HEAVY MENSTRUAL BLEEDING)
Israel	241595	הרכב לשימוש בשיטות לטיפול בדימום ווסתי כבד הקשור לשרירנים ברחם (A combination for use in treating heavy menstrual bleeding associated with uterine fibroids)

ORIAHNN (copackaged) market dynamics and financial trajectory: pricing, utilization, payer access, and exclusivity-driven competition

Last updated: July 30, 2026

ORIAHNN (elagolix/estradiol/norethindrone acetate copackaged; AbbVie) has operated in a defined niche tied to endometriosis pain control and has faced constrained adoption versus broader gynecologic pain therapies. Financial trajectory has been shaped by (1) payer coverage selectivity for endometriosis symptom control, (2) competition from LNG-IUDs, GnRH antagonists, and hormonal regimens, and (3) the compound exclusivity timeline that governs when generic or “authorized” competitors can pressure pricing.

The key market dynamic is that ORIAHNN is priced and marketed as a convenience product that combines a GnRH antagonist with add-back hormone therapy in a single monthly regimen. That convenience supports prescribing in patients who previously cycled through multiple hormonal or device-based approaches, but it also raises payer scrutiny because coverage is often conditioned on documented endometriosis diagnosis and prior therapy history.

---

What does ORIAHNN (copackaged) treat and how does that drive market demand?

Featured answer: ORIAHNN is used for the management of moderate to severe pain associated with endometriosis. Demand depends on endometriosis diagnosis rates, persistence of pain symptoms, and the willingness of clinicians and payers to treat earlier-line versus later-line after failures of hormonal therapy.

Endometriosis pain market structure

• Endometriosis pain management is dominated by hormonal therapies (progestins, combined oral contraceptives), procedural pathways (laparoscopy and adjunct procedures), and device-based options (LNG-IUDs).
• ORIAHNN’s positioning targets patients with persistent pain where a GnRH antagonist mechanism is considered, including those who want an oral regimen with built-in add-back.

Uptake drivers specific to the copackaged format

• Copackaging reduces regimen complexity versus prescribing separate add-back components.
• Convenience can improve adherence versus regimens requiring multiple agents and dose scheduling.
• The add-back component shifts clinical decision-making from “tolerability management” to “one packaged therapy,” which can accelerate formulary acceptance where coverage committees evaluate treatment-limiting side-effect risk.

Constraints on addressable demand

• ORIAHNN uptake is limited by payer requirement patterns (diagnosis confirmation, pain severity documentation, step edits).
• Clinician behavior often starts with cheaper hormonal regimens or LNG-IUDs, delaying use of newer oral antagonists.

---

How do ORIAHNN market dynamics compare with elagolix competitors and other endometriosis pain therapies?

Featured answer: ORIAHNN competes in the GnRH-axis class and in the broader hormonal regimen space. Class competition is usually closer in mechanism, while the strongest economic pressure comes from entrenched hormonal and device therapies.

Direct and near-direct competitors (mechanism and class adjacency)

• Other oral hormonal options used for endometriosis pain, including combined oral contraceptives and progestin-based regimens.
• Device-based therapy such as LNG-IUDs that can reduce the need for recurrent pharmacotherapy.

Economic comparison drivers

• Net price to payer after rebates and utilization management.
• Total cost of care under real-world persistence, including discontinuations driven by tolerability and symptom recurrence.
• Patient journey timing, including whether clinicians reserve GnRH-axis agents for later-line.

Formulary realities

• Endometriosis therapies often face utilization management even when clinically supported.
• ORIAHNN’s formulary fate depends on whether payers treat it as preferred in a given line of therapy or as a restricted option after failure of lower-cost alternatives.

---

What is the pricing and payer access pattern for ORIAHNN (copackaged) and how does it shape revenues?

Featured answer: ORIAHNN revenues track payer adoption because endometriosis is not an emergency category and prescribers are sensitive to formulary placement, especially when alternative hormonal therapies are substantially cheaper.

Payer access levers that typically determine uptake

• Prior authorization triggers tied to diagnosis codes and pain severity evidence.
• Step therapy requirements (failure or intolerance of at least one hormonal therapy).
• Quantity and duration controls, consistent with labeling limits and typical payers’ risk management.

How rebates and contract status change the financial trajectory

• In managed care, headline launch price rarely maps to net price.
• ORIAHNN’s commercial outcomes depend on contracting success with major PBMs and national plans and on whether it is tiered as preferred or non-preferred.

What “copackaged” changes for payer negotiation

• Copackaging simplifies claims adjudication versus multi-component therapy, reducing administrative friction.
• That can support faster plan contracting, but it does not remove medical-necessity scrutiny.

---

When does ORIAHNN exclusivity expire and when could generics or challengers pressure revenue?

Featured answer: ORIAHNN’s revenue protection is governed by patent and regulatory exclusivity layers (Orange Book listed patents and statutory exclusivity). Generic pressure typically becomes viable only after the relevant listed patents expire and any exclusivity is exhausted, with Paragraph IV challenges advancing launch timing through settlement.

How to think about the exclusivity stack for revenue

1. Regulatory exclusivity (New Chemical Entity and related exclusivities where applicable) determines the earliest lawful pathway.
2. Listed Orange Book patents determine when an ANDA can be approved for competing small molecules.
3. Patent term adjustments and pediatric exclusivity can shift end dates.
4. Settlement agreements can delay or accelerate launch depending on timing and scope.

Revenue impact of exclusivity cliff

• In endometriosis, generic timing tends to hit a market where the “new MOA” differentiation decays as prescribers reset to cheaper options.
• The magnitude of price erosion depends on (1) number of eligible competitors, (2) contractual rebate intensity, and (3) persistence and switching under real-world therapy management.

(Note: A precise patent-by-patent exclusivity calendar requires Orange Book and litigation data tied to ORIAHNN’s specific listed patents and is not included in the information provided.)

---

What is the Orange Book status of ORIAHNN (copackaged): which patents block generic entry?

Featured answer: ORIAHNN’s Orange Book status is the controlling map of small-molecule patents listed against the drug product and likely includes formulation, method-of-use, and combination-related patents. Generic entry risk begins only when the listed patents are cleared.

Patent estate components that typically protect a copackaged combination

• Composition/formulation patents: formulations and dosing schedules for each component.
• Combination-product patents: the packaged regimen and dosing coordination.
• Method-of-use patents: claims tied to endometriosis pain outcomes or dosing regimens to achieve add-back while maintaining efficacy.
• Manufacturing/process patents: preparation and packaging procedures.

How to forecast generic entry risk once patents near expiry

• Identify which listed patents cover the claim scope actually asserted in prior litigation.
• Track whether generic applicants file ANDAs with Paragraph IV certifications to each listed patent.
• Evaluate whether any settlements were entered and how they define launch dates and permissible carve-outs.

(Note: A complete Orange Book patent list with publication and expiration dates cannot be produced from the information provided.)

---

Which ORIAHNN patent litigation and Paragraph IV challenges affect launch timing?

Featured answer: ORIAHNN’s generic launch timing is typically affected by Paragraph IV litigation over Orange Book listed patents and any settlements that constrain the first generic’s effective date and marketing design.

Litigation patterns that matter financially

• Court rulings on combination-product and dosing regimen claims.
• Settlement terms that limit switching incentives (e.g., exclusivity carve-outs, launch timing, or supply commitments).

Financial relevance of litigation outcome

• Settlement delays can preserve higher net pricing and reduce discounting pressure.
• A loss or early adverse decision can accelerate erosion through faster-than-expected competitor entry.

(Note: Litigation docket specifics are not provided, so a case-by-case timeline cannot be stated.)

---

What formulations and regimen details are protected for ORIAHNN, and how could that limit “work-alike” competition?

Featured answer: For copackaged regimens, the most protective IP is usually tied to dosing schedules, add-back coordination, and the specific regimen design that enables safety and efficacy together. “Work-alike” competitors must clear those claim scopes or rely on designing around them.

Formulation/regimen IP categories relevant to design-around

• Tablet or pack configuration aligned with monthly dosing.
• Add-back hormone ratios integrated into the regimen.
• Claim coverage that ties regimen administration to endometriosis pain endpoints and tolerability.

How design-around affects launch economics

• Design-around efforts raise development costs and time to market.
• If design-around requires new clinical bridging, payers can resist early adoption, reducing the commercial upside for challengers.

---

What commercial metrics determine ORIAHNN’s financial trajectory?

Featured answer: ORIAHNN’s financial trajectory is best explained by the interaction of prescription growth, persistence/discontinuation, payer coverage breadth, and net price after rebates.

Core metrics to track

• Script volume trends by quarter.
• Patient persistence (duration of therapy per prescription cohort).
• Discontinuation rates due to tolerability and side effects.
• Net price trend by plan and channel.
• Segment mix between commercial and government coverage.

Relationship to revenue recognition

• Revenue is dominated by net sales after contractual rebates and discounts.
• Changes in formulary tier status can cause inflection points by shifting volume and net price simultaneously.

---

How do key endometriosis market shifts affect ORIAHNN revenue outlook?

Featured answer: ORIAHNN’s outlook is sensitive to (1) shifts toward competing hormonal strategies, (2) payer tightening around authorization, and (3) clinician preference changes driven by safety and tolerability experience.

Likely demand modifiers

• Increasing preference for long-acting device therapy can reduce oral therapy share.
• Broader adoption of competing GnRH-axis agents, if any, can dilute the orphan-like “new mechanism” uptake advantage.
• Plan changes in prior authorization criteria can either accelerate or dampen prescribing.

---

How many years of growth runway does ORIAHNN have before major competitive pressure?

Featured answer: The runway depends on the final expiration of the Orange Book patent set and any regulatory exclusivity remaining, with generic entry effectively starting only after clearance of the controlling patents. Without a listed-patent expiration calendar and any Paragraph IV settlement dates, runway cannot be quantified.

(No numeric exclusivity timeline is provided in the input.)

---

Key Takeaways

• ORIAHNN demand is driven by endometriosis pain treatment needs and constrained by payer coverage selectivity and step edits.
• The copackaged regimen supports adherence and can help formulary adoption, but does not eliminate managed care scrutiny.
• Financial trajectory is primarily shaped by net price (rebates and tiering) and persistence-driven utilization.
• Competitive pressure from generics or “work-alike” regimens typically activates at the Orange Book exclusivity cliff plus any litigation/settlement-defined launch delays.
• A patent-by-patent exclusivity and litigation-driven launch forecast requires the Orange Book listed patents and corresponding litigation history, which are not included in the provided material.

---

FAQs

1. How does ORIAHNN copackaged dosing influence payer prior authorization and quantity limits?
2. What endometriosis pain treatment alternatives most directly substitute for ORIAHNN in commercial formularies?
3. How should net price and rebate rate changes be modeled to explain ORIAHNN quarterly revenue variability?
4. What Orange Book patent types usually create the biggest barriers for ANDA design-around in copackaged regimens?
5. How do Paragraph IV settlement terms typically impact real-world timing of generic ORIAHNN adoption by major PBMs?

---

References

1. (No sources were provided in the prompt; no external citations can be generated.)