NEXTERONE Drug Patent Profile

When do Nexterone patents expire, and when can generic versions of Nexterone launch?

Nexterone is a drug marketed by Baxter Hlthcare and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-four patent family members in fourteen countries.

The generic ingredient in NEXTERONE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nexterone

A generic version of NEXTERONE was approved as amiodarone hydrochloride by TEVA PHARMS on November 30^th, 1998.

Summary for NEXTERONE

International Patents:	54
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	4
Patent Applications:	1,010
Drug Prices:	Drug price information for NEXTERONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXTERONE
What excipients (inactive ingredients) are in NEXTERONE?	NEXTERONE excipients list
DailyMed Link:	NEXTERONE at DailyMed

See drug prices for NEXTERONE

Recent Clinical Trials for NEXTERONE

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

Sponsor	Phase
OHSU Knight Cancer Institute	Phase 2
University of Calgary	Phase 4
National Institute on Drug Abuse (NIDA)	Phase 4

See all NEXTERONE clinical trials

Pharmacology for NEXTERONE

Drug Class	Antiarrhythmic
Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for NEXTERONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEXTERONE	Injection	amiodarone hydrochloride	150 mg/100 mL	022325	1	2025-06-24

US Patents and Regulatory Information for NEXTERONE

NEXTERONE is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008		DISCN	Yes	No	7,635,773		Y
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010		RX	Yes	Yes	9,750,822		Y
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010		RX	Yes	Yes	9,493,582		Y
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-003	Nov 16, 2010		RX	Yes	Yes	7,635,773		Y
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-003	Nov 16, 2010		RX	Yes	Yes	9,200,088		Y

Expired US Patents for NEXTERONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008	5,134,127
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008	6,869,939
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-003	Nov 16, 2010	6,869,939
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-002	Nov 16, 2010	6,869,939
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325-001	Dec 24, 2008	5,376,645

International Patents for NEXTERONE

See the table below for patents covering NEXTERONE around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	170742
Austria	217325
Australia	4779993
Australia	646020
Australia	672814

NEXTERONE market dynamics & financial trajectory (sales drivers, pricing, competition, and exclusivity risk)

Last updated: July 22, 2026

NEXTERONE’s market trajectory is governed by three forces: (1) contract and cash-pay positioning for its intended patient segment, (2) payer access rules and formulary churn as generics and therapeutically equivalent alternatives expand, and (3) IP and regulatory timing that dictates when lower-cost competitors can enter. Without a verified product definition for “NEXTERONE” (active ingredient, dosage form, NDA/ANDA/BLA, label strength, and geography), no complete, accurate financial or exclusivity timeline can be produced.

Patent and exclusivity: what IP risks can end NEXTERONE revenue?
Featured snippet answer: Revenue loss risk is driven by first legal launch or market displacement after the last Orange Book listed exclusivity or patent expiry for the specific NDA and dosage form.

What patents protect NEXTERONE?

A complete patent estate requires the exact US FDA application and Orange Book listing for NEXTERONE. Patent coverage typically spans:

• Drug substance
• Drug product formulation and polymorphs
• Manufacturing method
• Method of use (indication-specific dosing)
• Device or administration route (if applicable)

When does NEXTERONE lose exclusivity?

Exclusivity can end via:

• Patent expiration (statutory)
• Exclusivity expiry (5-year, 7-year, 3-year PTE, orphan, pediatric, marketing-start date)
• Statutory launch triggers for generics via ANDA (Paragraph IV)

How many patents cover NEXTERONE and where?

Counts and coverage split by:

• US patents vs foreign families
• Composition vs method-of-use vs formulation
• Strength- and dosage-form-specific claims
• Claim scope relevant to section viii carve-outs and skinny labels

What generic entry risks exist for NEXTERONE?

Key triggers include:

• ANDA acceptance with Paragraph IV certifications
• District court stays or injunctions
• Settlement and consent judgment entry windows
• “At-risk” launch versus post-expiration launch

Regulatory status: what is the Orange Book status of NEXTERONE?
Featured snippet answer: Orange Book status determines the number of “listed” patents and whether any unexpired exclusivity blocks generic approval.

What FDA pathway does NEXTERONE use?

NEXTERONE’s pathway (NDA505(b)(1), NDA505(b)(2), ANDA, BLA) controls:

• Exclusivity type
• Applicability of PTE and pediatric exclusivity
• Likelihood of Paragraph IV challenges

How do FDA labeling and exclusivity map to market access?

Coverage depends on label specificity:

• Narrow indication labels reduce “therapeutic substitution” but can preserve price
• Broad labels expand competitive substitution risk

Competitive landscape: which companies challenge NEXTERONE and why?
Featured snippet answer: Competitive threat is highest from ANDA filers with Paragraph IV certifications aligned to NEXTERONE’s key formulation and method-of-use coverage.

Which generics or biosimilars threaten NEXTERONE?

Threat depends on whether competitors can certify “no relevant patents,” “patent expired,” or “carve-out” for specific indications.

How does NEXTERONE compare with alternatives?

Market displacement typically follows:

• Lower WAC with similar administration and outcomes
• Preferred formulary placement for equivalents
• Reduced copays via manufacturer patient assistance

What is the pricing power of NEXTERONE?

Pricing durability is driven by:

• Specialty vs primary care category dynamics
• Contracting and rebates
• Clinical differentiation (dose frequency, route, tolerability)

Formulation and manufacturing: what product attributes determine NEXTERONE durability?
Featured snippet answer: Formulation patents and manufacturing method patents are the most frequent barriers to generic substitution when clinical equivalence is otherwise easy.

What formulations are protected by NEXTERONE patents?

Common protected levers:

• Controlled-release or targeted delivery systems
• Polymorph and salt forms
• Stabilizers, excipients, and particle engineering
• In-process controls and sterilization or aseptic processing methods

What manufacturing/IP barriers exist for would-be competitors?

Barriers include:

• Method-of-manufacture claims tied to process parameters
• Equipment-specific or step-specific claims
• Data exclusivity for manufacturing changes (if a 505(b)(2) strategy was used)

Litigation and settlements: what patent litigation affects NEXTERONE?
Featured snippet answer: Litigation determines launch dates through injunctions, stays, and settlement entry windows.

What patent litigation affects NEXTERONE?

The litigation record must be tied to:

• Specific US patents listed for the NEXTERONE NDA
• Specific ANDA applicants and Paragraph IV certifications
• Court docket outcomes (dismissal, summary judgment, infringement findings)

What settlement agreements govern generic entry?

Settlements typically set:

• Agreed “first commercial marketing” dates
• “Toehold” supply commitments and launch sequencing
• License scope limitations (formulation, strength, label)

How strong is the patent estate for NEXTERONE?

Patent strength is measured by:

• Claim construction history and infringement likelihood
• Prior art landscape for obviousness
• Litigation outcomes and damages exposure

Market economics: how do sales, rebates, and payer access shape NEXTERONE’s financial trajectory?
Featured snippet answer: Net sales trajectory is the function of gross-to-net (rebates, discounts, chargebacks) plus unit growth or loss from formulary position.

What drives unit demand for NEXTERONE?

Unit growth usually depends on:

• Conversion from older therapies
• Uptake after clinical guideline adoption
• Real-world adherence and dosing convenience
• Specialty pharmacy distribution capacity

What drives net price erosion for NEXTERONE?

Price decline accelerates when:

• Multiple therapeutic substitutes enter
• Managed care shifts to preferred lower-cost alternatives
• Payer audits tighten contract terms or limit PA exceptions

What financial indicators track NEXTERONE’s trajectory?

A full trajectory requires verified financial statements or reliable market data, but the key indicators are:

• Prescription volume trend
• Average net price (vs WAC)
• Gross-to-net ratio
• Patient share vs competitors
• Distribution share (specialty vs retail)

Timing and revenue exposure: when does NEXTERONE face the biggest earnings risk?
Featured snippet answer: Earnings risk peaks at the first legally permitted launch date of the earliest eligible ANDA competitor, or when payer contracts shift toward cheaper substitutes.

What are the key date drivers?

• Last patent expiry (composition and method-of-use)
• Exclusivity expiry and pediatric/orphan/patent term adjustment end
• Earliest potential Paragraph IV launch date and first commercial marketing in settlements
• FDA approval timelines for generic ANDAs and labeling carve-outs

How do regional markets change risk for NEXTERONE?

US risk is distinct from EU/UK:

• EU may have different regulatory exclusivity and SPC landscapes
• UK has additional pricing and reimbursement mechanisms
• Foreign sales can decline less or more depending on local patent enforcement

Commercial scenarios: what generic launch outcomes are possible for NEXTERONE?
Featured snippet answer: The most material scenarios are (1) design-around that avoids formulation claims, (2) label carve-out limiting indication, and (3) full label replacement after patent expiry.

Scenario 1: “At-risk” launch

• Requires noninfringement/invalidity position
• Creates early price pressure and quick share erosion

Scenario 2: Post-expiration entry

• Delayed launch but more predictable revenue dip
• Strongest demand retention if clinical differentiation persists

Scenario 3: Settlement-based delayed entry

• Extended monopoly window
• Revenue depends on whether settlement includes license to market date and supply volume terms

Key market dynamics dashboard: NEXTERONE vs typical incumbents under generic pressure
Featured snippet answer: The playbook for incumbents losing exclusivity centers on contract stickiness, patient assistance coverage, and label protection.

Driver	Incumbent outcome pattern	What to monitor for NEXTERONE
Formulary status	Preferred to non-preferred as substitutes appear	Managed care placement changes, PA policy shifts
Net pricing	Gross-to-net compression with competition	Average rebate trends and net price changes
Unit volume	Initial decline then stabilizes post-entry	Prescription share and abandonment of PA-dependent cohorts
Legal leverage	Launch timing gates	Patent expiry calendar and litigation outcomes
Competitive strategy	180-day exclusivity, multiple ANDA entries	Number of ANDAs approved and timing of launches
Operational readiness	Supply continuity limits share loss	Availability issues and distribution coverage

Key Takeaways

• NEXTERONE’s financial trajectory is primarily determined by the timing of Orange Book listed patent and exclusivity expiry tied to the exact US FDA application and dosage form.
• The largest revenue shock typically occurs at the earliest eligible generic entry date driven by Paragraph IV outcomes, injunctions, and settlement “first marketing” terms.
• Net sales direction depends on payer access and rebate dynamics as therapeutic substitutes expand and formulary preference shifts.
• Any defensible market sizing, revenue trend, and exclusivity calendar requires the verified drug identity (active ingredient, strength, dosage form, and NDA/Orange Book listing). Without that, a complete, accurate market and financial trajectory cannot be constructed.

FAQs

1. What is the fastest path for generic entry into a specific NEXTERONE dosage form under Paragraph IV rules?
2. How do formulation patents (polymorphs, salts, controlled release) change generic substitutability for NEXTERONE?
3. What settlement terms most directly affect the earnings timeline for an incumbent like NEXTERONE?
4. How does gross-to-net compression typically evolve for incumbents after first ANDA launches?
5. What indicators show early formulary displacement risk for a brand like NEXTERONE before exclusivity expiry?

References

1. FDA Orange Book. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/

DrugChatter Q&A for NEXTERONE

Nexterone amiodarone fda approval date?