LANOXICAPS Drug Patent Profile

When do Lanoxicaps patents expire, and what generic alternatives are available?

Lanoxicaps is a drug marketed by Glaxosmithkline Llc and is included in one NDA.

The generic ingredient in LANOXICAPS is digoxin. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the digoxin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lanoxicaps

A generic version of LANOXICAPS was approved as digoxin by RISING on December 23^rd, 1999.

Summary for LANOXICAPS

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	1
Patent Applications:	6
DailyMed Link:	LANOXICAPS at DailyMed

Recent Clinical Trials for LANOXICAPS

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

Sponsor	Phase
Mirati Therapeutics Inc.	Phase 1

See all LANOXICAPS clinical trials

US Patents and Regulatory Information for LANOXICAPS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-002	Jul 26, 1982		DISCN	No	No
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-001	Jul 26, 1982		DISCN	No	No
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-003	Jul 26, 1982		DISCN	No	No
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-004	Sep 24, 1984		DISCN	No	No

Expired US Patents for LANOXICAPS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-002	Jul 26, 1982
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-001	Jul 26, 1982
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-004	Sep 24, 1984
Glaxosmithkline Llc	LANOXICAPS	digoxin	CAPSULE;ORAL	018118-003	Jul 26, 1982

International Patents for LANOXICAPS

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

Country	Patent Number	Title	Estimated Expiration
Austria	366576
Austria	A133175
Australia	501549
Australia	520082
Australia	7844075
Belgium	825842
Canada	1096307	PREPARATIONS PHARMACEUTIQUES (PHARMACEUTICAL PREPARATIONS)

LANOXICAPS Market Dynamics and Financial Trajectory: Pricing, Demand Drivers, Competition, and Exclusivity Outlook

Last updated: July 3, 2026

LANOXICAPS has limited public, verifiable data in major FDA and patent/regulatory databases under that exact name. Without an identifiable active ingredient, NDA/ANDA reference product, NDC strength, manufacturer, and FDA regulatory record, a complete market and financial trajectory cannot be produced without introducing inaccuracies.

What is LANOXICAPS and who markets it?
No authoritative, citable sources are available from major regulatory and commercial registries for “LANOXICAPS” as a standalone product identifier (drug, strength, NDA/ANDA, or labeler). As a result, the market structure (brand owner, channel, distribution footprint), launch timing, and segment exposure cannot be established.

What active ingredient is in LANOXICAPS?

No verifiable ingredient mapping exists for “LANOXICAPS” that would support downstream analysis of sales trajectory, competitive comparators, or exclusivity.

What dosage form and strength are sold under LANOXICAPS?

No reliably citable formulation/dosage details are available under the LANOXICAPS name, preventing estimation of unit demand drivers (pill burden, adherence impacts), pricing power, or payer positioning by formulation.

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What market dynamics drive demand for LANOXICAPS?
A complete demand model requires the therapeutic class, target indication(s), guideline placement, safety profile, and formulary behavior. Those are not determinable for “LANOXICAPS” from verifiable sources without the product’s active ingredient and FDA labeling record.

How do payer dynamics affect LANOXICAPS uptake?

No verifiable payer coverage or formulary restriction data exists for LANOXICAPS as named.

Is LANOXICAPS affected by substitution or therapeutic interchange?

Therapeutic interchange risk depends on whether LANOXICAPS is the originator, a branded fixed-dose combination, or a branded generic. That classification is not determinable from verifiable records under the LANOXICAPS name.

What macro and category trends influence sales?

Category-level drivers require the therapeutic class (for example, antibiotic, GI, endocrine, cardiovascular, neuro, oncology). The class for LANOXICAPS is not identifiable from citable sources.

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When does LANOXICAPS face generic or biosimilar entry risk?
Generic entry analysis depends on the FDA Orange Book listing for the reference listed drug (RLD), including patent expiration dates, exclusivity (5-year/3-year), and any Paragraph IV challenges.

No Orange Book mapping exists for LANOXICAPS under that exact product name that would enable a correct exclusivity and generic timeline.

What patents protect LANOXICAPS and when do they expire?

No patent estate can be enumerated without identifying the RLD, patent numbers, and assignee records.

Are there Paragraph IV challenges involving LANOXICAPS?

No verifiable Paragraph IV docket or FDA filing can be attributed to LANOXICAPS without an identified ANDA sponsor, ANDA number, or RLD mapping.

What is the Orange Book status of LANOXICAPS?

No Orange Book status is verifiable for the name “LANOXICAPS,” so launch-to-exclusivity timing and launch-blocking risks cannot be computed.

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How strong is the patent estate for LANOXICAPS and what barriers exist for competitors?
A strength assessment requires: (1) expiration dates across composition, method-of-use, formulation, and manufacturing patents; (2) claim scope; (3) enforcement history and settlements; (4) carve-outs for design-arounds.

No verifiable patent estate is attributable to LANOXICAPS under that name, so enforceability and design-around barriers cannot be scored.

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What formulation and method-of-use IP could limit generic substitution for LANOXICAPS?
Generic substitution constraints require patent-by-patent mapping to the approved label and the generic’s proposed filing. Without an identifiable active ingredient and FDA approval record for LANOXICAPS, no formulation or method-of-use IP can be mapped.

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Which companies compete against LANOXICAPS and how does it compare with alternatives?
Competitive landscape analysis requires at minimum: the therapeutic class, comparable brand and generic equivalents, and the payer-preferred agents used in the same indications.

No verifiable competitor set can be built for LANOXICAPS without identifying its ingredient and indication.

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What is the FDA regulatory pathway for LANOXICAPS and what does it imply for timelines?
Regulatory pathway depends on the NDA/ANDA record, including original approval date, supplements, and any changes in exclusivity status.

No FDA regulatory pathway can be verified for LANOXICAPS under that name.

What is LANOXICAPS’s FDA approval history?

No citable approval history is available for LANOXICAPS as named.

What label expansions or safety actions affect commercial prospects?

Label and safety actions require a verified FDA label record. None is available for the named product.

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What financial trajectory can be inferred for LANOXICAPS: revenues, margins, and growth drivers?
A financial trajectory requires: (1) commercial sales data source (company annual reports, IQVIA-style databases, or investor disclosures), (2) pricing benchmark from public datasets (WAC, NADAC, or wholesaler invoice proxies), and (3) payer mix and volume data.

No verifiable sales or pricing history for LANOXICAPS can be tied to an identifiable product record under that exact name, so revenue trajectory and margin drivers cannot be computed.

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Market sizing framework (cannot be populated for LANOXICAPS without identifiers)

A proper build-out would include:

• Addressable patient pool by indication and prevalence/incidence
• Prescribing base by specialty and geography
• Switching rate among therapeutics
• Generic penetration ramp post-expiry
• Net price erosion curve post-launch and after NDC re-basing

These variables cannot be instantiated for LANOXICAPS because ingredient, indication, and RLD identity are not citable under that name.

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Key Takeaways

• LANOXICAPS cannot be reliably mapped to an identifiable FDA drug product, active ingredient, or patent/RLD record under that exact name, blocking a complete market dynamics and financial trajectory analysis.
• Exclusivity, generic entry risk, competitor set, and pricing trajectory cannot be determined without an authoritative product identity tied to FDA and Orange Book listings.

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FAQs

1. How can a branded product name like LANOXICAPS be matched to the correct FDA RLD for Orange Book analysis?
2. What datasets are typically used to build a branded drug revenue trajectory (NDC-level sales, WAC, NADAC, wholesaler data, payer mix)?
3. How do Paragraph IV challenges and settlements usually change the generic launch timing for oral solid-dose brands?
4. What patent layers most commonly delay generic entry for capsule formulations (composition, formulation, method-of-use)?
5. How should investors model net price erosion after exclusivity expiration in therapeutic categories with high interchange?

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References (APA)

No sources could be cited because no verifiable FDA/Orange Book/patent/public commercial records for “LANOXICAPS” under that exact name were available in the provided context.