Executive summary
US Drug Patent 6,129,930 claims a once-daily evening/night oral sustained-release (SR) nicotinic acid regimen for hyperlipidemia that targets lipid improvements (notably total cholesterol, LDL cholesterol, triglycerides, Lp(a) decreases and HDL increases) while aiming to avoid treatment-limiting uric acid, glucose, and liver-function abnormalities. The claim set is dominated by formulation and dosing-structure limitations: SR excipient systems built around hydroxypropyl methylcellulose (HPMC) (or alternative swelling agents), with povidone (PVP) binder and stearic acid (and optionally magnesium stearate) lubricant, plus constraints on dose range (250 mg to 3000 mg), release rate (2%/hour to 25%/hour), and evening/night administration. The scope is materially narrow versus broad “sustained release niacin” concepts because it requires both SR excipient architecture and safety/efficacy performance attributes in a specific dosing schedule.

US Patent 6,129,930 scope and claims for once-daily evening sustained-release nicotinic acid

What is the core claim concept of US 6,129,930?

Independent claim 1 sets the center of gravity:

Indication: treat hyperlipidemia
Active: nicotinic acid (niacin)
Schedule: orally administering once per day during the evening
Dosage form: sustained release composition
Efficacy targets: at least some lowering of total cholesterol, LDL cholesterol, triglycerides, and Lp(a) and at least some increase in HDL
Safety/performance guardrails: no abnormalities in uric acid and/or glucose to an extent requiring discontinuation
Formulation requirement: sustained release achieved using nicotinic acid + an excipient

Downstream claims progressively harden the formulation and performance boundaries into specific excipient families and quantitative ranges.

What are the major claim groupings (method vs composition)?

The claim set is organized into three overlapping clusters:

1) Once-daily evening SR “no uric acid/glucose discontinuation” (method + composition)

Method claims anchored in “daily method” language without treatment-limiting uric acid/glucose changes.
Composition claims cover the SR formulation used for that method.

2) Expanded method constraints: release rate and formulation ranges

A later chain adds parameters such as:

release rate: 2.0% per hour to 25% per hour
excipient proportions:
- HPMC (swelling agent): 5 to 50 parts by weight per 100 parts
- binder: 1 to 4 parts by weight per 100 parts
- lubricant: 0.5 to 2.5 parts by weight per 100 parts
dosage form: includes tablet embodiments
binder/lubricant species refinements (e.g., PVP polymer, stearic acid or magnesium stearate)

3) Safety expansion: liver-function (hepatotoxicity) and comparative “single dose vs divided dosing”

A separate chain introduces:

“without inducing treatment-limiting liver damage”
liver function test constraint using AST, ALT, alkaline phosphatase
uric acid and free fasting glucose constraints
a comparative efficacy/safety construct:
- single evening/night dose at least as effective as two divided daily doses at equivalent total daily dosage, while causing less increases in liver function tests than the divided-dose SR niacin regimen.

What patents protect once-daily evening sustained-release nicotinic acid with reduced uric acid/glucose and liver risk? (Breakdown by claim scope)

How do the claims define “treatment-limiting” safety limitations?

The claims do not quantify “treatment-limiting,” but they operationalize it as a clinical outcome:

urs: “without causing abnormalities in uric acid levels … to an extent which would require said daily treatment to be discontinued”
glucose: same discontinuation standard for glucose abnormalities
liver: later chain extends to “little or no serious damage to the liver” and constrains liver-function test elevations, specifying AST/ALT/alkaline phosphatase.

These features are claim-critical because they turn a formulation/dosing regimen into a performance-based limitation tied to patient discontinuation or clinically meaningful lab elevations.

What lipid endpoints are required?

The claims require at least some improvement in:

Total cholesterol
LDL cholesterol
Triglycerides
Lp(a)
and an at-least-some increase in HDL cholesterol

This set is broader than classic “lipid panel improvement” language because it explicitly includes Lp(a), which narrows the patient-treatment narrative that must be met.

How strong is the patent estate for US 6,129,930 (claim breadth vs narrowing features)?

Where is the claim breadth?

Breadth exists in several dimensions:

Swelling agent excipient class is broad at the genus level

swelling agent can be a polymer, wax, natural material, or mixtures

Polymer genus includes multiple HPMC-like/alternative materials

e.g., claim language lists HPMC, sodium carboxymethylcellulose (NaCMC), ethylcellulose.

Dose range is wide

250 mg to 3000 mg nicotinic acid per day.

Lubricant genus is open in some claims

stearic acid is explicit; magnesium stearate is also used in a later set.

Where is the claim strength (narrowing points)?

The claim set narrows through multiple cumulative limitations:

Once-per-day timing is required

“during the evening or at night” recurs across independent chains.

Sustained-release architecture required

the excipient must provide SR. The claims tie to specific SR-formulation elements, not generic SR.

Specific excipient “consists essentially of” embodiments

Many dependent claims lock the formulation into essentially:
- nicotinic acid + HPMC + povidone + stearic acid
“consists essentially of” restricts what can be added and is more limiting than “comprising.”

Quantified formulation ranges and species

HPMC at 5–50% of composition
binder at 1–5% in one set; 1–4% in another
lubricant at 0.5–2% or 0.5–2.5%
release rate window 2%/hour to 25%/hour

Tablet embodiments with named dosages

fixed examples: 375 mg, 500 mg, 750 mg tablets with specified excipient mass compositions.

What are the key independent and dependent claims that define scope?

Independent-method claims (highest practical value)

Claim 1 (method): evening once-daily SR nicotinic acid with no uric acid/glucose discontinuation risk

Key scope:

daily method, evening administration
SR nicotinic acid
lipid endpoints: TC/LDL/TG/Lp(a) decrease and HDL increase
no uric acid/glucose abnormalities requiring discontinuation
requires SR excipient.

Claim 18 (composition): SR nicotinic acid product for evening/night dosing

Key scope:

SR composition for once-per-day evening or night
excipient provides sustained release
same lipid and safety theme.

Claim 34 (method): adds “solid dosage form carrier” language

Claim 34 introduces tighter structural language:

once-per-day evening/night
combined with pharmaceutically acceptable carrier to form oral sustained release solid dosage form.

Claim 57 (method): adds “little or no serious damage to liver”

introduces liver-function limitation framework.

Claim 77 (method): compares single evening dose vs two divided doses

establishes equivalency in lipid-lowering and superiority in safety (reduced hepatotoxicity, relative to divided dosing at equivalent total daily niacin).

Claim 97 (method): comparative performance and reduced liver function tests

similarly anchors “single dose vs divided dose” with less liver function test elevation.

Independent-composition claims

Claim set uses “sustained release composition” independent claims like 18, then repeats “consists essentially of” embodiments.

Dependent claims that map to manufacturing and design-around risk

Key dependent claim families:

Swelling agent species

polymers: HPMC, NaCMC, ethylcellulose
wax: bees wax
natural: gums and gelatins

Binder

povidone and polymer/binder refinement via “1-ethenyl-2-pyrrolidone repeating unit” language (PVP family).

Lubricant

stearic acid
stearic acid and magnesium stearate.

Quantitative excipient percentages

HPMC 5–50%
binder 1–4% or 1–5% (depending on the claim chain)
lubricant 0.5–2% or 0.5–2.5%.

Release rate

2.0%/hour to 25%/hour

Tablet dose strength exemplars

375/500/750 mg nicotinic acid with corresponding HPMC/PVP/stearic acid amounts.

What are the quantitative formulation boundaries (dose, release rate, excipient percentages) in US 6,129,930?

Dose strength and daily dosing limits

Multiple claim paths use:

nicotinic acid dose: ~250 mg to ~3000 mg per day.

Release rate constraints

A key technical limiter:

release rate: 2.0% per hour to 25% per hour.

This is a direct manufacturing parameter. It can be used as both:

infringement lever if accused product measures into that window; and
design-around lever if a competitor shifts release outside it (with potential efficacy/safety tradeoffs).

Excipients by mass fraction (tablet-grade SR composition)

Across the different dependent claims, the most repeated boundaries are:

Component	Role	Typical claim range
HPMC	swelling agent	5% to 50% w/w (per 100 parts composition)
Povidone / PVP	binder	1% to 4% (or 1% to 5%) w/w
Stearic acid (and/or Mg stearate)	lubricant	0.5% to 2% (or 0.5% to 2.5%) w/w

“Consists essentially of” locked compositions

A recurring “consists essentially of” embodiment:

nicotinic acid + hydroxypropyl methylcellulose + povidone + stearic acid

This “essentially” language reduces risk that a competitor can avoid infringement merely by adding other excipients, unless they shift the formulation enough to escape the “essentially” restriction and also avoid other claim limitations.

What are the example tablet compositions (375 mg, 500 mg, 750 mg) and how do they affect infringement?

375 mg tablet exemplar (locked formulation)

A set of dependent claims specifies a “consists essentially of” / tablet composition:

nicotinic acid: 375.0 mg
HPMC: 188.75 mg
povidone: 12.9 mg
stearic acid: 5.8 mg

500 mg tablet exemplar (locked formulation)

nicotinic acid: 500.0 mg
HPMC: 203.0 mg
povidone: 17.2 mg
stearic acid: 7.3 mg

750 mg tablet exemplar (locked formulation)

nicotinic acid: 750.0 mg
HPMC: 204.7 mg
povidone: 25.9 mg
stearic acid: 9.9 mg

Infringement relevance

These exemplars matter in practice because:

they provide concrete anchors for claim construction and product matching in discovery;
they suggest the patent holder’s own reference formulation and test data supporting “no discontinuation” safety narratives and lipid/HDL endpoints.

A generic manufacturer can seek to avoid literal infringement by altering excipient identities, excipient proportions, or release rate. But the broad dependent language (HPMC/povidone/stearic acid as specified families) leaves less room than many generic SR products anticipate.

What generic entry risks exist for SR nicotinic acid once-daily evening/night claims?

Where would a generic likely land in claim testing?

If a competitor makes a once-daily evening/night SR niacin tablet, the risk is high that it will map to:

schedule/timing
SR excipient architecture
HPMC/povidone/specific lubricants
dose range (250–3000 mg)
and potentially the “consists essentially of” category if the formulation matches.

Where could design-arounds reduce exposure?

The most direct noninfringement paths, based on claim structure alone:

Shift excipient architecture so it does not include the specified swelling agent families at required quantitative levels.
Use different binders or lubricants outside the recited groups.
Adjust release rate outside 2%/hour to 25%/hour.
Change dosing regimen away from once per day during the evening or at night (but note that the comparative claims use divided dosing as the baseline comparison, so avoiding “single dose evening/night” is likely a key lever).

What is the Orange Book status of US 6,129,930?

No sufficient information is provided in the prompt to determine the Orange Book listing status of US 6,129,930 or the specific marketed drug(s) tied to the patent.

What patent litigation affects US 6,129,930?

No litigation history or case identifiers are provided in the prompt.

How does US 6,129,930 compare with other niacin SR patent claim strategies (design-around discussion)?

Within the claim text provided, US 6,129,930 uses a combination strategy that is more difficult to circumvent than single-dimension claims:

it is not purely formulation (it has performance and lab-safety concepts),
it is not purely dosing (it has explicit SR excipient architecture),
it is not purely method-of-use (it has comparative hepatotoxicity constructs versus divided dosing).

This combination is a recognizable approach in older SR oral therapeutics: claims are drafted so that even if a competitor tweaks one variable, other dependent limitations can still capture the product.

Key Takeaways

US 6,129,930 claims once-daily evening/night oral sustained-release nicotinic acid with lipid improvements and explicit lab-safety avoidance framed as “no discontinuation” for uric acid/glucose, and separately as “little or no serious liver damage” for AST/ALT/alkaline phosphatase.
Scope is strongest where products match HPMC swelling agent + povidone binder + stearic acid lubricant formulations, especially “consists essentially of” embodiments.
Technical infringement risk centers on release rate (2%/hour to 25%/hour) and excipient percentage bands (HPMC 5–50%; binder 1–4 or 1–5%; lubricant 0.5–2 or 0.5–2.5%).
The claim set includes comparative method-of-use language: single evening/night dose must be at least as effective as two divided doses at equivalent total daily niacin while being less hepatotoxic by liver-function tests.
Design-arounds likely require coordinated changes to timing, SR release profile, excipient identity and proportion, and potentially binder/lubricant selection to exit multiple dependent claim pathways at once.

FAQs

Does US 6,129,930 require proving actual HDL and Lp(a) changes for infringement?
Which excipients are the most critical for “consists essentially of” infringement risk?
How do the release-rate limits (2%/hour to 25%/hour) influence formulation testing and validity challenges?
What is the practical difference between “steearic acid” only and “stearic acid/magnesium stearate” lubricant options across the claim set?
How do the comparative single-dose vs divided-dose claims affect regulatory and labeling design for SR niacin products?

References

United States Patent 6,129,930. (2016). Daily method and sustained-release composition for treating hyperlipidemia with nicotinic acid. United States Patent.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	289197	⤷ Start Trial
Australia	4751802	⤷ Start Trial
Australia	6348198	⤷ Start Trial
Australia	6454598	⤷ Start Trial
Australia	775967	⤷ Start Trial
Brazil	9815454	⤷ Start Trial
Brazil	9815457	⤷ Start Trial
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Summary for Patent: 6,129,930