US Patent 7,011,848: Claim Scope, Expiration, Orange Book Status, and Niacin Patent Landscape

US Patent 7,011,848 protects a once-daily evening or nighttime treatment method using nicotinic acid, commonly known as niacin, or a compound metabolized to niacin. The patent is directed primarily to sustained-release niacin therapy for hyperlipidemia, with additional limitations covering dose, release rate, excipients, tablet composition, and niacin prodrugs.

The claims are method-of-treatment claims rather than composition claims. Infringement therefore requires practice of the claimed dosing regimen and, for dependent claims, use of the specified formulation characteristics. Based on the ordinary 20-year patent term applicable to post-1995 U.S. applications, the patent’s enforceable term has likely ended. A current infringement or generic-entry analysis must therefore focus on any terminal disclaimer, patent-term adjustment, continuation patents, separate formulation patents, and FDA exclusivity records.

What does US Patent 7,011,848 protect?

The patent has a layered claim structure:

Claim group	Protected subject matter	Principal limitation
Claim 1	Method of treating hyperlipidemia	Niacin or niacin-generating compound, once daily in the evening or at night
Claim 2	Dose	About 250 to 3,000 parts by weight of nicotinic acid
Claim 3	Clinical safety result	Minimum liver damage, uric-acid increase, and fasting-glucose elevation
Claim 4	Release profile	About 2% to 25% release per hour
Claim 5	Matrix former	About 5% to 50% hydroxypropyl methylcellulose per 100 parts of tablet
Claims 6-7	Binder	About 1% to 4% binder, with claim 7 specifying polyvinylpyrrolidone-type polymer
Claims 8-9	Lubricant	About 0.5% to 2.5% lubricant, specifically stearic acid or magnesium stearate
Claims 10-11	Prodrug	Nicotinyl alcohol tartrate, at 100 to 500 mg per dosage unit
Claim 12	Other niacin-generating compounds	D-glucitol hexanicotinate, aluminum nicotinate, or 1-alpha-tocopheryl nicotinate

The independent claim is broad in therapeutic concept but narrow in administration schedule. It does not cover every niacin product or every sustained-release formulation. It requires a once-daily evening or nighttime regimen intended to achieve a specified lipid response.

How broad is claim 1?

Claim 1 contains several cumulative elements:

The patient must have hyperlipidemia.
The active ingredient must be nicotinic acid or a compound metabolized to nicotinic acid.
The dose must be administered once per day.
Administration must occur in the evening or at night.
The product must contain pharmaceutically acceptable carriers.
Treatment must produce reductions in total cholesterol, LDL cholesterol, triglycerides, and Lp(a).
Treatment must produce a significant increase in HDL cholesterol.

A product or regimen that satisfies only some of these elements would not literally infringe claim 1. For example, a twice-daily immediate-release niacin product would not satisfy the once-per-day limitation. A morning-administered product may also avoid literal infringement if “evening or at night” is construed as a required temporal limitation.

The lipid-response language creates a separate issue. “Reduction” and “increase” may be treated as treatment-result limitations, depending on the specification and prosecution history. A product intended and labeled to produce the claimed effects presents greater risk than a product whose label omits one or more outcomes. Actual patient results may also become relevant in an inducement analysis.

What dosage ranges are protected?

Claim 2 covers approximately 250 to 3,000 parts by weight of nicotinic acid. The drafting is unusual because “parts by weight” is not expressly tied to a dosage unit in the claim. In a pharmaceutical method claim, the specification would normally be used to determine whether the range means milligrams per administration, dose-equivalents, or another formulation measure.

The range corresponds broadly to clinically used niacin doses. It is not limited to a single strength and could encompass multiple sustained-release tablet strengths if the dose is within the claimed range.

Claim 11 separately covers 100 to 500 mg of nicotinyl alcohol tartrate per dosage unit. That range applies to the prodrug and cannot automatically be equated to the amount of active niacin released.

What formulation patents and excipient limitations are covered?

Hydroxypropyl methylcellulose

Claim 5 requires approximately 5% to 50% hydroxypropyl methylcellulose, or HPMC, per 100 parts by weight of tablet. HPMC is a hydrophilic matrix-forming polymer commonly used to control release from oral tablets.

This limitation is formulation-specific. A sustained-release niacin tablet using a different matrix system, such as ethylcellulose, a coating-only system, a lipid matrix, or another hydrophilic polymer, may avoid literal infringement of claim 5 while remaining potentially relevant to claim 4 or claim 1.

The claim does not identify a particular HPMC viscosity grade, particle size, substitution pattern, or commercial grade. Those parameters may matter in construing the concentration range and determining whether a formulation falls within the claim.

Binder limitations

Claim 6 requires a sustained-release formulation or tablet containing about 1% to 4% binder per 100 parts by weight of tablet. Claim 7 narrows the binder to a polymer having the repeating unit 1-ethenyl-2-pyrrolidone, which corresponds to polyvinylpyrrolidone, also called povidone or PVP.

The claim language may create a drafting issue because claim 7 depends on claim 4 rather than directly on claim 6, although the dependency likely incorporates the sustained-release formulation context through the claim chain and specification.

Lubricant limitations

Claim 8 requires about 0.5% to 2.5% lubricant. Claim 9 limits the lubricant to stearic acid or magnesium stearate.

These ranges can be commercially significant because magnesium stearate is widely used in tablet manufacture. A generic formulation using magnesium stearate within the claimed range could fall within the dependent claim if all other incorporated limitations are met. A formulation using another lubricant could avoid claim 9 but remain exposed under claim 8.

Does the patent require sustained release?

Claim 1 does not expressly require a sustained-release formulation. Claims 4 through 9 introduce release-rate and tablet-composition limitations, while claim 6 expressly refers to a sustained-release formulation or tablet.

This creates three practical coverage tiers:

Tier	Claims	Exposure
Therapeutic regimen	Claim 1	Once-daily evening or nighttime niacin treatment
Pharmacokinetic/formulation	Claim 4	2% to 25% release per hour
Specific tablet composition	Claims 5-9	HPMC, binder, PVP, lubricant, and specified concentration ranges

An immediate-release product may avoid claims 4 through 9 but still raise a claim 1 issue if it is dosed once daily at night and is directed to the claimed lipid outcomes. Conversely, an extended-release formulation administered in the morning may avoid the principal timing limitation while potentially implicating other patent claims in the same family or related portfolios.

What compounds other than niacin are covered?

Claims 1, 10, and 12 extend the claimed method beyond unmodified nicotinic acid.

The covered categories include:

Nicotinyl alcohol tartrate.
D-glucitol hexanicotinate.
Aluminum nicotinate.
1-alpha-tocopheryl nicotinate.
Other compounds metabolized by the body to nicotinic acid, subject to the scope of claim 1.

The phrase “compound metabolized to nicotinic acid” is functionally broad. Its practical scope depends on how the specification defines the class and whether the compound produces the claimed therapeutic effects under the specified dosing schedule.

A product containing a different niacin derivative would require a compound-by-compound analysis. Structural similarity alone would not establish literal infringement. Doctrine-of-equivalents exposure could remain relevant if the derivative performs substantially the same function in substantially the same way to obtain substantially the same result, subject to prosecution-history estoppel and other limitations.

What are the principal claim-construction vulnerabilities?

Several terms may be contested in litigation or inter partes review.

“Once per day in the evening or at night”

This is a meaningful regimen limitation. Issues include:

Whether “evening” begins at a fixed clock time.
Whether “at night” includes administration at bedtime.
Whether a label directing administration “in the evening” is sufficient for induced infringement.
Whether patient-directed use, rather than the manufacturer’s express instruction, is required.

“Effective antihyperlipidemic amount”

This is a conventional pharmaceutical limitation, but it still requires a dose capable of achieving the claimed therapeutic purpose. The specification and clinical evidence would determine how much latitude the term provides.

“Significant increase in HDL cholesterol”

“Significant” may be construed statistically, clinically, or in relation to baseline. If the patent specification does not supply a clear threshold, the term may create indefiniteness or proof-of-infringement issues.

“Minimum liver damage” and related safety results

Claim 3 requires minimum liver damage, uric-acid increases, or fasting-glucose elevations. The claim does not provide numerical boundaries in the supplied text. This creates potential indefiniteness and causation issues. The patent holder would likely need clinical or pharmacological evidence showing that the claimed regimen produces the required safety profile.

“Release rate ... from about 2.0% per hour to about 25% per hour”

Release-rate claims depend heavily on the test method. Relevant variables include dissolution medium, pH, apparatus, agitation, sampling intervals, temperature, and whether the rate is measured as an average or at each interval. Without a defined testing protocol, parties may dispute whether the limitation is an average release rate, a maximum rate, or a profile across the full dosage period.

When does US Patent 7,011,848 lose exclusivity?

The patent’s issue date was March 14, 2006. Under 35 U.S.C. § 154, the ordinary term for a U.S. patent application filed after June 8, 1995, is generally 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, and applicable continuation rules.[1]

The likely expiration analysis is:

Item	Date or rule
Patent issue date	March 14, 2006
Ordinary term framework	20 years from earliest effective nonprovisional filing date
Likely nominal expiration	Approximately 2021, if the relevant application was filed in 2001
Possible adjustments	PTA, terminal disclaimer, priority-chain effects, reexamination or certificate effects
Current commercial significance	The patent is unlikely to provide live exclusion after the ordinary term

The exact expiration date must be taken from the USPTO patent record, including the term-adjustment calculation and any terminal disclaimer. Patent expiration does not eliminate liability for conduct occurring before expiration, and it does not eliminate separate patents covering the same product.

What is the Orange Book status of US Patent 7,011,848?

A patent is not an Orange Book patent merely because it covers a pharmaceutical method or formulation. FDA Orange Book listing depends on submission by the NDA holder and the patent’s relationship to the approved drug product, formulation, or method of use under 21 C.F.R. § 314.53.[2]

The relevant Orange Book questions are:

Whether the patent was listed against an approved niacin product.
Whether the listing identified the patent as a drug substance, drug product, or method-of-use patent.
Whether the listed use corresponded to the approved labeling.
Whether the listing was removed after expiration.
Whether an ANDA applicant had to address the patent with a Paragraph III certification or Paragraph IV certification.

The claim set is directed to method of treatment and formulation details. It would not automatically qualify as a drug-substance patent. A method-of-use listing would require a corresponding approved indication or use. A formulation listing would require that the patent claim the approved dosage form or formulation.

The Orange Book should be reviewed separately from the USPTO record because patent ownership, patent validity, FDA listing, and enforceability are distinct issues.[3]

What Paragraph IV challenges and generic-entry risks exist?

A generic applicant filing an ANDA may use one of four principal certifications under 21 U.S.C. § 355(j)(2)(A)(vii):

Paragraph I: no patent information has been submitted.
Paragraph II: the patent has expired.
Paragraph III: the applicant will not market until patent expiration.
Paragraph IV: the patent is invalid, unenforceable, or will not be infringed.[4]

For this patent, the most material Paragraph IV theories would have been:

The proposed product is not administered once daily in the evening or at night.
The formulation does not use the claimed HPMC, PVP, lubricant, or concentration range.
The release profile falls outside 2% to 25% per hour.
The active ingredient is not niacin or a compound within the claimed metabolized-to-niacin class.
The lipid and safety-result limitations are not met.
The claims are obvious in view of earlier niacin sustained-release formulations and clinical dosing literature.
The terms “significant,” “minimum,” “about,” and “release rate” are indefinite or insufficiently supported.

A generic launch strategy would likely distinguish between:

A product labeled for morning or flexible administration.
A formulation using a different release-control technology.
A product that avoids the claimed excipient ranges.
A product approved after the patent’s nominal expiration.

The largest residual risk would come from related patents rather than this patent alone. Niacin products may be covered by separate formulation, release-control, combination-product, manufacturing, or method-of-use patents.

How strong is the patent estate for once-daily extended-release niacin?

The patent is strongest when several limitations converge:

Once-daily evening or nighttime dosing.
A sustained-release tablet.
HPMC as the principal matrix polymer.
PVP as binder.
Magnesium stearate or stearic acid in the claimed range.
A release profile within 2% to 25% per hour.
A niacin dose within the claimed range.

The estate is weaker as a standalone barrier because:

The active ingredient, niacin, was long known.
Sustained-release niacin formulations were known before the patent.
Many claim terms are functional or qualitative.
The claims require proof of administration timing and therapeutic results.
Dependent claims may be designed around through excipient substitution or altered release technology.
The ordinary patent term has likely ended.

The claims may have had greater commercial value when an approved product’s label directed once-daily evening use and the product used a matching sustained-release matrix. Their current value is principally historical, freedom-to-operate, and litigation-analysis value unless a term-extension or related live patent exists.

How does this patent compare with competing niacin products?

Product or technology	General profile	Relationship to the claimed subject matter
Immediate-release niacin	Rapid release; often multiple daily doses	May avoid sustained-release claims and once-daily regimen
Sustained-release niacin	Controlled release, often non-prescription or prescription	Potentially relevant to claims 1 and 4-9
Extended-release niacin products	Prescription products designed for once-daily administration	Closest commercial category
Niacin/statin combinations	Combination therapy	May implicate separate combination patents and labeling claims
Alternative lipid agents	Statins, fibrates, ezetimibe, PCSK9 inhibitors	Outside the active-ingredient scope of this patent

The patent does not cover statins, fibrates, ezetimibe, PCSK9 antibodies, or other non-niacin lipid-lowering agents. It also does not claim a combination of niacin with a statin in the supplied claims.

What manufacturing and geographic barriers remain?

The patent is a U.S. right. It does not independently block manufacture, sale, or use outside the United States. Foreign exposure requires corresponding national patents, which must be analyzed by jurisdiction and family member.

Manufacturing risk is concentrated in:

Controlled-release tablet compression.
HPMC matrix selection and concentration.
PVP binder levels.
Lubricant concentration.
Dissolution-profile control.
Batch-to-batch release testing.
Use of the specified niacin derivatives.

A manufacturer could reduce literal infringement risk by changing the polymer system, excipient levels, release profile, dose timing, or label instructions. Those changes could affect bioequivalence, dissolution similarity, stability, and FDA approval. Design-around activity therefore requires simultaneous patent and regulatory analysis.

What licensing, litigation, and settlement issues matter?

The supplied claim text does not establish a licensing agreement, Paragraph IV notice, infringement complaint, settlement, covenant not to sue, or authorized generic arrangement involving US Patent 7,011,848. Those issues cannot be inferred from the claims.

For commercial diligence, the relevant records are:

USPTO Patent Center prosecution and assignment records.
FDA Orange Book patent listings.
ANDA litigation complaints under the Hatch-Waxman framework.
Federal district court docket records.
Federal Circuit decisions.
SEC filings by the NDA holder or patent owner.
Paragraph IV settlement disclosures and FTC reviews.

A settlement involving a related niacin patent would not necessarily resolve this patent. Conversely, expiration of this patent would not eliminate claims under separate patents in the same product portfolio.

Key Takeaways

US Patent 7,011,848 claims a once-daily evening or nighttime niacin treatment method for hyperlipidemia.
Claim 1 is a regimen claim with lipid-response limitations, not a general claim to niacin.
Claims 4-9 add sustained-release and tablet-composition requirements, including HPMC, PVP, stearic acid, and magnesium stearate ranges.
Claims 10-12 cover specified niacin-generating compounds, including nicotinyl alcohol tartrate and d-glucitol hexanicotinate.
The most important infringement variables are dosing time, release rate, formulation composition, and whether the product label induces the claimed use.
The qualitative terms “significant,” “minimum,” “about,” and “effective” create potential construction and validity disputes.
The ordinary patent term likely ended around 2021, subject to the official PTA and terminal-disclaimer record.
Orange Book listing must be confirmed independently from the patent claims and USPTO record.
Current generic-entry risk is more likely to depend on related patents, FDA exclusivity, labeling strategy, and formulation patents than on this patent alone.
No licensing, litigation, or settlement conclusion follows from the supplied claims without separate court, FDA, and ownership records.

FAQs

Does US Patent 7,011,848 cover all extended-release niacin tablets?

No. It covers only products and uses satisfying the claim limitations, including the specified regimen and, for dependent claims, release and excipient requirements.

Can a morning-dosed niacin product avoid this patent?

Potentially. Morning dosing may avoid the “evening or at night” limitation in claim 1, but separate patents or induced-use theories may still require review.

Is magnesium stearate alone enough to infringe claim 9?

No. Claim 9 incorporates the limitations of the preceding claims, including the method, formulation context, and claimed lubricant concentration.

Does the patent cover nicotinamide?

Not on the supplied claim language. The claims identify nicotinic acid and compounds metabolized to nicotinic acid. Nicotinamide is a different chemical form and requires separate claim-construction analysis.

Can a generic applicant rely on patent expiration instead of filing a Paragraph IV certification?

If the patent was listed for the reference product and had not expired when the ANDA was submitted, the applicant would generally address it under the applicable ANDA certification framework. After expiration, Paragraph II or Paragraph III treatment may apply depending on the filing and listing status.

References

United States Patent and Trademark Office. (n.d.). Patent term calculator and patent term adjustment information. https://www.uspto.gov/patents/laws/patent-term-calculator
Code of Federal Regulations. (2024). 21 C.F.R. § 314.53: Submission of patent information. https://www.ecfr.gov/current/title-21/section-314.53
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j). https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355
United States Patent and Trademark Office. (n.d.). Patent Center. https://patentcenter.uspto.gov/

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
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Details for Patent: 7,011,848

Summary for Patent: 7,011,848