US Patent 8,987,262: Scope, Claims, Expiration, Orange Book Status, and Hemangioma Patent Landscape

US Patent 8,987,262 protects methods of treating capillary or infantile hemangiomas with beta blockers. Its broadest independent claim covers administration of a pharmaceutically acceptable and effective beta-blocker dose, without limiting the claim to propranolol, a specific route, formulation, patient age, or dose. Claim 18 narrows the invention to infantile hemangioma treatment at no more than 10 mg/kg.

The patent is commercially relevant to propranolol products, including Pierre Fabre's Hemangeol oral solution. Its broad genus claim has substantial scope but faces potential validity pressure from the breadth of the beta-blocker class, the use of functional terms such as "efficient dose," and pre-2006 treatment disclosures involving propranolol and vascular lesions.

What patent is US 8,987,262?

US 8,987,262 is titled "Use of Beta Blockers for Treating Hemangiomas." The patent claims therapeutic use of beta blockers for capillary and infantile hemangiomas.

Field	Details
Patent number	US 8,987,262 B2
Title	Use of beta blockers for treating hemangiomas
Patent type	Utility patent
Technology	Beta-blocker treatment of hemangiomas
Primary therapeutic area	Dermatology, pediatrics, vascular anomalies
Core active ingredient	Broad beta-blocker genus; propranolol is expressly included
Priority date	June 8, 2006
Issue date	March 24, 2015
Patent holder associated with the family	Pierre Fabre entities
Principal commercial product	Hemangeol, propranolol hydrochloride oral solution
Patent-term basis	Generally 20 years from the earliest effective nonprovisional or PCT filing date, subject to statutory adjustments
Projected nominal expiration	Approximately June 2027, subject to patent-term adjustment or regulatory extension

The priority and bibliographic information should be read with the USPTO patent record and the relevant international family records. The patent issued well after the priority filing, making its commercial term principally dependent on the 2006 priority and applicable patent-term rules.[1]

What do the independent claims of US 8,987,262 cover?

The patent has two principal independent method claims.

Claim 1: broad beta-blocker treatment claim

Claim 1 covers:

A patient with a capillary or infantile hemangioma;
Administration of a beta blocker;
A pharmaceutically acceptable and effective dose.

The claim does not require:

Propranolol;
Oral administration;
A liquid formulation;
A particular patient age;
A particular hemangioma size or location;
A specific dosing schedule;
A particular treatment duration;
A mechanism of action; or
FDA-approved product labeling.

This makes claim 1 the principal genus claim. A product or clinical protocol using any beta blocker to treat an infantile hemangioma could fall within its literal scope if the dose is pharmaceutically acceptable and effective.

The claim is a method-of-treatment claim. It does not directly claim the beta blocker compound, a formulation, or the hemangioma indication as a product.

Claim 18: dose-limited infantile hemangioma claim

Claim 18 is narrower. It requires:

An infantile hemangioma;
Administration of a beta blocker; and
A dose of no more than 10 mg/kg of body weight.

Claim 18 does not require propranolol, but its dose limitation is commercially important because standard systemic propranolol regimens for infantile hemangioma generally fall well below 10 mg/kg/day. Hemangeol's labeled maintenance dose is 3.4 mg/kg/day, administered in two divided doses.[2]

Claim 18 therefore has a narrower statutory scope than claim 1 but may map more directly onto conventional systemic treatment protocols.

How do the dependent claims expand the patent's scope?

The dependent claims create multiple overlapping claim sets.

Claim group	Protected subject matter
Claims 2-8	Beta-blocker subclasses and intrinsic sympathomimetic activity
Claims 9-10	Acebutolol and timolol
Claim 11	Infantile hemangioma
Claims 12-15	Oral, topical, nasal, buccal, sublingual, and rectal administration
Claims 16-17	Doses of no more than 20 mg/kg and 10 mg/kg
Claims 19-20	Selected beta blockers and timolol under claim 18

Beta-blocker genus

Claim 2 reaches:

Non-selective beta blockers;
Beta-1-selective beta blockers;
Alpha-1/beta antagonists;
Beta-2-selective beta blockers; and
Combinations of beta blockers.

Claim 4 lists numerous non-selective agents, including propranolol, timolol, nadolol, carvedilol, labetalol, sotalol, and pindolol. Claim 6 lists beta-1-selective agents such as atenolol, metoprolol, bisoprolol, and nebivolol.

The claim architecture attempts to prevent design-around through selection of a different beta-blocker subclass. A manufacturer using atenolol rather than propranolol, for example, could still fall within claim 2 or claim 5 if the remaining limitations are met.

Intrinsic sympathomimetic activity

Claims 7 and 8 separately cover beta blockers having intrinsic sympathomimetic activity, including acebutolol, carteolol, pindolol, and propranolol. These claims reinforce coverage of agents that differ pharmacologically from pure beta antagonists.

Routes and dosage forms

Claims 12-15 attempt to cover a broad delivery platform:

Oral liquids;
Syrups;
Suspensions;
Emulsions;
Oral drops;
Effervescent forms;
Powders;
Multiparticulate systems;
Orodispersible dosage forms;
Ointments;
Creams;
Gels;
Lotions;
Patches;
Foams;
Nasal, buccal, sublingual, and rectal administration.

Claim 14, as supplied, depends on claim 13 while changing from oral liquid formulations to topical formulations. That dependency is unusual and may create a claim-construction issue. A court would examine the issued patent's exact text, prosecution history, and any certificate of correction before assigning legal effect to the apparent inconsistency.

What formulations are protected by US 8,987,262?

The patent is not limited to Hemangeol's formulation. The formulation claims are route-focused rather than compositionally specific.

Hemangeol is a propranolol hydrochloride oral solution containing 4.28 mg/mL propranolol hydrochloride, equivalent to 3.75 mg/mL propranolol base. The labeled product is administered orally to pediatric patients with proliferating infantile hemangioma.[2]

US 8,987,262 does not, based on the supplied claims, require:

A specific propranolol concentration;
A particular buffer;
A particular sweetener;
A specific preservative;
A defined pH;
A flavor system;
A particular bottle or syringe; or
A specific pharmacokinetic profile.

Those limitations would generally belong in separate formulation claims, if present elsewhere in the patent family or in related patents.

When does US 8,987,262 lose exclusivity?

The nominal patent term is expected to end around June 2027, based on the June 8, 2006 priority date and the standard 20-year patent term framework. The exact expiration date depends on the effective filing date used for patent-term calculation and any patent-term adjustment listed in the USPTO record.[1]

The FDA regulatory exclusivity associated with Hemangeol is separate from the patent term.

Exclusivity or protection	Approximate timing	Commercial effect
Hemangeol approval	March 14, 2014	FDA approval of propranolol oral solution for infantile hemangioma
Three-year clinical investigation exclusivity	Approximately through March 2017	Restricted approval of certain abbreviated applications relying on the protected clinical investigations
Pediatric exclusivity	Six-month extension where applicable	Extends eligible listed patents and regulatory exclusivity
US 8,987,262 patent term	Approximately through June 2027	Potential method-of-use barrier
Post-expiration market	From patent expiration, subject to other patents	Generic or alternative-product entry becomes more feasible

The patent expiration date should not be confused with FDA exclusivity. Regulatory exclusivity can expire years before a patent, while a patent can remain relevant after regulatory exclusivity ends.

What is the Orange Book status of US 8,987,262?

Hemangeol was approved under NDA 205410. The FDA Orange Book is the central source for listed patents and exclusivity tied to approved drug products.[3]

US 8,987,262 is associated with the Hemangeol patent estate and is commercially relevant as a method-of-use patent. The legal impact of an Orange Book listing depends on:

Whether the patent is currently listed;
The use code assigned to the listing;
Whether a generic applicant seeks the protected indication;
Whether the applicant submits a Paragraph IV certification; and
Whether the NDA holder files timely infringement litigation.

A method-of-use patent does not necessarily block approval of a generic product for every use. A generic applicant may pursue a section viii statement that omits the patented indication, provided the proposed labeling and marketing conduct do not induce infringement.

Which companies are challenging US 8,987,262?

Publicly available records through June 2024 do not establish a widely reported final appellate decision invalidating US 8,987,262 or a definitive settlement that eliminates its effect. The principal potential challengers are manufacturers seeking approval for:

Propranolol oral solutions;
Pediatric beta-blocker formulations;
Generic versions of Hemangeol; and
Products labeled for infantile hemangioma.

The principal litigation pathway would be a Paragraph IV certification under the Hatch-Waxman Act if the patent is listed for the relevant approved use. A Paragraph IV certification can trigger a 45-day period during which the patent owner may file an infringement action, potentially imposing a 30-month stay on approval under the statutory framework.[4]

The absence of a publicly established final judgment does not mean the patent is immune from challenge. Likely attack grounds include:

Anticipation by earlier beta-blocker treatment disclosures;
Obviousness based on propranolol's known vascular effects and clinical observations;
Lack of written description for the full beta-blocker genus;
Lack of enablement across all listed beta blockers and routes;
Indefiniteness of "pharmaceutically acceptable and efficient dose";
Indefiniteness or dependency problems in the formulation claims; and
Double patenting over related family members.

How strong is the patent estate for beta-blocker treatment of hemangiomas?

The estate is strongest against direct commercial use of a beta blocker for the infantile hemangioma indication. It is weaker against products that:

Use a beta blocker for a different indication;
Omit infantile hemangioma from the label;
Rely on topical timolol for small, superficial lesions;
Use a non-beta-blocking vascular therapy; or
Avoid the claimed treatment method through a carefully drafted label and promotional strategy.

Strengths

The claims have several commercial strengths:

Claim 1 is broad across beta-blocker subclasses.
Propranolol is expressly identified in multiple dependent claims.
Claim 18 aligns with clinically relevant pediatric dosing.
The claims cover systemic and several non-oral routes.
The patent can be asserted against method infringement even when the underlying active ingredient is old.

Weaknesses

The principal weaknesses are breadth and claim clarity. The patent attempts to cover many compounds with materially different pharmacology, multiple routes, and broad dose ranges. A challenger could argue that the disclosure does not adequately support or enable every claimed beta blocker, formulation, and administration route.

The term "efficient dose" may also invite indefiniteness arguments unless the specification supplies objective criteria for determining efficacy. Claim 14's apparent dependency problem creates a separate prosecution-history and claim-construction issue.

How does Hemangeol compare with topical timolol and generic propranolol?

Product or approach	Active ingredient	Typical route	FDA status for infantile hemangioma	Patent risk
Hemangeol	Propranolol hydrochloride	Oral solution	FDA-approved	Highest exposure to listed method patents
Generic propranolol tablets or solutions	Propranolol	Oral	Product approval does not automatically authorize the hemangioma indication	Depends on label, patents, and induced-infringement facts
Topical timolol	Timolol	Topical	Commonly used off-label; not equivalent to Hemangeol approval	Potentially within claims 10, 15, and 20
Other beta blockers	Atenolol, nadolol, acebutolol, metoprolol, others	Usually oral	Generally not FDA-approved specifically for hemangioma	Claims 2-8 and 19 may be relevant
Non-beta-blocker treatment	Varies	Varies	Alternative therapy	Outside the literal beta-blocker claims

Topical timolol is particularly important because claim 10 expressly identifies timolol and the broader claims cover topical administration. Whether a specific topical product infringes depends on the exact product, route, dose, indication, and conduct of the manufacturer or prescriber.

What generic entry risks exist?

Generic entry can occur through several scenarios.

Full-label entry

A generic applicant seeks labeling for infantile hemangioma and must address listed method-of-use patents through Paragraph IV certification, a section viii carve-out, or acceptance of patent expiry.

Skinny-label entry

The applicant omits infantile hemangioma from the label. This can reduce, but not eliminate, litigation risk. Promotional activity, distribution practices, product design, and foreseeable use may support an induced-infringement theory.

Alternative beta-blocker entry

A company commercializes atenolol, nadolol, timolol, or another beta blocker for hemangioma treatment. The broad genus claims are designed to reach these alternatives, but validity and infringement would turn on the specific product and clinical use.

Post-2027 entry

After patent expiry, direct method-of-use competition becomes more likely unless related formulation, manufacturing, pediatric dosing, or regulatory exclusivity rights remain active.

What manufacturing and geographic barriers remain?

US 8,987,262 is a US method patent. It does not independently prevent manufacture or sale in every country. Commercial risk must be assessed against corresponding national family members in Europe, Canada, Japan, Australia, and other target markets.

The patent also does not claim, on the supplied language, a proprietary manufacturing process for propranolol hydrochloride or a unique oral-solution composition. Manufacturing barriers are therefore more likely to arise from:

Separate formulation patents;
Trade secrets;
Pediatric stability data;
Product-specific regulatory requirements;
Controlled manufacturing of liquid dosage forms; and
Clinical or bridging-study requirements in individual jurisdictions.

What is the commercial exposure?

Hemangeol is the principal product directly associated with the patented indication. Its commercial exposure is tied to the pediatric vascular-anomaly market rather than to propranolol's much larger cardiovascular market.

The relevant risk is not loss of propranolol exclusivity generally. Propranolol is an old active ingredient. The risk is erosion of the approved infantile hemangioma indication through:

Generic propranolol products;
Off-label use of inexpensive tablets or compounded liquids;
Topical timolol;
Other beta blockers;
Hospital-compounded formulations; and
Skinny-label generic launches.

Revenue protection therefore depends more heavily on method-of-use enforcement, formulation differentiation, pediatric labeling, and physician adoption than on compound exclusivity.

Key Takeaways

US 8,987,262 claims beta-blocker treatment of capillary and infantile hemangiomas.
Claim 1 is the broadest claim and is not limited to propranolol, oral dosing, or a specific formulation.
Claim 18 covers infantile hemangioma treatment at no more than 10 mg/kg.
Propranolol and timolol are expressly covered by dependent claims.
The patent reaches oral, topical, nasal, buccal, sublingual, and rectal administration, subject to claim construction.
The nominal patent term is expected to extend approximately through June 2027, subject to USPTO term adjustments.
Hemangeol's FDA approval does not itself establish patent validity, and FDA exclusivity is separate from patent protection.
Generic risk is highest for propranolol products seeking the infantile hemangioma indication.
Topical timolol and alternative beta blockers present commercial competition but may remain within the patent's broad method claims.
The main validity issues are prior art, enablement, written description, indefiniteness, and the apparent dependency problem in claim 14.

FAQs

Can a generic propranolol product enter before US 8,987,262 expires?

Yes, potentially. A generic applicant may use a Paragraph IV certification, a section viii labeling carve-out, or wait for patent expiry. The commercial outcome depends on the patent listing, proposed label, litigation, and any other patents in the Hemangeol estate.

Does US 8,987,262 cover propranolol itself?

No. It does not claim propranolol as a chemical compound. It claims methods of using beta blockers, including propranolol, to treat hemangiomas.

Is topical timolol covered by the patent?

Potentially. Claims 10 and 20 identify timolol, while the administration claims include topical dosage forms. Infringement requires analysis of the product's use, route, dose, label, and relevant claim limitations.

Can a physician's off-label use infringe the patent?

A physician's treatment activity may satisfy the method steps, but patent enforcement generally focuses on the actors and entities involved in commercial manufacture, sale, promotion, or inducement. The facts of each use and the applicable statutory defenses control.

Does approval of Hemangeol give Pierre Fabre exclusivity over all propranolol products?

No. Hemangeol approval protects the approved product through FDA regulatory mechanisms and may be supported by listed patents. It does not create compound exclusivity over propranolol or prevent all propranolol products from entering the market.

References

United States Patent and Trademark Office. (2015). US Patent No. 8,987,262 B2, Use of beta blockers for treating hemangiomas.
U.S. Food and Drug Administration. (2014). Hemangeol (propranolol hydrochloride) oral solution prescribing information.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
United States Code. (2023). 21 U.S.C. § 355, New drugs.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eton	HEMANGEOL	propranolol hydrochloride	SOLUTION;ORAL	205410-001	Mar 14, 2014		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				METHOD TO TREAT INFANTILE HEMANGIOMA	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	07291273	Oct 19, 2007

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	068927	⤷ Start Trial
Austria	E512661	⤷ Start Trial
Australia	2008313405	⤷ Start Trial
Brazil	PI0816536	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 8,987,262

Which drugs does patent 8,987,262 protect, and when does it expire?

Summary for Patent: 8,987,262