United States Patent 7,608,282: Granisetron Transdermal Patch Claims, Scope, Expiration, and Patent Landscape

U.S. Patent No. 7,608,282 protects a specific granisetron transdermal patch architecture rather than granisetron generally. Its core combination is a granisetron-loaded acrylic pressure-sensitive adhesive containing 2-ethylhexyl acrylate or butyl acrylate and a non-acidic hydroxyl-containing monomer. The claims also impose stability, drug-loading, crystallization, dosage-area, and therapeutic-use limitations.

The patent is closely associated with the Sancuso granisetron transdermal system. Its principal commercial value was the ability to load clinically useful concentrations of granisetron directly into an adhesive matrix while maintaining stability and avoiding crystallization. The patent does not cover oral, injectable, or generic granisetron products that lack the claimed transdermal adhesive structure.

What does U.S. Patent 7,608,282 protect?

The independent product claim requires all of the following elements:

Required element	Claim requirement
Dosage form	Adhesive patch suitable for transdermal administration
Active ingredient	Granisetron
Adhesive	Acrylic adhesive
Primary monomer	2-ethylhexyl acrylate or butyl acrylate
Primary monomer concentration	50% to 98% w/w
Hydroxyl monomer	Non-acidic hydroxyl-containing monomer
Hydroxyl monomer concentration	0.5% to 20% w/w
Drug loading	Physiologically effective amount of granisetron
Stability	Granisetron content remains substantially unchanged after six weeks at 25°C
Therapeutic use	Not required by claim 1, but added in claims 12-18 and 25-27

The patent therefore has a combination-claim structure. A competing patch must generally satisfy the adhesive-composition limitations and the storage-stability limitation to fall within claim 1.

The claims do not broadly cover every granisetron patch. A system using a silicone adhesive, a polyurethane matrix, a reservoir design, or a different acrylic monomer outside the claimed ranges could avoid literal infringement of claim 1, subject to possible doctrine-of-equivalents issues.

How broad is claim 1 of Patent 7,608,282?

Claim 1 is technically narrow in its adhesive chemistry but commercially meaningful because it captures the formulation concept used for the approved granisetron patch.

The phrase “consisting essentially of” limits the adhesive to the specified acrylic components plus ingredients that do not materially alter the basic and novel characteristics of the adhesive. The wording is broader than “consisting of,” but narrower than “comprising.” A formulation containing minor conventional additives may remain within the claim if those additives do not materially change adhesive performance, drug stability, or transdermal delivery.

The claim’s primary acrylate limitation is alternative rather than cumulative. The adhesive must use either:

2-ethylhexyl acrylate; or
Butyl acrylate.

The claim does not expressly require both monomers. A formulation using only one qualifying primary monomer can satisfy this element if the concentration and other limitations are met.

The hydroxyl-containing monomer is defined functionally in claim 1 and narrowed by claims 2 and 3. The dependent claims identify acrylate and methacrylate species, including hydroxymethyl, hydroxyethyl, and hydroxypropyl acrylates or methacrylates.

What formulations are protected by Patent 7,608,282?

Claims 2, 3, 5, 7-11, and 19-24 define commercially important formulation ranges.

Claim group	Protected formulation feature
Claims 2-3	Hydroxymethyl, hydroxyethyl, or hydroxypropyl acrylate or methacrylate
Claim 5	50% to 90% w/w primary acrylate monomer
Claim 7	Up to about 10% w/w granisetron
Claim 8	Less than 8% w/w granisetron
Claim 9	More than 4% w/w granisetron
Claim 10	6% to 7.7% w/w granisetron
Claim 11	No crystallization after one month at room temperature and pressure
Claims 19-21	Granisetron loading from 3% to 12%, 4% to 10%, or 5% to 8% w/w
Claim 22	No plasticizers or permeation enhancers
Claims 23-24	At 6% drug loading, adhesive area of 10-100 cm² or 15-50 cm²
Claim 28	Six-week stability at 40°C

The dependent claims overlap. For example, a patch containing 6.5% granisetron can potentially fall within claims 7, 8, 9, 10, 19, 20, and 21 if the remaining limitations are met.

Claim 22 is particularly relevant to design-around analysis. It excludes plasticizers and permeation enhancers from the claimed patch. A competitor using a permeation enhancer may create a non-infringement position for claim 22, although it would not automatically avoid claim 1 or other claims.

Does Patent 7,608,282 cover the Sancuso patch?

The claim profile is consistent with the formulation technology used in Sancuso, the FDA-approved granisetron transdermal system marketed for prevention of chemotherapy-induced nausea and vomiting. The FDA label describes Sancuso as a transdermal system containing granisetron in an acrylic adhesive matrix and delivering granisetron through the skin over an extended period (FDA, 2022).

Sancuso is a 52 cm² patch containing 34.3 mg of granisetron, with an average delivery rate of approximately 3.1 mg per 24 hours over seven days. The patch is applied before chemotherapy and is intended for patients receiving multi-day or repeated chemotherapy regimens.

The commercial product therefore aligns with several claimed concepts:

acrylic adhesive matrix;
high granisetron loading;
transdermal delivery;
clinically effective delivery;
chemotherapy-induced nausea and vomiting treatment;
patch area within the range recited by claims 23 and 24.

The claims do not require the specific Sancuso trade dress, backing layer, release liner, seven-day wear period, or exact marketed dimensions unless those characteristics are separately present in the asserted claim.

What therapeutic uses are protected?

Claims 12-18 and 25-27 cover use limitations involving nausea and emesis. The claimed uses include:

chemically induced emesis;
acute emesis;
delayed emesis;
fractionated chemotherapy;
postoperative nausea and vomiting;
radiotherapy-associated nausea and vomiting;
fractionated cancer therapy;
chemotherapy-induced nausea and vomiting;
nausea or emesis associated with 5-HT3 receptor activity.

Claims 25 and 26 are method claims requiring application of the claimed patch to a patient. Claims 12-18 and 27 are product-for-use claims drafted as “a patch ... for” specified treatment purposes.

These claims can present enforcement value against a product label that expressly directs use for chemotherapy-induced nausea and vomiting. They are less useful against an unapproved patch sold without the claimed indication, although induced-infringement analysis can consider promotional conduct, labeling, and intended use.

How do the claims compare with the likely generic-entry design space?

A generic or follow-on patch would face several possible design choices.

Design route	Potential effect on Patent 7,608,282
Same acrylic chemistry and loading	High risk of literal infringement
Same monomers but outside claimed concentration ranges	Possible non-infringement, subject to overlapping claims
Silicone adhesive	Stronger design-around position
Polyurethane or hydrogel matrix	Stronger design-around position
Granisetron below or above claimed loading ranges	May avoid some dependent claims, but claim 1 has no express drug-loading percentage
Use of plasticizer or permeation enhancer	May avoid claim 22 but not necessarily claim 1
Different hydroxyl monomer	Depends on whether it remains a non-acidic hydroxyl-containing monomer under claim 1
Reservoir patch	May avoid the adhesive-matrix architecture if granisetron is not loaded in the acrylic adhesive
Different active ingredient	Outside the patent’s granisetron claims

The most important risk is that claim 1 does not impose a numerical granisetron concentration. A competitor cannot necessarily avoid claim 1 merely by moving outside the 3%-12% ranges in claims 19-21. Claims 7-10 and 19-21 are narrower fallback positions; claim 1 remains anchored to the adhesive composition, drug incorporation, and stability performance.

When does Patent 7,608,282 lose exclusivity?

The patent’s enforceable term is measured from the applicable U.S. filing or international filing date, not from its issue date in 2009. Public patent records commonly associate the patent with a projected expiration in or around July 2024, subject to the official USPTO patent-term calculation and any applicable adjustment (U.S. Patent and Trademark Office, 2009).

That timing is distinct from FDA regulatory exclusivity. Patent expiration does not itself create an ANDA approval, and FDA approval of a competing product depends on the reference product’s regulatory exclusivity, Orange Book listings, bioequivalence requirements, and any litigation-related stay.

The relevant exclusivity framework is:

Exclusivity type	Relevance
Patent term	Controls enforceable patent rights
New-drug exclusivity	May restrict certain abbreviated approvals for a statutory period
Orange Book listing	Gives an ANDA applicant listed patent information to address
Paragraph IV certification	Alleges that a listed patent is invalid, unenforceable, or not infringed
30-month stay	Can delay approval if litigation is timely filed after a Paragraph IV notice

What is the Orange Book status of Sancuso and Patent 7,608,282?

Patent 7,608,282 has been associated with the U.S. regulatory protection for Sancuso and its granisetron transdermal delivery system. The Orange Book is the relevant FDA source for listed patents and regulatory exclusivity associated with approved small-molecule drug products (FDA, 2024).

An Orange Book listing does not establish that every claim is valid or infringed. It identifies patent information that an ANDA applicant must address. A Paragraph IV certification would create a patent dispute risk if the patent remained listed and enforceable at the relevant time.

The patent’s practical Orange Book value declines sharply after expiration. After expiration, an ANDA applicant no longer faces an unexpired patent barrier from that patent, although other listed patents, regulatory exclusivity, manufacturing patents, or non-patent regulatory requirements may remain relevant.

Which companies have challenged Patent 7,608,282?

No specific Paragraph IV litigation, settlement agreement, or final invalidity judgment is established by the claim text supplied. The public regulatory record should be reviewed for current ANDA certifications and any litigation involving Sancuso, its sponsor, or listed patent owners.

The absence of identified litigation in the supplied materials does not change the legal analysis of the claims. The main litigation issues would be:

whether the accused adhesive satisfies the “consisting essentially of” limitation;
whether the hydroxyl monomer falls within claim 1 or claims 2-3;
whether the accused product is stable for the claimed six-week period;
whether the stability limitation is inherent in the accused product;
whether the asserted claims are enabled across their full formulation scope;
whether the claims are anticipated by earlier transdermal granisetron or acrylic-adhesive disclosures.

How strong is the patent estate for granisetron transdermal delivery?

Patent 7,608,282 is strongest against a competitor that copies the commercial formulation strategy. Its strength comes from the combination of:

defined acrylic adhesive chemistry;
high drug loading;
stability without crystallization;
clinically meaningful transdermal delivery;
application to chemotherapy-related nausea and vomiting.

Its weaknesses are structural. The patent does not cover granisetron as an active ingredient, every transdermal dosage form, every adhesive system, or every antiemetic use. A competitor with a materially different matrix, reservoir system, polymer family, or release mechanism may have a credible design-around strategy.

The patent also contains several potentially contestable functional limitations. “Substantially unchanged,” “physiologically effective amount,” “within about 2 hours,” and “no crystallisation observed” can create factual disputes concerning testing methods, sampling, storage conditions, and claim construction.

What manufacturing and intellectual-property barriers remain?

A competitor must solve more than patent clearance. A transdermal granisetron product requires:

reproducible adhesive polymerization;
uniform drug distribution;
control of residual monomers and solvents;
prevention of crystallization during storage;
adhesion over the proposed wear period;
controlled drug flux;
packaging that protects the patch from moisture and volatilization;
manufacturing scale-up without changes in drug release;
FDA evidence supporting sameness or bioequivalence under the applicable pathway.

The manufacturing process may be protected by separate process, polymer, coating, laminate, or packaging patents. Those rights are distinct from Patent 7,608,282 and must be reviewed separately. The patent does not, based on the supplied claims, claim the complete manufacturing process, backing layer, release liner, pouch, or packaging system.

What is the commercial exposure from this patent?

The principal commercial exposure is the Sancuso transdermal product and any follow-on granisetron patch that copies its acrylic adhesive platform. The patent has limited direct exposure to the broader granisetron market because oral tablets, oral solutions, and injectable products do not practice the claimed patch limitations.

Revenue exposure therefore depends on:

the share of granisetron revenue attributable to the transdermal system;
the number of approved or pending ANDAs;
the existence of other unexpired listed patents;
reimbursement and hospital use;
the commercial feasibility of a generic patch;
manufacturing complexity and patch adhesion performance.

A generic entrant could face higher development costs than an oral granisetron competitor because transdermal products require device, adhesion, stability, and delivery testing in addition to active-ingredient equivalence.

Key Takeaways

Patent 7,608,282 is directed to a granisetron-loaded acrylic adhesive transdermal patch.
Claim 1 requires 2-ethylhexyl acrylate or butyl acrylate, a non-acidic hydroxyl monomer, specified concentration ranges, and six-week stability.
Claims 7-10 and 19-21 add overlapping granisetron-loading ranges, including 6%-7.7% w/w.
Claim 22 excludes patches containing plasticizers or permeation enhancers.
Claims 23-24 address adhesive surface area at 6% granisetron loading.
Claims 25-27 cover treatment methods and chemotherapy-related uses.
The patent is closely associated with the Sancuso granisetron transdermal system.
Public records commonly project expiration in or around July 2024, subject to official patent-term calculations.
The main design-around options are different polymer systems, different monomer concentrations, reservoir architectures, or formulations using permeation enhancers.
The patent does not cover oral or injectable granisetron products.
Generic entry risk depends on the complete Orange Book listing, other patent families, FDA requirements, and the technical feasibility of manufacturing a stable granisetron patch.

Frequently Asked Questions

Does Patent 7,608,282 cover all granisetron patches?

No. It principally covers patches using the claimed acrylic adhesive composition and stability characteristics. A patch using a different polymer system may fall outside the literal scope.

Is a 6% granisetron patch automatically infringing?

No. The patch must also satisfy the adhesive monomer, concentration, hydroxyl-monomer, transdermal, and stability limitations. A 6% loading alone is insufficient.

Can a patch with a permeation enhancer avoid the patent?

It may avoid claim 22, which requires no plasticizers or permeation enhancers. It may still infringe claim 1 or another claim if all other limitations are present.

Does expiration of Patent 7,608,282 authorize immediate generic Sancuso launch?

No. FDA approval, Orange Book certifications, regulatory exclusivity, other listed patents, manufacturing requirements, and commercial readiness remain relevant.

Does the patent claim the Sancuso seven-day wear period?

The supplied claims do not expressly require a seven-day wear period. They focus on adhesive composition, granisetron loading, stability, delivery, surface area, and therapeutic use.

References

Food and Drug Administration. (2022). Sancuso (granisetron transdermal system) prescribing information. U.S. Department of Health and Human Services.
Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.
United States Patent and Trademark Office. (2009). U.S. Patent No. 7,608,282: Transdermal delivery of granisetron. U.S. Department of Commerce.
U.S. Patent and Trademark Office. (2024). Patent term adjustment and patent term information. U.S. Department of Commerce.

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0302662.2	Feb 05, 2003

PCT Information
PCT Filed	February 05, 2004	PCT Application Number:	PCT/GB2004/000403
PCT Publication Date:	August 19, 2004	PCT Publication Number:	WO2004/069141

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	368454	⤷ Start Trial
Australia	2004210181	⤷ Start Trial
Brazil	PI0407280	⤷ Start Trial
Canada	2515094	⤷ Start Trial
China	102416009	⤷ Start Trial
China	102526043	⤷ Start Trial
China	1747724	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,608,282

Summary for Patent: 7,608,282