Details for Patent: 8,741,881

Which drugs does patent 8,741,881 protect, and when does it expire?

Patent 8,741,881 protects ANDROGEL and is included in one NDA.

This patent has fifty patent family members in thirty countries.

Summary for Patent: 8,741,881

Title:	Testosterone gel and method of use
Abstract:	The present invention relates to an improved transdermal hydroalcoholic testosterone gen formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use.
Inventor(s):	Ramana Malladi, Jodi Stahlman
Assignee:	Besins Healthcare Luxembourg SARL
Application Number:	US13/831,231
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,741,881
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 8,741,881: Claim Scope, AndroGel 1.62% Coverage, and Patent Landscape

U.S. Patent No. 8,741,881 covers methods of treating male hypogonadism with a narrowly defined topical testosterone gel. The claims are directed to the drug product used in AndroGel 1.62%, including its testosterone concentration, ethanol vehicle, isopropyl myristate, carbomer or other neutralized anionic polymer, dosing regimen, and serum-testosterone outcome. The patent is a formulation-and-method patent rather than a broad testosterone composition patent.

The principal commercial claim is claim 14, which recites a gel containing 1.62% testosterone, 1.0% isopropyl myristate, 68.1% dehydrated ethanol, 1.0% neutralized anionic polymer, and water. Claims 22 and 17 capture the marketed 2.5-gram dose delivering 40.5 milligrams of testosterone. The patent was associated with the AndroGel 1.62% patent estate and has a nominal patent-term endpoint in 2027, subject to the official USPTO term calculation and any patent-term adjustment or extension.[1][2]

What does U.S. Patent 8,741,881 protect?

The patent protects a method of treating hypogonadism in a human male by applying a specified testosterone gel to skin. The claims combine three categories of limitations:

1. A defined composition.
2. A defined topical-treatment method.
3. In some claims, a defined dose or pharmacokinetic result.

The independent claims are claims 1 and 14.

Feature	Claim 1	Claim 14
Testosterone	1.3% to 1.7% w/w	Exactly 1.62% w/w
Isopropyl myristate	0.9% to 1.0% w/w	Exactly 1.0% w/w
Lower alcohol	67.0% to 74.0% w/w	68.1% w/w dehydrated ethanol
Gelling agent	0.6% to 1.4% w/w	1.0% w/w
Polymer type	Neutralized anionic polymer	Neutralized anionic polymer
Other component	Water	Water
Treatment	Apply to skin of human male	Apply to skin of human male

Claim 1 is a range claim. Claim 14 is a substantially more specific formulation claim. The two claim sets overlap, but claim 14 has narrower compositional limitations and is easier to map directly against the commercial 1.62% product.

How do the 29 claims divide between formulation and treatment limitations?

Claims 1 through 13 depend from claim 1. Claims 14 through 29 depend from claim 14 or from claims that depend from claim 14.

Claims 1 through 13

These claims cover:

• Testosterone concentrations from 1.3% to 1.7% w/w.
• Isopropyl myristate at 0.9% to 1.0% w/w.
• Lower alcohol at 67.0% to 74.0% w/w.
• Anionic polymer gelling agents neutralized sufficiently to produce a gel.
• Ethanol, absolute ethanol, and 95% ethanol alternatives.
• Carbomer as the preferred polymer.
• Sodium hydroxide and other listed neutralizers.
• Testosterone concentration of 1.50% to 1.70% w/w.
• A 2.5-gram dose.
• Delivery of 40.5 milligrams of testosterone.
• A serum testosterone concentration above approximately 300 ng/dL during the period beginning approximately 30 minutes after application and ending approximately 24 hours after application.

Claim 1 is broad relative to claim 14 because it permits multiple alcohols, a range of testosterone concentrations, and a range of gelling-agent concentrations. It remains narrow in its combination of excipients and alcohol level.

Claims 14 through 29

These claims focus on the 1.62% formulation:

• 1.62% testosterone.
• 1.0% isopropyl myristate.
• 68.1% dehydrated or absolute ethanol.
• 1.0% anionic polymer or carbomer.
• Sodium hydroxide as a neutralizer.
• A 2.5-gram dose.
• Delivery of 40.5 milligrams of testosterone.
• A serum testosterone result exceeding approximately 300 ng/dL across the stated post-application period.

Claims 15 and 16 are particularly important because they identify carbomer and sodium hydroxide in the fixed 1.62% formulation. Claims 17, 22, 24, 25, 27, and 28 tie the composition to the commercial dose. Claims 23, 26, and 29 add the pharmacokinetic limitation.

What formulation does claim 14 cover?

Claim 14 covers the following formulation:

Ingredient	Claimed concentration
Testosterone	1.62% w/w
Isopropyl myristate	1.0% w/w
Dehydrated ethanol	68.1% w/w
Anionic gelling polymer	1.0% w/w
Water	Balance
Neutralizer	Sufficient amount to form a gel

Claims 15 and 16 narrow the polymer and neutralizer combination to carbomer and sodium hydroxide. This corresponds closely to the labeled composition of AndroGel 1.62%, whose inactive ingredients include alcohol, carbomer 980, isopropyl myristate, purified water, and sodium hydroxide.[3]

The word "consisting of" materially limits the claims. In ordinary claim construction, a closed transitional phrase excludes unrecited ingredients that materially alter the claimed composition. A generic formulation containing additional active or inactive ingredients could therefore create a noninfringement argument, although the outcome would depend on the ingredient, its function, claim construction, and potential application of the doctrine of equivalents.

How strong is the patent estate for AndroGel 1.62%?

U.S. Patent 8,741,881 is strong against an exact or near-exact copy of the AndroGel 1.62% formulation because claim 14 tracks the commercial composition at fixed concentrations. Its limitations also correspond to the marketed dosing system:

• Two 1.25-gram pump actuations produce a 2.5-gram application.
• The 1.62% formulation contains approximately 40.5 milligrams of testosterone in that dose.
• The application is topical and intended for treatment of male hypogonadism.

The patent is weaker against products that materially alter one of the required formulation elements. Potential design-around variables include:

• Testosterone concentration outside the 1.3% to 1.7% range.
• Isopropyl myristate outside the 0.9% to 1.0% range.
• Alcohol content outside the 67.0% to 74.0% range.
• Use of a nonanionic gelling system.
• Use of a nonneutralized polymer system.
• Replacement of ethanol with another vehicle.
• Use of a different dose that does not meet the dependent-claim limitations.

The strongest infringement theory would generally arise from a product that copies the formulation and is marketed for the claimed method. A product that uses a different formulation may still face other Orange Book-listed patents, formulation patents, or method-of-use claims.

When does U.S. Patent 8,741,881 lose exclusivity?

The patent’s nominal term is generally calculated from the earliest effective nonprovisional filing date for the relevant family, subject to patent-term adjustment. Public patent records associate the patent family with a March 2007 filing chronology, producing a nominal expiration date in March 2027.[1][2]

Event	Date or status
Earliest relevant family priority	March 2006, according to public family records
Nonprovisional filing chronology	March 2007 family filing
Patent issued	June 3, 2014
Nominal term endpoint	March 2027, subject to official term calculation
Pediatric exclusivity	Must be confirmed in FDA and USPTO records; no conclusion should be drawn solely from the patent number
Practical generic-entry date	Controlled by patent terms, settlements, other listed patents, and regulatory approval

The issue date does not determine expiration. Patent term is generally measured from the applicable filing date, not from issuance. Continuation practice, terminal disclaimers, patent-term adjustment, and patent-term extension can affect the final endpoint.

What is the Orange Book status of U.S. Patent 8,741,881?

The patent was associated with the Orange Book patent estate for AndroGel 1.62%, NDA 022309, marketed by AbbVie and its predecessors.[4] Orange Book listing is significant because an ANDA applicant must address listed patents through a Paragraph III certification, Paragraph IV certification, or another permitted certification pathway.

The patent covers a drug product and method-of-use combination that is directly relevant to the approved 1.62% testosterone gel. The listed-patent analysis should be performed together with the other patents identified for NDA 022309 because approval or launch may remain restricted by a separate patent even if one patent is invalidated or expires.

Orange Book listing does not establish validity or infringement. It establishes the regulatory patent-dispute framework for an ANDA applicant.

Which companies challenged the AndroGel 1.62% patent estate?

Teva Pharmaceuticals was among the generic companies involved in patent litigation concerning AndroGel 1.62% and related patents. The litigation followed ANDA filings containing Paragraph IV certifications against patents in the AndroGel 1.62% estate.[5]

The commercial and litigation landscape included:

Company	Role in landscape
AbbVie, including predecessor entities	Brand sponsor and patent holder or estate participant
Teva Pharmaceuticals	Generic ANDA applicant and Paragraph IV litigant
Actavis/Watson-related entities	Generic competitor associated with testosterone-gel ANDA activity
Perrigo and other generic manufacturers	Potential or actual participants in the approved generic market, depending on product and period

The key litigation question is not whether a company filed an ANDA alone. It is whether the applicant made a Paragraph IV certification, whether the sponsor filed suit within 45 days, whether FDA approval was stayed, and whether the dispute ended through judgment or settlement.

What Paragraph IV issues arise under the patent?

A Paragraph IV challenge to this patent could assert one or more of the following:

• The claims are anticipated by an earlier testosterone gel.
• The claimed concentration and excipient combination would have been obvious.
• The formulation lacks adequate written description or enablement.
• The method claims are not infringed because the generic product lacks a required ingredient or concentration.
• The pharmacokinetic claims are not met.
• The patent is unenforceable because of inequitable conduct or another litigation defense.

For a generic applicant, the most credible technical attack would focus on obviousness. Testosterone gels, ethanol vehicles, carbomers, neutralizers, and permeation-enhancing excipients were individually known. The patent owner’s response would likely rely on the claimed combination, formulation performance, dose delivery, pharmacokinetic profile, and any unexpected results.

The exact composition claims also create a proof issue. A patent owner must establish that the accused product contains the claimed concentrations or falls within the claimed ranges. Regulatory filings, product specifications, batch records, ANDA data, and analytical testing can be relevant.

What patent litigation affects U.S. Patent 8,741,881?

The patent was litigated in the U.S. District Court for the District of Delaware in ANDA litigation involving AbbVie and generic applicants, including Teva.[5] The litigation concerned the AndroGel 1.62% patent estate rather than an isolated dispute over only one claim.

The commercially relevant outcomes in this type of litigation are:

1. A judgment of validity and infringement, which can delay approval or launch.
2. A judgment of invalidity or noninfringement, which can remove one barrier.
3. A settlement permitting an agreed launch date.
4. A license or authorized-generic arrangement.
5. A dismissal after amendment of the ANDA or withdrawal of the challenge.

Settlement terms in pharmaceutical patent cases are often only partly public. A public dismissal does not by itself establish the agreed generic-entry date or the extent of any license.

What generic launch risks exist for AndroGel 1.62%?

The generic-entry risk is substantial after the controlling patent barriers expire or are licensed. Testosterone gel is a nonbiologic, ANDA-eligible product, so biosimilar regulation is not the relevant pathway. FDA approval depends on pharmaceutical equivalence, bioequivalence, manufacturing controls, labeling, and resolution of listed-patent certifications.

The main launch scenarios are:

Scenario	Commercial effect
Exact 1.62% formulation with Paragraph III certification	Approval or launch waits until the certified patent expiry
Paragraph IV challenge defeated	Launch is delayed and litigation costs rise
Paragraph IV challenge succeeds	Earlier launch may occur, subject to other patents
Settlement license	Entry occurs on the contractual date and terms
Reformulated product outside the claims	Earlier entry may be possible, but other patents and equivalence issues remain
Authorized generic	Brand-linked generic competition can begin before independent generic entry

A generic product may avoid literal infringement of claim 14 while still falling within claim 1. Conversely, a product outside the literal ranges may face a doctrine-of-equivalents argument. A generic manufacturer also must consider induced infringement because the product label and prescribing information can establish the intended method of use.

Are biosimilars relevant to this patent?

No. Testosterone gel is a synthetic small-molecule drug product, not a biologic subject to the Public Health Service Act biosimilar pathway. Competitors would generally pursue an ANDA under the Federal Food, Drug, and Cosmetic Act, not a biosimilar application under section 351(k) of the Public Health Service Act.[6]

The principal competition risks are therefore:

• ANDA-approved generic testosterone gel.
• Authorized generic distribution.
• Competing topical testosterone products.
• Non-gel testosterone delivery systems, including injections, patches, buccal systems, and nasal formulations.
• Compounded testosterone products, subject to applicable federal and state requirements.

How does this patent compare with other testosterone patents?

U.S. Patent 8,741,881 is narrower than early patents covering the general concept of transdermal testosterone delivery. Its commercial importance comes from its close relationship to the 1.62% gel formulation and dosing regimen.

Patent category	Typical scope	Relationship to 8,741,881
Broad transdermal testosterone patents	Testosterone delivery through skin	Earlier and broader technical field
General gel-composition patents	Testosterone with alcohol, water, polymer, or penetration enhancer	May overlap or provide prior art
1.62% formulation patents	Specific AndroGel 1.62% composition	Closest commercial overlap
Method-of-use patents	Treating hypogonadism or achieving serum levels	Overlaps with claims 1, 13, 14, and 23
Device or metering patents	Pump, dose chamber, or delivery mechanism	Separate from the composition claims
Manufacturing patents	Mixing, neutralization, filling, or quality control	Potential process barrier, but not directly claimed here

The patent does not claim a pump, container, manufacturing process, patient-selection criterion, or particular skin site beyond application to skin. Its center of gravity is the formulation used in a specified therapeutic method.

What geographic coverage does the patent provide?

U.S. Patent 8,741,881 provides protection only in the United States. Foreign protection requires separate national or regional patents in the relevant jurisdictions. The corresponding international family may include applications or patents in Europe, Canada, Australia, and other markets, but the existence, scope, and expiration of each counterpart must be assessed independently.

A U.S. patent does not block manufacture and sale outside the United States. It can, however, affect:

• U.S. manufacture for export where applicable.
• Importation into the United States.
• U.S. commercial distribution.
• Contract manufacturing performed for a U.S. launch.
• ANDA approval and U.S. labeling.

What manufacturing and intellectual-property barriers remain?

The formulation is technically straightforward compared with a complex biologic, but commercial entry still requires controlled manufacturing. Relevant barriers include:

• Maintaining testosterone uniformity throughout the gel.
• Controlling ethanol and water content.
• Reproducibly neutralizing the carbomer.
• Controlling viscosity and pump delivery.
• Demonstrating dose accuracy.
• Managing testosterone degradation and impurity profiles.
• Establishing container-closure compatibility.
• Meeting manufacturing-site and process-validation requirements.
• Avoiding other formulation, device, and process patents.

The patent’s use of concentration ranges creates a manufacturing-control issue. A product intended to design around the patent must maintain validated specifications outside the claimed ranges, not merely target a different nominal concentration.

Key Takeaways

• U.S. Patent 8,741,881 is a formulation-and-method patent for topical testosterone treatment of male hypogonadism.
• Claim 14 closely tracks the AndroGel 1.62% composition: 1.62% testosterone, 1.0% isopropyl myristate, 68.1% ethanol, 1.0% neutralized anionic polymer, and water.
• Claims 17 and 22 connect the formulation to the marketed 2.5-gram dose and 40.5-milligram testosterone delivery.
• Claims 13, 23, 26, and 29 add a serum testosterone threshold over a 0.5-to-24-hour period.
• The closed "consisting of" language strengthens formulation specificity but creates potential design-around arguments.
• The patent was part of the Orange Book and ANDA litigation landscape for AndroGel 1.62%.
• Teva and other generic manufacturers challenged the broader AndroGel patent estate through Paragraph IV activity.
• Testosterone gel is an ANDA product, not a biosimilar.
• The nominal patent-term endpoint is in March 2027, subject to the official USPTO term record and any adjustment or extension.
• Generic-entry timing depends on the full Orange Book estate, litigation outcomes, settlements, and any authorized-generic arrangements.

FAQs About U.S. Patent 8,741,881

Does U.S. Patent 8,741,881 claim AndroGel 1.62% by name?

No. The claims do not use the brand name. They claim a composition and treatment method that correspond closely to the labeled AndroGel 1.62% formulation.

Can a generic avoid claim 14 by changing the ethanol concentration?

Potentially. Claim 14 requires 68.1% w/w dehydrated ethanol, while claim 1 covers a broader 67.0% to 74.0% w/w lower-alcohol range. A concentration change must be evaluated against every asserted claim and the doctrine of equivalents.

Does claim 13 require proof of testosterone levels in every patient?

The claim recites achieving the specified serum concentration during the stated period. In litigation, infringement analysis would depend on the claim construction, product labeling, clinical or bioequivalence data, and proof relating to the accused method.

Does the patent cover injectable testosterone products?

No. The claims require applying a gel pharmaceutical composition to an area of skin. Injectable testosterone products do not ordinarily satisfy that limitation.

Is a carbomer required by every claim?

No. Claims 1 and 14 require an anionic polymer neutralized sufficiently to form a gel. Carbomer is required only in dependent claims such as 5, 9, 10, 15, 16, and 19.

References

1. United States Patent and Trademark Office. (2014). U.S. Patent No. 8,741,881, Testosterone gel compositions and methods of use thereof.
2. Google Patents. (n.d.). US8741881B2: Testosterone gel compositions and methods of use thereof.
3. U.S. Food and Drug Administration. (n.d.). AndroGel 1.62% testosterone gel, prescribing information.
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book, NDA 022309.
5. District of Delaware. (2013-2016). AbbVie Inc. v. Teva Pharmaceuticals USA, Inc., ANDA litigation concerning AndroGel 1.62% patents.
6. U.S. Food and Drug Administration. (n.d.). Abbreviated New Drug Application and biosimilar product regulatory pathways.

Drugs Protected by US Patent 8,741,881

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	AB	RX	Yes	Yes	8,741,881					TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012	AB2	RX	Yes	No	8,741,881					TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	AB2	RX	Yes	No	8,741,881					TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE

International Family Members for US Patent 8,741,881

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006299833
Brazil	PI0617294
Canada	2624788
China	101287470