AXIRON Drug Patent Profile

Which patents cover Axiron, and when can generic versions of Axiron launch?

Axiron is a drug marketed by Eli Lilly And Co and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in fifteen countries.

The generic ingredient in AXIRON is testosterone. There are sixty-nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Axiron

A generic version of AXIRON was approved as testosterone by ACTAVIS LABS UT INC on January 27^th, 2006.

Summary for AXIRON

International Patents:	37
US Patents:	6
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	9
Patent Applications:	4,604
Drug Prices:	Drug price information for AXIRON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AXIRON
What excipients (inactive ingredients) are in AXIRON?	AXIRON excipients list
DailyMed Link:	AXIRON at DailyMed

See drug prices for AXIRON

See drug sales revenues for AXIRON

Recent Clinical Trials for AXIRON

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
INC Research	Phase 3
Clarus Therapeutics, Inc.	Phase 3
Syneos Health	Phase 3

See all AXIRON clinical trials

Paragraph IV (Patent) Challenges for AXIRON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AXIRON	Topical Solution	testosterone	30 mg/1.5 mL	022504	1	2013-01-29

US Patents and Regulatory Information for AXIRON

AXIRON is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	8,435,944
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	8,993,520
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	9,180,194
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	8,807,861		Y
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	8,419,307
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	9,289,586

Expired US Patents for AXIRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	8,993,520
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	6,299,900
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	6,923,983
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	8,784,878
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	8,071,075
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	9,180,194

EU/EMA Drug Approvals for AXIRON

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Warner Chilcott UK Ltd.	Intrinsa	testosterone	EMEA/H/C/000634Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.	Withdrawn	no	no	no	2006-07-28
Warner Chilcott  Deutschland GmbH	Livensa	testosterone	EMEA/H/C/000630Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.	Withdrawn	no	no	no	2006-07-28

International Patents for AXIRON

See the table below for patents covering AXIRON around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	324865
Austria	410136
Austria	472997
Australia	1713497
Australia	5258999
Australia	706967

Supplementary Protection Certificates for AXIRON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0901368	CA 2012 00010	Denmark
0901368	91973	Luxembourg		91973, EXPIRES: 20220219
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1769785	CA 2012 00011	Denmark

AXIRON (testosterone topical solution) market dynamics and financial trajectory: sales trends, channel economics, exclusivity and generic risk

Last updated: July 29, 2026

AXIRON is an established, low-to-mid single product within the U.S. testosterone replacement therapy (TRT) market, with revenue constrained by payer coverage variability, ongoing substitution pressure from lower-cost branded and generic testosterone products, and a declining long-term growth profile driven by a mature category. Market dynamics are dominated by (1) clinician and formulary preferences, (2) pharmacy benefit manager (PBM) contracting and tier placement, and (3) generic entry risk tied to formulation and Orange Book–listed patents around topical testosterone solutions.

What market dynamics shape AXIRON sales and pricing in the testosterone replacement therapy category?

AXIRON is a topical testosterone therapy used for men with hypogonadism who require testosterone replacement. Its commercial performance is primarily determined by how payers and prescribers position topical formulations relative to injectables, gels, and patches.

What drives demand for topical testosterone like AXIRON?

• Clinical practice patterns favor steady-state testosterone delivery. Topical solutions compete on convenience, perceived absorption, and dosing flexibility versus gels and patches.
• Safety monitoring (hematocrit, prostate-related outcomes) is consistent across testosterone modalities, so prescribing decisions are often driven by tolerability, patient preference, and insurance coverage rather than differential safety.
• Patient education and administration technique affect outcomes and adherence for topical solutions. Misapplication and skin transfer risks can drive switching.

How do PBM formularies and rebates influence AXIRON net pricing?

• Tiering and formulary access are the central determinants of realized net price for mid-pack branded products in testosterone.
• Rebate intensity tends to rise when a brand faces generic substitution risk or if PBMs narrow preferred tiers to specific products.
• Switching risk increases when competitors undercut on cost-per-therapeutic-day through manufacturer contracting or generic availability.

How is AXIRON positioned versus gels, patches, and injectables?

Within TRT, products compete on:

• First-fill access: prior authorization (PA) and step therapy can limit branded topical uptake.
• Stability and handling: sprays/solutions versus gels and patches.
• Out-of-pocket cost: patient price sensitivity pushes demand toward preferred lower-cost options.
• Brand-to-brand substitution: when payers restrict to one or two topical SKUs.

How has AXIRON performed financially: revenue trend, profitability profile, and volume drivers?

AXIRON’s financial trajectory is expected to track a mature category with flat-to-declining brand revenues as generics and lower-priced alternatives increase penetration and as payer coverage tightens around preferred formulary choices.

What does the revenue trajectory typically look like in mature topical TRT?

In established testosterone topical brands, revenue dynamics often follow a pattern:

• Early phase: growth supported by incremental prescriptions and expanding coverage.
• Maturation: plateau as competitive fill-rate stabilizes.
• Late phase: brand erosion as generics gain share and as payers reduce access to non-preferred branded SKUs.

What margins and cost structure are most relevant for AXIRON?

• COGS for topical solutions is generally stable per unit but net margin is heavily influenced by:
  • rebate and discount spend to secure formulary placement
  • distribution fees and chargebacks
  • defense of exclusivity and patent challenges (litigation/legal costs)
• Sales force leverage in mature TRT becomes less productive as formulary restrictions increase, pushing growth into contracting and access expansion.

What volume and share metrics determine near-term outcomes?

The key commercial indicators for AXIRON include:

• New-to-therapy starts (affected by hypogonadism diagnosis patterns, guideline adherence, and payer rules)
• Switching from other testosterone modalities
• Refill persistence (affected by tolerability, administration usability, and insurance continuity)
• Net-to-gross compression driven by contracting with PBMs

What exclusivity and patent-life factors determine AXIRON’s financial downside or upside?

Brand value in testosterone topicals is highly sensitive to Orange Book-listed patent status (composition, formulation, and method-of-use) and to whether competitors can enter via ANDA with Paragraph IV certifications (or, where applicable, through other regulatory pathways).

When does AXIRON lose exclusivity?

The relevant exclusivity drivers are:

• U.S. patent expiration for listed Orange Book patents covering the drug product and its protected attributes
• Any pediatric exclusivity or additional exclusivity triggered by regulatory events
• Secondary patent expiration that clears the way for generic formulations consistent with patent carve-outs

Because AXIRON is a legacy product with a long commercial history, its valuation is typically governed more by how quickly generic competitors can establish “at-risk” entry than by early exclusivity windows.

What patents protect AXIRON?

Protection in topical testosterone products commonly covers:

• formulation composition and concentration
• delivery system characteristics (vehicle, solvents, permeation modifiers)
• dosing, use, or treatment regimens
• manufacturing methods and control strategies

What generic entry risks exist for AXIRON under Paragraph IV ANDA challenges?

In mature branded injectables and topicals, generic entry risk increases when Orange Book patents narrow to a small number of defensible claims or when courts sustain noninfringement/invalidity outcomes.

How does Paragraph IV litigation affect AXIRON revenue?

A Paragraph IV filing can drive:

• loss of formulary position ahead of launch (payers anticipate competition)
• price concessions and higher rebates to defend share
• temporary sales boost if wholesalers front-load product or patients switch before launch (less common in later-cycle products)

What generic entry scenarios can reduce AXIRON sales fastest?

• First generic approval and immediate launch at a significantly lower WAC and/or with preferred PBM contracting
• Multiple labelers launching within a short window, increasing payer leverage
• Formulation overlap that reduces substitution friction for pharmacies

What is the Orange Book status of AXIRON and what does it imply for near-term competition?

The Orange Book status is the best single predictor for whether additional branded protection remains that can delay generic entry, and whether at-risk companies are likely to time launches around patent expirations.

How to interpret Orange Book listings for AXIRON market timing?

Key interpretive signals:

• number of listed patents per active ingredient and NDA
• whether patents are product-specific or cover use/formulation variants
• whether patents have survived prior litigation
• whether there are recent regulatory submissions signaling impending entry

Which companies are likely competitors to AXIRON, and how does competitive pressure change pricing?

AXIRON competes within the TRT universe. Competitive intensity is shaped by:

• branded topical peers (gels/solutions/patches)
• generic topical versions once patents clear
• injectables that can be favored by payers for cost

How does competition translate into net price pressure?

• If AXIRON is not preferred, PBM contracting can push it down tiers.
• Generic launch shifts pricing leverage to payers, compressing net price through greater rebate pressure.
• Competing brands may respond with promotional discounting or contract renegotiations.

What reimbursement and payer dynamics affect AXIRON adoption and retention?

TRT coverage varies by payer and plan type, and topicals can face more barriers if the plan’s preferred product is a gel or patch.

What coverage terms most affect AXIRON?

• prior authorization requirements tied to diagnosis criteria and baseline testosterone levels
• step therapy forcing trial of preferred products before a non-preferred option
• quantity limits and dosing requirements
• exclusion for off-label use patterns

How do payers steer patients to cheaper alternatives?

Typical steering mechanics:

• higher copays or coinsurance for non-preferred brands
• narrow preferred formularies
• automatic substitution at the pharmacy level for generics or therapeutically equivalent products where allowed

What FDA pathway and regulatory milestones shape AXIRON’s lifecycle?

AXIRON’s regulatory path is established, but its commercial trajectory remains affected by:

• labeling changes that may require physician education
• safety-related updates and classwide testosterone communications
• the timing and number of generic approvals that can follow ANDA submissions

How do FDA label updates influence market share?

• label tightening can reduce prescriber confidence for marginal candidates
• new contraindications or monitoring recommendations can shift treatment to modalities considered easier to monitor or administer

How does AXIRON compare with other testosterone topical products on market risk?

AXIRON’s competitive profile versus other topical testosterone products depends on how payers evaluate:

• per-dose cost and patient adherence
• ease of administration
• product characteristics affecting switching behavior

What does a “topical solution” delivery profile imply commercially?

Topical solutions can be advantaged or disadvantaged versus gels based on:

• perceived absorption and consistency
• residue and transfer concerns
• patient preference for application method
• training requirements at initiation

What do key financial and market milestones mean for investors and licensors?

For valuation and licensing decisions, the main drivers are:

• remaining enforceable IP (Orange Book patent status and expiration sequence)
• probability and timing of generic entry
• net revenue erosion risk from payer contracting once generic threats intensify
• litigation outcomes that can delay or accelerate competition

What are the highest-leverage questions for AXIRON business planning?

• Is there a remaining set of Orange Book patents with strong enforcement that can delay ANDA approvals or launches?
• Are there credible generics preparing for entry at the next expiration milestone?
• Will PBMs pre-emptively shift volume away from AXIRON before entry, forcing margin compression even if launch timing slips?

Key Takeaways

• AXIRON’s financial trajectory is constrained by mature-category dynamics: steady-state demand is limited, and brand economics depend on PBM positioning and rebates.
• Revenue risk is primarily driven by formulary access and substitution pressure from other testosterone modalities and eventual generic topical competitors as patents expire.
• Orange Book-listed patent status and Paragraph IV litigation timing are the dominant determinants of when commercial pressure accelerates.
• Net price and net-to-gross compression, not WAC, are the most important near-term financial indicators for AXIRON.

FAQs

1) Does AXIRON face generic competition already, and how would that affect current sales?

Generic entry reduces brand share and compresses net price through payer and pharmacy switching dynamics.

2) What payer policies most strongly influence whether AXIRON is prescribed?

PA, step therapy, and tier placement via PBM formularies are the main determinants of access and persistence.

3) How do patent expiration dates typically impact testosterone topical brands like AXIRON?

Patent expiration can trigger multiple ANDA attempts and coordinated launch timing, leading to rapid net revenue erosion.

4) What role do litigation outcomes play in delaying or accelerating generic entry?

Sustained infringement findings can delay entry, while invalidity or noninfringement decisions accelerate launch timelines.

5) How does switching between testosterone formulations change market outcomes?

Switching is driven by payer cost and patient administration experience, which can quickly shift volume away from non-preferred brands.

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References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. U.S. FDA. Drug Approval Reports and related labeling information for testosterone topical products (Accessed 2026).