AVEED Drug Patent Profile

Which patents cover Aveed, and what generic alternatives are available?

Aveed is a drug marketed by Endo Operations and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-two patent family members in thirty-eight countries.

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

DrugPatentWatch^® Generic Entry Outlook for Aveed

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2027. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (testosterone undecanoate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for AVEED

International Patents:	52
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	1,651
Drug Prices:	Drug price information for AVEED
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVEED
What excipients (inactive ingredients) are in AVEED?	AVEED excipients list
DailyMed Link:	AVEED at DailyMed

See drug prices for AVEED

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AVEED

Constraining patent/regulatory exclusivity:

7,718,640

NDA:

022219

Dosage:

INJECTABLE;INTRAMUSCULAR

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for AVEED

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Paragraph IV (Patent) Challenges for AVEED

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVEED	Injection	testosterone undecanoate	250 mg/mL	022219	1	2014-06-11

US Patents and Regulatory Information for AVEED

AVEED is protected by two US patents.

This potential generic entry date is based on patent 7,718,640.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	AVEED	testosterone undecanoate	INJECTABLE;INTRAMUSCULAR	022219-001	Mar 5, 2014		RX	Yes	Yes	8,338,395
Endo Operations	AVEED	testosterone undecanoate	INJECTABLE;INTRAMUSCULAR	022219-001	Mar 5, 2014		RX	Yes	Yes	7,718,640		Y

International Patents for AVEED

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

Country	Patent Number	Title	Estimated Expiration
Argentina	043603	COMPOSICIONES INYECTABLES PARA USO INTRAMUSCULAR CONTENIENDO ESTERES DE TESTOSTERONA Y UN VEHICULO QUE COMPRENDE ACEITE DE RICINO Y UN COSOLVENTE
Austria	336251
Australia	2004218893	Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Brazil	PI0400214	Composições e aplicações farmacêuticas para a obtenção confiável de nìveis aceitáveis de testosterona no soro
Canada	2518910	PROCEDES ET COMPOSITIONS PHARMACEUTIQUES POUR OBTENIR DE MANIERE FIABLE DES NIVEAUX ACCEPTABLES DE TESTOSTERONE DANS LE SERUM (METHODS AND PHARMACEUTICAL COMPOSITIONS FOR RELIABLE ACHIEVEMENT OF ACCEPTABLE SERUM TESTOSTERONE LEVELS)
Chile	2004000527	COMPOSICION FARMACEUTICA PARA INYECCION INTRAMUSCULAR QUE COMPRENDE UN ESTER DE TESTOSTERONA, 25 A 45% V/V DE ACEITE DE RICINO COMO VEHICULO Y UN COSOLVENTE, FORMULACION FARMACEUTICA, Y USO.
China	101884639	Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels

AVEED (testosterone undecanoate) market dynamics and financial trajectory: pricing, demand, exclusivity, and generic risk

Last updated: July 25, 2026

Executive summary: AVEED (testosterone undecanoate) is a testosterone replacement therapy (TRT) with a long-acting dosing schedule intended to improve adherence versus shorter-acting injectables. Revenue growth and pricing power depend on (1) patient access and payer coverage for intramuscular TRT, (2) uptake versus competing long-acting injectables, (3) label compliance tied to AVEED-specific REMS-style risk controls, and (4) how quickly and how broadly competing products gain share as branded and authorized generics expand. Financial trajectory is typically driven by steady TRT demand, mid-single-digit prescription volatility, and pricing actions constrained by payer policies and state formularies. Generic entry risk centers on the timing and strength of AVEED Orange Book-listed patents and any Paragraph IV challenges that can accelerate generic availability and force price competition.

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What is AVEED’s market position in testosterone replacement therapy (TRT)?

AVEED is positioned in the long-acting injectable segment of TRT. The market has three key demand forces:

1. Chronic disease management behavior: TRT is sustained, not episodic. Once treated, patients often remain on therapy for years, limiting unit churn even when switching occurs.
2. Access and payer coverage: TRT coverage is increasingly managed through prior authorization (PA), step edits, and preferred-product lists.
3. Formulation and dosing convenience: Long-acting intramuscular options often win against more frequent regimens by reducing office burden and improving adherence.

Practical implication for market share: AVEED’s performance tends to track physician prescribing preferences for long-acting testosterone and the reimbursement “stickiness” of an established branded product. Switching is usually driven by payer incentives, contracting, and supply disruptions rather than purely clinical preference.

Which competitors most affect AVEED share?

AVEED competes against other injectable and non-injectable TRT offerings that shape pricing pressure:

• Other testosterone injectables (weekly or biweekly dosing, where covered)
• Long-acting testosterone options within injectables
• Topical gels and patches (often preferred on formularies because of ease of use, despite application burden)
• Oral or alternative delivery TRT options where clinically and payer-access permitted

Competitive dynamic: injectable competitors can apply share pressure when their pricing and contracting reduce the incremental cost of switching. Non-injectable products can apply pressure where payers steer patients to preferred topical agents.

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How do pricing and payer coverage dynamics influence AVEED revenue growth?

TRT pricing power is constrained by payer management and increased use of cost-effectiveness framing in prior authorization reviews.

What payer levers drive AVEED net price

The dominant levers that determine AVEED’s financial trajectory:

• Formulary placement (preferred vs non-preferred)
• Prior authorization requirements and denial rates
• Quantity limits and step edits (often tied to testosterone levels and symptom documentation)
• Contracting with pharmacy benefit managers (PBMs) and Medicare Part D formulary position

Net pricing sensitivity to competitive entry

In branded TRT, net revenue typically remains resilient until meaningful competitors gain formulary advantage. Once a competitor is preferred or gains broader formulary presence, net prices on AVEED can decline via:

• Rebates and discounts
• Higher patient cost-sharing steering non-adherent use
• Increased patient switching

Financial implication: if AVEED maintains preferred status, revenue can grow through volume and mild price actions. If payer contracts shift, the revenue profile becomes more “flat to down” with intermittent rebounds from re-pulls of favored coverage.

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When does AVEED lose exclusivity and what drives the generic entry window?

Generic risk is determined by a combination of:

1. Patent expiration dates (Orange Book-listed)
2. Regulatory exclusivities (e.g., pediatric exclusivity, if applicable)
3. Market-based entry timing (authorized generics, launch logistics)
4. Risk that a Paragraph IV (PIV) challenge leads to earlier US FDA approval

How to think about the exclusivity timeline

For AVEED, the exclusivity clock is typically segmented into:

• Core composition/use patent term
• Additional blocking patents (formulations, methods of use, manufacturing, and specific risk mitigation practices)
• Potential pediatric exclusivity extensions (if triggered)

Generic entry window is usually the earlier of:

• Patent expiration that removes the blocking barrier, or
• A settlement-triggered launch date following a patent dispute, or
• A successful PIV challenge leading to an FDA approval date that aligns with any statutory forfeiture rules

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What patents protect AVEED and how strong is the patent estate?

A complete and accurate patent estate requires Orange Book listings and the associated US patent documents that enumerate claims by strength and coverage. Without the specific Orange Book table for AVEED and its patent numbers, an exact count and expiration map cannot be produced with correctness.

Market-facing takeaway, without patent enumeration: in long-acting injectable TRTs, the patent estate typically includes composition and dosing-related protections plus formulation and method-of-use claims that can delay generic launch and limit “at-risk” approvals.

What formulation or method-of-use protections can block generics?

For testosterone undecanoate products, patent families commonly cover:

• Composition and concentration ranges for injectable stability
• Manufacturing controls that impact release and bioavailability
• Method-of-use claims tied to injection schedules or patient monitoring
• Claims connected to risk mitigation language that can affect labeling design for generics

Commercial consequence: strong blocking patents can force delay, extend branded pricing power, and sustain unit share even when competitors are clinically substitutable.

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What generic entry risks exist for AVEED (Paragraph IV, at-risk launches, and settlement scenarios)?

Paragraph IV challenge and settlement impact

For injectable branded drugs with complex patent estates, PIV outcomes often include:

• Launch “carve-outs” after a settlement date
• Narrow design-around labeling that can reduce immediate interchangeability
• Required commercialization timing commitments in licensing agreements

At-risk launch probability

Market risk for AVEED rises sharply if there is evidence of:

• A PIV filing with strong generic preparedness
• Court rulings that invalidate or narrow key claims
• Settlement terms that permit earlier than the nominal patent expiration

Financial implication: a confirmed approach to generic launch usually causes an immediate repricing of the branded asset in payer negotiations, as manufacturers accelerate contracting changes ahead of volume loss.

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What is the Orange Book status of AVEED?

An accurate Orange Book status table (NDA number, listed patents, expiration dates, and exclusivity codes) requires direct Orange Book listing data. Without that listing snapshot, an “as-of” status cannot be stated correctly here.

Decision-grade takeaway: Orange Book status is the single most actionable document for forecasting the generic launch calendar. For AVEED, the presence of multiple blocking patents typically means the net exclusivity end date is later than the first patent family expiration.

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What litigation or settlements affect AVEED competition?

Patent litigation and settlements for a branded injectable can materially reshape the financial trajectory by:

• Delaying generic approvals beyond statutory dates
• Allowing a competitor to launch with a specific labeling posture
• Creating uncertainty that affects payer contracting and stocking decisions

Market-facing takeaway: the revenue curve for AVEED often flattens when litigation uncertainty is high, and then steepens in risk-adjusted terms when settlement dates become concrete.

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What FDA pathway factors matter for AVEED’s competitive landscape?

Once a generic is approved, substitution depends on:

• Whether the product is rated as pharmaceutically equivalent and therapeutically substitutable by state rules
• Whether the generic’s label alignment supports clinical and payer switching
• Supply capability and distribution readiness

Why REMS-style controls can change switch velocity

For TRT products with specific risk communications and monitoring requirements, even an FDA-approved generic can see slower adoption if:

• Office workflows and patient monitoring processes favor the originator’s familiar labeling
• Payer programs require documentation tied to originator-specific steps
• Distribution coverage in local markets lags for new entrants

Financial impact: adoption curves for generics in injectables can be slower than “approval implies immediate price collapse,” which can extend AVEED’s revenue duration even after a generic approval.

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How does AVEED compare with other testosterone undecanoate and long-acting TRT injectables?

Brand vs class positioning

AVEED’s competitive posture is driven by:

• Dosing schedule convenience
• Clinical comfort with AVEED-specific administration and follow-up
• Payer and prescriber familiarity
• Contracting economics

Switch drivers

Prescribing switches typically follow:

• Payer step edits that designate another long-acting injectable as preferred
• Manufacturer rebates that improve the net cost of the competitor
• Shortages or administration capacity constraints
• New clinical guidance or safety communications that reshape physician risk-benefit perception

Financial implication: sustained growth requires continued payer alignment and stable patient retention; competitive erosion shows up first in managed-care net pricing and then in unit volume.

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What commercial KPelines should investors and brand teams track for AVEED?

To model AVEED’s financial trajectory, track metrics that move revenue before headline earnings:

1. TRx and patient starts for long-acting injectable TRT
2. Persistence and discontinuation rates by payer cohort
3. Net price trend (list price less rebates) and payer mix shift
4. Formulary status changes at the top PBMs and Medicare Part D plans
5. Wholesale acquisition cost and contract dynamics with major channels
6. Hospital/clinic administration footprint changes (where relevant to injection setting)
7. Competitor share drift among injectable TRT

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Key scenarios for AVEED’s near- to mid-term revenue trajectory

Because an exact exclusivity calendar and patent-by-patent expiration mapping are not included here, the most decision-relevant forecast is scenario-based.

Base case (no major competitive shock)

• Revenue grows at or slightly above general TRT demand due to ongoing chronic treatment population.
• Price/mix remains stable to mildly pressured by payer contracting.
• Unit volume is steady with modest growth from adherence and prescriber preference.

Payer contraction scenario

• Net price pressure rises as AVEED loses preferred status or faces PA tightening.
• Unit growth slows as patients are steered to preferred alternatives.
• Revenue growth decelerates and may trend flat.

Generic launch or authorized generic scenario

• Revenue drops rapidly in the first 6 to 18 months following meaningful substitution.
• The decline is moderated if uptake is slowed by administration and monitoring workflow.
• Margins compress via price concessions and channel rebalancing.

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Key takeaways

• AVEED’s market dynamics are driven by TRT chronic demand, payer coverage controls, and switching incentives more than by short-term clinical variability.
• Revenue trajectory is most sensitive to net pricing changes and formulary position, which can flip before any FDA-approval-based competition.
• Generic risk is a function of Orange Book blocking patents and any litigation settlement that shifts launch timing. When market certainty increases, payer contracting usually responds quickly.
• Competitive adoption curves for injectable TRT generics can be slower than approval announcements, extending branded revenue even after exclusivity ends.

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FAQs

1) How does AVEED’s dosing schedule affect payer coverage and patient persistence?
Long-acting dosing supports persistence and can improve retention metrics, but payer coverage still hinges on PA criteria and preferred-product contracting.

2) What factors most accelerate switching from AVEED to alternative TRT products?
Loss of preferred formulary status, step edits, rebates that favor competitors, and any supply or office-admin workflow changes.

3) What market signals indicate higher probability of AVEED generic launches?
Public information on Paragraph IV filings, court claim rulings, and settlement dates that allow earlier-than-expected entry.

4) Does AVEED face slower generic adoption than oral testosterone products?
In many cases, yes. Injection administration logistics and monitoring workflows can slow substitution even after FDA approval.

5) What should be monitored to anticipate AVEED net price compression?
PBM contracting changes, Medicare Part D formulary updates, PA denial/approval patterns, and rebate rate adjustments.

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References (APA)

1. U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. FDA. Drug Approval Packages and label information for AVEED (testosterone undecanoate).
3. FDA REMS and labeling resources related to testosterone products.

DrugChatter Q&A for AVEED

Aveed testosterone undecanoate drug profile 2024?