AFINITOR DISPERZ Drug Patent Profile

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

Afinitor Disperz is a drug marketed by Novartis Pharm and is included in one NDA.

The generic ingredient in AFINITOR DISPERZ is everolimus. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the everolimus profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Afinitor Disperz

A generic version of AFINITOR DISPERZ was approved as everolimus by HIKMA on April 12^th, 2018.

Summary for AFINITOR DISPERZ

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	1
Patent Applications:	2,412
Drug Prices:	Drug price information for AFINITOR DISPERZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AFINITOR DISPERZ
DailyMed Link:	AFINITOR DISPERZ at DailyMed

See drug prices for AFINITOR DISPERZ

Recent Clinical Trials for AFINITOR DISPERZ

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 3

See all AFINITOR DISPERZ clinical trials

Pharmacology for AFINITOR DISPERZ

Drug Class	Kinase Inhibitor mTOR Inhibitor Immunosuppressant
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Paragraph IV (Patent) Challenges for AFINITOR DISPERZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AFINITOR DISPERZ	Tablets for Oral Suspension	everolimus	2 mg, 3 mg and 5 mg	203985	1	2016-12-30

US Patents and Regulatory Information for AFINITOR DISPERZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-001	Aug 29, 2012	AB	RX	Yes	No
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-002	Aug 29, 2012	AB	RX	Yes	No
Novartis Pharm	AFINITOR DISPERZ	everolimus	TABLET, FOR SUSPENSION;ORAL	203985-003	Aug 29, 2012	AB	RX	Yes	Yes

EU/EMA Drug Approvals for AFINITOR DISPERZ

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Afinitor	everolimus	EMEA/H/C/001038Hormone-receptor-positive advanced breast cancerAfinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.Neuroendocrine tumours of pancreatic originAfinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.Neuroendocrine tumours of gastrointestinal or lung originAfinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.Renal-cell carcinomaAfinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.	Authorised	no	no	no	2009-08-02
Novartis Europharm Limited	Votubia	everolimus	EMEA/H/C/002311Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.The evidence is based on analysis of change in sum of angiomyolipoma volume.Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC)Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery.The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease‑related symptoms, has not been demonstrated.	Authorised	no	no	no	2011-09-02

International Patents for AFINITOR DISPERZ

See the table below for patents covering AFINITOR DISPERZ around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	173736
Austria	272063
Australia	4819293

Supplementary Protection Certificates for AFINITOR DISPERZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0663916	300154	Netherlands		PRODUCT NAME: EVEROLIMUSUM; NATIONAL REGISTRATION NO/DATE: RVG 30041 20040610; FIRST REGISTRATION: SE 18690 20030718
0663916	91104	Luxembourg		91104, EXPIRES: 20180718
0663916	CA 2004 00020	Denmark		PRODUCT NAME: EVEROLIMUS

Afinitor Disperz (everolimus) market dynamics and financial trajectory: sales trends, exclusivity timeline, competitive pressure, and generic/biosimilar risk

Last updated: June 1, 2026

Afinitor Disperz (everolimus) is marketed as a dispersible oral solid for pediatric and adult patients needing an everolimus dose regimen aligned to specific indications (notably oncology and some non-oncologic uses, depending on geography and labeling). The commercial trajectory for Afinitor Disperz is shaped less by platform-cycle dynamics than by: (1) the broader everolimus franchise competition from branded and authorized generics and (2) patent and exclusivity timing that governs when lower-cost entrants can switch on for the same therapeutic molecule.

Below is the market and financial readout framework focused on what actually moves revenue for Afinitor Disperz: exclusivity end points for everolimus in relevant oral dosage forms, payer and channel pressure once competitors enter, and the litigation pathway that determines “first-to-file” and “at-risk” launch timing.

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What drives Afinitor Disperz sales performance: payer mix, channel access, and everolimus franchise substitution?

Answer: Afinitor Disperz revenue moves with everolimus demand, net price after discounts, and treatment-line penetration, then declines once competing everolimus options gain share through lower acquisition cost and formulary coverage.

How net pricing and rebates affect Afinitor Disperz

Key commercial mechanics for specialty oncology and immune-modulating drugs apply directly to Afinitor Disperz:

• Manufacturer rebates and distribution channel discounts determine net price more than list price.
• Interchange and formulary tiering matter where payers allow equivalent everolimus dosing regardless of brand.
• Pharmacy benefit management (PBM) and specialty distribution contracting drive “share-of-therapy,” not just total prescriptions.

Implication for trajectory: if generics or authorized generics of everolimus tablets disperzible-equivalent become available, payers can shift patients to lower-cost products even when prescribers remain aligned to the molecule.

Formulation substitution risk: dispersible vs tablet

Afinitor Disperz is a dosage-form variant positioned for dosing flexibility, especially where dispersible administration improves adherence or pediatric suitability. Once a competitor product offers equivalent everolimus content and approved dosing conversion, the “dispersible” advantage compresses quickly through:

• therapeutic substitution by payer policy,
• switching protocols in oncology clinics,
• pharmacy dispensing defaults for formulary-preferred equivalents.

Clinical demand dependence: indication breadth and line-of-therapy

Everolimus is used across multiple tumor types and disease contexts in many jurisdictions. Revenue performance for a dosage form is therefore a function of:

• which indications remain on formulary in a given country,
• how aggressively clinicians use everolimus in earlier lines,
• tolerability and dose interruptions, which drive persistence.

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When does Afinitor Disperz lose exclusivity and face generic entry?

Answer: The practical exclusivity cliff for Afinitor Disperz is governed by (1) composition-of-matter and (2) formulation and method-of-use patent coverage tied to everolimus and the dispersible dosage form, plus (3) regulatory exclusivities (where applicable) and (4) jurisdiction-specific filings and outcomes.

Exclusivity stack that controls timeline

For a branded everolimus dosage-form product, the relevant “stack” usually includes:

1. Regulatory exclusivity: New Chemical Entity (NCE) and other data exclusivities, where still applicable.
2. Patent estate: composition-of-matter and secondary patents such as formulation, polymorph, dispersible characteristics, manufacturing methods, or dosing regimens.
3. Orphan or pediatric exclusivity (if applicable to specific label claims in a jurisdiction).
4. Market exclusivity settlements that accelerate or delay generic entry.

Operational reality: what matters for revenue

Even if an earlier patent expires, revenue protection can persist if:

• secondary patents are asserted successfully in paragraph IV-type litigation equivalents, and/or
• dispersible-specific claims block generic manufacturing or labeling until cleared.

Once those barriers fall, entry often triggers immediate volume capture by lower-cost products via formulary switches.

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How does the patent estate for Afinitor Disperz compare with other everolimus formulations (tablets/other brands)?

Answer: Competition between everolimus dosage forms is primarily determined by whether competitors can design around dispersible-specific formulation or manufacturing claims. If not, market entry may be delayed for dispersible equivalents even when other everolimus products can launch.

Patent categories likely to matter for Afinitor Disperz

In dispersible oral systems for oncology drugs, the enforceable hooks usually fall into:

• formulation composition claims (excipients, granulation, dispersibility characteristics),
• solid-state claims (polymorph/crystal form),
• manufacturing processes that control particle size, wetting, or dissolution,
• method-of-use dosing schedules that map to approved labeling.

What to expect in competitive entry sequencing

A typical market pattern for dosage-form variants:

• first wave: generic of the “base” everolimus strength in an easier-to-produce form (commonly tablets or similar),
• second wave: product-by-product challengers for harder-to-match formulations (dispersible),
• subsequent wave: authorized generics or additional ANDA approvals as litigation closes.

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How strong is Afinitor Disperz patent protection versus generic/biosimilar risk?

Answer: Generic risk dominates for everolimus, not biosimilar risk. The patent strength determines whether ANDA-style entry is blocked, delayed, or accelerated by litigation outcomes and settlement terms.

Generic vs biosimilar reality

• Everolimus is a small molecule. Biosimilars do not apply.
• The “risk” is generic small-molecule substitution across dosage forms, strengths, and labeling.

Litigation as the primary determinant of launch timing

Revenue impact often aligns with:

• court outcomes on asserted patents,
• whether a first filer receives a “skinny label” or full label approval,
• the date competitors are allowed to market.

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What Paragraph IV and patent litigation patterns affect Afinitor Disperz?

Answer: Litigation is usually driven by challengers seeking patent carveouts for specific claims that cover the dispersible formulation or its manufacturing. Settlement terms can move launch timing by years.

How litigation timing maps to financial trajectory

• Filing of a challenger triggers the initiation of a delay mechanism until resolution.
• Court injunctions can prevent “at-risk” launch.
• Settlement can grant early entry or block full entry until a later date, shifting share capture and pricing.

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What is the FDA regulatory status of Afinitor Disperz and how does it influence market timing?

Answer: FDA approval and the Orange Book listing structure control the mechanics of ANDA filing and generic entry sequencing, which directly affects revenue trajectory.

Orange Book driven entry

For branded products, the key commercial timing inputs are:

• which patents are listed for the drug product,
• which patents are expiring first,
• whether challengers target those patents.

When the dispersible product is listed with specific formulation patents, that list governs what is litigated and when generic marketing can begin.

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How do generic entry scenarios typically play out for Afinitor Disperz?

Answer: Expect rapid net revenue compression after the first permitted generic launches, followed by deeper erosion after additional approvals broaden supply and drive payer switches.

Scenario framework tied to revenue

1. Delayed entry scenario: if formulation-specific patents or injunctions delay dispersible equivalents, revenue is preserved longer through branded share retention.
2. Single-entrant scenario: one generic/authorized generic can compress price quickly but maintains some share if other forms are still restricted.
3. Multi-entrant scenario: multiple ANDAs and expanded strength coverage intensify payer leverage and accelerate share shifts.

Channel and hospital contracting effects

Hospital formularies can:

• switch patient dispensing quickly if equivalents are accessible,
• renegotiate contracts for lowest-cost everolimus supply,
• standardize protocols that bypass branded dispersible unless a patient-specific need exists.

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Which companies are likely competitive substitutes for Afinitor Disperz in everolimus?

Answer: The competitive set is defined by everolimus generics and authorized generics and by branded everolimus alternatives available under similar patient populations and payer coverage.

Competition map by product form

• Branded everolimus products across oral solids (tablet vs dispersible) compete for the same treated patient populations.
• Generic entrants that offer bioequivalent everolimus strengths compete first on price, then on contract coverage and distribution availability.

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How does Afinitor Disperz revenue typically evolve across the lifecycle: launch-to-peak-to-decline?

Answer: The lifecycle for a branded specialized oral oncology drug follows:

• early growth tied to label expansion and guideline adoption,
• peak governed by coverage and pricing stability,
• plateau then decline triggered by generic entry and intensified payer pressure.

Dominant decline drivers

• generic/authorized generic adoption rate,
• net price erosion from formulary switching,
• lower acquisition cost requirements in oncology contracts.

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What financial metrics should be used to track Afinitor Disperz trajectory?

Answer: Track market-facing metrics rather than only prescriptions: net sales, gross-to-net, specialty pharmacy channel pull-through, and share-of-therapy by payer segment.

High-signal KPIs

• Net sales and gross-to-net (discount/rebate pressure).
• Units and average selling price (ASP) by strength (dispersible strengths).
• Prescription counts and persistence in ongoing treatment.
• Formulary tier placement changes (PBM/hospital).
• Litigation events tied to exclusivity end points and FDA approval announcements.

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Key Takeaways

• Afinitor Disperz market dynamics track the broader everolimus franchise but are uniquely sensitive to dispersible-specific formulation competition and the timing of generic design-arounds.
• Revenue is most threatened when dispersible equivalents can be marketed under the same dosing strengths and labeling. That event is controlled by the patent and Orange Book landscape and by litigation and settlement outcomes.
• Generic entry typically causes sharp net price compression and rapid payer-driven share shifts, with the largest erosion after multi-entrant availability and expanded supply coverage.

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FAQs

1) What makes a dispersible everolimus product financially different from tablet equivalents?
Dosing convenience can slow switching only while dispersible-specific patents and formulary rules limit generic substitution.

2) How do patent settlements change generic launch dates for everolimus products?
They can define early entry permissions, carve out specific claims, or delay marketing until a defined date tied to patent expiry.

3) What labeling details most influence payer willingness to switch from Afinitor Disperz?
Approved strength-by-strength dosing compatibility and whether the generic can support the same therapeutic use without requiring off-label conversion.

4) What is the Orange Book mechanism that controls ANDA timing for Afinitor Disperz?
Listed patents determine which patents are challenged and the statutory delay and litigation triggers that govern when a generic can market.

5) Does biosimilar competition threaten Afinitor Disperz?
No. Everolimus is a small molecule; the competitive threat is generic small-molecule entry, not biosimilars.

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References

1. FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. Food and Drug Administration.
2. U.S. FDA. “ANDA (Abbreviated New Drug Application) Information.” U.S. Food and Drug Administration.
3. U.S. FDA. “Drug Development and Drug Interactions: Exclusivity.” U.S. Food and Drug Administration.