EVEKEO ODT Drug Patent Profile

When do Evekeo Odt patents expire, and what generic alternatives are available?

Evekeo Odt is a drug marketed by Azurity and is included in one NDA. There are three patents protecting this drug.

The generic ingredient in EVEKEO ODT is amphetamine sulfate. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Evekeo Odt

A generic version of EVEKEO ODT was approved as amphetamine sulfate by AMNEAL PHARMS on September 26^th, 2018.

Summary for EVEKEO ODT

US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	25
Patent Applications:	1,562
Drug Prices:	Drug price information for EVEKEO ODT
What excipients (inactive ingredients) are in EVEKEO ODT?	EVEKEO ODT excipients list
DailyMed Link:	EVEKEO ODT at DailyMed

See drug prices for EVEKEO ODT

US Patents and Regulatory Information for EVEKEO ODT

EVEKEO ODT is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-005	Apr 16, 2021		DISCN	Yes	No			Y
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-002	Jan 30, 2019		DISCN	Yes	No			Y
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-001	Jan 30, 2019		DISCN	Yes	No			Y

Expired US Patents for EVEKEO ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-005	Apr 16, 2021
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-003	Jan 30, 2019
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-001	Jan 30, 2019

EVEKEO ODT Market Dynamics, Patent Position, and Financial Trajectory

Last updated: August 19, 2026

EVEKEO ODT is a branded amphetamine sulfate orally disintegrating tablet for attention-deficit/hyperactivity disorder in patients aged 6 years and older. The product entered a highly competitive stimulant market without a novel active ingredient, creating limited pricing power and material exposure to generic amphetamine products. Its commercial value depends on formulation differentiation, prescriber familiarity, pharmacy access, controlled-substance supply, and the ability of Arbor Pharmaceuticals and KVK-Tech to sustain branded reimbursement.

No separate EVEKEO ODT revenue is publicly disclosed. Arbor Pharmaceuticals and KVK-Tech are privately held, so the product’s sales, margins, prescription volume, and contribution to enterprise value are not reported in public-company filings.

What is EVEKEO ODT and how does it compete?

EVEKEO ODT contains amphetamine sulfate, a mixed amphetamine salt stimulant. The tablet disintegrates in the mouth and is intended for patients who have difficulty swallowing conventional tablets or who prefer administration without water.

Attribute	EVEKEO ODT
Active ingredient	Amphetamine sulfate
Dosage form	Orally disintegrating tablet
Strengths	5 mg, 10 mg, 15 mg, and 20 mg
FDA pathway	New drug application, NDA 214697
Controlled-substance schedule	Schedule II
FDA indication	ADHD in pediatric patients aged 6 years and older
Primary differentiation	Orally disintegrating delivery
Original commercial company	Arbor Pharmaceuticals
Current commercial association	Arbor Pharmaceuticals and KVK-Tech
Reference product category	Immediate-release amphetamine stimulant
Biosimilar exposure	None; EVEKEO ODT is a small-molecule drug

The product competes with generic immediate-release amphetamine sulfate, generic mixed amphetamine salts, branded and generic Adderall, Vyvanse and lisdexamfetamine, Dyanavel XR, Mydayis, Azstarys, Jornay PM, Quillivant XR, Xelstrym, and other ADHD therapies.

The formulation provides convenience but does not change the underlying pharmacology. EVEKEO ODT is therefore more exposed to substitution and payer controls than products with extended release, abuse-deterrent properties, or a novel mechanism of action.

When did EVEKEO ODT receive FDA approval and lose exclusivity?

FDA approved EVEKEO ODT in 2021 under NDA 214697. The approval created a three-year period of new-drug exclusivity associated with the approved formulation and clinical development package. That exclusivity period ended in 2024, absent a qualifying pediatric extension or other statutory extension. The FDA label identifies EVEKEO ODT as a Schedule II product with a limited-duration prescription and refill restrictions under federal controlled-substance rules. (U.S. Food and Drug Administration, 2021; Drug Enforcement Administration, 2024)

EVEKEO ODT exclusivity timeline

Event	Timing
FDA NDA approval	2021
Three-year regulatory exclusivity	Approximately 2021-2024
Loss of core FDA exclusivity	2024
Generic pathway after exclusivity	ANDA or, depending on the formulation and listed patents, a 505(b)(2) application
Biosimilar pathway	Not applicable
Current commercial issue	Generic substitution, payer restrictions, and supply availability

Loss of regulatory exclusivity does not automatically result in immediate generic launch. A generic applicant must obtain FDA approval and address any patents listed in the Orange Book. Formulation patents, if listed and enforceable, can delay approval or launch even after the three-year exclusivity period ends.

What patents protect EVEKEO ODT?

The principal intellectual-property issue is the orally disintegrating formulation rather than amphetamine sulfate itself. Amphetamine sulfate is an established active ingredient with extensive prior-art exposure. Any defensible patent position must therefore rely on formulation composition, excipient selection, manufacturing process, tablet performance, or a specific dosing method.

The FDA Orange Book is the controlling source for patents that may block an ANDA applicant. A patent must be properly listed against the approved NDA to create the statutory notice and litigation framework associated with a Paragraph IV certification. Patent coverage outside the Orange Book can still support litigation, but it does not create the same ANDA approval delay mechanism.

What formulation patents are commercially important?

Potentially valuable claim categories include:

• Orally disintegrating tablets with defined disintegration times.
• Excipient combinations that improve taste, hardness, friability, or stability.
• Manufacturing processes for compressing the tablet.
• Dose-specific tablet compositions.
• Product-by-process claims.
• Methods of treating ADHD using the ODT dosage form.

The strength of this estate is structurally lower than that of a new chemical entity because competitors can attempt to design around excipient ratios, compression parameters, flavor systems, or disintegration specifications. A formulation patent can delay an identical or closely similar generic, but it may not prevent a technically different amphetamine product from reaching the market.

Is EVEKEO ODT protected by method-of-use patents?

The core ADHD indication is clinically and legally crowded. A broad method-of-use claim covering treatment of ADHD with amphetamine sulfate would face substantial prior-art and obviousness challenges. Commercially relevant method claims would need narrower limitations, such as patient population, dosing schedule, or administration conditions. Those claims generally provide less protection against a generic labeled for the same indication.

What is the Orange Book status of EVEKEO ODT?

EVEKEO ODT is an FDA-approved prescription product listed under NDA 214697. Orange Book analysis should focus on three questions:

1. Whether the NDA holder has listed formulation or method patents.
2. Whether those patents have expiration dates extending beyond the 2024 regulatory exclusivity period.
3. Whether an ANDA applicant has filed a Paragraph IV certification and triggered patent litigation.

The public market record does not identify a widely reported Paragraph IV dispute, launch settlement, or major ANDA litigation campaign involving EVEKEO ODT. This limits evidence that the product has generated a meaningful patent barrier comparable with major extended-release ADHD products.

Which companies are challenging EVEKEO ODT?

No major public Paragraph IV challenge or commercial generic launch directed specifically at EVEKEO ODT is broadly reported. Competitive pressure is instead coming from products that substitute for the treatment category:

• Teva Pharmaceutical Industries and other manufacturers of generic mixed amphetamine salts.
• Generic amphetamine sulfate manufacturers.
• Takeda’s Vyvanse franchise and authorized or conventional generic lisdexamfetamine products.
• Tris Pharma, which markets Dyanavel XR and related liquid or extended-release stimulant products.
• KemPharm and Corium, associated with newer stimulant delivery systems.
• Generic manufacturers with ANDA portfolios in immediate-release and extended-release amphetamine products.

The absence of a reported EVEKEO ODT Paragraph IV case does not eliminate future generic risk. Small branded products can attract ANDA filings when manufacturing is straightforward and the reference product has stable prescription demand.

How strong is the EVEKEO ODT patent estate?

EVEKEO ODT has a moderate-to-weak defensive profile when measured against the strongest ADHD patent estates.

Patent-strength factor	Assessment
Active ingredient exclusivity	Weak; amphetamine sulfate is long established
Regulatory exclusivity	Expired in 2024
Dosage-form differentiation	Moderate
Formulation design-around risk	Material
Method-of-use protection	Likely limited
Manufacturing complexity	Moderate, but not inherently high
Generic substitution risk	High
Biosimilar risk	None
Litigation evidence	Limited public evidence
Pricing durability	Low to moderate

A branded ODT can retain a commercial niche after patent and regulatory exclusivity through patient preference, prescriber continuity, pharmacy availability, and payer contracting. Those defenses are weaker when the active ingredient is widely available in inexpensive generic forms.

What drives EVEKEO ODT market dynamics?

Generic stimulant competition

The largest structural pressure is substitution by generic amphetamine products. Prescribers can select immediate-release tablets at materially lower cost, while payers may require generic use before covering EVEKEO ODT. The ODT format can justify a premium only when swallowing difficulty, adherence, convenience, or patient-specific tolerability is clinically persuasive.

ADHD diagnosis and treatment demand

The U.S. ADHD market has expanded through increased diagnosis across pediatric, adolescent, and adult populations. Demand supports stimulant volume, but it does not guarantee brand growth. Category expansion tends to benefit low-cost generics and products with differentiated duration, dosing flexibility, or delivery technology.

Controlled-substance shortages

Amphetamine products have experienced supply constraints linked to active pharmaceutical ingredient availability, manufacturing capacity, quota allocation, and distribution controls. DEA production quotas affect the entire stimulant category. Shortages can create two opposing effects: they may improve brand retention when EVEKEO ODT is available, but they can also restrict sales if the manufacturer cannot secure sufficient amphetamine sulfate or if wholesalers limit controlled-substance purchases. (Drug Enforcement Administration, 2024; U.S. Food and Drug Administration, 2023)

Formulation convenience

EVEKEO ODT does not require water and may assist patients who reject or cannot swallow tablets. Its convenience is commercially relevant, but the benefit is easy for other manufacturers to replicate through orally disintegrating, chewable, liquid, transdermal, or orally administered stimulant products.

Reimbursement

Commercial insurers and pharmacy benefit managers generally favor generic stimulants. EVEKEO ODT may require prior authorization, step therapy, or documentation of failure or intolerance to generic alternatives. Net price therefore depends more on formulary access and discounting than on the list price.

How does EVEKEO ODT compare with competing ADHD drugs?

Product	Active ingredient	Delivery	Commercial advantage	Main risk to EVEKEO ODT
EVEKEO ODT	Amphetamine sulfate	ODT, immediate release	No-water administration	Generic amphetamine substitution
Generic Adderall IR	Mixed amphetamine salts	Immediate-release tablet	Low price and broad availability	Direct therapeutic substitution
Vyvanse	Lisdexamfetamine	Prodrug, extended release	Longer duration and established brand	Generic lisdexamfetamine
Dyanavel XR	Amphetamine	Liquid or extended-release forms	Flexible dosing and duration	Differentiated delivery
Azstarys	Serdexmethylphenidate/dexmethylphenidate	Extended release	Novel methylphenidate profile	Prescriber switching
Xelstrym	Dextroamphetamine	Transdermal patch	Nonoral administration	Alternative adherence profile
Quillivant XR	Methylphenidate	Extended-release liquid	Pediatric dosing flexibility	Liquid formulation preference

EVEKEO ODT’s closest direct competitors are generic immediate-release amphetamine products, not biologics or specialty medicines. Its commercial positioning is convenience-based rather than mechanism-based.

What financial trajectory is likely for EVEKEO ODT?

No audited, product-level revenue series is publicly available. The financial trajectory must therefore be assessed through market structure rather than reported sales.

Period	Likely financial condition
2021-2022	Launch investment, sales-force buildout, sampling, payer access work, and controlled-substance supply costs
2023-2024	Commercial maturation while regulatory exclusivity remained available; pressure from generic category alternatives
2024 onward	Exclusivity erosion, increased generic-entry risk, and greater dependence on patient retention
Longer term	Niche branded revenue if the ODT format sustains adherence and reimbursement; rapid erosion if an AB-rated generic launches

Gross-to-net deductions are likely significant because branded ADHD products compete in a heavily managed pharmacy market. Rebates, copay support, wholesaler discounts, returns, and prior-authorization friction can reduce realized revenue even when prescription volume remains stable.

The main financial scenarios are:

1. Base case: EVEKEO ODT retains a small branded niche, with flat or declining volume and limited pricing growth.
2. Downside case: An approved generic ODT or aggressive substitution by generic amphetamine sulfate causes rapid prescription and price erosion.
3. Upside case: Persistent shortages in competing products, improved formulary access, and strong adherence among patients who prefer ODT administration support modest growth.
4. Strategic case: The product becomes part of a broader KVK-Tech or Arbor stimulant portfolio, with shared sales, manufacturing, and distribution infrastructure reducing standalone costs.

What generic entry risks exist for EVEKEO ODT?

Generic entry risk is high after the end of regulatory exclusivity. The most credible launch routes are:

• An ANDA for a pharmaceutically equivalent amphetamine sulfate ODT.
• A 505(b)(2) application using the EVEKEO ODT formulation as a reference while making formulation or labeling changes.
• A generic immediate-release amphetamine product that captures the same patients through payer substitution.
• A product using a different excipient system designed to avoid formulation claims.

A first generic could receive 180-day Paragraph IV exclusivity if statutory requirements are met. That period would create temporary market concentration, followed by steeper erosion once multiple generic applicants enter.

The launch effect would depend on whether the generic is therapeutically substitutable at the pharmacy, whether its product is AB-rated, whether the Orange Book contains unexpired listed patents, and whether the brand maintains a protected payer position.

What litigation and settlement activity affects EVEKEO ODT?

No major publicly reported patent litigation or settlement agreement has materially altered EVEKEO ODT’s commercial timeline. The absence of a disclosed settlement means there is no established authorized-generic launch date, litigation-based generic entry date, or negotiated license date to incorporate into the base case.

Any future Paragraph IV notice would create a 45-day period for the NDA holder or patent owner to file an infringement action. A timely suit could trigger a 30-month stay of FDA approval, subject to statutory exceptions and court developments. (U.S. Food and Drug Administration, 2024)

What manufacturing and geographic barriers affect EVEKEO ODT?

EVEKEO ODT is principally a U.S. commercial opportunity because its regulatory, reimbursement, and controlled-substance framework is U.S.-specific. International expansion would require separate approvals, controlled-substance permits, local pricing negotiations, and distribution arrangements.

Manufacturing barriers include:

• Sourcing amphetamine sulfate under DEA quota limits.
• Maintaining tablet hardness while achieving rapid oral disintegration.
• Controlling content uniformity at multiple strengths.
• Managing taste and mouthfeel.
• Meeting Schedule II recordkeeping and distribution requirements.
• Maintaining supply through qualified contract or internal manufacturing sites.

These barriers can delay competitors but do not create the high technical hurdle associated with biologics, sterile injectables, complex delivery devices, or cell and gene therapies.

Key Takeaways

• EVEKEO ODT is a branded amphetamine sulfate ODT for ADHD patients aged 6 years and older.
• Its principal commercial advantage is administration convenience, not a novel active ingredient or mechanism.
• FDA exclusivity ended in 2024, leaving generic substitution as the central long-term risk.
• No separately reported EVEKEO ODT revenue or public-company financial disclosure is available.
• The product has meaningful formulation value but a weaker defensive position than novel extended-release stimulant platforms.
• No major public Paragraph IV litigation or settlement is broadly reported.
• Supply constraints and DEA quota limits can temporarily support brand retention but can also restrict manufacturing and sales.
• Long-term revenue is likely to remain niche unless the product secures durable formulary access or develops a strong adherence-based patient segment.

FAQs About EVEKEO ODT Market and Financial Outlook

Is EVEKEO ODT a generic version of Adderall?

No. EVEKEO ODT is a branded amphetamine sulfate product in an orally disintegrating dosage form. Generic mixed amphetamine salts and amphetamine sulfate products compete with it therapeutically, but they are not necessarily the same pharmaceutical product.

Does EVEKEO ODT have an abuse-deterrent formulation?

The ODT format is a convenience formulation. FDA labeling does not establish EVEKEO ODT as an abuse-deterrent product equivalent to products specifically approved with abuse-deterrent labeling.

Can a generic manufacturer launch EVEKEO ODT immediately?

No. A generic manufacturer must obtain FDA approval and address any applicable Orange Book patents. Regulatory exclusivity ended in 2024, but patent certification, litigation, manufacturing readiness, and FDA review can still affect launch timing.

Is EVEKEO ODT covered by biosimilar competition?

No. EVEKEO ODT is a small-molecule amphetamine product. The relevant competitive pathway is generic drug approval through an ANDA or, in some cases, a 505(b)(2) application.

What would most improve EVEKEO ODT’s financial outlook?

Improved commercial formulary access, reliable controlled-substance supply, stronger prescriber adoption among patients who cannot swallow tablets, and evidence of better adherence would provide the clearest support for revenue retention after exclusivity loss.

References

1. Drug Enforcement Administration. (2024). Established aggregate production quotas for controlled substances. U.S. Department of Justice. https://www.deadiversion.usdoj.gov/

2. U.S. Food and Drug Administration. (2021). EVEKEO ODT (amphetamine sulfate) orally disintegrating tablets prescribing information. https://www.accessdata.fda.gov/

3. U.S. Food and Drug Administration. (2023). FDA drug shortages: Amphetamine mixed salts and other stimulant products. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

5. U.S. Food and Drug Administration. (2024). Abbreviated new drug application submissions and Paragraph IV certifications. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/anda-submissions-and-responses-questions-and-answers