DAYTRANA Drug Patent Profile

When do Daytrana patents expire, and when can generic versions of Daytrana launch?

Daytrana is a drug marketed by Noven Pharms Inc and is included in one NDA.

The generic ingredient in DAYTRANA is methylphenidate. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methylphenidate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Daytrana

A generic version of DAYTRANA was approved as methylphenidate by MYLAN TECH VIATRIS on March 14^th, 2022.

Summary for DAYTRANA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	15
Patent Applications:	7,012
Drug Prices:	Drug price information for DAYTRANA
Drug Sales Revenues:	Drug sales revenues for DAYTRANA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DAYTRANA
What excipients (inactive ingredients) are in DAYTRANA?	DAYTRANA excipients list
DailyMed Link:	DAYTRANA at DailyMed

See drug prices for DAYTRANA

See drug sales revenues for DAYTRANA

Recent Clinical Trials for DAYTRANA

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2/Phase 3
M.D. Anderson Cancer Center	Phase 2/Phase 3
Matthew O'Brien	Phase 4

See all DAYTRANA clinical trials

Pharmacology for DAYTRANA

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Paragraph IV (Patent) Challenges for DAYTRANA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DAYTRANA	Transdermal System	methylphenidate	10 mg/9 hrs 15 mg/9 hrs 20 mg/9 hrs 30 mg/9 hrs	021514	1	2011-04-13

US Patents and Regulatory Information for DAYTRANA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-001	Apr 6, 2006	AB	RX	Yes	No
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006	AB	RX	Yes	Yes
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-002	Apr 6, 2006	AB	RX	Yes	No
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006	AB	RX	Yes	No

Expired US Patents for DAYTRANA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-002	Apr 6, 2006
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-001	Apr 6, 2006
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-002	Apr 6, 2006

International Patents for DAYTRANA

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

Country	Patent Number	Title	Estimated Expiration
Canada	2110914	SYSTEME DE DELIVRANCE DE MEDICAMENTS BASE SUR LES PARAMETRES DE SOLUBILITE ET METHODE POUR MODIFIER LE TAUX DE SATURATION D'UN MEDICAMENT (SOLUBILITY PARAMETER BASED DRUG DELIVERY SYSTEM AND METHOD FOR ALTERING DRUG SATURATION CONCENTRATION)
Brazil	9206208
Spain	2196055
Japan	2659837
European Patent Office	0728477
South Africa	9811429	Compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder with methylphenidate.

DAYTRANA Market Analysis and Financial Projection

Last updated: April 24, 2026

DAYTRANA (amphetamine/dextroamphetamine) Market Dynamics and Financial Trajectory

DAYTRANA is an extended-release (ER) prescription stimulant for attention-deficit/hyperactivity disorder (ADHD). Market dynamics in this class are dominated by chronic pediatric/adolescent demand, payer coverage design, generic penetration in immediate-release stimulants, and tightly controlled prescriber and dispensing practices. For branded ER products, pricing power tends to compress as formularies add generics or therapeutic alternates, while patient adherence and dose stability support repeat demand. The net effect is a “volume-to-price” tradeoff: volumes can hold through brand loyalty and coverage, but realized price trends down as competitive pressure rises.

What matters for investors and business planners: Daytrana’s financial trajectory is not set by “one-time launches.” It is set by (1) formulary positioning versus other ER stimulants (including generics), (2) persistent demand generation through pediatric channels, (3) pharmacy benefit design (tiering, PA/step edits), and (4) channel inventory cycles in managed care.

---

How does DAYTRANA’s market structure shape demand and pricing?

1) Class demand is stable; brand pricing is not

DAYTRANA sits in the ADHD stimulant market, where the patient base is recurring and medication is long-tenured. In such markets, branded product revenues depend on maintenance of covered share rather than new-patient adoption alone. Coverage typically follows a structured reimbursement logic: higher copays for non-preferred brands reduce script share unless a plan’s therapeutic equivalent list and prior authorization constraints still permit access.

Implication for financial trajectory

• Revenues track formulary access and refill continuity.
• Price realization declines when payers increase generic substitution or expand preferred ER options.

2) Payer tactics drive share more than marketing

ADHD formularies frequently implement one or more of these controls:

• Step edits (start on specific agents or classes)
• Prior authorization (documentation of diagnosis, trial, or dosing history)
• Quantity limits (target daily dose compliance)
• Tier placement (preferred vs non-preferred)

These mechanisms systematically compress branded gross-to-net over time, especially once competing ER entries gain preferred status.

3) Supply chain and inventory dynamics can swing quarter-to-quarter results

Stimulants are dispensed under pharmacy benefit management with ongoing replenishment. That produces measurable quarter-to-quarter volatility from:

• channel inventory build or draw,
• seasonal prescription patterns, and
• payer-driven utilization changes.

For branded ER stimulants, the revenue line often shows smoother underlying demand than immediate-release products, but realized performance still reflects inventory normalization and coverage-driven switching.

---

Who competes with DAYTRANA, and how does that competition affect revenue trajectory?

DAYTRANA’s competitive set is the ER ADHD stimulant landscape. Economic outcomes depend on which alternatives a payer lists as preferred and how quickly those alternatives gain traction.

Key competitive categories impacting DAYTRANA

• Other ER oral amphetamine and methylphenidate products (preferred placement drives substitution)
• Generic stimulants (price compression and step edits reduce brand share)
• Transdermal and non-transdermal therapeutic alternatives (patient and prescriber preference can prevent total collapse but not eliminate price erosion)

Switching is dose- and patient-behavior dependent

Transdermal delivery affects onset profile and patient tolerance. This can protect a segment of the patient population from full substitution. But prescribers typically switch when formulary economics change and when competing products deliver acceptable efficacy and tolerability within the covered tier.

Net effect

• Brand share can persist in specific patient subgroups.
• Net price and gross-to-net usually drift downward as coverage broadens for lower-cost alternatives.

---

What does the financial trajectory look like under typical branded-ADHD economics?

1) Revenue curve tends to “flatten then decline” after competitive intensification

For long-standing branded stimulants, the common pattern is:

• early stability during initial access,
• mid-life share pressure as generics or competing ERs enter formularies,
• continued demand but reduced net price from tiering and rebates.

DAYTRANA’s long-run performance should be assessed through its position in payer formularies rather than through one-time growth catalysts.

2) Gross-to-net compression is the main value-destructor

Even when unit volumes remain relatively steady, branded stimulants often show:

• higher rebate rates versus prior periods,
• increased managed care pressure,
• larger net-to-gross gaps as utilization shifts to preferred alternatives.

That drives earnings volatility if costs do not fall proportionally.

3) Channel inventory cycles can mask underlying trends

If inventory builds ahead of expected payer changes or seasonal demand, a reported quarter can look stronger than true underlying utilization. Subsequent sell-through can then reverse.

Interpretation for “financial trajectory”

• Track trailing twelve-month trends, not single quarters.
• Focus on scripts, covered lives, and payer mix to separate utilization from channel mechanics.

---

How do formularies and reimbursement rules convert into financial outcomes?

1) Prior authorization changes are “binary” for access

When PA requirements tighten, access drops quickly. When requirements ease, access can rebound quickly. This is why branded stimulant performance can show sharper movement around formulary updates than pure epidemiology would suggest.

2) Tier migration matters

A move from preferred to non-preferred typically changes:

• patient copay burden,
• prescriber willingness to initiate or continue the brand,
• refill persistence.

In chronic therapy, reduced persistence lowers long-term revenue beyond the initial patient switching wave.

3) Quantity limits shape adherence and persistence

If quantity limits tighten to enforce daily dose norms, brand outcomes can improve in compliance but can reduce revenue if some doses are excluded or require additional documentation.

---

Operational drivers that can stabilize DAYTRANA economics

1) Patient adherence tied to delivery profile

Transdermal dosing can reduce caregiver burden compared with multiple daily oral dosing approaches in some scenarios. That can improve persistence for eligible patients, supporting unit volume stability.

2) Prescriber confidence and substitution friction

Switching friction is highest when:

• efficacy is stable on the current agent,
• tolerability is proven,
• caregivers and clinicians have minimized disruption.

Even under payer pressure, this can slow down total share erosion.

---

What financial indicators should be used to measure DAYTRANA trajectory?

Use these metrics to map market dynamics to financial outcomes:

1. Net sales vs prior-year periods adjusted for channel effects
2. Script volume trends (or TRx if available)
3. Gross-to-net ratio movement
4. Rebate and charge dynamics tied to formulary changes
5. Payer mix shifts (preferred versus non-preferred access)
6. Regional coverage differentials (managed care intensity varies)

When gross-to-net increases faster than unit volume, the brand is losing economic position even if utilization holds.

---

Key Takeaways

• DAYTRANA’s market is driven by chronic ADHD demand, but branded financial outcomes are governed primarily by payer access and gross-to-net compression.
• Competition from ER stimulant categories and generic alternatives usually produces a “share pressure with price erosion” pattern rather than a collapse in utilization overnight.
• The dominant measurable financial mechanisms are tier migration, prior authorization tightening, and rebate escalation, with quarter-to-quarter noise from inventory cycles.
• The brand’s transdermal profile can support persistence for a defined subgroup, slowing share erosion even as net price declines.

---

FAQs

1) What primarily drives DAYTRANA net sales performance?

Payer formulary access and the resulting net price (gross-to-net), with unit volume persistence in covered patient subgroups.

2) How does competition in ER ADHD stimulants affect DAYTRANA?

It increases substitution pressure when payers favor competing ER options or require step edits toward lower-cost agents.

3) Does channel inventory distortion matter for DAYTRANA reporting?

Yes. Stimulus supply and seasonal patterns can create short-term swings that do not reflect underlying utilization changes.

4) What is the biggest threat to branded economics in ADHD stimulants?

Gross-to-net erosion driven by higher rebates and non-preferred tier placement as formularies evolve.

5) What protects DAYTRANA from complete commoditization?

Patient-specific tolerability and adherence benefits from transdermal delivery, which creates switching friction in some subgroup populations.

---

References

[1] FDA. “DailyMed: Daytrana (Methylphenidate) Transdermal System.” U.S. Food and Drug Administration.
[2] SSR Health. “Stimulants and ADHD Market Dynamics: U.S. Payer and Formulary Trends.” SSR Health (industry and payer analytics reporting).
[3] National Association of Medicaid Directors (NAMD) and affiliated Medicaid policy materials on prior authorization and formulary management for ADHD drugs (managed care reimbursement frameworks).
[4] U.S. Centers for Medicare & Medicaid Services (CMS). Part D formulary and utilization management policy documentation (prior authorization, step therapy, and utilization controls).