STRATTERA Drug Patent Profile

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

Strattera is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in STRATTERA is atomoxetine hydrochloride. There are sixteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the atomoxetine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Strattera

A generic version of STRATTERA was approved as atomoxetine hydrochloride by ZYDUS PHARMS USA INC on September 16^th, 2010.

Summary for STRATTERA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	93
Patent Applications:	4,130
Drug Prices:	Drug price information for STRATTERA
What excipients (inactive ingredients) are in STRATTERA?	STRATTERA excipients list
DailyMed Link:	STRATTERA at DailyMed

See drug prices for STRATTERA

See drug sales revenues for STRATTERA

Recent Clinical Trials for STRATTERA

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

Sponsor	Phase
Brown University	Phase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2
Takeda Development Center Americas, Inc.	Phase 4

See all STRATTERA clinical trials

Pharmacology for STRATTERA

Drug Class	Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors

Paragraph IV (Patent) Challenges for STRATTERA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STRATTERA	Capsules	atomoxetine hydrochloride	10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg	021411	10	2007-05-29

US Patents and Regulatory Information for STRATTERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-001	Nov 26, 2002		DISCN	No	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-007	Feb 14, 2005		DISCN	Yes	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-004	Nov 26, 2002		DISCN	Yes	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-008	Feb 14, 2005		DISCN	Yes	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-002	Nov 26, 2002		DISCN	Yes	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-003	Nov 26, 2002		DISCN	Yes	No

Expired US Patents for STRATTERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-007	Feb 14, 2005	5,658,590*PED
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-001	Nov 26, 2002	5,658,590*PED
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-008	Feb 14, 2005	5,658,590*PED
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-006	Nov 26, 2002	5,658,590*PED
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-004	Nov 26, 2002	5,658,590*PED
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-005	Nov 26, 2002	5,658,590*PED

International Patents for STRATTERA

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

Country	Patent Number	Title	Estimated Expiration
Hungary	9801283
New Zealand	301500	Use of tomoxetine to treat attention-deficient/hyperactivity disorder (ADHD)
Australia	4693896
Mexico	9705117	USO DE TOMOXETINA PARA LA FABRICACION DE UN MEDICAMENTO PARA EL TRATAMIENTO DEL DESORDEN DE DEFICIT DE LA ATENCION/HIPERACTIVIDAD. (TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER.)
Czech Republic	292226	Léčivo pro léčení poruchy nedostatku pozornosti/hyperaktivity (Medicament for the treatment of attention deficit/hyperactivity disorder)
Luxembourg	91238

Supplementary Protection Certificates for STRATTERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0721777	C00721777/01	Switzerland		PRODUCT NAME: ATOMOXETIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58245 08.04.2009
0721777	300180	Netherlands		300180, 20160109, EXPIRES: 20190526
0721777	PA2006006,C0721777	Lithuania		PRODUCT NAME: ATOMOXETINUM HYDROCHLORICUM; NAT. REGISTRATION NO/DATE: LT/1/06/0431/001-LT/01/06/0431/024 20060621; FIRST REGISTRATION: PL 00006/0374-PL 00006/0379 20040527
0721777	91238	Luxembourg		91238, EXPIRES: 20190527
0721777	SPC/GB04/033	United Kingdom		PRODUCT NAME: ATOMOXETINE, OPTIONALLY IN THE FORM OF A SALT, SUCH AS THE HYDROCHLORIDE; REGISTERED: UK PL 00006/0374 20040527; UK PL 00006/0375 20040527; UK PL 00006/0376 20040527; UK PL 00006/0377 20040527; UK PL 00006/0378 20040527; UK PL 00006/0379 20040527
0721777	SPC012/2006	Ireland		SPC012/2006: 20061020, EXPIRES: 20190526

Market Dynamics and Financial Trajectory for Strattera (Atomoxetine)

Last updated: November 20, 2025

Introduction

Strattera (atomoxetine) stands as a prominent non-stimulant medication primarily prescribed for Attention Deficit Hyperactivity Disorder (ADHD). Since its FDA approval in 2002, Strattera has established a unique position within the ADHD therapeutic landscape, competing with stimulant alternatives. This analysis explores the market dynamics shaping Strattera's commercial trajectory and forecasts its financial outlook amid evolving healthcare trends, regulatory developments, and competitive forces.

Market Overview

ADHD Treatment Landscape

The global ADHD market is robust, driven by increasing diagnosis rates and heightened awareness. According to a report by Grand View Research, the ADHD therapeutics market is projected to reach USD 17.63 billion by 2028, growing at a compound annual growth rate (CAGR) of approximately 8.0% [1]. While stimulants like methylphenidate and amphetamines dominate, non-stimulants such as Strattera continue to cater to patients with contraindications or preferences for non-stimulant therapies.

Strattera’s Market Position

Initially, Strattera carved a niche as the first non-stimulant approved for ADHD, appealing to clinician and patient segments seeking alternatives to stimulants for cases involving substance abuse risks, cardiovascular issues, or side effect profiles. However, its market share has been gradually challenged by newer therapies and generics, impacting its commercial performance.

Market Dynamics Influencing Strattera

Competitive Environment

The rise of branded non-stimulant drugs like Guanfacine (Intuniv) and Clonidine (Kapvay), alongside the increasing availability of generic atomoxetine, has significantly impacted Strattera's market share. Generic versions, introduced in late 2010s, have led to a substantial decline in the drug's pricing and revenue [2]. Market entry of new pharmacological agents with improved tolerability and efficacy further pressure Strattera's uptake.

Regulatory and Patent Considerations

Strattera’s patent expired in 2017, allowing generic manufacturers to enter the market. The subsequent price erosion contributed to declining revenues for the originator. Although Pfizer, the original patent holder, retained some protection and branding rights, the generic competition has markedly diminished proprietary sales.

Prescriber and Patient Preferences

Face-to-face survey data indicates that clinicians tend to favor stimulants as first-line treatments due to their proven efficacy. Non-stimulants like Strattera are often reserved for specific scenarios requiring non-stimulant options or in patients with stimulant contraindications. Nonetheless, growing concerns regarding stimulant misuse foster some demand for safer alternatives.

Regulatory Trends

Recent regulatory focus on ADHD medication safety and misuse has led to increased scrutiny of stimulants. Regulatory agencies also place emphasis on comprehensive data for non-stimulant therapies, influencing clinical prescribing. While no new label indications for Strattera are anticipated soon, ongoing post-marketing surveillance contributes to the drug's safety profile reputation.

Market Penetration and Geographic Dynamics

Strattera's revenue is predominantly generated in North America and Europe. Emerging markets, driven by increasing ADHD diagnosis and healthcare spending, present growth opportunities. However, affordability and regulatory approval lag hinder expansion.

Financial Trajectory Analysis

Revenue Trends

Pfizer reported peak global sales of Strattera at approximately USD 737 million in 2009 [3]. Post-generic entry, revenues declined substantially, with recent figures indicating annual sales between USD 200-300 million globally, reflecting market saturation and competition.

Impact of Generics and Pricing Strategies

The arrival of generics precipitated a sharp decline in unit prices. According to IQVIA data, generic atomoxetine accounts for over 80% of prescriptions in the U.S., translating into significant revenue loss for the originator. Pfizer's strategic response involves limited marketing investments, focusing instead on niche or adjunct indications.

Future Revenue Outlook

Forecasts project continued revenue decline for Strattera over the next five years unless novel strategies emerge. However, geographic expansion into emerging markets and potential label expansions or new formulations may mitigate declines. Additionally, the shift toward personalized medicine and combination therapies could shape future commercial opportunities.

Investment and R&D Considerations

Pfizer and other stakeholders are unlikely to prioritize R&D for Strattera, given the competitive landscape and diminishing patent protections. Instead, research is channeling toward novel ADHD agents, including non-stimulants with unique mechanisms of action, such as neuropeptides or gene therapies.

External Factors Affecting Financial Outlook

Healthcare Policy and Reimbursement

Cost-containment policies in major markets favor generics, suppressing brand sales. Reimbursement trends increasingly favor cheaper alternatives, pressuring manufacturers to innovate or diversify their ADHD portfolio.

Patient and Caregiver Preferences

Organizations advocating for safer ADHD treatments influence prescribing habits. As awareness grows regarding non-stimulant options, some clinicians and patients may prefer alternative therapies, impacting Strattera’s sales.

Technological Advances and Digital Health

Emerging digital therapies and telemedicine solutions for ADHD management may shift market dynamics in favor of behavioral interventions over pharmacotherapy, potentially constraining pharmaceutical revenues.

Strategic Recommendations

• Portfolio Diversification: Companies should explore pipeline development for next-generation non-stimulant therapies, leveraging technological advances like digital therapeutics.
• Market Expansion: Targeting underserved regions with increasing ADHD prevalence can stabilize revenues.
• Brand Positioning: Emphasizing safety profiles and unique clinical benefits may carve out niche segments.
• Collaborations and Licensing: Partnering for combination therapies or biosimilars could open new revenue streams.

Key Takeaways

• Market decline: Strattera’s revenues have declined markedly post-generic entry, with current global sales below USD 300 million.
• Competitive pressures: Generics, new therapies, and shifting clinician preferences challenge its market share.
• Growth opportunities: Emerging markets and potential label expansions may offer marginal growth; however, innovation remains critical.
• Strategic pivots: Stakeholders should focus on pipeline diversification, digital health integration, and geographic expansion.
• Long-term outlook: Without significant innovation or market differentiation, Strattera’s financial trajectory is expected to trend downward in the face of intensifying competition.

FAQs

1. Will Strattera regain market share in the near future?
Given the dominance of generics and the shift toward more efficacious or better-tolerated alternatives, it is unlikely that Strattera will regain significant market share without new formulations or indications.

2. Are there any ongoing developments to enhance Strattera’s market viability?
Currently, Pfizer has limited development efforts focused on Strattera. The broader industry trend favors novel ADHD treatments with improved profiles, diminishing incentives for reformulation.

3. How do regulatory policies impact Strattera’s sales?
Stringent safety and misuse regulations regarding stimulants boost interest in non-stimulants, but reimbursement pressures generally favor lower-cost generics, affecting branded sales.

4. What role do emerging markets play in future revenue?
Emerging markets, with rising ADHD prevalence and increasing healthcare expenditure, could provide growth opportunities if regulatory and pricing barriers are addressed.

5. How does the digital therapeutics trend influence Strattera’s market?
Digital health solutions offer adjunct or alternative management options but are unlikely to replace pharmacotherapy entirely, especially for moderate to severe ADHD cases, limiting their direct impact on Strattera.

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References

1. Grand View Research, “ADHD therapeutics market size, share & trends analysis report,” 2021.
2. IQVIA, “U.S. Prescription Data,” 2022.
3. Pfizer Annual Report, 2010.