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:	156
Clinical Trials:	93
Patent Applications:	4,119
Drug Prices:	Drug price information for STRATTERA
Drug Sales Revenues:	Drug sales revenues 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	AB	RX	Yes	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-004	Nov 26, 2002	AB	RX	Yes	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-008	Feb 14, 2005	AB	RX	Yes	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-002	Nov 26, 2002	AB	RX	Yes	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-003	Nov 26, 2002	AB	RX	Yes	No
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-006	Nov 26, 2002	AB	RX	Yes	Yes

Expired US Patents for STRATTERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-005	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-001	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-007	Feb 14, 2005
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-006	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-004	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-003	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-002	Nov 26, 2002

International Patents for STRATTERA

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0721777
Brazil	9606903
Finland	972922
Germany	69623141
World Intellectual Property Organization (WIPO)	9621430
Japan	H10512262
Norway	317027

Supplementary Protection Certificates for STRATTERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0721777	SPC012/2006	Ireland		SPC012/2006: 20061020, EXPIRES: 20190526
0721777	PA2006006	Lithuania		PRODUCT NAME: ATOMOXETINUM HYDROCHLORICUM; REG. NO/DATE: PL 00006/0374-0379 20040527
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	CA 2006 00030	Denmark		PRODUCT NAME: ATOMOXETIN, EVENTUELT I FORM AF ET SALT DERAF, SASOM HYDROCHLORIDET
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	C00721777/01	Switzerland		PRODUCT NAME: ATOMOXETIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58245 08.04.2009

STRATTERA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Strattera

Introduction to Strattera

Strattera, known generically as atomoxetine, is a non-stimulant medication approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It works by preventing neurons from reuptaking norepinephrine, thereby improving attention spans in patients with ADHD[1].

Market Position and Competition

Approval and Early Success

Strattera was the first non-stimulant drug approved for ADHD and enjoyed significant market success since its approval in the early 2000s. It was a major revenue generator for Eli Lilly, with sales reaching close to blockbuster status, particularly in the years leading up to its patent expiration[1].

Generic Competition

In 2017, Strattera faced its first wave of generic competition as several pharmaceutical companies, including Apotex, Aurobindo, Glenmark, and Teva, received FDA approval to market generic versions of the drug. This marked a significant turning point in Strattera's market trajectory, as generic competition typically leads to a rapid decline in revenue for the original brand[1].

Financial Impact of Generic Competition

Revenue Decline

The introduction of generic versions of Strattera led to a substantial decline in its revenue. In 2016, Strattera generated $854.7 million in sales, but this figure dropped to $618.2 million in 2017 following the entry of generics. By 2022, global sales had further declined to $115.3 million[3].

Impact on Eli Lilly's Neuroscience Portfolio

Strattera and another Eli Lilly drug, Cymbalta (duloxetine), were major contributors to the company's neuroscience revenue. However, with the patent expirations of both drugs, Eli Lilly's neuroscience unit saw a significant decline in sales, highlighting the need for the company to innovate and introduce new products to maintain revenue levels[1].

Market Trends and Drivers

Growing Demand for Non-Stimulant ADHD Treatments

The ADHD market is expected to grow, driven in part by the increasing prevalence of the disorder and a preference for non-stimulant treatments. Non-stimulant drugs like Strattera and Qelbree are gaining traction, especially among patients who experience significant side effects from stimulants or have concerns about potential abuse[4].

Cost and Affordability

The availability of generic versions of Strattera has made the medication more affordable. Generic forms of Strattera can be as cheap as $30 for a prescription, making it a cost-effective option compared to newer non-stimulant drugs like Qelbree, which, although slightly cheaper than brand-name Strattera, are more expensive than generic Strattera[3].

Comparative Analysis with Qelbree

Mechanism of Action and Effectiveness

Both Strattera and Qelbree are serotonin-norepinephrine reuptake inhibitors (SNRIs) and work similarly to treat ADHD. Studies have shown the effectiveness of both drugs in reducing ADHD symptoms across different age groups. However, Qelbree has seen significant growth since its approval in 2021, particularly with its expanded approval for adult use[3].

Revenue and Market Share

While Strattera's revenue has declined significantly since the introduction of generics, Qelbree has seen a notable increase in sales. Qelbree's net product sales grew from $9.9 million in 2021 to $61.3 million in 2022, driven by increases in the average daily dose, prescription size, and an expanding prescriber base[3].

Future Outlook and Market Projections

ADHD Market Growth

The ADHD market is projected to reach $16.9 billion by 2028, with a compound annual growth rate (CAGR) of four percent. The non-stimulant segment, which includes drugs like Strattera and Qelbree, is expected to grow, driven by the increasing prevalence of ADHD and a preference for non-stimulant treatments[3].

Expanding Indications and Generic Impact

The expansion of indications for atomoxetine beyond ADHD, such as treating comorbid conditions like depression and anxiety, contributes to its market growth. However, the presence of generic versions will continue to impact the revenue of brand-name Strattera, making it essential for Eli Lilly to focus on other products and innovations[4].

Financial Performance of Eli Lilly

Impact on Revenue and Operating Income

The loss of exclusivity for Strattera, along with other drugs like Cymbalta, has affected Eli Lilly's financial performance. The company has seen a decline in revenue from its neuroscience portfolio, which has been partially offset by the success of newer medicines. Eli Lilly has been working to reduce its cost structure and invest in new research and development to mitigate these losses[1][5].

Key Takeaways

• Generic Competition: The introduction of generic versions of Strattera in 2017 led to a significant decline in its revenue.
• Market Trends: There is a growing demand for non-stimulant ADHD treatments, driven by the increasing prevalence of ADHD and preferences for non-stimulant options.
• Cost and Affordability: Generic Strattera is more affordable than brand-name Strattera and newer non-stimulant drugs like Qelbree.
• Comparative Analysis: Qelbree has seen significant growth since its approval, while Strattera's revenue continues to decline.
• Future Outlook: The ADHD market is projected to grow, with the non-stimulant segment expected to expand.

FAQs

What is Strattera used for?

Strattera, or atomoxetine, is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

How does Strattera work?

Strattera works by preventing neurons from reuptaking norepinephrine, which improves attention spans in patients with ADHD.

What happened to Strattera's revenue after generic competition?

Strattera's revenue declined significantly after the introduction of generic versions in 2017, from $854.7 million in 2016 to $115.3 million in 2022.

How does Strattera compare to Qelbree?

Both Strattera and Qelbree are SNRIs used to treat ADHD, but Qelbree has seen significant growth since its approval, while Strattera's revenue has declined due to generic competition.

What is the projected growth of the ADHD market?

The ADHD market is projected to reach $16.9 billion by 2028, with a CAGR of four percent, driven by the increasing prevalence of ADHD and a preference for non-stimulant treatments.

Sources

1. Biopharma Dive: "Lilly's Strattera faces first wave of generic competition"
2. Eli Lilly Investor Relations: "Q3 2023 Financial Workbook"
3. Xtalks: "Non-Stimulant ADHD Drugs: Qelbree Versus Strattera"
4. IMARC Group: "Atomoxetine (Strattera) Manufacturing Plant Report 2024"
5. Eli Lilly Investor Relations: "Lilly Reports Strong Fourth-Quarter and Full-Year 2018 Financial"