VYVANSE Drug Patent Profile

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

Vyvanse is a drug marketed by Takeda Pharms Usa and is included in two NDAs.

The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. Twenty suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vyvanse

A generic version of VYVANSE was approved as lisdexamfetamine dimesylate by ACTAVIS ELIZABETH on August 25^th, 2023.

Summary for VYVANSE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	65
Patent Applications:	293
Drug Prices:	Drug price information for VYVANSE
Drug Sales Revenues:	Drug sales revenues for VYVANSE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYVANSE
What excipients (inactive ingredients) are in VYVANSE?	VYVANSE excipients list
DailyMed Link:	VYVANSE at DailyMed

See drug prices for VYVANSE

See drug sales revenues for VYVANSE

Recent Clinical Trials for VYVANSE

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

Sponsor	Phase
University of Minnesota	Early Phase 1
Yale University	Phase 2/Phase 3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3

See all VYVANSE clinical trials

Pharmacology for VYVANSE

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

Paragraph IV (Patent) Challenges for VYVANSE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VYVANSE	Capsules	lisdexamfetamine dimesylate	10 mg	021977	1	2020-04-09
VYVANSE	Capsules	lisdexamfetamine dimesylate	20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg	021977	6	2011-02-23

US Patents and Regulatory Information for VYVANSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-007	Oct 30, 2014	AB	RX	Yes	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-003	Feb 23, 2007	AB	RX	Yes	Yes
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-005	Dec 10, 2007	AB	RX	Yes	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-005	Jan 28, 2017	AB	RX	Yes	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-001	Jan 28, 2017	AB	RX	Yes	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-004	Dec 10, 2007	AB	RX	Yes	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-001	Feb 23, 2007	AB	RX	Yes	No

International Patents for VYVANSE

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

Country	Patent Number	Title	Estimated Expiration
Israel	155905	PHARMACEUTICAL COMPOSITIONS CONTAINING POLYPEPTIDES COVALENTLY ATTACHED TO ACTIVE AGENTS AND METHODS FOR MAKING AND USING SAME
Australia	2001286599
South Korea	20060073538	ABUSE RESISTANT AMPHETAMINE COMPOUNDS
South Korea	100905627
Canada	2420590	SYSTEMES DE LIBERATIONS D'AGENTS ACTIFS ET PROCEDES DE PROTECTION ET D'ADMINISTRATION D'AGENTS ACTIFS (ACTIVE AGENT DELIVERY SYSTEMS AND METHODS FOR PROTECTING ANDADMINISTERING ACTIVE AGENTS)
Japan	2012006978	ABUSE RESISTANT AMPHETAMINE COMPOUNDS
World Intellectual Property Organization (WIPO)	03020200

Supplementary Protection Certificates for VYVANSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1644019	C01644019/01	Switzerland		VERTRETERLOESCHUNG
1644019	CR 2013 00043	Denmark		PRODUCT NAME: LISDEXAMFETAMIN, EVENTUELT I FORM AF ET MESYLAT ELLER HYDROCHLORID SALT DERAF; NAT. REG. NO/DATE: MT499080, MT499081, MT499082 20130214; FIRST REG. NO/DATE: PL PL 08081/0050-0052 20130201
1644019	2020C/543	Belgium		PRODUCT NAME: LISDEXAMFETAMINE, OPTIONEEL IN DE VORM VAN EEN MESYLAAT- OF HYDROCHLORIDE-ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE562026, BE562035, BE562044, BE562053, BE562062, BE562071 20200520
1644019	SPC/GB13/052	United Kingdom		PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; REGISTERED: UK PL08081/0050-2 20130201; UK PL08081/0062-4 20130201
1644019	549	Finland
1644019	37/2016	Austria		PRODUCT NAME: LISDEXAMFETAMIN, OPTIONAL IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, INSBESONDERE EINES MESILAT-SALZES; NAT. REGISTRATION NO/DATE: 136851-136853 20160412; FIRST REGISTRATION: PL08081/0050-PL08081/0052 20130201
1644019	1390058-4	Sweden		PRODUCT NAME: LISDEXAMFETAMIN VALFRITT I FORMEN AV ETT FARMACEUTISKT GODTAGBART SALT, SAERSKILT ETT MESYLATSALT; NAT. REG. NO/DATE: 47382 20130722; FIRST REG.: GB PL 08081/0050-52 20130201

Market Dynamics and Financial Trajectory for Vyvanse

Overview of Vyvanse

Vyvanse, also known as lisdexamfetamine dimesylate, is a prominent attention-deficit/hyperactivity disorder (ADHD) medication developed and marketed by Takeda. First approved in 2003, Vyvanse has been a cornerstone in Takeda's portfolio, contributing significantly to the company's revenue.

Historical Performance

In the years leading up to 2023, Vyvanse was one of Takeda's top-selling drugs, generating substantial revenue. For instance, in 2022, Vyvanse achieved approximately $2.5 billion in sales across the five major markets of the US, Japan, Germany, Spain, and the UK[5].

Loss of Exclusivity

A critical turning point for Vyvanse came in 2023 when it lost several crucial patent protections. The patents covering adult indications expired in February 2023, and those for pediatric use expired in August 2023. This loss of exclusivity paved the way for generic versions of Vyvanse to enter the market[2][3].

Impact of Generic Competition

The introduction of generic versions of Vyvanse has significantly impacted Takeda's financial performance. Since August 2023, at least 12 generic versions of Vyvanse have been launched by companies such as Sandoz, Teva, and Mylan. As a result, Vyvanse sales have declined substantially. For example, during the first nine months of Takeda's 2023 fiscal year, Vyvanse sales fell by 12.1% to 312.9 billion yen ($2.14 billion)[3].

Sales Decline

The sales decline of Vyvanse has been pronounced, with a 14% drop to 423 trillion yen ($2.7 billion) after generics entered the market. Initially, the impact was slightly milder than expected due to supply constraints affecting generic sales, but these constraints are expected to ease in the coming months[4].

Financial Implications for Takeda

The loss of exclusivity and subsequent generic competition have had a profound impact on Takeda's financials.

Revenue and Profit

For the fiscal year ending March 31, 2024, Takeda reported a revenue of over $27 billion, a 1.5% increase from the previous year. However, the company's net profit plummeted by 57% to $925 million, and the operating profit dropped by 50.3% to $1.37 billion. These declines are largely attributed to the reduced sales of Vyvanse and increased operating expenses, including impairments related to other products like Alofisel and Exkivity[1][2].

Future Outlook

Takeda has adjusted its core operating profit projections downward by about 10% for the upcoming fiscal year, anticipating around $6.4 million (¥1 billion). The company also expects revenue to be flat or slightly declining, primarily due to the continued sales erosion of Vyvanse[1][2].

Strategic Initiatives to Counter Loss

To mitigate the impact of Vyvanse's loss of exclusivity, Takeda is focusing on several strategic initiatives.

Pipeline Developments

Takeda is advancing several key pipeline projects. This includes initiating a Phase III trial of its tyrosine kinase 2 inhibitor zasocitinib for psoriatic arthritis and a comparative study against Bristol-Myers Squibb’s Sotyktu (deucravacitinib) in treating psoriasis. Additionally, Takeda is awaiting Phase III results for its cholesterol 24-hydroxylase inhibitor soticlestat, which is being investigated for Dravet syndrome and Lennox-Gastaut syndrome[1][2].

Enterprise-Wide Efficiency Program

Takeda is implementing an "enterprise-wide efficiency program" starting in fiscal year 2024, aimed at improving operational efficiency. This initiative is projected to cost nearly $900 million and will focus on organizational agility, procurement savings, and technological efficiencies[1][4].

Market Dynamics and Future Projections

ADHD Market Forecast

The ADHD market, dominated by Vyvanse, is forecasted to decline by $1 billion between 2022 and 2032. This decline is primarily driven by the increasing presence of generic versions of branded ADHD products, including Vyvanse. GlobalData predicts that API shortages affecting generic supplies will be resolved by 2027, leading to significant sales erosion of branded products[5].

Competitive Landscape

The entry of generic versions has altered the competitive landscape of the ADHD market. While Vyvanse's market share is eroding, Takeda's other products, such as Entyvio for inflammatory bowel disease (IBD) and the dengue fever vaccine Qdenga, are showing promising growth. Entyvio has maintained its top position in the U.S. IBD market, and Qdenga has seen strong initial demand in various countries[3].

Key Takeaways

• Loss of Exclusivity: Vyvanse lost critical patent protections in 2023, leading to the introduction of generic versions.
• Sales Decline: Vyvanse sales have declined significantly due to generic competition.
• Financial Impact: Takeda's revenue and profit have been negatively impacted, with a 57% drop in net profit and a 50.3% drop in operating profit.
• Strategic Initiatives: Takeda is focusing on pipeline developments and an enterprise-wide efficiency program to counter the loss.
• Market Forecast: The ADHD market is expected to decline due to increasing generic competition.

FAQs

Q: What was the impact of Vyvanse's loss of exclusivity on Takeda's financial performance?

A: The loss of exclusivity led to a significant decline in Vyvanse sales, resulting in a 57% drop in Takeda's net profit and a 50.3% drop in operating profit for the fiscal year ending March 31, 2024.

Q: How is Takeda responding to the decline in Vyvanse sales?

A: Takeda is advancing its pipeline with new drug trials and implementing an enterprise-wide efficiency program to improve operational efficiency and reduce costs.

Q: What are the key pipeline projects Takeda is focusing on?

A: Takeda is initiating a Phase III trial of its tyrosine kinase 2 inhibitor zasocitinib for psoriatic arthritis and a comparative study against Bristol-Myers Squibb’s Sotyktu. Additionally, it is awaiting Phase III results for its cholesterol 24-hydroxylase inhibitor soticlestat.

Q: How does the ADHD market forecast look in the coming years?

A: The ADHD market is expected to decline by $1 billion between 2022 and 2032 due to increasing generic competition, with API shortages affecting generic supplies expected to be resolved by 2027.

Q: What other products are driving growth for Takeda?

A: Takeda's GI franchise, particularly Entyvio for IBD, and the dengue fever vaccine Qdenga, are showing promising growth and helping to offset the decline in Vyvanse sales.

Sources

1. Synapse: Takeda Lowers Profit Forecast Amid Vyvanse Exclusivity Loss, Plans $900M Restructuring in 2024.
2. BioSpace: Takeda Lowers Profit Outlook Amid Vyvanse Loss of Exclusivity, Eyes $900M Restructuring in 2024.
3. FiercePharma: Takeda treads water despite loss of exclusivity on Vyvanse.
4. FiercePharma: As Vyvanse generics bite, Takeda sets out on $900M restructuring plan.
5. Clinical Trials Arena: 7MM ADHD market forecast to decline by $1bn between 2022 and 2032.

Last updated: 2024-12-17