VRAYLAR Drug Patent Profile

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

Vraylar is a drug marketed by Abbvie and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-one patent family members in forty-two countries.

The generic ingredient in VRAYLAR is cariprazine hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cariprazine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Vraylar

Vraylar was eligible for patent challenges on September 17, 2019.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for VRAYLAR

International Patents:	121
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	9
Patent Applications:	60
Drug Prices:	Drug price information for VRAYLAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VRAYLAR
What excipients (inactive ingredients) are in VRAYLAR?	VRAYLAR excipients list
DailyMed Link:	VRAYLAR at DailyMed

See drug prices for VRAYLAR

Recent Clinical Trials for VRAYLAR

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

Sponsor	Phase
The Medical Research Network	Phase 4
AbbVie	Phase 4
AbbVie	Phase 3

See all VRAYLAR clinical trials

Pharmacology for VRAYLAR

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for VRAYLAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VRAYLAR	Capsules	cariprazine hydrochloride	1.5 mg, 3 mg, 4.5 mg and 6 mg	204370	3	2019-09-17

US Patents and Regulatory Information for VRAYLAR

VRAYLAR is protected by fifteen US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-002	Sep 17, 2015		RX	Yes	No	RE49302
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015		RX	Yes	Yes	7,737,142		Y	Y
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-004	Sep 17, 2015		RX	Yes	No	7,943,621		Y	Y
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-002	Sep 17, 2015		RX	Yes	No	RE49110

International Patents for VRAYLAR

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

Country	Patent Number	Title	Estimated Expiration
Georgia, Republic of	P20125522	NOVEL PIPERAZINE SALTS AS D3/D2 ANTAGONISTS
Australia	2008249772	Novel piperazine salts as D3/D2 antagonists
San Marino	T201500063	Formulazioni farmaceutiche contenenti ligandi del recettore della dopamina
Denmark	1663996

Supplementary Protection Certificates for VRAYLAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663996	PA2017027,C1663996	Lithuania		PRODUCT NAME: KARIPRAZINAS, PASIRINKTINAI DRUSKOS FORMOS, ISKAITANT KARIPRAZINO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996	674	Finland
1663996	300913	Netherlands		PRODUCT NAME: CARIPRAZINE, OPTIONEEL IN DE VORM VAN EEN ZOUT, WAARONDER CARIPRAZINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/17/1209 20170717
1663996	122017000083	Germany		PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 20170713

VRAYLAR Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for VRAYLAR

Introduction to VRAYLAR

VRAYLAR, developed by AbbVie, is a significant player in the pharmaceutical market, particularly in the treatment of psychiatric and neurological disorders. Initially approved for schizophrenia and bipolar disorder, VRAYLAR has recently expanded its indications to include major depressive disorder (MDD), making it a crucial drug in the neuroscience portfolio.

Mechanism of Action and Clinical Use

VRAYLAR's mechanism of action is believed to involve partial agonist activity at central dopamine D2 and serotonin receptors, although the exact mechanism is still considered unknown[1].

The drug has been approved for several indications, including:

• Schizophrenia
• Depressive episodes associated with bipolar I disorder
• Acute manic and mixed episodes associated with bipolar I disorder
• Major depressive disorder (MDD) as an adjunctive therapy to antidepressants[1].

Market Approval and Impact

The FDA approval for MDD was based on a phase 3 trial involving 751 patients across seven countries who had an inadequate clinical response to antidepressant monotherapy. The trial demonstrated a statistically significant improvement in depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)[1].

This approval is particularly significant given the large patient population suffering from MDD, with about half of the patients experiencing persistent depressive symptoms despite initial treatment. The economic burden of MDD is substantial, estimated at around $326 billion in the U.S. in 2020[1].

Financial Performance

VRAYLAR has shown impressive financial growth, reflecting its increasing market presence and expanded indications.

• 2021 Sales: VRAYLAR garnered sales of just over $1.7 billion[1].
• 2023 Financial Results: Global Vraylar net revenues increased by 39.8% to $789 million[2].
• Third-Quarter 2024 Results: Global Vraylar net revenues rose by 16.6% to $875 million[5].

These figures indicate a strong upward trend in the drug's revenue, driven by its expanded use in treating MDD and other psychiatric conditions.

Market Forecast and Projections

Market forecasts suggest that VRAYLAR will continue to be a major player in the treatment-resistant depression market.

• Market Growth: The market for treatment-resistant depression is expected to expand due to extensive research and increased healthcare spending globally. This expansion will enable drug manufacturers to penetrate deeper into the market[3][4].
• Peak Sales Potential: AbbVie's CEO, Rick Gonzalez, has projected that VRAYLAR's peak sales could reach $4 billion, highlighting the drug's significant market potential[1].
• Forecasted Sales: Detailed market assessments predict continued growth in VRAYLAR sales through 2032, with comprehensive forecasts available for major markets including the U.S., EU5, and Japan[3][4].

Competitive Landscape

The market for MDD treatments is highly competitive, with several other drugs and emerging therapies.

• Competitors: Other notable treatments include Axome Therapeutics' Auvelity, the first fast-acting oral MDD treatment, and Johnson & Johnson's Spravato, an esketamine nasal spray approved in 2019[1].
• Emerging Therapies: The launch of late-stage emerging therapies in the near future is expected to provide significant competition to VRAYLAR, influencing its market dominance[3][4].

Regulatory and Developmental Milestones

VRAYLAR's development and regulatory milestones are crucial for its market position.

• Regulatory Approvals: The recent FDA approval for MDD is a significant milestone, expanding the drug's therapeutic scope[1].
• Clinical Trials: Ongoing and completed clinical trials continue to support VRAYLAR's efficacy and safety profile, which is essential for maintaining and growing its market share[4].

SWOT Analysis

A SWOT analysis provides a comprehensive view of VRAYLAR's market position:

• Strengths: Strong clinical trial data, expanded indications, and significant revenue growth.
• Weaknesses: Competition from emerging therapies, dependence on AbbVie's overall financial health.
• Opportunities: Growing market for MDD treatments, potential for further indication expansions.
• Threats: Biosimilar competition for other AbbVie drugs like Humira, regulatory challenges[3][4].

Key Takeaways

• VRAYLAR has secured a significant place in the treatment of psychiatric disorders, including MDD.
• The drug has shown robust financial growth and is projected to continue this trend.
• The competitive landscape is dynamic, with emerging therapies posing potential challenges.
• Regulatory and developmental milestones are critical for VRAYLAR's continued success.

FAQs

Q: What are the primary indications for VRAYLAR? A: VRAYLAR is approved for schizophrenia, depressive episodes associated with bipolar I disorder, acute manic and mixed episodes associated with bipolar I disorder, and major depressive disorder (MDD) as an adjunctive therapy to antidepressants[1].

Q: How has VRAYLAR performed financially in recent years? A: VRAYLAR has seen significant revenue growth, with sales increasing from $1.7 billion in 2021 to $789 million in the full year of 2023 and $875 million in the third quarter of 2024[1][2][5].

Q: What is the projected peak sales potential for VRAYLAR? A: According to AbbVie's CEO, Rick Gonzalez, VRAYLAR's peak sales could eventually reach $4 billion[1].

Q: What are the main competitors for VRAYLAR in the MDD market? A: Key competitors include Axome Therapeutics' Auvelity and Johnson & Johnson's Spravato, along with other emerging therapies[1].

Q: How does VRAYLAR's mechanism of action contribute to its efficacy? A: VRAYLAR's efficacy is believed to result from its partial agonist activity at central dopamine D2 and serotonin receptors, although the exact mechanism is still considered unknown[1].

Sources

1. FiercePharma: AbbVie's Vraylar approved to treat major depressive disorder[1].
2. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results[2].
3. ResearchAndMarkets: VRAYLAR, Emerging Drug Insight and Market Forecast - 2032[3].
4. MarketResearch: VRAYLAR Emerging Drug Insight and Market Forecast – 2032[4].
5. PR Newswire: AbbVie Reports Third-Quarter 2024 Financial Results[5].