Cariprazine hydrochloride - Generic Drug Details

What are the generic sources for cariprazine hydrochloride and what is the scope of patent protection?

Cariprazine hydrochloride is the generic ingredient in two branded drugs marketed by Sun Pharm, Zydus, and Abbvie, and is included in three NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cariprazine hydrochloride has one hundred and twenty-one patent family members in forty-two countries.

There are two drug master file entries for cariprazine hydrochloride. One supplier is listed for this compound.

Summary for cariprazine hydrochloride

International Patents:	121
US Patents:	5
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	45
Patent Applications:	243
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cariprazine hydrochloride
DailyMed Link:	cariprazine hydrochloride at DailyMed

Recent Clinical Trials for cariprazine hydrochloride

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

Sponsor	Phase
Mapi Pharma Ltd.	PHASE1
Centre for Addiction and Mental Health	PHASE1
University Health Network, Toronto	PHASE1

See all cariprazine hydrochloride clinical trials

Pharmacology for cariprazine hydrochloride

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for cariprazine hydrochloride

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for CARIPRAZINE HYDROCHLORIDE

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 cariprazine hydrochloride

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	204370-003	Sep 17, 2015		RX	Yes	No			Y	Y
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-002	Sep 17, 2015		RX	Yes	No			Y	Y
Sun Pharm	CARIPRAZINE HYDROCHLORIDE	cariprazine hydrochloride	CAPSULE;ORAL	213932-003	Sep 30, 2022		DISCN	No	No
Sun Pharm	CARIPRAZINE HYDROCHLORIDE	cariprazine hydrochloride	CAPSULE;ORAL	213932-004	Sep 30, 2022		DISCN	No	No
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-004	Sep 17, 2015		RX	Yes	No			Y	Y
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015		RX	Yes	Yes
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-004	Sep 17, 2015		RX	Yes	No

International Patents for cariprazine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Spain	2532636
Malaysia	142760	(THIO) CARBAMOYL-CYCLOHEXANE DERIVATIVES AS D3/D2 RECEPTOR ANTAGONISTS
South Korea	101612146
Hungary	S1700044
China	101679315
Colombia	6351689	FORMULACIONES FARMACEUTICAS QUE CONTIENEN LIGANDOS DE RECEPTORES DE DOPAMINA
Georgia, Republic of	P20125522

Supplementary Protection Certificates for cariprazine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663996	C201730042	Spain		PRODUCT NAME: CARIPRAZINA, O SUS SALES, INCLUYENDO HIDROCLORURO DE CARIPRAZINA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1209; DATE OF AUTHORISATION: 20170713; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1209; DATE OF FIRST AUTHORISATION IN EEA: 20170713
1663996	122017000083	Germany		PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 20170713
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	345 50018-2017	Slovakia		PRODUCT NAME: KARIPRAZIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1209 20170717
1663996	SPC/GB17/059	United Kingdom		PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING CARIPRAZINE HYDROCHLORIDE; REGISTERED: UK EU/1/17/1209/001-040 20170717; UK PLGB 04854/0173 20170717; UK PLGB 04854/0174 20170717; UK PLGB 04854/0175 20170717; UK PLGB 04854/0176 20170717
1663996	17C0008	France		PRODUCT NAME: CARIPRAZINE,FACULTATIVEMENT SOUS FORME D'UN SEL,INCLUANT L'HYDROCHLORURE DE CARIPRAZINE.; REGISTRATION NO/DATE: EU/1/17/1209 20170717
1663996	2017/050	Ireland		PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/17/1209 20170713

Market Dynamics and Financial Trajectory for Cariprazine Hydrochloride

Last updated: July 30, 2025

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Introduction

Cariprazine hydrochloride is an atypical antipsychotic developed by Gedeon Richter and marketed predominantly by Allergan (now part of AbbVie) under the brand name Vraylar in the United States. Approved by the FDA in 2015 for schizophrenia and bipolar disorder, cariprazine's unique pharmacological profile offers distinct therapeutic advantages. Understanding its market dynamics and financial trajectory requires analyzing current demand drivers, competitive landscape, regulatory influences, pricing strategies, and future growth prospects.

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Market Overview

The global antipsychotic drug market is projected to reach USD 28.66 billion by 2027, expanding at a CAGR of 4.4% (Research and Markets, 2022). Cariprazine occupies a specialized niche within this sector, predominantly targeting unmet needs in schizophrenia and bipolar disorder management. Its differentiation stems from receptor binding selectivity, particularly for dopamine D3 receptors, which may translate into fewer side effects and better adherence.

Key Market Drivers

1. Growing Incidence of Schizophrenia and Bipolar Disorder

The prevalence of schizophrenia globally affects approximately 20 million people, with bipolar disorder impacting over 60 million (WHO, 2021). Increasing diagnosis rates, driven by improved awareness and diagnostic tools, amplify demand for novel atypical antipsychotics such as cariprazine.

2. Unmet Medical Needs and Therapeutic Advantages

Cariprazine’s unique receptor profile offers potential benefits over other antipsychotics, including lower metabolic side effects and cognitive benefits. This positions it favorably for patients intolerant or resistant to existing therapies, expanding its market uptake.

3. Regulatory Support and Label Expansion

Post-approval, regulatory agencies have approved additional indications, including bipolar I disorder and depression adjunct therapy, broadening its therapeutic application and market segments.

Competitive Landscape

The market features several major players: Risperdal (risperidone), Zyprexa (olanzapine), Seroquel (quetiapine), and aripiprazole (Abilify). Cariprazine’s distinct receptor activity (notably for D3) offers a differentiated pharmacological edge, although competition remains fierce in terms of efficacy, safety profiles, and brand recognition.

Patent expiration concerns are less pressing for cariprazine; however, exclusivity periods are finite, prompting generic entrants post-expiry, which could impact revenue streams.

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Financial Trajectory and Revenue Drivers

Historical Revenue Performance

Since its launch, Vraylar’s sales have seen robust growth, driven by incremental approval and expanding indications. For instance, in 2021, AbbVie's Vraylar generated approximately USD 770 million globally, representing a notable increase from USD 620 million in 2020 (ABBV revenue reports). Such growth is expected to sustain as the drug penetrates new markets and indications.

Pricing Strategies

Pricing varies by country, with high reimbursement rates in the US and Europe. In the US, the average wholesale price (AWP) for Vraylar is approximately USD 35 per day, positioning it within the premium segment for antipsychotics. Market access negotiations, payor restrictions, and competition from generics post-patent expiry will influence future pricing and revenue.

Market Penetration and Expansion

• North America: Dominates sales, benefiting from early adoption, favorable reimbursement, and robust healthcare infrastructure. Add-on indications could significantly elevate revenues, especially if approved for treatment-resistant depression or other neuropsychiatric conditions.

• Europe and Asia-Pacific: Market entry and expansion are ongoing, with regulatory approvals in key countries like Germany, UK, Japan, and South Korea. Growth here hinges on local pricing policies, healthcare infrastructure, and awareness campaigns.

Future Growth Prospects

Analysts project Vraylar’s global sales could reach USD 2 billion by 2027, factoring in increased penetration, new indications, and increased adoption rates – a compounded annual growth rate (CAGR) of approximately 15-20%. Market share gains will depend on competitive developments, regulatory hurdles, and pricing flexibility.

Regulatory Trends and Challenges

Regulatory agencies are increasingly emphasizing safety and efficacy data, particularly for elderly populations and children. Pending data on long-term safety, cognitive benefits, and metabolic profiles could influence future approvals and prescribing patterns. Regulatory delays or rejections in key markets may impact revenue projections.

Market Risks and Opportunities

Risks

• Patent expiry could facilitate generic competition, reducing prices and margins.
• Emergence of new atypical antipsychotics with superior efficacy or safety profiles can threaten market share.
• Regulatory hurdles for expanding indications or in different regions may delay revenue growth.

Opportunities

• Expanding indications (e.g., depression adjunct therapy) could diversify revenue streams.
• Strategic alliances or licensing deals in emerging markets can accelerate growth.
• Ongoing clinical research could establish neuroprotective or cognitive-enhancing indications.

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Pricing and Reimbursement Outlook

Pricing remains a critical factor, with payers increasingly adopting value-based models. As long-term safety and efficacy data favor cariprazine, reimbursements are expected to stabilize, supporting revenue. Negotiations with payers and inclusion in formulary tiers will influence access and acceptance.

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Conclusion

Cariprazine hydrochloride’s market dynamics are shaped by its clinical positioning, growing prevalence of target disorders, and strategic expansion across indications and geographies. Its financial trajectory is promising, contingent upon market penetration, regulatory progress, and competitive pressures. Continued innovation, evidence generation, and strategic market development will be essential for AbbVie's long-term revenue growth.

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Key Takeaways

• Market Potential: The global antipsychotic market’s growth trajectory favors cariprazine, especially with expanding indications and increasing diagnosed cases.
• Revenue Outlook: Vraylar’s sales are projected to exceed USD 2 billion globally by 2027, driven by expanding indications and geographic penetration.
• Competitive Edge: Its unique receptor profile offers potential advantages, though patent expiration and generic competition pose future challenges.
• Pricing and Reimbursement: High drug prices sustain revenues but require strategic negotiations and payor alignments across markets.
• Risks and Opportunities: Patent cliffs, regulatory hurdles, and competitive dynamics present risks; ongoing clinical trials and indication expansions remain significant opportunities.

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FAQs

Q1: What are the primary therapeutic indications for cariprazine hydrochloride?
A1: Approved indications include schizophrenia and bipolar I disorder in adults. Expansion to adjunctive treatment for depression is under investigation.

Q2: How does cariprazine’s mechanism of action differ from other atypical antipsychotics?
A2: Cariprazine has high affinity for D3 and D2 dopamine receptors, with partial agonist activity at D3, which may contribute to cognitive and negative symptom improvements.

Q3: What is the competitive landscape for cariprazine?
A3: It faces competition from established atypical antipsychotics such as risperidone, olanzapine, quetiapine, and aripiprazole, which have broader market penetration and brand recognition.

Q4: What are the key factors affecting the revenue growth of Vraylar in emerging markets?
A4: Key factors include regulatory approval timelines, pricing negotiations, healthcare infrastructure, and market awareness.

Q5: What future developments could influence the financial trajectory of cariprazine?
A5: Successful approval for additional indications, long-term safety data, and strategic partnerships in emerging markets are likely to boost revenues; patent expirations and new competitors could dampen growth.

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References

1. Research and Markets. (2022). Global Antipsychotic Market Report.
2. WHO. (2021). Mental health: New understanding, new hope.
3. ABBVIE. (2022). Vraylar Sales Reports and Financials.

Note: All sales figures and projections are estimates based on available market reports and company disclosures.