Cariprazine hydrochloride - Generic Drug Details

What are the generic drug 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:	46
Clinical Trials:	41
Patent Applications:	195
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
The Medical Research Network	Phase 4
AbbVie	Phase 4
AbbVie	Phase 3

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	204370-004	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
Zydus	CARIPRAZINE HYDROCHLORIDE	cariprazine hydrochloride	CAPSULE;ORAL	213984-001	Sep 9, 2022		DISCN	No	No
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015		RX	Yes	Yes	RE49110
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015		RX	Yes	Yes	7,943,621		Y	Y

International Patents for cariprazine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Colombia	6241112	SALES NOVEDOSAS DE PIPERAZINA COMO ANTAGONISTAS D3/D2
Australia	2009270823	Pharmaceutical formulations containing dopamine receptor ligands
Serbia	56036	SOLI PIPERAZINA KAO D3/D2 ANTAGONISTI (PIPERAZINE SALTS AS D3/D2 ANTAGONISTS)
South Africa	200907511	Novel piperazine salts as D3/D2 antagonists
China	104997743	Pharmaceutical formulations containing dopamine receptor ligands

Supplementary Protection Certificates for cariprazine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1663996	PA2017027,C1663996	Lithuania		PRODUCT NAME: KARIPRAZINAS, PASIRINKTINAI DRUSKOS FORMOS, ISKAITANT KARIPRAZINO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996	47/2017	Austria		PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZIN HYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 (MITTEILUNG) 20170717
1663996	132017000122667	Italy		PRODUCT NAME: CARIPRAZINA, OPZIONALMENTE NELLA FORMA DI UN SALE, INCLUSO CARIPRAZINA CLORIDRATO(REAGILA - CARIPRAZINA); AUTHORISATION NUMBER(S) AND DATE(S): 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

Market Dynamics and Financial Trajectory for Cariprazine Hydrochloride

Market Overview

Cariprazine hydrochloride, marketed under the brand name Vraylar, is an atypical antipsychotic drug used primarily for the treatment of schizophrenia and as an adjunctive therapy for major depressive disorder (MDD). Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global cariprazine hydrochloride market was valued at US$ 258 million in 2023 and is projected to reach US$ 353.6 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.6% during the forecast period of 2024-2030[1].

Key Players

The market is dominated by several major pharmaceutical companies, including SUN PHARMACEUTICAL INDUSTRIES LTD, AUROBINDO PHARMA LTD, BIOPHORE INDIA PHARMACEUTICALS PVT LTD, MAPRIMED SA, MSN LABORATORIES PRIVATE LTD, and GEDEON RICHTER PLC[1].

Applications and Types

Cariprazine hydrochloride is available in various forms, primarily capsules, and is categorized based on purity levels: Purity ≥ 99% and Purity < 99%[1].

Economic Impact on MDD Treatment

The use of cariprazine as an adjunctive therapy for MDD has significant economic implications. Patients who received cariprazine as their first adjunctive therapy had 45% fewer mental health-related hospitalizations and 33% fewer outpatient visits compared to those who received it as a subsequent therapy. This resulted in $2,182 lower total mental health-related healthcare costs per patient per year, primarily due to reduced outpatient visit costs[2].

Cost Savings

• The average hospital stay for MDD lasts approximately 6 days, costing around $6,713 per hospitalization. Reducing these hospitalizations can lead to substantial cost savings for the healthcare system[2].

Long-term Implications

While the study highlighted significant short-term cost savings, it also noted limitations in assessing long-term outcomes due to the relatively short follow-up period of 1.2-1.7 years. Longer-term studies are needed to fully understand the economic benefits of early cariprazine use in MDD treatment[2].

Pharmacoeconomic Analysis

In pharmacoeconomic evaluations, cariprazine has been compared to other antipsychotic agents. For instance, in Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH) conducted a cost comparison that showed cariprazine to be more expensive than most other atypical antipsychotics (AAPs), except for certain doses of lurasidone and paliperidone. To be cost-effective, the price of cariprazine would need to be reduced by 71% to 93% to match the lowest-priced generic AAP (olanzapine)[3].

Comparative Efficacy and Costs

• The CADTH review indicated that the clinical benefit of cariprazine for treating predominant negative symptoms (PNS) and its long-term comparative efficacy are uncertain. The annual drug cost of cariprazine for treating schizophrenia is approximately $1,789 per patient, which is higher than most comparators[3].

Market Segmentation and Regional Analysis

The market for cariprazine hydrochloride is segmented by type, application, production region, and consumption region. Key regions include North America, Europe, Asia-Pacific, and others, each with varying market dynamics and growth prospects[4].

Challenges and Concerns

Reimbursement and Coverage

Drug plans have raised concerns about the high cost of cariprazine compared to other AAPs. There are also questions about whether cariprazine should be covered only as monotherapy and the need for increased monitoring due to its longer half-life, particularly in rural areas with limited psychiatric services[3].

Clinical Evidence and Efficacy

The clinical evidence supporting cariprazine’s efficacy, especially for PNS, is limited, and there is a lack of head-to-head studies comparing cariprazine to other AAPs. This uncertainty affects its reimbursement and coverage decisions[3].

Future Outlook

Given the growing prevalence of mental health disorders, the demand for effective treatments like cariprazine hydrochloride is expected to increase. However, the market's growth will be influenced by factors such as pricing strategies, reimbursement policies, and the availability of alternative treatments.

Potential in Treating Anhedonia

Cariprazine may also have potential in treating anhedonia, a key symptom of MDD, which could further expand its market scope and financial trajectory[2].

Key Takeaways

• Market Growth: The global cariprazine hydrochloride market is projected to grow at a CAGR of 4.6% from 2024 to 2030.
• Economic Impact: Early use of cariprazine in MDD treatment can lead to significant cost savings by reducing hospitalizations and outpatient visits.
• Pharmacoeconomic Analysis: Cariprazine is more expensive than most other AAPs, necessitating price reductions to be cost-effective.
• Challenges: High costs, limited clinical evidence, and reimbursement concerns are key challenges facing the market.

FAQs

What is the current market size of cariprazine hydrochloride?

The global cariprazine hydrochloride market was valued at US$ 258 million in 2023[1].

What is the projected growth rate of the cariprazine hydrochloride market?

The market is expected to grow at a CAGR of 4.6% from 2024 to 2030[1].

How does cariprazine impact the cost of treating MDD?

Cariprazine can reduce MDD-related hospitalizations and outpatient visits, leading to lower healthcare costs, with an estimated $2,182 savings per patient per year[2].

Why is cariprazine more expensive than other AAPs?

Cariprazine's higher cost is due to its pricing strategy and the lack of evidence to justify a price premium over other AAPs, necessitating significant price reductions to be cost-effective[3].

What are the main concerns regarding the reimbursement of cariprazine?

Concerns include its high cost, the need for increased monitoring due to its longer half-life, and limited clinical evidence supporting its efficacy compared to other AAPs[3].

Sources

1. Valuates Reports: Global Cariprazine Hydrochloride Market Report.
2. Drug Discovery Trends: Exploring the potential of cariprazine for MDD cost savings.
3. NCBI Bookshelf: Pharmacoeconomic Review - Cariprazine (Vraylar).
4. Market Research Reports: Global Cariprazine Hcl API Market 2024 by Manufacturers, Regions, Type, and Application Forecast to 2030.

Last updated: 2024-12-16