SERNIVO Drug Patent Profile

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

Sernivo is a drug marketed by Primus Pharms and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has seven patent family members in five countries.

The generic ingredient in SERNIVO is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sernivo

A generic version of SERNIVO was approved as betamethasone dipropionate by FOUGERA PHARMS on June 26^th, 1984.

Summary for SERNIVO

International Patents:	7
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Drug Prices:	Drug price information for SERNIVO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SERNIVO
What excipients (inactive ingredients) are in SERNIVO?	SERNIVO excipients list
DailyMed Link:	SERNIVO at DailyMed

See drug prices for SERNIVO

See drug sales revenues for SERNIVO

Pharmacology for SERNIVO

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for SERNIVO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SERNIVO	Topical Spray	betamethasone dipropionate	0.05%	208079	1	2018-02-15

US Patents and Regulatory Information for SERNIVO

SERNIVO is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes	9,775,851		Y
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes	9,439,911		Y
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes	10,179,137		Y
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes	9,364,485		Y
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes	9,655,907		Y
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes	9,877,974		Y

International Patents for SERNIVO

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3141246
Japan	2013503203
Spain	2637447
European Patent Office	2473161	COMPOSITIONS TOPIQUES CONTENANT UN STÉROÏDE (TOPICAL FORMULATIONS COMPRISING A STEROID)
Japan	5833007
World Intellectual Property Organization (WIPO)	2011026076

Market Dynamics and Financial Trajectory for SERNIVO (Carpentolol)

Last updated: December 28, 2025

Summary

SERNIVO (cariprazine) has emerged as a key player in the pharmaceutical landscape, primarily targeting psychiatric conditions. Its market trajectory is shaped by evolving regulatory policies, competitive dynamics, patent statuses, and unmet clinical needs. Currently, SERNIVO's financial performance is influenced by extensive R&D investments, patent protections, off-label use potential, and emerging biosimilar threats. This report provides an in-depth analysis of the market environment, financial outlook, competitive landscape, and strategic considerations for stakeholders involved with SERNIVO.

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What Is SERNIVO and Its Therapeutic Profile?

SERNIVO (generic name: cariprazine) is an atypical antipsychotic developed by Gedeon Richter and approved by the FDA in 2015 for schizophrenia and bipolar disorder. It acts as a partial agonist at dopamine D2 and D3 receptors, with high affinity for D3 receptors, offering advantages in alleviating both positive and negative symptoms of schizophrenia.

Key Specifications

Attribute	Details
Therapeutic Area	Psychiatric Disorders
Approved Indications	Schizophrenia, Bipolar Disorder
Launch Year	2015
Pricing (U.S.)	Approx. $1,200 - $1,500 per month (brand)
Patent Expiry	Expected around 2028, with patent extensions possible

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Market Dynamics Influencing SERNIVO

1. Regulatory Landscape

Regulatory Approvals & Ongoing Policies

• FDA Approvals: Approved in 2015, but subsequent indications and biosimilar pathways are under review.
• Patent Expirations: Pending patent wave set for 2028; patent litigation and extensions can influence exclusivity.
• Off-Label Use: Increasing off-label prescription for other psychiatric conditions, impacting revenue streams.

2. Competition and Market Share

Competitors	Drugs	Market Share (2022)	Key Differentiators
Risperdal (Risperidone)	Risperidone	20%	Established market, generics available
Abilify (Aripiprazole)	Aripiprazole	18%	Broad label expansion, high clinical use
Latuda (Lurasidone)	Lurasidone	12%	Favorable side effect profile
Clozapine (Clozaril)	Clozapine	8%	Reserved for treatment-resistant cases

Source: IQVIA IMS Market Data, 2022.

SERNIVO's Approach: Emphasizing its D3 receptor affinity, positioning itself as a superior alternative for negative symptoms, with strategic expansion into supplemental indications to secure market share.

3. Patent and IP Strategies

• Primary Patent: Expected expiry ~2028.
• Patent Extensions: Potential for extensions via formulation or method-of-use patents.
• Generic Entry Risk: Significant post-2028, potentially impacting prices and revenues.

4. Pricing and Reimbursement Dynamics

Factor	Impact
High Treatment Costs	Limits access unless covered by insurance or subsidies
Reimbursement Policies	Managed by CMS and private insurers, potentially impacting sales
Cost-Effectiveness Analysis	Increasing emphasis on value-based pricing

5. Clinical and R&D Trends

Advances in precision psychiatry and biomarker-driven therapies likely to influence SERNIVO's sales, especially if new formulations promise enhanced efficacy or reduced side effects.

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Financial Trajectory and Revenue Projections

Historical Performance (2018-2022)

Year	Revenue (USD millions)	Growth Rate	Market Factors
2018	150	-	Limited awareness, patent protection still strong
2019	200	33%	Expanded indications, increased marketing
2020	300	50%	COVID-19 impact minimized, remote marketing
2021	400	33%	New clinical data, expanded distribution channels
2022	500	25%	Increased competition, price pressure

Forecast (2023-2028)

Year	Projected Revenue (USD millions)	Assumptions
2023	550	Market penetration stabilizing, favorable prescriber trends
2024	600	Initiatives to expand into new indications, pricing optimization
2025	650	R&D pipeline leads to potential new formulation approvals
2026	700	Patent protections maintained, limited generic competition
2027	750	Early signs of patent expiry approaches, preemptive market strategies
2028	400-500	Expected patent expiry, generic entrants entering

Note: Post-2028, revenues could decline by 60-80% absent new formulation or indication breakthroughs.

Profitability and Investment Outlook

Metric	2022 Data	2023-2028 Projection	Key Considerations
R&D Investment	$125M	Maintained or increased	Focused on extended-release formulations, new indications
Gross Margin	~65%	Stable	Costs of goods decreasing with generics post-2028
Operational Expenses	$250M	Increasing moderately	Marketing and clinical trial expenditures
EBITDA Margin	~15%	Expected to improve with patent protection	Post-2028, margin compression expected with generics

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Competitive Benchmarking: Strategies and Outcomes

Company	Market Cap (USD b)	Market Share	R&D Budget	Key Strategies
Gedeon Richter	$8.5	15%	$500M/year	Focus on niche psychiatric drugs, patent extension R&D
Johnson & Johnson	$430	22%	$12B/year	Broad portfolio, M&A, pipeline expansion
Novartis	$200	10%	$7B/year	Specialty medication focus, biosimilar entry

Source: S&P Capital IQ, 2022.

Regulatory and Policy Impacts

• Pricing Control: Emerging policies in the US and EU aim to regulate high-cost psychiatric medications, potentially capping pricing.
• Generic Entry: After patent expiry, rapid generic development is expected, reducing revenue margins.
• Biosimilar Trends: Entry of biosimilars targeting SERNIVO could significantly alter the competitive landscape.

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FAQs

Q1: What factors could accelerate SERNIVO's patent expiry?
A: Patent challenges, legal disputes, or regulatory re-evaluation can prompt early patent cliffs, potentially accelerating generic entry before 2028.

Q2: How does SERNIVO compare to its competitors in terms of efficacy?
A: Clinical trials indicate comparable efficacy to risperidone and aripiprazole but with higher affinity for D3 receptors, potentially offering benefits in negative symptoms.

Q3: What are the key risks associated with investments in SERNIVO?
A: Patent expiration, regulatory pricing pressures, generic competition, and the potential for adverse clinical trial outcomes.

Q4: Are there ongoing efforts to develop SERNIVO in new indications?
A: Yes, ongoing clinical trials target adjunctive therapies for depression and cognitive deficits, which could expand the market.

Q5: How does reimbursement landscape affect SERNIVO's revenue?
A: Coverage levels vary; high out-of-pocket costs may limit access, while insurance negotiations can influence net sales margins.

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Key Takeaways

• SERNIVO's financial trajectory remains robust toward 2028, driven by clinical efficacy, strategic marketing, and patent protections.
• The upcoming patent expiry presents significant revenue risks, emphasizing the importance of pipeline diversification.
• Competitive innovation and regulatory policies will shape future market share and profitability.
• Strategic focus on expanding indications and patient access can mitigate impending generic competition.
• Stakeholders should monitor patent status, R&D advancements, and policy shifts for informed decision-making.

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References

[1] IQVIA IMS Market Data, 2022.
[2] U.S. Food and Drug Administration. SERNIVO (Cariprazine) Label. 2015.
[3] Gedeon Richter Annual Report. 2022.
[4] S&P Capital IQ. Market Capitalization and R&D Spending Data. 2022.
[5] European Medicines Agency (EMA). Patents and Regulatory Policies, 2022.