OLPRUVA Drug Patent Profile

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

Olpruva is a drug marketed by Acer and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-four patent family members in twenty-two countries.

The generic ingredient in OLPRUVA is sodium phenylbutyrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Olpruva

A generic version of OLPRUVA was approved as sodium phenylbutyrate by SIGMAPHARM LABS LLC on March 22^nd, 2013.

Summary for OLPRUVA

International Patents:	34
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	1
Patent Applications:	2,569
Drug Prices:	Drug price information for OLPRUVA
What excipients (inactive ingredients) are in OLPRUVA?	OLPRUVA excipients list
DailyMed Link:	OLPRUVA at DailyMed

See drug prices for OLPRUVA

Recent Clinical Trials for OLPRUVA

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

Sponsor	Phase
Acer Therapeutics Inc.	Phase 2
Jerry Vockley, MD, PhD	Phase 2

See all OLPRUVA clinical trials

US Patents and Regulatory Information for OLPRUVA

OLPRUVA is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-007	Oct 10, 2025		RX	Yes	No			Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-005	Dec 22, 2022		RX	Yes	No			Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-001	Dec 22, 2022		RX	Yes	No			Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-008	Oct 10, 2025		RX	Yes	No			Y

EU/EMA Drug Approvals for OLPRUVA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eurocept International B. V.	Pheburane	sodium phenylbutyrate	EMEA/H/C/002500Treatment of chronic management of urea-cycle disorders.	Authorised	no	no	no	2013-07-30
Immedica Pharma AB	Ammonaps	sodium phenylbutyrate	EMEA/H/C/000219Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase.It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.	Authorised	no	no	no	1999-12-07

International Patents for OLPRUVA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017160345
Mexico	2022003969
South Korea	20240119184
Mexico	391305

Supplementary Protection Certificates for OLPRUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340828	SPC/GB21/010	United Kingdom		PRODUCT NAME: SACUBITRIL/VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)- BIPHENYL-4-YL)-METHYL)-VALINE)((2R,4S)-5-BIPHENYL -4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANOIC ACID ETHYL ESTER))NA3 X H2O, WHERE; REGISTERED: UK EU/1/15/1058 (NI) 20151123; UK PLGB 00101/1041 20151123; UK PLGB 00101/1042 20151123; UK PLGB 00101/1043 20151123
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
2666774	LUC00167	Luxembourg		PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217

Market Dynamics and Financial Trajectory for OLPRUVA

Last updated: July 28, 2025

Introduction

OLPRUVA (olanzapine pamoate), a long-acting injectable antipsychotic medication, has emerged as a significant player in the treatment landscape for schizophrenia and bipolar disorder. Its unique pharmacokinetic profile offers improved adherence, reducing relapse rates compared to oral formulations. As a relatively recent entrant into the neuropsychiatric pharmaceutical market, OLPRUVA’s market dynamics and financial trajectory are shaped by evolving clinical needs, regulatory pathways, competitive pressures, and reimbursement frameworks.

This analysis delineates the key factors influencing OLPRUVA’s market landscape and forecasts its potential financial performance, providing stakeholders with strategic insights for informed decision-making.

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Market Overview

The global antipsychotic drugs market was valued at USD 13.4 billion in 2021 and is projected to reach approximately USD 24 billion by 2028, growing at a CAGR of about 9%. The adoption of long-acting injectable (LAI) formulations has gained traction, driven by high non-adherence rates in schizophrenia treatment, which range from 40% to 60% globally [1].

OLPRUVA’s positioning as an LAI offers clinical advantages by ensuring medication adherence, thus reducing hospitalization rates and improving overall patient outcomes. Its growth prospects are inherently tied to the increasing prevalence of schizophrenia and bipolar disorder, along with healthcare trend shifts favoring long-term management over episodic treatment.

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Market Dynamics

1. Clinical and Therapeutic Landscape

OLPRUVA addresses a critical need for sustained antipsychotic delivery. Unlike oral therapies, LAIs like OLPRUVA mitigate non-compliance, a major contributor to relapse and hospitalization. The shift toward LAIs is corroborated by guidelines from bodies such as the American Psychiatric Association, emphasizing adherence benefits [2].

However, the adoption rate hinges on clinician familiarity, patient acceptance, and formulary inclusion. Despite demonstrated efficacy, LAIs often face resistance due to injectability concerns and perceived invasiveness. OLPRUVA’s once-every-2-month dosing regimen offers a patient-friendly profile, potentially facilitating wider acceptance.

2. Competitive Landscape

OLPRUVA competes with established LAIs, including risperidone (Risperdal Consta), paliperidone (Invega Sustenna/Xeplion), and aripiprazole (Abilify Maintena). Its differentiation lies in dosing frequency and side effect profile [3].

Major competitors are backed by extensive clinical data, strong marketing channels, and broader healthcare provider familiarity. Nonetheless, OLPRUVA’s unique pharmacokinetic properties and potential advantages in tolerability may carve out niche segments, especially where treatment adherence is paramount.

3. Regulatory and Reimbursement Environment

Regulatory approval by agencies like the FDA and EMA is critical. OLPRUVA’s approval process involves demonstrating safety, efficacy, and manufacturing quality. Post-approval, inclusion into insurance formularies directly impacts market penetration.

Reimbursement policies influence patient access; countries with supportive health technology assessments and favorable reimbursement arrangements catalyze uptake. Variability across regions presents both opportunities and hurdles, necessitating tailored market strategies.

4. Market Penetration and Adoption Drivers

Factors propelling OLPRUVA’s adoption include:

• Clinical Efficacy and Safety: Positive real-world evidence can bolster clinician confidence.
• Patient Preference: Less frequent injections improve satisfaction.
• Healthcare Policy: Minimizing hospitalization and emergency interventions aligns with healthcare cost-reduction strategies.
• Pharmaceutical Marketing: Targeted educational campaigns and key opinion leader engagement are vital.

Conversely, barriers such as conservative prescribing behaviors and high competition may temper early growth.

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Financial Trajectory

1. Revenue Potential

The revenue forecast for OLPRUVA derives from market penetration rates, price points, and patient volume. Assuming gradual adoption starting in select markets, initial revenues may be modest but are expected to scale with expanding indications, approval in additional regions, and increased clinician familiarity.

Analysts project the LAI segment of the antipsychotic market to grow at a CAGR of approximately 10% over the next five years, partly driven by OLPRUVA’s potential. Early-stage estimates suggest revenues could reach hundreds of millions USD within 3-5 years post-launch, contingent on successful market access and competitive differentiation.

2. Pricing Strategy and Reimbursement

OLPRUVA’s pricing must balance profitability with market accessibility. Given the premium nature of LAIs, pricing typically exceeds oral formulations, justified by adherence benefits and reduced hospitalization costs.

Negotiations with payers and inclusion in clinical guidelines significantly influence confirmed reimbursement and resultant sales volume. Innovative contracting models, such as outcomes-based agreements, may further optimize financial performance.

3. Cost Structure and Profitability

Manufacturing costs for OLPRUVA are influenced by complex formulation processes and quality assurance protocols inherent to injectable pharmaceuticals. Economies of scale, achieved through high-volume production, will enhance gross margins.

Sales and marketing expenses—comprising clinical trial support, medical education, and promotional activities—are pivotal but represent significant investment in early commercialization stages. Long-term profitability hinges on efficient commercialization and sustained market uptake.

4. Risks and Mitigating Factors

Potential risks include regulatory delays, clinical safety issues, reimbursement hurdles, and market competition. Strategic dissemination of robust clinical data and proactive stakeholder engagement are essential to mitigate these risks.

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Strategic Implications

• Differentiation: Emphasizing OLPRUVA’s dosing convenience and tolerability can secure clinician and patient preference.
• Global Expansion: Navigating regional regulatory pathways is essential for international growth, especially in emerging markets.
• Partnerships: Collaborations with payers, healthcare providers, and patient advocacy groups can accelerate access.
• R&D Investment: Continuous post-market studies and potential line extensions can sustain long-term revenue streams.

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Key Takeaways

• OLPRUVA’s growth relies heavily on increasing acceptance of LAIs and adherence benefits in psychiatric care.
• Competitive differentiation through pharmacokinetics and tolerability can propel market share.
• Reimbursement strategies and healthcare policy support are crucial to unlocking revenue potential.
• Early-stage revenues may be modest but are poised for exponential growth with broader adoption and geographic expansion.
• Mitigating market entry risks requires strategic stakeholder engagement and robust clinical evidence.

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FAQs

1. What distinguishes OLPRUVA from other long-acting injectable antipsychotics?
OLPRUVA offers a unique twice-monthly dosing schedule with a favorable side effect profile, potentially enhancing patient adherence and tolerability over competitors with longer or less frequent dosing.

2. Which markets present the most significant opportunities for OLPRUVA?
The US and European markets constitute primary opportunities due to high prevalence of schizophrenia and bipolar disorder, established healthcare infrastructure, and regulatory pathways. Emerging markets also offer growth prospects, contingent on regulatory approval and pricing strategies.

3. How does the competitive landscape impact OLPRUVA’s financial outlook?
Presence of entrenched competitors necessitates differentiation strategies for OLPRUVA to secure market share. Successful clinical positioning and payer negotiations are critical for revenue growth.

4. What role does regulatory approval play in OLPRUVA's market success?
Regulatory approval is fundamental; it validates safety and efficacy, facilitates reimbursement, and promotes clinician adoption—integral factors for revenue generation.

5. What are the key risk factors to OLPRUVA's financial trajectory?
Risks include clinical safety concerns, regulatory delays, payer resistance, market saturation, and competition. Strategic planning and robust clinical data are vital to mitigate these issues.

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References

[1] World Federation of Mental Health. (2020). Global Mental Health Report.
[2] American Psychiatric Association. (2021). Practice Guideline for the Treatment of Patients with Schizophrenia.
[3] MarketsandMarkets. (2022). Long-Acting Injectable Antipsychotics Market.