You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

PALIPERIDONE PALMITATE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Paliperidone Palmitate, and when can generic versions of Paliperidone Palmitate launch?

Paliperidone Palmitate is a drug marketed by Teva Pharms Usa and is included in one NDA.

The generic ingredient in PALIPERIDONE PALMITATE is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Paliperidone Palmitate

A generic version of PALIPERIDONE PALMITATE was approved as paliperidone palmitate by TEVA PHARMS USA on July 6th, 2021.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for PALIPERIDONE PALMITATE?
  • What are the global sales for PALIPERIDONE PALMITATE?
  • What is Average Wholesale Price for PALIPERIDONE PALMITATE?
Drug patent expirations by year for PALIPERIDONE PALMITATE
Recent Clinical Trials for PALIPERIDONE PALMITATE

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

SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Janssen-Cilag International NVPhase 4
Luye Pharma Group Ltd.Phase 1

See all PALIPERIDONE PALMITATE clinical trials

Medical Subject Heading (MeSH) Categories for PALIPERIDONE PALMITATE
Anatomical Therapeutic Chemical (ATC) Classes for PALIPERIDONE PALMITATE
Paragraph IV (Patent) Challenges for PALIPERIDONE PALMITATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
INVEGA TRINZA Extended-release Injectable Suspension paliperidone palmitate 273 mg/0.875 mL and 410 mg/1.315 mL 207946 1 2021-07-14
INVEGA TRINZA Extended-release Injectable Suspension paliperidone palmitate 819 mg/2.625 mL 207946 1 2021-04-30
INVEGA TRINZA Extended-release Injectable Suspension paliperidone palmitate 546 mg/1.75 mL 207946 1 2020-06-24
INVEGA SUSTENNA Extended-release Injectable Suspension paliperidone palmitate 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL and 234 mg/1.5 mL 022264 1 2017-11-21

US Patents and Regulatory Information for PALIPERIDONE PALMITATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa PALIPERIDONE PALMITATE paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 211149-001 Jul 6, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa PALIPERIDONE PALMITATE paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 211149-004 Jul 6, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa PALIPERIDONE PALMITATE paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 211149-002 Jul 6, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa PALIPERIDONE PALMITATE paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 211149-003 Jul 6, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa PALIPERIDONE PALMITATE paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 211149-005 Jul 6, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PALIPERIDONE PALMITATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Paliperidone Palmitate

Introduction

Paliperidone palmitate, a long-acting injectable atypical antipsychotic, has been gaining significant traction in the pharmaceutical market due to its efficacy in treating schizophrenia and other psychiatric disorders. This article delves into the market dynamics and financial trajectory of paliperidone palmitate, highlighting key trends, drivers, and challenges.

Market Growth and Projections

The paliperidone palmitate API market has experienced rapid and substantial growth in recent years. Projections indicate a continued significant expansion from 2023 to 2031, driven by the upward trend in market dynamics and sustained growth rates[1].

Segmentation and Market Size

The market is segmented based on type (min purity less than 98%, min purity 98%-99%, min purity more than 99%) and application (research, pharmaceutical). Geographically, the market spans North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The report provides detailed market size and predictions in USD million across these segments[1].

Drivers of Market Growth

Several factors are driving the growth of the paliperidone palmitate market:

Improved Medication Adherence

Long-acting injectable (LAI) formulations of paliperidone palmitate significantly improve medication adherence among patients with schizophrenia, reducing recurrence and rehospitalization rates without compromising clinical efficacy[3].

Clinical Efficacy

Paliperidone palmitate has demonstrated superior performance in reducing recurrence rates, treating negative symptoms, and improving patients’ quality of life compared to first-generation antipsychotics[3].

Economic Benefits

Cost-utility analyses indicate that paliperidone palmitate formulations are more cost-effective than oral extended-release (ER) formulations, especially when considering the long-term benefits and reduced hospitalization costs[3][4].

Financial Performance of Key Players

Companies like Johnson & Johnson, which markets paliperidone palmitate under brands such as INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA, have seen significant sales growth. For instance, Johnson & Johnson reported a 13.8% increase in pharmaceutical sales in 2021, partly driven by the performance of these products[2].

Competitive Scenario

The market is competitive, with several key players including Tecoland, Jigs Chemical, VEEPRHO, Bal Pharma, Venkatasai Life Sciences, MuseChem, Pharmaffiliates, Wuhan Fortuna Chemical, and CHEMVON BIOTECHNOLOGY (SHANGHAI). These companies are profiled in market reports, providing insights into their market entry, product offerings, and other relevant factors[1].

Market Outlook and Trends

Porter's 5 Forces Framework

The market outlook includes an extensive exploration of Porter's 5 Forces Framework, which helps in understanding the competitive intensity and attractiveness of the market. This framework considers factors such as the threat of new entrants, the threat of substitute products, the bargaining power of buyers and suppliers, and the intensity of competitive rivalry[1].

Macroeconomic Scrutiny

Macroeconomic factors, including national GDP, dynamics within the overarching market and its submarkets, and the economic, political, and social landscapes of countries, are crucial in shaping the market trajectory. These factors influence product pricing, market penetration, and consumer behavior[1].

Value Chain Analysis

A detailed value chain analysis provides insights into the various stages of the product lifecycle, from raw material sourcing to end-user delivery. This analysis helps in identifying cost-saving opportunities and optimizing the supply chain[1].

Cost-Utility Analysis

Studies have shown that paliperidone palmitate formulations are cost-effective compared to oral extended-release formulations. For example, a cost-utility analysis in China revealed that after 20 years, the use of paliperidone palmitate 1-month formulation (PP1M) and 3-month formulation (PP3M) resulted in increased quality-adjusted life years (QALYs) at a lower incremental cost-effectiveness ratio (ICER) than ER[3].

Regional Market Dynamics

Asia-Pacific

In countries like China, despite the advantages of LAIs, their usage remains relatively low due to high costs. However, with paliperidone palmitate included in the national medical insurance system, prescription rates are expected to increase gradually[3].

Developed Markets

In developed countries, the prescription rate for antipsychotic LAIs is significantly higher, ranging from 18% to 30%. This difference in usage highlights the potential for growth in emerging markets[3].

Challenges and Opportunities

High Costs

One of the primary challenges is the high cost of paliperidone palmitate, which can be a barrier to adoption, especially in regions with limited healthcare budgets[3].

Generic Entry

The entry of generic versions of paliperidone palmitate could reduce costs and increase accessibility. Simulations suggest that price reductions due to generic entry could make these formulations more cost-effective[3].

Regulatory Environment

Changes in regulatory policies and reimbursement rates can significantly impact the market. For instance, the inclusion of paliperidone palmitate in national medical insurance systems can boost prescription rates[3].

Future Prospects

The future of the paliperidone palmitate market looks promising, driven by increasing demand for effective and adherence-friendly treatments for schizophrenia. As more countries include these formulations in their healthcare systems, the market is expected to expand further.

Key Takeaways

  • The paliperidone palmitate API market is projected to experience significant growth from 2023 to 2031.
  • Improved medication adherence and clinical efficacy are key drivers of market growth.
  • Cost-utility analyses indicate that paliperidone palmitate formulations are more cost-effective than oral ER formulations.
  • Regional dynamics, including regulatory changes and generic entry, will play a crucial role in shaping the market.
  • High costs remain a challenge, but inclusion in medical insurance systems can mitigate this issue.

FAQs

What are the primary drivers of the paliperidone palmitate market growth?

The primary drivers include improved medication adherence, superior clinical efficacy, and cost-effectiveness compared to oral extended-release formulations.

Which regions have the highest prescription rates for antipsychotic LAIs?

Developed countries have the highest prescription rates, ranging from 18% to 30%, while emerging markets like China have lower rates due to high costs.

How does the inclusion of paliperidone palmitate in national medical insurance systems impact the market?

Inclusion in national medical insurance systems can significantly increase prescription rates by reducing the financial burden on patients and making the treatment more accessible.

What is the impact of generic entry on the paliperidone palmitate market?

Generic entry is expected to reduce costs, making the treatment more affordable and increasing its accessibility, thereby boosting market growth.

What are the key challenges facing the paliperidone palmitate market?

High costs and limited adoption in some regions due to financial constraints are significant challenges, although these can be mitigated by regulatory changes and generic entry.

Sources

  1. Market Research Intellect, "Paliperidone Palmitate API Market Size, Scope And Forecast Report," November 2024.
  2. Johnson & Johnson, "FOR IMMEDIATE RELEASE • Total sales growth of 10.7% to $23.3 billion," October 19, 2021.
  3. Frontiers in Pharmacology, "Cost-utility analysis of using paliperidone palmitate in schizophrenia in China," August 3, 2023.
  4. Analysis Group, "Projecting the Economic Outcomes of Switching Patients with Schizophrenia from Oral Atypical Antipsychotics to Once-Monthly, Once-Every-3-Months, and Once-Every-6-Months Paliperidone Palmitate."

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.