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Last Updated: December 22, 2024

ONSURA Drug Patent Profile


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When do Onsura patents expire, and what generic alternatives are available?

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

The generic ingredient in ONSURA is ethinyl estradiol; norelgestromin. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.

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Summary for ONSURA
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:ONSURA at DailyMed
Drug patent expirations by year for ONSURA

US Patents and Regulatory Information for ONSURA

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 ONSURA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 213977-001 Aug 25, 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

EU/EMA Drug Approvals for ONSURA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gedeon Richter Plc. Evra norelgestromin, ethinyl estradiol EMEA/H/C/000410
Female contraception.Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.
Authorised no no no 2002-08-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

ONSURA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ONSURA and Similar Prescription Drugs

Introduction

ONSURA, a brand of naloxegol, is an opioid antagonist used to treat opioid-induced constipation in adults with chronic non-cancer pain. Understanding the market dynamics and financial trajectory of ONSURA and similar prescription drugs involves analyzing various factors, including market trends, regulatory environments, and economic implications.

Market Size and Growth

The global opioids drugs market, which includes medications like ONSURA, was valued at US$ 27.28 billion in 2022 and is projected to reach US$ 37.24 billion by 2029, growing at a CAGR of 4.54% during the forecast period[1].

Driving Factors

Several factors drive the growth of the opioids drugs market, including:

  • Rising Prevalence of Chronic Pain: The increasing demand for pain therapeutics in treating chronic pain is a significant driver.
  • Regulatory Approvals: The approval of innovative drug formulations, including abuse-deterrent opioid drugs, contributes to market growth.
  • Cancer and Other Conditions: The rising prevalence of cancer and other conditions requiring pain management also fuels the demand for opioids and related medications like ONSURA[1].

Challenges

Despite the growth, the market faces several challenges:

  • Misuse and Overdose: Extensive misuse of opioids and the growing incidence of opioid-related deaths hinder market growth.
  • Legal and Regulatory Issues: Lawsuits against opioid manufacturers and stringent regulatory measures also pose significant challenges[1].

Market Segmentation

The opioids drugs market is segmented by product and application:

  • Products: Includes buprenorphine, fentanyl, hydrocodone, morphine, oxycodone, tramadol, and other products.
  • Applications: Encompasses anesthesia, pain relief, cough suppression, diarrhea suppression, and deaddiction[1].

Economic Implications

Prescription Drug Spending

Prescription drug spending, including for opioids and related medications, has seen significant increases. In 2022, prescription drug spending rose by 8.4% to $405.9 billion, outpacing the 6.8% growth in 2021[5].

Cost Savings Initiatives

Pharmacies and healthcare providers are implementing cost-saving measures to mitigate the financial burden of prescription drugs. For example, AON Pharmacy achieved $2 million in cost savings by reassessing prescriptions and reducing unnecessary refills, highlighting the potential for process improvements to reduce costs[2].

Impact of Regulatory Changes

Regulatory changes, such as those introduced by the Inflation Reduction Act (IRA), are expected to impact Medicare spending and prescription drug costs. The IRA includes provisions like a $2,000 cap on out-of-pocket spending for Part D drugs and drug price negotiations, which could lower spending growth rates for Medicare and reduce out-of-pocket costs for patients[5].

Competition in Prescription Drug Markets

The competition in prescription drug markets is influenced by the number of manufacturers and the type of drugs. For small molecule drugs, the number of drugs with 6+ manufacturers increased between 2017 and 2022, while those with a single manufacturer declined. This shift indicates a more competitive market for certain types of drugs, which can affect pricing and innovation[4].

Precision Medicines and Innovation

The pharmaceutical industry is increasingly focusing on precision medicines and targeted therapies, which have economic implications for drug development and pricing. These products often target small patient populations and can command higher prices due to their high value to those patients[3].

Patient Affordability and Access

The rising costs of prescription drugs, including opioids and related medications, pose significant affordability challenges for patients. One-third of adults report being unable to afford critical medications, leading to non-adherence to treatment schedules and other adverse health outcomes[2].

Role of Pharmacies in Cost Management

Pharmacies play a crucial role in managing prescription drug costs. AON Pharmacy's model, which includes comprehensive reassessment of prescriptions, insurance and copay assistance, and patient support, demonstrates how pharmacies can help reduce costs and improve patient care[2].

Future Outlook

The future of the opioids drugs market, including medications like ONSURA, will be shaped by ongoing regulatory changes, technological innovations, and shifting market dynamics. As the market continues to grow, addressing the challenges of misuse, overdose, and affordability will be critical.

Key Takeaways

  • The global opioids drugs market is expected to grow at a CAGR of 4.54% from 2022 to 2029.
  • Regulatory approvals and the rising prevalence of chronic pain are key drivers of market growth.
  • Misuse and overdose, along with legal and regulatory issues, are significant challenges.
  • Prescription drug spending continues to rise, with regulatory changes aiming to reduce costs.
  • Pharmacies can play a vital role in cost management through process improvements and patient support.

FAQs

What is the projected growth rate of the global opioids drugs market?

The global opioids drugs market is expected to grow at a CAGR of 4.54% from 2022 to 2029[1].

How do regulatory changes impact the prescription drug market?

Regulatory changes, such as those introduced by the IRA, can lower spending growth rates for Medicare and reduce out-of-pocket costs for patients through measures like drug price negotiations and caps on out-of-pocket spending[5].

What role do pharmacies play in managing prescription drug costs?

Pharmacies can significantly reduce costs through comprehensive reassessment of prescriptions, reducing unnecessary refills, and providing insurance and copay assistance[2].

How does the focus on precision medicines affect drug pricing?

Precision medicines often target small patient populations and can command higher prices due to their high value to those patients, changing optimal pricing strategies and the structure of R&D incentives[3].

What are the main challenges facing the opioids drugs market?

The main challenges include extensive misuse of opioids, the growing incidence of opioid-related deaths, and legal and regulatory issues against opioid manufacturers[1].

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