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Last Updated: February 12, 2025

ABSTRAL Drug Patent Profile


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

Abstral is a drug marketed by Sentynl Theraps Inc and is included in one NDA.

The generic ingredient in ABSTRAL is fentanyl citrate. There are thirty-one drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Abstral

A generic version of ABSTRAL was approved as fentanyl citrate by HIKMA on July 11th, 1984.

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Drug patent expirations by year for ABSTRAL
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Recent Clinical Trials for ABSTRAL

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SponsorPhase
M.D. Anderson Cancer CenterPhase 3
National Cancer Institute (NCI)Phase 3
Institute of Mountain Emergency MedicinePhase 4

See all ABSTRAL clinical trials

Paragraph IV (Patent) Challenges for ABSTRAL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ABSTRAL Sublingual Tablets fentanyl citrate 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg 022510 1 2014-06-19

US Patents and Regulatory Information for ABSTRAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-001 Jan 7, 2011 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-002 Jan 7, 2011 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-006 Jan 7, 2011 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ABSTRAL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-002 Jan 7, 2011 ⤷  Try for Free ⤷  Try for Free
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 ⤷  Try for Free ⤷  Try for Free
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 ⤷  Try for Free ⤷  Try for Free
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-006 Jan 7, 2011 ⤷  Try for Free ⤷  Try for Free
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-006 Jan 7, 2011 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ABSTRAL

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

Country Patent Number Title Estimated Expiration
Czech Republic 20080315 ⤷  Try for Free
Slovakia 4022001 PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF ACUTE DISORDERS ⤷  Try for Free
European Patent Office 1115384 COMPOSITION DE FENTANYL POUR LE TRAITEMENT DES DOULEURS AIGUES (FENTANYL COMPOSITION FOR THE TREATMENT OF ACUTE PAIN) ⤷  Try for Free
Spain 2498095 ⤷  Try for Free
Denmark 2236133 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ABSTRAL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0383579 C960030 Netherlands ⤷  Try for Free PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
1635783 122014000024 Germany ⤷  Try for Free PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1635783 C300653 Netherlands ⤷  Try for Free PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0836511 SPC/GB06/022 United Kingdom ⤷  Try for Free PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
0975367 122011000009 Germany ⤷  Try for Free PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for ABSTRAL

Introduction

ABSTRAL, a sublingual tablet formulation of fentanyl citrate, is a potent opioid used for the management of breakthrough pain in adult cancer patients who are already receiving maintenance opioid therapy. Here, we will delve into the market dynamics and financial trajectory of ABSTRAL, highlighting its performance, usage, and economic impact.

Market Demand and Growth

The demand for rapid onset opioids (ROOs) like ABSTRAL has been increasing due to the growing need for effective management of breakthrough cancer pain (BTcP). According to market data, the use of ROOs has seen significant growth. For instance, the ROO market showed a 35% growth rate in 2020 compared to 2016, indicating a rising demand for these medications[4].

Clinical Efficacy and Safety

ABSTRAL has demonstrated clinical efficacy in managing BTcP. In a Phase III study, ABSTRAL showed a statistically significant improvement over placebo in reducing pain intensity within 30 minutes of dosing. The study involved opioid-tolerant cancer patients and highlighted the drug's safety and tolerability over a 12-month period[1].

Dosage and Administration

The dosage of ABSTRAL is individualized based on the severity of pain and the patient's response. The initial dose is typically 100 mcg, and patients are titrated up to a tolerable dose that provides adequate analgesia. The drug is administered sublingually, and patients are advised not to use more than four doses per day for breakthrough pain episodes[3].

Financial Performance

The financial performance of ABSTRAL is closely tied to its market demand and the overall strategy of its manufacturers and distributors. In 2012, royalty revenues from ABSTRAL increased by 66% to MSEK 55.8, reflecting strong market performance during that period[5].

Revenue Trends

In recent years, the revenue from ABSTRAL has been influenced by several factors, including the growth of global strategic products and changes in the business model of its distributors. For example, Kyowa Kirin, a company involved in the distribution of ABSTRAL, reported an increase in revenue due to the growth of global strategic products and technology out-licensing. However, the shift to a joint venture with Grünenthal for established medicines led to a decrease in revenue from established medicines, including ABSTRAL[2].

Impact of Business Strategies

The financial trajectory of ABSTRAL has also been affected by strategic decisions such as the transfer of rights for certain medications. For instance, in October 2023, Kyowa Kirin recorded revenue of £62.5 million (¥11.5 billion) due to the transfer of the rights for Tostran, an established medicine. While this does not directly impact ABSTRAL, it reflects the broader financial strategies and adjustments within the company[2].

Regional Market Dynamics

The market dynamics for ABSTRAL vary by region. In Korea, for example, there has been an increasing interest in BTcP and the use of ROOs. A study aimed to provide an objective index for selecting optimal ROOs for Korean patients, reflecting local BTcP patterns and economic circumstances. This indicates a growing market in regions like Korea, driven by specific patient needs and economic factors[4].

Economic Circumstances

The economic circumstances of patients and healthcare systems play a crucial role in the adoption and usage of ABSTRAL. The cost-effectiveness of ROOs, including ABSTRAL, is an important consideration. Studies have highlighted the need for an objective index to select optimal ROOs based on economic circumstances, suggesting that the financial viability of these medications is a key factor in their market dynamics[4].

Challenges and Considerations

Despite its efficacy, ABSTRAL faces challenges related to opioid abuse and misuse. Healthcare providers must screen patients for risk factors and monitor them closely to prevent overdose and death associated with opioid use. This necessitates careful dosing and administration protocols, which can impact the drug's market trajectory[3].

Conclusion

ABSTRAL's market dynamics are influenced by its clinical efficacy, growing demand for ROOs, and the financial strategies of its manufacturers and distributors. The drug has shown significant revenue growth in the past, although recent changes in business models and regional market dynamics have introduced some variability. As the healthcare landscape continues to evolve, the financial trajectory of ABSTRAL will likely be shaped by factors such as patient needs, economic circumstances, and regulatory considerations.

Key Takeaways

  • Growing Demand: The market for ROOs like ABSTRAL is growing due to increasing needs for BTcP management.
  • Clinical Efficacy: ABSTRAL has demonstrated significant efficacy in reducing BTcP.
  • Financial Performance: Revenue from ABSTRAL has been strong but is influenced by broader business strategies and regional dynamics.
  • Economic Considerations: The cost-effectiveness of ABSTRAL is crucial for its adoption.
  • Challenges: Opioid abuse and misuse are significant challenges that impact the drug's market.

FAQs

Q: What is ABSTRAL used for? A: ABSTRAL is used for the management of breakthrough pain in adult cancer patients who are already receiving maintenance opioid therapy.

Q: How is ABSTRAL administered? A: ABSTRAL is administered sublingually, and the dosage is individualized based on the patient's response and pain severity.

Q: What are the common side effects of ABSTRAL? A: Common side effects include nausea, constipation, somnolence, and other typical opioid adverse reactions.

Q: How has the revenue from ABSTRAL been trending? A: The revenue from ABSTRAL has seen growth in the past, though recent changes in business models and regional dynamics have introduced some variability.

Q: What are the key challenges facing ABSTRAL in the market? A: Key challenges include opioid abuse and misuse, as well as the need for careful dosing and administration protocols.

Sources

  1. ABSTRAL® (fentanyl citrate) sublingual tablets - Product Information for AusPAR, A. Menarini Australia Pty Ltd.
  2. Consolidated Financial Summary (IFRS) Fiscal 2023 - Kyowa Kirin.
  3. ABSTRAL - FDA Label.
  4. Comparison of Fentanyl-Based Rapid Onset Opioids for the Relief of Breakthrough Cancer Pain - European Journal of Clinical Pharmacology.
  5. Interim report, January-June 2012 - Cision.

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