ABSTRAL Drug Patent Profile

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. Ten 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 11^th, 1984.

Summary for ABSTRAL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	7
Drug Prices:	Drug price information for ABSTRAL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABSTRAL
What excipients (inactive ingredients) are in ABSTRAL?	ABSTRAL excipients list
DailyMed Link:	ABSTRAL at DailyMed

See drug prices for ABSTRAL

Recent Clinical Trials for ABSTRAL

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 3
National Cancer Institute (NCI)	Phase 3
Institute of Mountain Emergency Medicine	Phase 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
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-004	Jan 7, 2011		DISCN	Yes	No
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-002	Jan 7, 2011		DISCN	Yes	No
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-003	Jan 7, 2011		DISCN	Yes	No
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-006	Jan 7, 2011		DISCN	Yes	No

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	022510-004	Jan 7, 2011
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-006	Jan 7, 2011
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-005	Jan 7, 2011
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-002	Jan 7, 2011
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-003	Jan 7, 2011

International Patents for ABSTRAL

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0016750
Israel	142135
Spain	2507579
Denmark	2805716
Germany	69936393

Supplementary Protection Certificates for ABSTRAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	122015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
1635783	122014000024	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
1635783	300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0383579	C960030	Netherlands		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

ABSTRAL Market Analysis and Financial Projection Experimental

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.