FENTORA Drug Patent Profile

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

Fentora is a drug marketed by Cephalon and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-six patent family members in twenty-nine countries.

The generic ingredient in FENTORA 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 Fentora

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

Summary for FENTORA

International Patents:	66
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	12
Patent Applications:	2,564
Drug Prices:	Drug price information for FENTORA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FENTORA
What excipients (inactive ingredients) are in FENTORA?	FENTORA excipients list
DailyMed Link:	FENTORA at DailyMed

See drug prices for FENTORA

Recent Clinical Trials for FENTORA

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 3
National Cancer Institute (NCI)	Phase 3
Augusta University	Phase 4

See all FENTORA clinical trials

Pharmacology for FENTORA

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Paragraph IV (Patent) Challenges for FENTORA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FENTORA	Buccal Tablets	fentanyl citrate	0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg	021947	1	2007-11-13

US Patents and Regulatory Information for FENTORA

FENTORA is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006		DISCN	Yes	No	7,862,833		Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006		DISCN	Yes	No	8,119,158		Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		DISCN	Yes	No	8,092,832		Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		DISCN	Yes	No	7,862,832		Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006		DISCN	Yes	No	7,862,833		Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006		DISCN	Yes	No	8,092,832		Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-006	Mar 2, 2007		DISCN	Yes	No

Expired US Patents for FENTORA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006	6,200,604
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006	8,765,100
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006	6,974,590
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-006	Mar 2, 2007	6,974,590
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-004	Sep 25, 2006	6,974,590
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006	6,974,590
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-004	Sep 25, 2006	8,753,611

International Patents for FENTORA

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

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	010826	ЛЕКАРСТВЕННАЯ ФОРМА ФЕНТАНИЛА ДЛЯ ПЕРОРАЛЬНОГО ПРИМЕНЕНИЯ, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И СПОСОБЫ ЛЕЧЕНИЯ (FENTANYL DOSAGE FORM FOR ORAL ADMINISTRATION, METHODS OF MAKING THEREOF AND METHODS OF TREATMENT)
Cyprus	1109176
Israel	176452	צורת מינון תוססת למתן דרך הפה של אופיאט ושימושה להכנת תרופה (Effervescent oral opiate dosage form and use thereof for preparation of a medicament)
Austria	E500821
Japan	4954170
European Patent Office	1082106	COMPRIME EFFERVESCENT POUR UNE ADMINISTRATION SUBLINGUALE, BUCCALE ET GINGIVALE DE FENTANYL (EFFERVESCENT TABLET FOR THE SUBLINGUAL, BUCCAL AND GINGIVAL ADMINISTRATION OF FENTANYL)
Japan	5244318

Supplementary Protection Certificates for FENTORA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0836511	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID
1635783	CA 2014 00016	Denmark		PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
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
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006

FENTORA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FENTORA

Introduction

FENTORA, a fentanyl citrate tablet, is a potent opioid agonist indicated for the management of breakthrough pain in cancer patients who are already receiving and tolerant to around-the-clock opioid therapy. Understanding the market dynamics and financial trajectory of FENTORA is crucial for stakeholders, including healthcare providers, patients, and investors.

Market Indications and Usage

FENTORA is specifically designed for opioid-tolerant patients with cancer, who experience breakthrough pain despite their ongoing opioid therapy. This niche market is critical, as breakthrough pain can significantly impact the quality of life for these patients[1][4].

Efficacy and Clinical Trials

The efficacy of FENTORA has been demonstrated in several clinical trials. Studies have shown statistically significant reductions in pain intensity compared to placebo, with improvements observed as early as 10 minutes after administration and sustained up to 120 minutes[3]. This efficacy supports its strong market position in managing breakthrough pain.

Safety and Adverse Reactions

While FENTORA is effective, it comes with significant safety concerns, including the risk of addiction, abuse, and misuse, which can lead to overdose and death. Common adverse events include nausea, vomiting, fatigue, dizziness, somnolence, and headache. These risks necessitate strict prescribing and dispensing protocols, including the TIRF REMS program[2][4].

Regulatory Environment

FENTORA is available only through the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, which is designed to mitigate the risks associated with fentanyl products. This program requires enrollment by patients, healthcare providers, and pharmacies, and it imposes strict guidelines for prescribing and dispensing[2][4].

Pricing and Cost-Effectiveness

FENTORA is available in various strengths (100 mcg to 800 mcg) with a manufacturer-submitted price of $10.89 per tablet. The daily cost can range from $10.89 to $43.56, depending on the dose and frequency of use. However, cost-utility analyses have raised questions about its cost-effectiveness. For instance, a Canadian analysis suggested that FENTORA would need a significant price reduction to achieve an acceptable incremental cost-utility ratio (ICUR) of $50,000 per quality-adjusted life-year (QALY)[3].

Market Competition

The market for breakthrough pain management in cancer patients is competitive, with other fentanyl products like Actiq and generic alternatives. However, FENTORA's unique delivery mechanism and higher bioavailability compared to Actiq give it a competitive edge[1].

Financial Performance

The financial performance of FENTORA is influenced by several factors, including its pricing, market demand, and regulatory environment. Given its restricted access and high cost, the revenue generated from FENTORA is substantial but limited by the niche market it serves. The manufacturer's economic submissions and cost-utility analyses highlight the need for careful pricing strategies to ensure accessibility and financial sustainability.

Reimbursement and Access

Reimbursement policies play a crucial role in the financial trajectory of FENTORA. In some jurisdictions, reimbursement is conditional on specific criteria, such as lack of adequate relief or intolerable toxicity from other opioids. The Canadian Drug Expert Committee (CDEC) has recommended against reimbursement for patients with dysphagia, further complicating access[3].

Patient and Prescriber Compliance

The TIRF REMS program ensures that patients and prescribers are aware of the risks and benefits of FENTORA. Compliance with this program is essential for maintaining market access and ensuring patient safety. Non-compliance can lead to regulatory actions and impact sales.

Future Outlook

The future outlook for FENTORA is shaped by ongoing clinical research, regulatory updates, and market dynamics. As healthcare systems continue to evolve, there may be increased scrutiny on the cost-effectiveness and safety of high-cost opioid products. Innovations in pain management and alternative therapies could also impact the market share of FENTORA.

Key Takeaways

• Efficacy: FENTORA is highly effective in managing breakthrough pain in opioid-tolerant cancer patients.
• Safety Concerns: It carries significant risks of addiction, abuse, and respiratory depression.
• Regulatory Environment: Strict prescribing and dispensing protocols are in place through the TIRF REMS program.
• Pricing and Cost-Effectiveness: High cost with questionable cost-effectiveness in some analyses.
• Market Competition: Unique delivery mechanism but faces competition from other fentanyl products.
• Financial Performance: Substantial revenue but limited by niche market and regulatory constraints.
• Reimbursement and Access: Conditional reimbursement policies affect market access.

FAQs

Q: What is FENTORA indicated for?

FENTORA is indicated for the management of breakthrough pain in cancer patients who are already receiving and tolerant to around-the-clock opioid therapy.

Q: What are the common adverse events associated with FENTORA?

Common adverse events include nausea, vomiting, fatigue, dizziness, somnolence, and headache.

Q: Why is FENTORA available only through a restricted program?

FENTORA is available only through the TIRF REMS Access program to mitigate the risks of addiction, abuse, and misuse.

Q: How does the cost of FENTORA compare to other pain management options?

FENTORA is costly, with a daily cost ranging from $10.89 to $43.56, and its cost-effectiveness is a subject of debate in various analyses.

Q: Can FENTORA be substituted with other fentanyl products?

No, FENTORA should not be substituted with any other fentanyl products due to the risk of fatal overdose.

Cited Sources

1. FENTORA Label - accessdata.fda.gov
2. FENTORA Tablet Label - accessdata.fda.gov
3. CDEC FINAL RECOMMENDATION - Fentanyl (Fentora) - NCBI
4. FENTORA- fentanyl tablet - DailyMed - dailymed.nlm.nih.gov