DURAGESIC-100 Drug Patent Profile

Which patents cover Duragesic-100, and what generic alternatives are available?

Duragesic-100 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in DURAGESIC-100 is fentanyl. There are thirty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

Summary for DURAGESIC-100

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	26
Patent Applications:	4,384
DailyMed Link:	DURAGESIC-100 at DailyMed

Recent Clinical Trials for DURAGESIC-100

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

Sponsor	Phase
Jiarong Chen, MD	Phase 4
Emory University	Phase 4
Loyola University	Phase 2/Phase 3

See all DURAGESIC-100 clinical trials

US Patents and Regulatory Information for DURAGESIC-100

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	DURAGESIC-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-001	Aug 7, 1990		DISCN	Yes	No

Expired US Patents for DURAGESIC-100

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	DURAGESIC-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-001	Aug 7, 1990
Janssen Pharms	DURAGESIC-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-001	Aug 7, 1990
Janssen Pharms	DURAGESIC-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-001	Aug 7, 1990

EU/EMA Drug Approvals for DURAGESIC-100

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Kyowa Kirin Holdings B.V.	PecFent	fentanyl	EMEA/H/C/001164 PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.	Authorised	no	no	no	2010-08-31
Takeda Pharma A/S	Instanyl	fentanyl	EMEA/H/C/000959 Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.	Authorised	no	no	no	2009-07-20
Teva B.V.	Effentora	fentanyl	EMEA/H/C/000833 Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain., , BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain., , Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. ,	Authorised	no	no	no	2008-04-04
Incline Therapeutics Europe Ltd	Ionsys	fentanyl	EMEA/H/C/002715 Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.	Withdrawn	no	no	no	2015-11-18
Eli Lilly and Company Limited	Recuvyra	fentanyl	EMEA/V/C/002239 For the control of pain associated with orthopaedic and soft tissue surgery in dogs.	Withdrawn	no	no	no	2011-10-06
Janssen-Cilag International NV	Ionsys	fentanyl	EMEA/H/C/000612 Management of acute moderate to severe post-operative pain for use in a hospital setting only	Withdrawn	no	no	no	2006-01-24	2008-07-25

International Patents for DURAGESIC-100

See the table below for patents covering DURAGESIC-100 around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8707667
Spain	557179
Belgium	905568
United Kingdom	8514445
Spain	545366
Japan	S6137725	SKIN ADMINISTRATION OF FENTANYL AND DEVICE

Supplementary Protection Certificates for DURAGESIC-100

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

DURAGESIC-100 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Duragesic-100 (Fentanyl Pain Patches)

Introduction

Duragesic-100, also known as the fentanyl transdermal system, is a potent opioid pain patch manufactured by Johnson & Johnson's subsidiary, Janssen Pharmaceuticals. This product has been a significant player in the opioid market, but its trajectory has been marked by both financial success and legal challenges.

Historical Context and Approval

The fentanyl pain patch, including Duragesic-100, was first approved by the FDA in the mid-1990s. It was designed to provide continuous pain relief for patients with chronic pain who are tolerant to opioid therapy. The patch releases fentanyl, a highly potent opioid, through the skin over a period of 48 to 72 hours.

Market Success and Financial Performance

Peak Sales and Revenue

Duragesic patches, particularly the Duragesic-100, were highly lucrative products. By the late 2000s, Duragesic sales had reached significant heights, with revenues of $50 million in the second quarter of 2009, down slightly from $70 million in the second quarter of 2008[2].

Market Share and Competition

The fentanyl pain patch market was dominated by a few key players, including Johnson & Johnson's Duragesic and other generic versions. Despite competition, Duragesic maintained a strong market presence due to its brand recognition and the effectiveness of the product.

Legal Challenges and Litigation

Defective Product Allegations

One of the major challenges faced by Duragesic-100 was the series of lawsuits alleging that the patches delivered unsafe amounts of fentanyl. These lawsuits claimed that manufacturing defects, such as leaking patches, led to overdose deaths and serious injuries. The first lawsuit was filed in 2007, and it resulted in a $5.5 million verdict against Johnson & Johnson. Subsequent lawsuits led to significant payouts, including a $417 million award in 2016[2].

Impact on Sales and Reputation

The legal battles and negative publicity surrounding the defective patches had a detrimental impact on sales and the product's reputation. While the company continued to generate revenue, the legal costs and settlements eroded some of the profits.

Regulatory and Compliance Issues

Corporate Integrity Agreement

Following a guilty plea by Purdue Pharma for misbranding OxyContin, a similar opioid product, there was increased scrutiny on opioid manufacturers. Although Duragesic was not directly involved in this case, the broader opioid crisis led to stricter regulatory oversight. Companies like Johnson & Johnson had to navigate complex corporate integrity agreements to ensure compliance and avoid further legal repercussions[5].

Current Status and Market Trends

Decline in Litigation

By the mid-2010s, the number of new lawsuits against the manufacturers of fentanyl pain patches began to decline. Many cases were settled out of court, and the litigation landscape became less intense. However, the legacy of these lawsuits continues to impact the company's reputation and financials[2].

Shift in Opioid Market Dynamics

The opioid market has undergone significant changes due to the opioid epidemic and increased regulatory scrutiny. The rise of illicitly manufactured fentanyls (IMFs) has altered the landscape, with these potent opioids becoming dominant in the illegal drug supply. This shift has further complicated the market for prescription opioids like Duragesic-100, as healthcare providers and regulators become more cautious in prescribing these medications[4].

Financial Trajectory

Revenue Impact

The financial trajectory of Duragesic-100 has been marked by initial success followed by a decline due to legal and regulatory challenges. The peak revenues in the late 2000s were not sustained as the company faced numerous lawsuits and settlements. While the product still generates revenue, it is significantly lower than its peak.

Cost of Litigation and Settlements

The cost of litigation and settlements has been substantial. The company has paid hundreds of millions of dollars in verdicts and settlements, which has directly impacted its bottom line.

User Demand and Harm Reduction

User Demand for Harm Reduction

Interestingly, despite the controversies surrounding fentanyl, there is still user demand for harm reduction and self-medicated recovery. This is evident from the presence of opioid agonists like methadone, buprenorphine, and naloxone on darknet markets, indicating a need for safer alternatives within the opioid user community[1].

Global Impact and Illicit Markets

Illicit Fentanyl and Global Markets

The availability of fentanyl on darknet markets and its illicit manufacture have global implications. Fentanyl's potency and ease of modification have led to the production of many derivatives, contributing to the opioid epidemic worldwide. This has also led to unintended consequences, such as the displacement of production to less regulated states[1][3].

Conclusion

The market dynamics and financial trajectory of Duragesic-100 are complex and influenced by a mix of regulatory, legal, and market factors. While the product was highly successful financially in its early years, it has faced significant challenges due to manufacturing defects, litigation, and the broader opioid crisis.

Key Takeaways

• Financial Success: Duragesic-100 was a highly lucrative product in the late 2000s.
• Legal Challenges: The product faced numerous lawsuits due to manufacturing defects and overdose deaths.
• Regulatory Scrutiny: Increased regulatory oversight has impacted the opioid market, affecting prescription opioids like Duragesic-100.
• Market Shifts: The rise of IMFs has altered the opioid market dynamics, making prescription opioids less prominent.
• User Demand: There is still demand for harm reduction and safer opioid alternatives.

FAQs

Q: What was the peak revenue for Duragesic patches?

A: Duragesic patches reached peak revenues of $70 million in the second quarter of 2008[2].

Q: What were the main allegations in the lawsuits against Duragesic manufacturers?

A: The lawsuits alleged that the patches delivered unsafe amounts of fentanyl due to manufacturing defects, leading to overdose deaths and serious injuries[2].

Q: How has the opioid epidemic impacted the market for Duragesic-100?

A: The opioid epidemic has led to increased regulatory scrutiny and a shift towards safer alternatives, reducing the market share of prescription opioids like Duragesic-100[4].

Q: Are fentanyl pain patches still available on the market?

A: Yes, fentanyl pain patches, including Duragesic-100, are still available but with stricter prescribing guidelines and regulatory oversight[2].

Q: What role do darknet markets play in the distribution of fentanyl?

A: Darknet markets are an avenue for distributing synthetic opioids like fentanyl, with vendors using postal services to distribute these highly potent substances[1].

Sources

1. Australian Institute of Criminology - Fentanyl availability on darknet markets[1].
2. Miller and Zois - Fentanyl Pain Patch Lawsuits[2].
3. Congressional Research Service - Illicit Fentanyl and Mexico's Role[3].
4. Centers for Disease Control and Prevention - Detection of Illegally Manufactured Fentanyls and Carfentanil[4].
5. Seattle City Attorney's Office - Complaint against McKinsey & Company[5].