DURAGESIC-75 Drug Patent Profile

Which patents cover Duragesic-75, and what generic alternatives are available?

Duragesic-75 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in DURAGESIC-75 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-75

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	26
Patent Applications:	4,382
DailyMed Link:	DURAGESIC-75 at DailyMed

Recent Clinical Trials for DURAGESIC-75

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-75 clinical trials

US Patents and Regulatory Information for DURAGESIC-75

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-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-002	Aug 7, 1990		DISCN	Yes	No

Expired US Patents for DURAGESIC-75

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	DURAGESIC-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-002	Aug 7, 1990	4,060,084
Janssen Pharms	DURAGESIC-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-002	Aug 7, 1990	4,588,580*PED
Janssen Pharms	DURAGESIC-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-002	Aug 7, 1990	4,144,317

EU/EMA Drug Approvals for DURAGESIC-75

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

International Patents for DURAGESIC-75

See the table below for patents covering DURAGESIC-75 around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8707667
Spain	557179
Belgium	905568
United Kingdom	8514445

Supplementary Protection Certificates for DURAGESIC-75

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

DURAGESIC-75 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DURAGESIC-75 (Fentanyl Transdermal System)

Introduction to DURAGESIC-75

DURAGESIC-75, also known as the fentanyl transdermal system, is a potent opioid agonist used for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients. Manufactured by Ortho-McNeil-Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, this product has been a significant player in the pain management market since its approval in 1990[4][5].

Market Presence and Competition

Approval and Launch

DURAGESIC-75 was approved by the FDA on August 7, 1990, and has since become a widely recognized brand in the opioid pain management sector. The product is available in various strengths, including 12.5, 25, 50, 75, and 100 micrograms per hour[4].

Generic Equivalents

Over the years, generic versions of fentanyl transdermal systems have entered the market, increasing competition. Companies like Mylan Technologies and Sandoz Inc. have received FDA approvals for their generic fentanyl patches, which are equivalent to DURAGESIC-75. This competition has impacted the market share and pricing dynamics of the original brand[5].

Financial Performance

Historical Sales

DURAGESIC has been a lucrative product for Johnson & Johnson. For instance, in the second quarter of 2009, Duragesic sales reached $50 million, down from $70 million in the second quarter of 2008. Despite the decline, the product remained a significant contributor to the company's revenue[2].

Patent and Exclusivity

The original patents for DURAGESIC expired, allowing generic versions to enter the market. However, the presence of multiple patents and regulatory protections has continued to influence the market dynamics. For example, Janssen Pharmaceuticals holds several patents related to the formulation and delivery system of DURAGESIC, which have helped maintain some level of market exclusivity[5].

Regulatory and Legal Impacts

Recalls and Litigation

The market trajectory of DURAGESIC-75 has been affected by several recalls and lawsuits. Notable recalls include those due to manufacturing defects, such as the leaking of fentanyl gel, which led to significant legal and financial repercussions. For instance, a federal jury in Florida awarded $5.5 million to a family whose member died from a fentanyl overdose caused by a defective patch. Similar lawsuits have resulted in substantial payouts, impacting the financial performance of the product[2].

Safety and Abuse Concerns

The high potency and potential for abuse of fentanyl have led to strict regulatory oversight. DURAGESIC is classified as a Schedule II opioid, indicating a high potential for abuse and associated risk of fatal overdose. These concerns have influenced prescribing practices and market demand, with a focus on safer alternatives and stricter monitoring of opioid use[4].

Market Trends and Challenges

Opioid Epidemic

The opioid epidemic has significantly impacted the market for DURAGESIC-75. Regulatory bodies and healthcare providers have been pushing for non-opioid pain management options to reduce the risk of addiction and overdose. This shift has led to a decline in the prescription rates of opioids, including fentanyl-based products[3].

Global Market Dynamics

The global illicit fentanyl market has also affected the legitimate pharmaceutical market. The availability of fentanyl on darknet markets and its use in illicit drug trade have raised concerns about diversion and abuse. This has led to increased scrutiny and regulatory measures, further impacting the market dynamics of prescription fentanyl products[1].

User Demand and Harm Reduction

Clinical Use

Despite the challenges, DURAGESIC-75 remains a vital option for managing chronic pain in opioid-tolerant patients. The product's efficacy in providing continuous, around-the-clock opioid administration has maintained its relevance in clinical practice. However, the use of DURAGESIC is strictly regulated, and it is prescribed only by healthcare professionals knowledgeable in the administration of potent opioids[4].

Harm Reduction

There is also a noted demand for harm reduction measures among opioid users. The presence of opioid agonists like methadone, buprenorphine, and naloxone in the market suggests a user demand for self-medicated recovery and harm reduction strategies. This trend indicates a broader shift towards safer opioid use practices, which could influence the future market trajectory of DURAGESIC-75[1].

Conclusion

The market dynamics and financial trajectory of DURAGESIC-75 are complex and influenced by multiple factors, including regulatory oversight, competition from generics, legal challenges, and the broader context of the opioid epidemic. While the product remains a significant player in pain management, its market presence is continually evolving in response to these challenges.

Key Takeaways

• Regulatory Oversight: Strict regulations and recalls have impacted the market performance of DURAGESIC-75.
• Competition: Generic equivalents have entered the market, increasing competition and affecting pricing.
• Legal Challenges: Lawsuits related to defective patches and overdose deaths have resulted in significant financial payouts.
• Opioid Epidemic: The shift towards non-opioid pain management options has reduced prescription rates.
• Global Market: Illicit fentanyl markets have raised concerns about diversion and abuse, leading to increased scrutiny.

FAQs

What is DURAGESIC-75 used for?

DURAGESIC-75 is used for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients.

Who manufactures DURAGESIC-75?

DURAGESIC-75 is manufactured by Ortho-McNeil-Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson.

What are the potential risks associated with DURAGESIC-75?

The product carries a high potential for abuse and associated risk of fatal overdose due to respiratory depression.

Have there been any recalls of DURAGESIC-75?

Yes, there have been recalls due to manufacturing defects, such as the leaking of fentanyl gel.

How has the opioid epidemic affected the market for DURAGESIC-75?

The opioid epidemic has led to a decline in prescription rates as healthcare providers push for non-opioid pain management options.

Sources

1. Australian Institute of Criminology - Fentanyl availability on darknet markets[1]
2. Miller and Zois - Fentanyl Pain Patch Lawsuits[2]
3. The President's Commission on Combating Drug Addiction and the Opioid Crisis - Final Report Draft[3]
4. FDA - Duragesic Label Page[4]
5. Drug Patent Watch - Generic FENTANYL INN equivalents, drug patent expiry and market dynamics[5]