Fentanyl - Generic Drug Details

What are the generic drug sources for fentanyl and what is the scope of patent protection?

Fentanyl is the generic ingredient in twenty-five branded drugs marketed by Janssen Pharms, Actavis Labs Ut Inc, Difgen Pharms, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, Specgx Llc, Zydus Pharms, Btcp Pharma, Adalvo, Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Dr Reddys, Rising, Exela Pharma, Dr Reddys Labs Sa, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and The Medicines Co, and is included in thirty-four NDAs. There are twenty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fentanyl has thirty-two patent family members in seventeen countries.

There are thirty-one drug master file entries for fentanyl. Seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for fentanyl

International Patents:	32
US Patents:	21
Tradenames:	25
Applicants:	26
NDAs:	34
Drug Master File Entries:	31
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	1,654
Patent Applications:	6,430
Drug Prices:	Drug price trends for fentanyl
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fentanyl
What excipients (inactive ingredients) are in fentanyl?	fentanyl excipients list
DailyMed Link:	fentanyl at DailyMed

See drug prices for fentanyl

See drug sales revenues for fentanyl

Recent Clinical Trials for fentanyl

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

Sponsor	Phase
University of Alabama at Birmingham	Phase 1
Merck Sharp & Dohme LLC	N/A
University Hospital "Sestre Milosrdnice"	N/A

See all fentanyl clinical trials

Generic filers with tentative approvals for FENTANYL

Applicant	Application No.	Strength	Dosage Form
		EQ 0.05MG BASE/ML	INJECTABLE;INJECTION
		800MCG	TABLET;BUCCAL
		600MCG	TABLET;BUCCAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for fentanyl

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for fentanyl

Adjuvants, Anesthesia

Analgesics, Opioid

Anesthetics, Intravenous

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for fentanyl

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

N02AB	Phenylpiperidine derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for FENTANYL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUBSYS	Sublingual Spray	fentanyl	0.1 mg/spray, 0.2 mg/spray, 0.6 mg/spray, 0.8 mg/spray, 1.2 mg/spray, 1.6 mg/spray	202788	1	2017-12-07
SUBSYS	Sublingual Spray	fentanyl	0.4 mg/spray	202788	1	2017-05-22

US Patents and Regulatory Information for fentanyl

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-001	Jan 4, 2012		DISCN	Yes	No			Y
Noven	FENTANYL-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077775-003	Oct 16, 2009		DISCN	No	No
Difgen Pharms	FENTANYL-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077449-002	Oct 20, 2008	AB	RX	No	No
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-002	Jan 4, 2012		DISCN	Yes	No			Y
Specgx Llc	FENTANYL-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077154-001	Feb 9, 2011	AB	RX	No	Yes

Expired US Patents for fentanyl

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-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-004	Aug 7, 1990
Janssen Pharms	DURAGESIC-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-001	Aug 7, 1990
Janssen Pharms	DURAGESIC-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-002	Aug 7, 1990
Janssen Pharms	DURAGESIC-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-003	Aug 7, 1990

EU/EMA Drug Approvals for fentanyl

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

International Patents for fentanyl

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2432950	ПОДЪЯЗЫЧНЫЙ СПРЕЙ НА ОСНОВЕ ФЕНТАНИЛА (SUBLINGUAL FENTANYL-BASED SPRAY)
Russian Federation	2008130763	СУБЛИНГВАЛЬНЫЙ АЭРОЗОЛЬ НА ОСНОВЕ ФЕНТАНИЛА
Portugal	1976521
Denmark	2180844
Poland	1976521

Supplementary Protection Certificates for fentanyl

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	122014000024	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION 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
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

Market Dynamics and Financial Trajectory of Fentanyl

Introduction

Fentanyl, a synthetic opioid, has become a pivotal and contentious drug in both medical and illicit markets. Its market dynamics are influenced by a complex interplay of factors, including medical demand, illicit trafficking, and regulatory efforts.

Medical Market Dynamics

Market Size and Growth

The fentanyl market is substantial and growing. As of 2024, the global fentanyl market size was over USD 17.02 billion and is projected to exceed USD 37.54 billion by 2037, with a Compound Annual Growth Rate (CAGR) of over 6.4% during the forecast period of 2025-2037[1].

Drivers of Growth

The growth in the fentanyl market is primarily driven by the increasing prevalence of cancer worldwide. Cancer is a leading cause of premature death globally, and governments are investing heavily in cancer prevention and treatment initiatives. The World Health Organization (WHO) reported over 10 million cancer deaths in 2020, up from 9.6 million in 2018. This increase in cancer cases, along with rising global healthcare spending and awareness campaigns about the therapeutic effects of fentanyl, is expected to boost market growth[1].

End-User Segmentation

The global fentanyl market is segmented by end-users into hospitals, oncology centers, surgical centers, and others. Oncology centers are expected to hold the largest market share, approximately 35% by 2037, due to the specialized cancer treatments they offer and the increasing pool of cancer patients[1].

Regional Market Dynamics

North America

The North American region is projected to hold the largest market share, around 35% by 2037. This is attributed to the growing population, research activities, health insurance coverage for cancer diagnoses, and the rising economic status and affordability of advanced treatments. In the United States, for example, personal income and spending have seen steady growth, and insurance companies offer efficient reimbursement policies for cancer treatments, further boosting the market[1].

Asia Pacific

The Asia Pacific region is expected to hold the second-largest market share, around 24% during the forecast period. The growth here is driven by the rapidly aging population, which is more prone to cancer. Government initiatives to raise awareness about cancer and its treatments are also expected to contribute to market growth in this region[1].

Europe

While specific market share projections for Europe are not detailed, the region is also expected to see significant growth due to increasing cancer cases and deaths, as well as increased funding for medical infrastructure.

Illicit Market Dynamics

Global Trafficking

Fentanyl has become a major player in the illicit drug market, particularly in North America. It is often used as a cheaper and more potent substitute for heroin and is also mixed with other substances like cocaine and methamphetamine. The illicit supply chain involves transnational criminal organizations, with precursor chemicals often sourced from China and India and transported through Mexico[2][3].

Darknet Markets

Fentanyl is widely available on darknet markets, where it is distributed through postal services. The potency and low mass of fentanyl make it a lucrative product for illicit traders, with significant revenue potential. For instance, one kilogram of fentanyl can produce approximately 1 million counterfeit pills, generating millions of dollars in revenue[3].

Impact on Public Health

The illicit fentanyl market has led to a significant increase in overdose deaths. In 2021, nearly 107,000 Americans died from overdoses, with 65% of these deaths attributed to fentanyl. The DEA seized over 379 million deadly doses of fentanyl in 2021, highlighting the scale of the problem[2].

Financial Trajectory

Medical Market Revenue

The medical fentanyl market is expected to see substantial revenue growth, driven by increasing demand for cancer pain management. The market size is projected to grow from USD 17.88 billion in 2025 to over USD 37.54 billion by 2037[1].

Illicit Market Financial Flows

The financial flows associated with illicit fentanyl involve complex money laundering schemes. These typically include financial transfers through banks, prepaid cards, and other methods to facilitate the trafficking of fentanyl. The revenue generated from illicit fentanyl sales is significant, with a small amount of the drug capable of generating large profits due to its potency and low weight[5].

Regulatory Efforts

Legislative Actions

To combat the illicit fentanyl crisis, legislative actions such as the Fentanyl Eradication and Narcotics Deterrence (FEND) Off Fentanyl Act have been introduced. This bill aims to target the illicit fentanyl supply chain by imposing sanctions on transnational criminal organizations and those involved in money laundering to facilitate opioid trafficking[2].

Enforcement and Interdiction

Law enforcement agencies are working to disrupt fentanyl supply chains through enhanced interdiction efforts and sanctions. The DEA and other agencies have seized significant quantities of fentanyl, but the ongoing challenge is to address the global proliferation of the drug[2].

Challenges and Opportunities

Challenges

The fentanyl market faces several challenges, including the illicit trafficking and overdose crisis, regulatory hurdles, and the need for balanced access to the drug for medical purposes while preventing abuse.

Opportunities

Despite the challenges, there are opportunities for growth in the medical fentanyl market, particularly in regions with aging populations and increasing cancer prevalence. Additionally, advancements in treatment and awareness campaigns can help expand the market.

Key Takeaways

• The global fentanyl market is expected to grow significantly, driven by medical demand and increasing cancer cases.
• The illicit fentanyl market poses a major public health threat, with significant overdose deaths and complex money laundering schemes.
• Regulatory efforts are underway to combat the illicit fentanyl supply chain.
• Regional markets, especially North America and Asia Pacific, are expected to see substantial growth.
• The balance between medical access and preventing abuse remains a critical challenge.

FAQs

What is the projected growth rate of the global fentanyl market?

The global fentanyl market is projected to grow at a CAGR of over 6.4% from 2025 to 2037[1].

Which region is expected to hold the largest market share for fentanyl?

The North American region is projected to hold the largest market share, around 35% by 2037[1].

How does the illicit fentanyl market impact public health?

The illicit fentanyl market has led to a significant increase in overdose deaths, with 65% of overdose deaths in 2021 attributed to fentanyl in the United States[2].

What are the main drivers of growth in the medical fentanyl market?

The main drivers include the increasing prevalence of cancer, rising global healthcare spending, and increasing awareness campaigns about the therapeutic effects of fentanyl[1].

What legislative actions are being taken to combat the illicit fentanyl crisis?

The Fentanyl Eradication and Narcotics Deterrence (FEND) Off Fentanyl Act aims to target the illicit fentanyl supply chain by imposing sanctions and enhancing interdiction efforts[2].

Sources

1. Research Nester: Fentanyl Market Size | Growth Analysis 2025-2037.
2. Brown.Senate.Gov: Brown Introduces Bipartisan Bill to Target the Illicit Fentanyl Supply Chain.
3. Australian Institute of Criminology: Fentanyl availability on darknet markets.
4. Brookings Institution: The dynamics of US drug markets.
5. CRS Reports: Illicit Fentanyl and Mexico's Role.

Last updated: 2024-12-16