IONSYS Drug Patent Profile

Which patents cover Ionsys, and what generic alternatives are available?

Ionsys is a drug marketed by The Medicines Co and is included in one NDA. There are seven patents protecting this drug.

This drug has eighty-six patent family members in eighteen countries.

The generic ingredient in IONSYS is fentanyl hydrochloride. There are thirty-one drug master file entries for this compound. Additional details are available on the fentanyl hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Ionsys

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 30, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for IONSYS

International Patents:	86
US Patents:	7
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	7
Patent Applications:	4,486
DailyMed Link:	IONSYS at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for IONSYS

NDA:

021338

Dosage:

SYSTEM;IONTOPHORESIS, TRANSDERMAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for IONSYS

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

Sponsor	Phase
Hospital for Special Surgery, New York	Phase 4
The Medicines Company	Phase 4
Incline Therapeutics, Inc.	Phase 3

See all IONSYS clinical trials

US Patents and Regulatory Information for IONSYS

IONSYS is protected by seven US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No			Y
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No			Y
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No			Y
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No			Y
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No			Y

Expired US Patents for IONSYS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006

International Patents for IONSYS

When does loss-of-exclusivity occur for IONSYS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

India

Israel

Japan

Mexico

New Zealand

Portugal

Russian Federation

Singapore

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering IONSYS around the world.

Country	Patent Number	Title	Estimated Expiration
China	103501854	Two-part electrotransport device
Finland	974418
Greece	1002982	ΣΥΣΚΕΥΗ ΔΙΑΔΕΡΜΙΚΗΣ ΧΟΡΗΓΗΣΗΣ ΤΩΝ ΦΕΝΤΑΝΙΛ ΚΑΙ ΣΟΥΦΕΝΤΑΝΙΛ ΜΕ ΗΛΕΚΤΡΟΜΕΤΑΦΟΡΑ. (Device for transdermal electrotransport delivery of fentanyl and sufentanil.)
Japan	4442928
Russian Federation	2014153102	УПРАВЛЕНИЕ ТОКОМ ДЛЯ ЭЛЕКТРОПЕРЕНОСА ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ
Russian Federation	2232608	УСТРОЙСТВО ДЛЯ ЧРЕСКОЖНОЙ ДОСТАВКИ ЛЕКАРСТВЕННОГО СРЕДСТВА ЭЛЕКТРОПЕРЕНОСОМ И СПОСОБ ЕГО ИЗГОТОВЛЕНИЯ, СПОСОБ ЧРЕСКОЖНОЙ ДОСТАВКИ ЛЕКАРСТВЕННОГО СРЕДСТВА ПАЦИЕНТУ ЭЛЕКТРОПЕРЕНОСОМ (DEVICE AND METHOD FOR TRANSCUTANEOUSLY DELIVERING DRUG BY MEANS OF ELECTRIC TRANSFER AND METHOD FOR PRODUCING THE DEVICE)
South Africa	200103523	Electrotransport device including a compatible antimicrobial agent.

Supplementary Protection Certificates for IONSYS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
0975367	122011000009	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1635783	122014000024	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0836511	91265	Luxembourg		91265, EXPIRES: 20210124
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0836511	SPC/GB06/022	United Kingdom		PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124

Market Dynamics and Financial Trajectory for IONSYS

Introduction

IONSYS, a fentanyl iontophoretic transdermal system, is a potent opioid agonist designed for the short-term management of acute postoperative pain. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Indicators and Demand

IONSYS is indicated for patients requiring opioid analgesics in a hospital setting where alternative treatments are inadequate. The demand for such a product is driven by the need for effective pain management post-surgery.

Patient Population

The target patient population includes those undergoing surgeries that result in severe pain, for which non-opioid analgesics are insufficient. This niche market ensures a consistent demand for IONSYS, particularly in hospitals and surgical centers[4].

Competitive Landscape

The opioid market is highly competitive, with various products offering similar pain management solutions. However, IONSYS stands out due to its unique iontophoretic delivery system, which provides on-demand pain relief. This differentiation can influence market share and pricing strategies[4].

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of IONSYS.

FDA Approval and Labeling

IONSYS was approved by the FDA for the management of acute postoperative pain. The labeling includes warnings about life-threatening respiratory depression, addiction, abuse, and misuse, as well as interactions with cytochrome P450 3A4 inhibitors. These warnings can impact prescribing habits and patient safety protocols[1][4].

Controlled Substance Status

As a Schedule II controlled substance, IONSYS is subject to strict regulations and monitoring to prevent abuse and misuse. This status can affect distribution channels and prescribing practices[5].

Financial Aspects

Revenue Model

The revenue generated from IONSYS is primarily from hospital and healthcare facility purchases. The pricing strategy is influenced by the cost of development, production, and the value it brings to patients in terms of effective pain management.

Partnership and Licensing

Strategic partnerships, such as the one between The Medicines Company and SymBio Pharmaceuticals, can impact the financial trajectory of IONSYS. These partnerships can facilitate market expansion, especially in regions like Japan, and enhance revenue through shared resources and expertise[2].

Cost Structure

The cost structure includes research and development expenses, manufacturing costs, regulatory compliance, and marketing expenditures. The unique iontophoretic technology and the need for rigorous clinical trials contribute to higher development costs[1][4].

Pharmacokinetics and Clinical Studies

Understanding the pharmacokinetics of IONSYS is crucial for its financial success, as it directly impacts its efficacy and safety profile.

Systemic Absorption

IONSYS delivers fentanyl through iontophoresis, with systemic absorption increasing over time. Clinical studies have shown that the delivery of fentanyl is consistent whether applied on the upper outer arm or the chest, although it is approximately 20% lower when applied on the lower inner arm[1].

Clinical Trials

Clinical trials have demonstrated the efficacy of IONSYS in managing acute postoperative pain. These trials also highlight the need for careful patient selection and monitoring to mitigate risks associated with opioid use[1].

Market Size and Growth Potential

The market size for IONSYS is influenced by the number of surgical procedures requiring postoperative pain management and the adoption rate of the product in hospitals.

Market Size

The opioid analgesic market is substantial, and IONSYS, with its unique delivery system, can capture a significant share. However, the market size is also influenced by the availability of generic alternatives and other opioid products[3].

Growth Potential

The growth potential for IONSYS is tied to its ability to penetrate new markets, expand its user base, and maintain a competitive edge through innovative marketing and distribution strategies. Partnerships and licensing agreements can further enhance growth by expanding the product's reach[2].

Challenges and Risks

Regulatory Risks

Changes in regulatory policies or increased scrutiny on opioid products can impact the market dynamics and financial trajectory of IONSYS. Strict regulations and monitoring requirements can affect sales and profitability[4].

Competition from Generics

The entry of generic competitors can significantly reduce the market share and revenue of IONSYS. Generic prices tend to decline as more competitors enter the market, which can erode the pricing power of branded products[3].

Safety Concerns

The risks associated with opioid use, including life-threatening respiratory depression and addiction, can impact prescribing habits and patient safety protocols. These concerns can lead to reduced sales and increased costs related to safety monitoring and education[4].

Financial Performance and Projections

Historical Performance

Historical financial performance data for IONSYS would typically include revenue figures, profit margins, and market share. However, specific financial data is not publicly available due to the discontinuation of the brand name IONSYS, although the product remains available under different labels[4].

Future Projections

Future financial projections for IONSYS would depend on several factors, including market expansion, competitive landscape, regulatory environment, and the ability to maintain a competitive edge. Strategic partnerships and innovative marketing strategies can positively impact these projections[2].

Key Takeaways

• Unique Delivery System: IONSYS offers a unique iontophoretic delivery system, providing on-demand pain relief.
• Regulatory Environment: Strict regulations and monitoring requirements due to its Schedule II controlled substance status.
• Market Demand: Consistent demand driven by the need for effective postoperative pain management.
• Competitive Landscape: Highly competitive opioid market with potential competition from generics.
• Financial Trajectory: Influenced by partnerships, licensing agreements, and the ability to maintain a competitive edge.

FAQs

What is IONSYS used for?

IONSYS is used for the short-term management of acute postoperative pain severe enough to require an opioid analgesic in the hospital setting.

What are the key risks associated with IONSYS?

Key risks include life-threatening respiratory depression, addiction, abuse, and misuse, as well as interactions with cytochrome P450 3A4 inhibitors.

How does IONSYS deliver fentanyl?

IONSYS delivers fentanyl through an iontophoretic transdermal system, providing on-demand systemic delivery over a 10-minute period upon each activation.

Is IONSYS still available on the market?

Yes, although the brand name IONSYS is discontinued, the product remains available under different labels.

What are the implications of IONSYS being a Schedule II controlled substance?

As a Schedule II controlled substance, IONSYS is subject to strict regulations and monitoring to prevent abuse and misuse, which can affect distribution channels and prescribing practices.

Sources

1. IONSYS™ (fentanyl iontophoretic transdermal system) 40 mcg ... - FDA.
2. The Medicines Company and SymBio Pharmaceuticals Establish ... - Business Wire.
3. Generic Drug Industry Dynamics - Federal Trade Commission.
4. Ionsys (Fentanyl Iontophoretic Transdermal System) - RxList.
5. carr, kenneth warren, m.d. (g 40398), carlsbad, ca - MBC.