TARGINIQ Drug Patent Profile

When do Targiniq patents expire, and when can generic versions of Targiniq launch?

Targiniq is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and fifty-one patent family members in forty-one countries.

The generic ingredient in TARGINIQ is naloxone hydrochloride; oxycodone hydrochloride. There are twelve drug master file entries for this compound. Additional details are available on the naloxone hydrochloride; oxycodone hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Targiniq

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 30, 2025. This may change due to patent challenges or generic licensing.

There have been twenty-eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TARGINIQ

International Patents:	151
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Patent Applications:	7
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TARGINIQ
What excipients (inactive ingredients) are in TARGINIQ?	TARGINIQ excipients list
DailyMed Link:	TARGINIQ at DailyMed

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

NDA:

205777

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*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.

US Patents and Regulatory Information for TARGINIQ

TARGINIQ is protected by two 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
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014		DISCN	Yes	No			Y	Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014		DISCN	Yes	No				Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014		DISCN	Yes	No				Y

Expired US Patents for TARGINIQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014

International Patents for TARGINIQ

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	200408394	Matrix for sustained, invariant and independent release of active compounds
European Patent Office	2426132	Procédé de préparation de compositions contenant de l'hydrochlorure d'oxycodone et moins de 25ppm de 14-hydroxycodéinone (Process for preparing oxycodone hydrochloride compositions having less than 25ppm 14-hydroxycodeinone)
Slovenia	2425824

Supplementary Protection Certificates for TARGINIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	122013000082	Germany		PRODUCT NAME: KOMBINATION VON OXYCODON ALS KOMPONENTE A UND NALOXON ALS KOMPONENTE B IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: 64537.00.00 64538.00.00 64540.00.00 64541.00.00 73083.00.00 73084.00.00 73085.00.00 73086.00.00 20060530
1685839	C300619	Netherlands		PRODUCT NAME: EEN COMBINATIE VAN OXYCODON ALS COMPONENT A EN NALOXON ALS COMPONENT B IN ALLE VORMEN ZOALS DEZE DOOR HET BASIS OCTROOI ONDER BESCHERMING WORDEN GESTELD; REGISTRATION NO/DATE: 64537.00.00 64538.00.00 64540.00.00 64541.00.00 20060530
1685839	CA 2013 00052	Denmark		PRODUCT NAME: KOMBINATION AF OXYCODON SOM KOMPONENT A OG NALOXON SOM KOMPONENT B, HERUNDER OXYCODONHYDROCHLORID OG NALOXONHYDROCHLORIDDIHYDRAT; NAT. REG. NO/DATE: 43673, 43674 20081117; FIRST REG. NO/DATE: DE 64537.00.00, 64538.00.00, 64540.00.00, 64541.00.00 20060530

TARGINIQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Targiniq ER

Introduction

Targiniq ER, an extended-release opioid analgesic, is a significant player in the market for chronic pain management, particularly due to its abuse-deterrent properties. Here, we delve into the market dynamics and financial trajectory of Targiniq ER, highlighting its development, regulatory approvals, and market impact.

Development and Regulatory Approval

Targiniq ER is a combination product containing oxycodone and naloxone, designed to mitigate the risk of opioid abuse. The FDA approved Targiniq ER in July 2013, making it the second extended-release/long-acting (ER/LA) opioid analgesic with FDA-approved labeling describing its abuse-deterrent properties[4].

Abuse-Deterrent Properties

The inclusion of naloxone in Targiniq ER is a key feature that distinguishes it from other opioids. Naloxone is an opioid antagonist that helps to deter abuse by reducing the euphoric effects of oxycodone when the drug is crushed or dissolved. This formulation aims to reduce the risk of overdose and diversion, addressing a critical aspect of the opioid crisis[4].

Market Positioning

Targiniq ER enters a market dominated by other opioid analgesics, including OxyContin and Suboxone. However, its unique formulation sets it apart, particularly for patients who are at risk of abusing opioids. The drug's labeling highlights its abuse-deterrent properties, which can be a significant selling point in a market where safety and compliance are paramount[4].

Commercial Strategy

The commercial success of Targiniq ER is closely tied to its marketing and distribution strategies. The drug is part of a broader effort by pharmaceutical companies to develop and market abuse-deterrent opioids. Companies like Purdue Pharma and Collegium Pharmaceutical have invested heavily in sales force expansion and marketing programs to promote their products, including Targiniq ER[2][3].

Sales and Revenue Projections

While specific revenue figures for Targiniq ER are not widely available, the overall market for ER/LA opioids is substantial. Drugs like Sublocade, another abuse-deterrent opioid, are projected to achieve significant sales, with Sublocade anticipated to reach $1.464 billion in sales by 2023[1].

Given the competitive landscape and the growing demand for safer opioid alternatives, Targiniq ER is likely to capture a notable share of the market. However, its financial performance will also depend on factors such as prescription rates, insurance coverage, and competition from other abuse-deterrent opioids.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Targiniq ER. The FDA has been proactive in promoting the development and use of abuse-deterrent opioids. For instance, the FDA has mandated a single-shared Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products, which includes Targiniq ER. This REMS program aims to ensure safe use and reduce the risk of overdose and abuse[4].

Challenges and Risks

Despite its potential, Targiniq ER faces several challenges. One of the primary concerns is the mixed success of abuse-deterrent opioids. While these formulations can reduce individual patient abuse, there is insufficient evidence to demonstrate their effectiveness on a population level. Additionally, there is a risk that individuals may seek non-tamper-resistant, potentially more dangerous drugs like fentanyl and heroin[1].

Patient Access and Compliance

Patient access and compliance are critical factors in the success of Targiniq ER. The drug's extended-release formulation and the presence of naloxone can make it less appealing to some patients who may find it less effective for immediate pain relief. However, for patients who struggle with compliance or are at high risk of abuse, Targiniq ER offers a safer alternative[4].

Competitive Landscape

The market for ER/LA opioids is highly competitive, with several players offering abuse-deterrent formulations. Collegium Pharmaceutical's XTAMPZA ER, another abuse-deterrent opioid, has also received Fast Track status from the FDA and is expected to compete directly with Targiniq ER. The competition is driven by the need to address the opioid crisis while providing effective pain management[3].

Financial Impact on Pharmaceutical Companies

For pharmaceutical companies, the financial impact of Targiniq ER and similar drugs is significant. The development and marketing of these products require substantial investments. However, the potential returns are high, given the large and growing market for chronic pain management. Companies like Purdue Pharma have realized billions of dollars in sales from their opioid products, and Targiniq ER is expected to contribute to this revenue stream[5].

Key Takeaways

• Regulatory Approval: Targiniq ER was approved by the FDA in July 2013 with labeling describing its abuse-deterrent properties.
• Market Positioning: The drug is positioned as a safer alternative in the market for ER/LA opioids.
• Commercial Strategy: Heavy investment in marketing and sales force expansion is crucial for its success.
• Revenue Projections: While specific figures are not available, the overall market for ER/LA opioids is substantial.
• Regulatory Environment: The FDA's REMS program and other regulatory measures support the use of abuse-deterrent opioids.
• Challenges and Risks: Mixed success of abuse-deterrent opioids and potential for patients to seek other dangerous drugs.
• Patient Access and Compliance: Critical factors that influence the drug's adoption and effectiveness.

FAQs

What is Targiniq ER?

Targiniq ER is an extended-release opioid analgesic that combines oxycodone and naloxone, designed to mitigate the risk of opioid abuse.

How does Targiniq ER deter abuse?

The presence of naloxone in Targiniq ER reduces the euphoric effects of oxycodone when the drug is crushed or dissolved, thereby deterring abuse.

What is the regulatory status of Targiniq ER?

Targiniq ER was approved by the FDA in July 2013 with labeling describing its abuse-deterrent properties.

How does Targiniq ER compare to other opioids in the market?

Targiniq ER is unique due to its abuse-deterrent properties, setting it apart from other opioids like OxyContin and Suboxone.

What are the challenges faced by Targiniq ER in the market?

Despite its potential, Targiniq ER faces challenges such as mixed success of abuse-deterrent opioids and the risk of patients seeking other dangerous drugs.

Sources

1. Clarivate: The opioid crisis: a 21st century pain - Clarivate
2. Mass.gov: EXHIBITS TO AFFIDAVIT OF SYDENHAM B. ALEXANDER III ...
3. Collegium Pharmaceutical Inc.: SEC Filing – Collegium Pharmaceutical Inc.
4. FDA: Overdose Prevention Activities Timeline - FDA
5. Texas Attorney General: STATE OF TEXAS'S ORIGINAL PETITION D-1-GN-18-002403 345TH