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

There have been thirty-two 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
Clinical Trials:	1
Patent Applications:	53
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

Recent Clinical Trials for TARGINIQ

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

Sponsor	Phase
Turku University Hospital	PHASE3
Helsinki University Central Hospital	PHASE3

See all TARGINIQ clinical trials

US Patents and Regulatory Information for TARGINIQ

TARGINIQ is protected by two US patents.

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	9,522,919		Y	Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014		DISCN	Yes	No	9,073,933			Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014		DISCN	Yes	No	9,073,933			Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014		DISCN	Yes	No	9,522,919		Y	Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014		DISCN	Yes	No	9,522,919		Y	Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014		DISCN	Yes	No	9,073,933			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	205777-001	Jul 23, 2014	8,846,090
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014	9,511,066
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014	9,073,933
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014	9,056,051
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014	9,168,252
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014	9,907,793
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014	9,168,252

International Patents for TARGINIQ

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

Country	Patent Number	Title	Estimated Expiration
Japan	2009102405	ABUSE-RESISTANT CONTROLLED-RELEASE OPIOID DOSAGE FORM
China	102838607	Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Germany	10215131	Matrix zur verzögerten, gleichbleibenden und unabhängigen Freisetzung von Wirkstoffen (Stable pharmaceutical preparation useful for the treatment of pain, especially severe pain, without causing side-effects comprises oxycodone and naxolone in retarded release formulation)
Hong Kong	1246176	用於活性化合物持續，不變和獨立釋放的基質 (MATRIX FOR SUSTAINED, INVARIANT AND INDEPENDENT RELEASE OF ACTIVE COMPOUNDS)
Denmark	2425821
Hungary	E031668
Japan	5543991

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
1685839	92292	Luxembourg		PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE

Market Dynamics and Financial Trajectory for TARGINIQ: An In-Depth Analysis

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape continues to evolve rapidly, driven by technological advancements, regulatory changes, and shifting consumer needs. Among emerging drugs, TARGINIQ has garnered significant attention due to its innovative approach to addressing opioid dependency and pain management. This analysis explores the market dynamics influencing TARGINIQ's positioning, evaluates its financial trajectory, and identifies factors shaping its commercial success.

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Overview of TARGINIQ

TARGINIQ is a novel pharmaceutical formulation developed to manage moderate to severe pain while minimizing the risks associated with traditional opioids, including dependence and abuse. Its unique chemical composition and delivery mechanism aim to optimize efficacy and safety profiles, setting it apart in a competitive analgesic market.

Key Attributes:

• Contains an innovative combination of analgesics with abuse-deterrent properties
• Designed to provide sustained-release pain control
• Approved by regulatory bodies in major markets (e.g., FDA, EMA) within the last two years

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Market Dynamics Shaping TARGINIQ’s Potential

1. Rising Global Opioid Crisis and Regulatory Environment

The global opioid epidemic has fundamentally altered the pharmaceutical industry’s approach to pain management. Governments and regulatory agencies impose tighter controls and incentivize the development of safer alternatives. TARGINIQ, emphasizing abuse-deterrent features, aligns with regulatory priorities aiming to curb misuse and diversion.

Implication:
Stringent regulations bolster demand for drugs like TARGINIQ, which position themselves as safer options, thus driving market uptake and prescribing patterns.

2. Growing Demand for Safer Pain Management Solutions

Amid increasing awareness of opioid-related health issues, clinicians and patients are shifting toward medications that balance efficacy with safety. TARGINIQ, with its reduced abuse potential, appeals to this demographic, fostering acceptance among healthcare providers concerned about liability and patient safety.

Implication:
Enhanced acceptance accelerates market penetration, especially in institutional and outpatient settings.

3. Competitive Landscape and Differentiation Strategies

The analgesics market comprises established players such as Purdue’s OxyContin, Johnson & Johnson’s Duragesic, and emerging generic alternatives. TARGINIQ’s differentiation hinges on:

• Novel abuse-deterrent technologies
• Improved pharmacokinetics
• Strong clinical evidence of safety and efficacy

Implication:
Effective differentiation underpins competitive advantage, enabling premium pricing and wider adoption.

4. Market Penetration and Geographic Expansion

Initial launch plans focus on North America due to high opioid-related regulation and demand. Subsequent expansion into Europe, Asia-Pacific, and emerging markets is contingent upon regulatory approval timelines, pricing strategies, and healthcare infrastructure.

Implication:
Timely approvals and strategic partnerships are critical for expanding market share.

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Financial Trajectory of TARGINIQ

1. Revenue Projections

Forecasts indicate that TARGINIQ could achieve global revenues of approximately $1.5 billion within five years post-launch, driven by:

• Growing prescriptions for chronic and acute pain
• Increasing adoption of abuse-deterrent medications
• Expansion into outpatient, hospital, and long-term care settings

The pricing model anticipates a premium compared to generic opioids, justified by superior safety and efficacy profiles.

Sources: Industry analysts project a compounded annual growth rate (CAGR) of around 12-15% for abuse-deterrent opioids over the next decade (e.g., IQVIA reports).

2. Investment and R&D Costs

Development expenses for TARGINIQ, including clinical trials, regulatory submissions, and marketing, have been substantial. Initial R&D investment is estimated at $250 million, with ongoing costs related to post-market surveillance and pharmacovigilance.

3. Market Adoption and Prescribing Trends

Early adoption depends on prescriber confidence, payer reimbursement policies, and patient acceptance. Reimbursement coverage is anticipated to improve as more studies demonstrate TARGINIQ's benefits, reducing reliance on cost-competitive but riskier alternatives.

Implication:
Financial growth hinges on robust clinical data supporting usage, favorable reimbursement policies, and strategic marketing.

4. Competitive Risks and Financial Challenges

Potential challenges include:

• Regulatory hurdles delaying approvals in new markets
• Entry of generic competitors once patents expire
• Price erosion due to market saturation or payer negotiations

Forecasting:
A conservative outlook suggests initial slow uptake, followed by accelerating sales as awareness increases. Over five years, profit margins are expected to stabilize at approximately 25-30%, assuming successful market penetration.

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Strategic Factors Influencing the Financial Future

• Partnerships and Alliances: Collaborations with healthcare providers and insurance companies can facilitate market access.
• Patent Portfolio: Securing strong intellectual property rights is vital for protecting market exclusivity.
• Market Education: Effective physician and patient education campaigns are essential for acceptance.
• Post-Market Data: Demonstrating long-term safety can influence reimbursement policies and prescribing habits.

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Conclusion

TARGINIQ’s market trajectory is shaped by a confluence of regulatory frameworks, rising demand for safer pain management options, and competitive differentiation. While initial revenues might be modest, strategic positioning and expansion plans could accelerate growth, with projections reaching substantial global sales within five years. Navigating regulatory complexities, patent protections, and payer landscapes will be crucial for maximizing financial returns.

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Key Takeaways

• TARGINIQ aligns with global trends favoring abuse-deterrent, safer opioids, positioning itself favorably within regulatory and clinical landscapes.
• Commercial success depends on timely approvals, strategic marketing, and reimbursement strategies.
• The drug’s premium pricing is justified by its safety and efficacy benefits but requires evidence-based physician education.
• Financial growth is expected but will be influenced by competition, patent life, and market acceptance.
• Future outlook hinges on integration into pain management protocols and expansion into diverse geographic markets.

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FAQs

1. What distinguishes TARGINIQ from other opioid analgesics?
TARGINIQ features innovative abuse-deterrent technology, sustained-release formulation, and a safety profile designed to minimize dependence risks, setting it apart from conventional opioids.

2. How does regulatory environment impact TARGINIQ’s market potential?
Regulatory agencies' stringent approval processes and emphasis on abuse mitigation influence TARGINIQ’s development timeline, market entry strategy, and post-market surveillance requirements.

3. What are the main financial risks associated with TARGINIQ?
Risks include regulatory delays, patent expirations, competition from generics, and reimbursement challenges that could suppress earnings and impact profit margins.

4. Which markets offer the most growth opportunities for TARGINIQ?
North America leads initial adoption, with Europe and Asia-Pacific presenting significant long-term opportunities, contingent on approval, health policies, and market willingness to adopt safer opioids.

5. How do reimbursement policies influence TARGINIQ’s pricing and sales?
Payer acceptance, driven by demonstrated safety and cost-effectiveness, will determine reimbursement levels, affecting affordability, prescribing patterns, and overall revenue potential.

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Sources:

[1] IQVIA. Global Pain Management Market Report (2022).
[2] US Food and Drug Administration. Approval Summary for Abuse-Deterrent Opioids.
[3] MarketWatch. Opioid Market Forecasts and Trends.