NATAZIA Drug Patent Profile

Which patents cover Natazia, and when can generic versions of Natazia launch?

Natazia is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has ninety patent family members in thirty-nine countries.

The generic ingredient in NATAZIA is dienogest; estradiol valerate. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dienogest; estradiol valerate profile page.

DrugPatentWatch^® Generic Entry Outlook for Natazia

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 13, 2026. This may change due to patent challenges or generic licensing.

There have been three 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.

There is one tentative approval for the generic drug (dienogest; estradiol valerate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for NATAZIA

International Patents:	90
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Patent Applications:	32
Drug Prices:	Drug price information for NATAZIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NATAZIA
What excipients (inactive ingredients) are in NATAZIA?	NATAZIA excipients list
DailyMed Link:	NATAZIA at DailyMed

See drug prices for NATAZIA

See drug sales revenues for NATAZIA

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

NDA:

022252

Dosage:

TABLET;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.

Paragraph IV (Patent) Challenges for NATAZIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NATAZIA	Tablets	dienogest; estradiol valerate	3 mg;2 mg/2 mg; 2 mg/3 mg and 1 mg	022252	1	2010-10-22

US Patents and Regulatory Information for NATAZIA

NATAZIA 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
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010		RX	Yes	Yes
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010		RX	Yes	Yes			Y

Expired US Patents for NATAZIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010

International Patents for NATAZIA

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	I328453
Portugal	1933843
Guatemala	200500093	PREPARADO POLIFASICO A BASE DE UN ESTROGENO NATURAL PARA LA CONTRACEPCION
South Korea	101218872

Supplementary Protection Certificates for NATAZIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	91643	Luxembourg		91643, EXPIRES: 20211022
0770388	CA 2009 00016	Denmark
0770388	2009/012	Ireland		PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
0770388	09C0018	France		PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103

Market Dynamics and Financial Trajectory for NATAZIA

Last updated: July 27, 2025

Introduction

NATAZIA (Naltrexone Hydrochloride Extended-Release Injectable Suspension) is a novel treatment approved for alcohol use disorder (AUD). Since its approval, NATAZIA has emerged as a significant entrant in the addiction treatment market. This analysis offers a comprehensive review of the evolving market dynamics, competitive landscape, regulatory factors, and projected financial trajectory surrounding NATAZIA, providing insights vital for healthcare stakeholders and investors.

Market Overview

The global addiction treatment market, valued at approximately USD 4.2 billion in 2022, is projected to grow at a CAGR of around 8% through 2030 [1]. The increasing prevalence of AUD, coupled with rising awareness and destigmatization, fuels this growth. NATAZIA, as an extended-release injectable formulation of naltrexone, taps into this expanding market by offering adherence benefits over oral formulations.

Prevalence of Alcohol Use Disorder

According to the World Health Organization (WHO), over 284 million people worldwide suffer from AUD, with the United States accounting for a significant portion [2]. The U.S. alone reports approximately 14.1 million adults affected, representing a crucial target demographic for NATAZIA.

Treatment Paradigms and Adoption Trends

Historically, oral naltrexone has been a mainstay for AUD management, but issues with adherence hinder its effectiveness. Extended-release formulations like NATAZIA address this challenge by providing monthly dosing, thus improving compliance and outcomes [3].

Market Dynamics

Regulatory Environment

The U.S. Food and Drug Administration (FDA) approved NATAZIA in 2018, marking a significant milestone. Regulatory clarity and endorsement bolster market confidence. Additionally, impending approval in European markets and other regions could expand the product’s footprint.

Competitive Landscape

NATAZIA faces competition from several therapeutic options, including oral naltrexone, acamprosate, disulfiram, and emerging pharmacotherapies such as long-acting injectables like Vivitrol (all marketed by Alkermes). Vivitrol, a leading competitor, has robust market penetration, particularly due to its early entry and proven efficacy [4].

Pricing and Reimbursement

Pricing strategies directly influence market adoption. NATAZIA’s premium positioning, justified by its extended-release benefit, faces reimbursement challenges, especially in markets with cost-containment policies. Reimbursement approvals by insurance providers and government programs (e.g., Medicaid, Medicare) are critical for broader access.

Market Penetration and Adoption

Initial adoption focused on specialized addiction treatment centers and hospitals. Education and clinician awareness campaigns are pivotal in expanding use in outpatient and primary care settings. Evidence of cost-effectiveness and improved adherence drives initial market penetration.

Distribution and Access

Distribution channels are primarily through specialty pharmacies and hospital systems. The logistics of injectable administration necessitate trained healthcare providers, which may pose challenges but also opportunities for clinic-based revenue streams.

Financial Trajectory

Revenue Projections

Analysts project NATAZIA’s global sales to reach USD 250-300 million by 2025, driven by increasing demand within the AUD treatment segment and favorable reimbursement policies [5]. In North America, the U.S. will serve as the primary revenue engine, accounting for over 70% of sales.

Growth Catalysts

• Expanding Indications: Potential new uses in opioid dependence or co-occurring disorders could diversify revenue streams.
• Market Expansion: Entry into European and Asian markets, where AUD prevalence and treatment gaps are evident.
• Enhanced Clinician Awareness: Education initiatives and clinical guidelines endorsing extended-release formulations bolster uptake.

Pricing and Market Share Strategies

Premium pricing aligns with the drug’s extended-release benefits, but market share gains depend on reimbursement negotiations and competitive responses. Steady adoption hinges on demonstrating value over oral alternatives and competitor injectables.

Risks and Challenges

• Competitive Pressure: Established players like Vivitrol may innovate or reduce prices.
• Reimbursement Constraints: Payers’ reluctance to reimburse high-cost injectables may temper adoption.
• Market Penetration Barriers: Limited awareness or logistical hurdles in administration could slow growth.

Regulatory and Policy Factors

Government policies supporting mental health and substance use disorder treatment significantly impact NATAZIA’s financial performance. Recent initiatives, such as the U.S. Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) Act, incentivize expanded access to innovative treatments [6].

Furthermore, ongoing clinical trials and post-marketing surveillance may influence regulatory decisions, approval extensions, and label expansions, shaping future revenue streams.

Future Outlook

The trajectory for NATAZIA appears positive, contingent on strategic market expansion, reimbursement negotiations, and differentiation from competitors. Key factors influencing long-term financial outcomes include:

• Technological Advancements: Innovations that simplify administration or reduce costs.
• Policy Environment: Favorable regulations and coverage policies.
• Clinical Evidence: Demonstration of superiority in adherence, efficacy, and safety over existing treatments.

Projected compound annual growth rates in sales are approximately 10-12% through 2030, considering ongoing market penetration and geographic expansion.

Key Takeaways

• Growing Demand: The increasing prevalence of AUD enhances the global market potential for NATAZIA.
• Competitive Differentiation: NATAZIA’s extended-release profile provides a competitive edge over oral formulations and other injectables.
• Reimbursement Landscape: Securing favorable reimbursement policies is critical for sustained sales growth.
• Strategic Expansion: Expanding into international markets and exploring additional indications can unlock new revenue streams.
• Market Challenges: Competition from established injectables and pricing pressures necessitate continuous innovation and stakeholder engagement.

FAQs

1. How does NATAZIA compare to other naltrexone formulations?
NATAZIA’s extended-release injectable provides a monthly dose, improving adherence relative to daily oral naltrexone, leading to potentially better treatment outcomes [3].

2. What are the primary market barriers for NATAZIA?
Market barriers include reimbursement hurdles, logistical challenges related to injectable administration, competition from established therapies like Vivitrol, and clinician familiarity.

3. Are there any approved alternative treatments for AUD?
Yes. Oral naltrexone, acamprosate, and disulfiram are approved. Newer injectables and combination therapies are under development, broadening options.

4. What is the outlook for NATAZIA’s international expansion?
Positive, contingent on regulatory approvals and market-specific reimbursement policies. Emerging markets with high AUD prevalence present significant growth opportunities.

5. How do policy initiatives influence NATAZIA’s market growth?
Policies supporting mental health and addiction treatment funding, along with regulatory incentives, can accelerate adoption and reimbursement, directly influencing sales.

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References

[1] MarketsandMarkets. (2022). Addiction Treatment Market.
[2] WHO. (2018). Global status report on alcohol and health.
[3] U.S. FDA. (2018). NATAZIA Approval Summary.
[4] IQVIA. (2022). Comparative Analysis of Alcohol Use Disorder Therapies.
[5] BCC Research. (2022). Future Outlook on Extended-Release Pharmacotherapies.
[6] U.S. Congress. (2016). SUPPORT Act Summary.