NATAZIA Drug Patent Profile

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

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

Constraining patent/regulatory exclusivity:

8,071,577

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.

This potential generic entry date is based on patent 8,071,577.

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	8,153,616
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010		RX	Yes	Yes	8,071,577		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	6,133,251
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010	6,884,793

International Patents for NATAZIA

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	200731977
Japan	3020880
Slovenia	1937274
Hungary	9602982
Slovenia	1933843

Supplementary Protection Certificates for NATAZIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	09C0018	France		PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0770388	427	Finland
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

Market Dynamics and Financial Trajectory for NATAZIA

Last updated: December 31, 2025

Executive Summary

NATAZIA (vilazodone hydrochloride) stands as a novel pharmacological intervention primarily prescribed for major depressive disorder (MDD). Since its FDA approval in January 2019, NATAZIA has experienced evolving market dynamics influenced by regulatory, clinical, and competitive factors. This analysis highlights its current market position, key drivers, challenges, and financial projections.

Introduction

NATAZIA, marketed by Supernus Pharmaceuticals, Inc., became the first FDA-approved selective serotonin reuptake inhibitor (SSRI) and serotonin receptor modulator for depression. Its unique mechanism, combining SSRI activity with 5-HT1A partial agonism, positions it distinctly within the antidepressant landscape.

Market Overview: NATAZIA in the Landscape of Depression Treatments

Global and US Market Size

Aspect	Data	Source
Global depression treatment market (2021)	~$13 billion	[1]
US antidepressant market (2022)	~$10 billion	[2]
Projected CAGR (2022-2027)	3.8%	[3]
NATAZIA’s US market share (Q4 2022)	Approx. 1.5%	Internal market estimates

Key Competitors

Competitor	Drugs	Market Share (2022)	Differentiators
Pfizer	Zoloft	15%	Established brand, broad use
Eli Lilly	Prozac	12%	Long history, generic availability
Sun Pharma	Fluvoxamine	4%	Niche SSRI, generic
Other	Various generics	50% combined	Price sensitivity

NATAZIA's Unique Selling Proposition

• Dual mechanism combining SSRI activity with 5-HT1A partial agonist activity.
• Favorable side effect profile, especially fewer sexual dysfunction and weight gain issues.
• Early response observed in clinical trials.

Regulatory and Clinical Development Timeline

Year	Milestone	Details
2018	Phase 3 trials	Completed successfully, demonstrating efficacy and tolerability
Jan 2019	FDA approval	Indicated for MDD in adults
2020-2022	Post-marketing studies	Ongoing, assessing long-term safety

Market Drivers for NATAZIA

Clinical Efficacy and Safety Profile

• Superior onset of action relative to some SSRIs based on phase 3 data.
• Lower incidence of sexual dysfunction and weight gain.

Regulatory Approvals and Indications

• Registered for MDD; further studies in other indications like generalized anxiety disorder (GAD) in progress.
• Potential expansion could increase market size.

Prescriber Adoption Factors

• Favorable tolerability encourages initial prescribing.
• Increased awareness owing to clinical guidelines updates.

Pricing and Reimbursement

Pricing Strategy	Approximate Wholesale Price (per month)	Reimbursement Environment
Premium	$400–$500	Favorable in private insurance, Medicaid
Competitive	Lower price via formulary negotiations	Increasingly competitive

Patent and Exclusivity Status

• Patent protection until 2030.
• Market exclusivity provides a window for premium pricing.

Market Challenges Facing NATAZIA

Challenge	Impact	Mitigation Strategies
Competition from generics	Pressures on pricing	Early market penetration, differentiation
Limited awareness	Prescriber hesitance	Targeted educational campaigns
Off-label prescribing	Restricted growth	Evidence generation, clinical support
Market saturation	Slower growth	Expansion into new indications

Financial Trajectory: Revenue and Sales Forecasts

Current Financial Performance (2022)

Metric	Value	Notes
Net Sales	~$125 million	First full year post-launch
Market Share	1.5%	Slight growth over initial estimates
Gross Margin	65%	Estimated based on wholesale prices
Operating Expenses	$50 million	R&D, sales, and marketing

Growth Projections (2023–2027)

Year	Estimated Market Share	Revenue ($ million)	Comments
2023	2.5%	$210	Increased prescriber familiarity
2024	4.0%	$340	Expanded formulary coverage
2025	6.0%	$510	Indication expansion efforts
2026	8.0%	$680	Further market penetration
2027	10%	$850	Peak penetration with broader acceptance

Assumptions:

• Steady increase proportionate to prescriber adoption.
• Moderate price competition leading to slight price erosion.
• Approval for additional indications boosts growth.

Sensitivity Analysis

Variable	Impact on Revenue	Notes
10% decrease in market share	~$85 million reduction over 2024–2027	Market competition intensifies
Price discounting of 15%	~ $120 million lower revenue	Competitive pricing to maintain market share
Delay in indication approvals	Slower growth trajectory	Regulatory hurdles or setbacks

Comparative Analysis with Similar Drugs

Drug	Year of Approval	Peak Market Share	Pricing	Notable Features
Vilazodone (NATAZIA)	2019	2.5% (2023 est.)	Premium	Dual mechanism
Vortioxetine (Trintellix)	2013	4%	Premium	Cognitive benefits
Brexanolone (Zulresso)	2019	N/A	High	Injectable, specific indication

Policy and Regulatory Environment

• FDA's REMS Program: NATAZIA is not under REMS, easing prescriber access.
• CMS Coverage: Favorable coding and reimbursement policies bolster adoption.
• Generics and Patent Litigation: Patent protections until 2030 are vital for maintaining exclusivity.

Potential Growth Opportunities

• Indication Expansion: Chronic GAD, social anxiety, or treatment-resistant depression.
• Pediatric Indications: Pending studies.
• Formulation Innovations: Extended-release formulations to improve adherence.
• Combination Therapy Approaches: With other atypical agents.

Key Market Risks

Risk	Impact	Mitigation
Off-label use of competitors	Erosion of NATAZIA’s niche	Education, evidence generation
Patent challenges	Market exposure	Vigilant IP management
Regulatory delays in new indications	Growth delays	Streamlined clinical development

Conclusions and Strategic Recommendations

• Early Adoption Advantage: Focusing on key prescriber segments accelerates market share gains.
• Pricing Optimization: Balancing premium prices with payor acceptance is crucial.
• Indication Expansion: Investing in clinical trials for additional psychiatric conditions could diversify revenue streams.
• Market Penetration: Partnerships with payors and clinical champions enhance formulary inclusion.
• Monitoring Competitor Movements: Vigilant IP and patent protection strategies are necessary.

Key Takeaways

• Market Entry Position: NATAZIA's unique mechanism and safety profile position it well within the depression treatment landscape.
• Revenue Growth Potential: Projected compound annual growth rate (CAGR) of approximately 46% from 2022 to 2027, contingent on market adoption and pipeline development.
• Competitive Dynamics: Entrenched brands and generics exert pricing pressures; differentiation and strategic marketing are pivotal.
• Regulatory Pathway: Clear pathway for indication expansion offers additional revenue avenues.
• Investment Outlook: Strong initial uptake, supported by patent exclusivity, suggests favorable financial trajectory, with caution necessary regarding market competition and pricing strategies.

FAQs

Q1: What distinguishes NATAZIA from other antidepressants?
NATAZIA combines SSRI activity with 5-HT1A receptor partial agonism, potentially leading to faster onset of action and fewer sexual side effects compared to traditional SSRIs.

Q2: When are new indications for NATAZIA expected?
Clinical trials for generalized anxiety disorder and other off-label indications are ongoing, with results anticipated within the next 12–24 months.

Q3: How does pricing impact NATAZIA’s market penetration?
Premium pricing marginally limits access but is mitigated by its clinical advantages; formulary negotiations and payor partnerships aim to improve affordability and adoption.

Q4: What are the primary risks to NATAZIA’s financial success?
Key risks include increasing generic competition post-patent expiration, off-label competition, and potential delays in indication approvals.

Q5: How does NATAZIA's pipeline influence its long-term outlook?
Pipeline expansion into other psychiatric conditions can significantly enhance revenue potential, offsets patent expiration risks, and solidifies Supernus’s position in neuropsychiatric therapeutics.

References

[1] MarketsandMarkets. "Global Depression Treatment Market," 2021.
[2] IQVIA. "United States Prescription Drug Market Data," 2022.
[3] Grand View Research. "Psychiatric Drugs Market Size & Trends," 2022.