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 has been one patent litigation case 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:	71
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
Croatia	P20090256
Czech Republic	290741	Vícefázový prostředek pro antikoncepci (Multiphase preparation for contraception)
Eurasian Patent Organization	200601844	МНОГОФАЗНЫЙ ПРЕПАРАТ ДЛЯ КОНТРАЦЕПЦИИ НА ОСНОВЕ НАТУРАЛЬНОГО ЭСТРОГЕНА
New Zealand	550417	Multi-phase contraceptive preparation based on a natural estrogen
Slovakia	281709
Slovenia	1933843
Taiwan	200731977	Use of estradiol valerate in combination with dienogest for the oral treatment of dysfunctional uterine bleeding in conjunction with oral contraception

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	2009/012	Ireland		PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
0770388	9/2009	Austria		PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
0770388	C00770388/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0770388	CA 2009 00016	Denmark
0770388	PA2009004	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0770388	SPC/GB09/026	United Kingdom		PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208

Market Dynamics and Financial Trajectory for Natazia

Introduction

Natazia, a novel oral contraceptive (OC) developed by Bayer, has been making significant waves in the pharmaceutical market since its approval in May 2010. This article delves into the market dynamics and financial trajectory of Natazia, highlighting its unique features, market performance, and the challenges it faces.

Unique Features of Natazia

Natazia stands out as the first oral contraceptive to combine a synthetic estrogen, estradiol valerate, and a progestin, dienogest. Unlike other combination OCs on the US market, which contain ethinyl estradiol, Natazia's formulation is distinct due to its use of estradiol valerate, which is converted to estradiol in the body[1][4].

Market Positioning

Bayer has positioned Natazia as a versatile contraceptive option that not only prevents pregnancy but also treats heavy menstrual bleeding. The drug's 4-phasic regimen, where the doses of progestin and estrogen vary at four different times throughout the 28-day treatment cycle, is a unique selling point. This regimen is designed to deliver the lowest effective doses of these hormones, potentially leading to shorter, lighter periods[1][4].

Clinical Efficacy

Clinical studies have demonstrated Natazia's efficacy in preventing pregnancy and reducing heavy menstrual bleeding. In two clinical studies, women taking Natazia experienced significant reductions in menstrual bleeding, with an average reduction of 90% and 87% in menstrual blood volume at Cycle 7 compared to placebo groups[3].

Safety and Side Effects

While Natazia is effective, it comes with serious risks, including an increased risk of blood clots, stroke, and heart attack, particularly during the first year of use. Common side effects include headache, breast pain, menstrual disorders, nausea, acne, mood changes, and weight gain[3].

Market Performance

Natazia entered the US market in 2010, expanding the range of contraceptive options available to women. The drug has been marketed through Bayer's field force and the Natazia.com website. However, specific financial data on Natazia's sales performance is not readily available, as it is often bundled within Bayer's broader pharmaceutical portfolio.

Financial Impact on Bayer

Bayer's financial reports do not provide detailed figures specifically for Natazia, but the company's overall performance in the pharmaceutical sector can give some insight. Bayer's pharmaceutical division is a significant contributor to its revenue, and the introduction of Natazia has likely played a role in maintaining or increasing market share in the contraceptive market.

Competitive Landscape

The oral contraceptive market is highly competitive, with numerous options available. Natazia's unique formulation and 4-phasic regimen set it apart, but it competes with other established brands. The market dynamics are influenced by factors such as patient preference, healthcare provider recommendations, and insurance coverage.

Regulatory Environment

Natazia's approval and continued use are subject to regulatory oversight. The FDA's approval in 2010 marked a significant milestone, and subsequent updates to prescribing information and safety warnings have been made to ensure patient safety[3].

Patient and Healthcare Provider Perception

Patient and healthcare provider perception of Natazia is crucial for its market success. Positive clinical outcomes and effective marketing have helped in building a favorable perception. However, the drug's side effects and serious risks must be carefully managed and communicated to ensure patient safety and trust.

Future Outlook

The future outlook for Natazia depends on several factors, including ongoing clinical research, market trends, and regulatory changes. As women's health continues to be a priority, innovative contraceptive options like Natazia are likely to remain in demand. Bayer's continued support through marketing and educational initiatives will be key to maintaining and growing Natazia's market share.

Key Takeaways

• Unique Formulation: Natazia combines estradiol valerate and dienogest, offering a distinct 4-phasic regimen.
• Clinical Efficacy: Effective in preventing pregnancy and reducing heavy menstrual bleeding.
• Safety Concerns: Increased risk of blood clots, stroke, and heart attack, particularly during the first year of use.
• Market Positioning: Positioned as a versatile contraceptive option with additional benefits for heavy menstrual bleeding.
• Regulatory Environment: Subject to FDA oversight with ongoing updates to safety information.

FAQs

What is Natazia and how does it differ from other oral contraceptives?

Natazia is an oral contraceptive that combines a synthetic estrogen (estradiol valerate) and a progestin (dienogest). It differs from other combination OCs by using estradiol valerate instead of ethinyl estradiol and features a unique 4-phasic regimen.

What are the most serious risks associated with taking Natazia?

The most serious risks include an increased risk of blood clots, stroke, and heart attack, particularly during the first year of use or when restarting the pill after a break of four weeks or more.

How effective is Natazia in preventing pregnancy and reducing heavy menstrual bleeding?

Natazia is highly effective in preventing pregnancy and significantly reduces heavy menstrual bleeding, with clinical studies showing an average reduction of 90% and 87% in menstrual blood volume at Cycle 7.

What are the common side effects of Natazia?

Common side effects include headache, breast pain, menstrual disorders, nausea, acne, mood changes, and weight gain.

Is Natazia suitable for all women?

Natazia is not suitable for women over 35 who smoke, those with a history of heart attack or stroke, or those who are or may be pregnant. Its efficacy in women with a BMI of >30 kg/m2 has not been evaluated.

Sources

1. MM+M - Medical Marketing and Media: Natazia.
2. Business Wire: Natuzzi Shareholder Letter and Financial Results 2024.
3. hcp.natazia.com: A birth control pill... - WORTH A CLOSER LOOK.
4. Managed Healthcare Executive: Estradiol valerate/dienogest (Natazia): The first 4-phasic oral contraceptive tablets for the prevention of pregnancy.