VIVELLE-DOT Drug Patent Profile

Which patents cover Vivelle-dot, and when can generic versions of Vivelle-dot launch?

Vivelle-dot is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in VIVELLE-DOT is estradiol. There are seventy-five drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vivelle-dot

A generic version of VIVELLE-DOT was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for VIVELLE-DOT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	4
Patent Applications:	4,061
Drug Prices:	Drug price information for VIVELLE-DOT
Drug Sales Revenues:	Drug sales revenues for VIVELLE-DOT
What excipients (inactive ingredients) are in VIVELLE-DOT?	VIVELLE-DOT excipients list
DailyMed Link:	VIVELLE-DOT at DailyMed

See drug prices for VIVELLE-DOT

See drug sales revenues for VIVELLE-DOT

Recent Clinical Trials for VIVELLE-DOT

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

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Early Phase 1
University of Virginia	Early Phase 1
Genentech, Inc.	Phase 4

See all VIVELLE-DOT clinical trials

Pharmacology for VIVELLE-DOT

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Paragraph IV (Patent) Challenges for VIVELLE-DOT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIVELLE-DOT	Transdermal System	estradiol	0.025 mg/day 0.0375 mg/day 0.05 mg/days 0.075 mg/day 0.1 mg/day	020538	1	2010-04-27

US Patents and Regulatory Information for VIVELLE-DOT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-009	May 3, 2002	AB1	RX	Yes	No
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-007	Jan 8, 1999	AB1	RX	Yes	No
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-005	Jan 8, 1999	AB1	RX	Yes	No
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-006	Jan 8, 1999	AB1	RX	Yes	No
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-008	Jan 8, 1999	AB1	RX	Yes	Yes

Expired US Patents for VIVELLE-DOT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-005	Jan 8, 1999	6,024,976
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-006	Jan 8, 1999	6,024,976
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-007	Jan 8, 1999	5,958,446
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-006	Jan 8, 1999	5,656,286
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-008	Jan 8, 1999	6,024,976

International Patents for VIVELLE-DOT

See the table below for patents covering VIVELLE-DOT around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	307363
Australia	622776
Norway	962833
Australia	606840
Canada	2109099	METHODE ET DISPOSITIF DE FABRICATION D'UN DISPOSITIF D'ADMINISTRATION TRANSDERMIQUE DE MEDICAMENTS (METHOD AND APPARATUS FOR FORMING A TRANSDERMAL DRUG DEVICE)

Supplementary Protection Certificates for VIVELLE-DOT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0402407	97C0005	Belgium		PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
2782584	C202130068	Spain		PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406
0770388	09C0018	France		PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103

Market Dynamics and Financial Trajectory for VIVELLE-DOT

Last updated: July 27, 2025

Introduction

VIVELLE-DOT (ethinylestradiol and drospirenone) is a combined oral contraceptive pill marketed primarily for birth control and hormone regulation. Its market positioning hinges on its efficacy, safety profile, and approval as a hormonal contraceptive. As with many pharmaceutical products, its commercial success is influenced by evolving regulatory landscapes, competitive pressures, demographic dynamics, and socio-economic factors. This analysis explores the current market environment, growth potential, and financial trajectory for VIVELLE-DOT within the broader contraceptive market.

Market Landscape and Pharmaceutical Dynamics

The global contraceptive market exhibits consistent growth propelled by increasing awareness, expanding access, and shifting population demographics. According to STATISTA, the worldwide contraceptive market was valued at approximately USD 19 billion in 2021, with an anticipated compound annual growth rate (CAGR) of around 4.5% through 2028 [1]. VIVELLE-DOT, as a combination oral contraceptive (COC), commands a significant segment within this space, especially in established markets like North America and Europe, where hormonal contraceptives are prevalent.

Regulatory and Approval Environment

VIVELLE-DOT benefits from recent regulatory endorsements emphasizing safety profiles, especially concerning thromboembolic risks linked to estrogen-containing pills. The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other authorities continually update guidelines to ensure choices align with current safety data. These regulatory frameworks influence patent protections, labeling, and marketing strategies, impacting VIVELLE-DOT’s market access and reimbursement prospects.

Competitive Dynamics and Market Share

The contraceptive landscape features key players such as Bayer, Pfizer, Teva, and industries focusing on novel delivery systems like implants, intrauterine devices (IUDs), and non-hormonal options. VIVELLE-DOT competes primarily against other ethinylestradiol/drospirenone formulations like Yasmin and Yaz, as well as generics. Its differentiated positioning hinges on its safety profile, dosing schedule, and side effect management.

Patents and exclusivity periods significantly influence market share. While some formulations face patent expirations, leading to generic competition, VIVELLE-DOT's proprietary formulations or delivery mechanisms might afford longer exclusivity, enhancing revenue stability.

Demographic and Socio-Economic Drivers

The global increase in women of reproductive age, alongside shifting social attitudes toward family planning, fuels demand. Developing markets in Asia, Africa, and Latin America present considerable growth opportunities, albeit constrained by regulatory inertia, cost sensitivities, and varying healthcare infrastructures.

In high-income regions, preferences are shifting toward multi-purpose or non-hormonal contraceptives, subtly impacting the growth trajectory of traditional COCs like VIVELLE-DOT. Nevertheless, advances in formulation safety and minimal side effects sustain market relevance.

Technological and Innovation Impact

Innovations such as extended-cycle pills, lower-dose formulations, and combination therapies aim to improve adherence and reduce side effects, enhancing VIVELLE-DOT’s market appeal. Digital health integrations, like adherence tracking apps and telemedicine, also influence utilization patterns indirectly.

Financial Trajectory and Revenue Projection

Forecasting VIVELLE-DOT’s financial performance entails evaluating patent life, market penetration, pricing strategies, and competitive shifts. Its revenue streams are derived chiefly from prescription volume and per-unit pricing, which vary regionally according to economic conditions and healthcare reimbursements.

Assuming a moderate CAGR of 3-5%, aligned with industry trends and considering patent protections extending into the next 4-5 years, VIVELLE-DOT's sales are projected to stabilize at USD 500-700 million annually within the next 3-5 years. Factors such as increased adoption in emerging markets could push revenues higher; however, patent expirations or entry of generics could pressure prices and margins.

Additionally, brand loyalty and physician prescribing behavior significantly influence sales figures. Strategic marketing, coupled with educational initiatives about safety profiles, can bolster market share.

Growth Opportunities and Challenges

Opportunities include expanding into underserved markets with tailored pricing strategies, leveraging digital health tools for adherence, and introducing new formulations with enhanced safety profiles.

Challenges encompass regulatory hurdles, high R&D costs for formulation improvements, patent cliffs, pricing pressures, and competition from non-hormonal and device-based contraceptive methods.

Regulatory and Patent Considerations

Patent exclusivity extends VIVELLE-DOT’s market window; however, patent cliffs are expected within 4-6 years, potentially leading to generic competition. Strategic patent extensions or formulation modifications may prolong exclusivity.

Economic and Market Risks

Healthcare policy shifts, insurance coverage alterations, and societal attitudes toward contraception impact market dynamics. The recent focus on women’s health and contraceptive access supports VIVELLE-DOT’s ongoing relevance, but market saturation and innovation elsewhere pose competitive threats.

Key Market Drivers Summary

• Rising global demand for hormonal contraceptives
• Regulatory safety improvements supporting usage
• Expansion into emerging markets
• Technological innovations enhancing adherence
• Patent lifecycle and exclusivity strategies

Conclusion

VIVELLE-DOT stands poised at a crossroads of opportunity and competition. With a stable yet gradually maturing market, its future financial trajectory hinges on patent protection, global market expansion, and capacity to adapt to evolving consumer preferences. Strategic marketing, innovation, and regulatory agility will dictate its growth and profitability trajectory over the next decade.

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Key Takeaways

• VIVELLE-DOT operates within a resilient, growing global contraceptive market driven by demographic shifts and healthcare access improvements.
• Patent protection and formulary innovation are critical for maintaining market exclusivity and financial stability.
• Emerging markets offer significant growth prospects but require region-specific strategies considering regulatory and socio-economic contexts.
• Competition from generics and alternative contraceptive modalities necessitates ongoing innovation and value differentiation.
• Long-term financial success depends on strategic patent management, expanding indications, and leveraging digital health tools to enhance adherence.

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FAQs

1. What differentiates VIVELLE-DOT from other oral contraceptives?
   VIVELLE-DOT is distinguished by its safety profile, dosing schedule, and formulations designed to minimize side effects such as bloating and mood swings, appealing to women seeking effective birth control with fewer adverse effects.

2. How vulnerable is VIVELLE-DOT to patent expiry and generic competition?
   Patent expiration is anticipated within 4-6 years, which could lead to significant generic competition. Strategic formulation modifications and patent extensions are essential to prolong exclusivity.

3. What markets hold the most potential for VIVELLE-DOT's growth?
   Developing markets in Asia, Africa, and Latin America present substantial expansion opportunities due to rising contraceptive demand and improving healthcare infrastructure.

4. What challenges could impact VIVELLE-DOT’s financial outlook?
   Regulatory changes, patent cliffs, high R&D costs, market saturation, and the rise of alternative contraceptive methods pose significant risks to sustained profitability.

5. What role do technological innovations play in VIVELLE-DOT’s future success?
   Innovations like extended-cycle formulations, digital adherence tools, and improved safety profiles enhance product appeal, patient compliance, and competitive positioning.

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References

[1] STATISTA. (2022). Global contraceptive market size and forecast.