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-seven 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
Nemours Children's Clinic	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	020538-007	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	020538-009	May 3, 2002	5,474,783
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-006	Jan 8, 1999	5,656,286
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-007	Jan 8, 1999	5,474,783
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-008	Jan 8, 1999	5,474,783
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-005	Jan 8, 1999	5,656,286

International Patents for VIVELLE-DOT

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

Country	Patent Number	Title	Estimated Expiration
Japan	H04504515
Australia	622776
European Patent Office	0634179
Singapore	77626	Compositions and methods for topical administration of pharmaceutically active agents
European Patent Office	0737066	DISPOSITIF D'ADMINISTRATION TRANSDERMIQUE CONTENANT DE LA POLYVINYLPYRROLIDONE EN TANT QU'AMPLIFICATEUR DE SOLUBILITE (TRANSDERMAL DEVICE CONTAINING POLYVINYLPYRROLIDONE AS SOLUBILITY ENHANCER)
Canada	2126366
Spain	2094906

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
0770388	2009/012	Ireland		PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
2782584	21C1058	France		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
2782584	122021000080	Germany		PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406

VIVELLE-DOT: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

VIVELLE-DOT, a transdermal estrogen patch for hormone replacement therapy (HRT), has maintained a consistent market presence. Its intellectual property landscape is largely defined by the expiration of its primary patents, leading to generic competition. Financial performance is primarily driven by prescription volume and pricing dynamics within the HRT market, which is influenced by evolving clinical guidelines and patient demographics.

What is VIVELLE-DOT's Core Therapeutic Indication?

VIVELLE-DOT is indicated for the treatment of moderate to severe menopausal symptoms, including hot flashes and vaginal dryness. It delivers estradiol, a form of estrogen, through the skin directly into the bloodstream. This transdermal delivery system bypasses the liver, potentially reducing first-pass metabolism compared to oral estrogen therapies. The product has been available in multiple dosages, typically ranging from 0.0375 mg/day to 0.1 mg/day of estradiol [1].

What is the Patent Expiration Status for VIVELLE-DOT?

The primary patents covering VIVELLE-DOT and its formulation have expired. Key patents, such as U.S. Patent No. 4,849,240, which claimed the transdermal drug delivery system, expired in 2007. Subsequent patents related to specific formulations or manufacturing processes have also expired. This expiration has opened the market to generic manufacturers offering bioequivalent versions of estradiol transdermal patches [2].

Who are the Key Manufacturers of VIVELLE-DOT and Generic Equivalents?

The originator of VIVELLE-DOT is Noven Pharmaceuticals, a subsidiary of Hisamitsu Pharmaceutical Co., Inc. Following patent expirations, other pharmaceutical companies have entered the market with generic estradiol transdermal patches. These include, but are not limited to, Teva Pharmaceuticals, Mylan N.V. (now part of Viatris), and Amneal Pharmaceuticals [3, 4]. The competitive landscape now includes multiple branded and generic options.

What are the Current Market Trends in Hormone Replacement Therapy?

The HRT market has experienced shifts influenced by safety concerns that emerged in the early 2000s, leading to a decline in usage. However, recent clinical evidence and evolving patient understanding have contributed to a resurgence, particularly for symptom management in menopausal women [5]. Current trends emphasize individualized treatment approaches, considering patient history, risk factors, and symptom severity. There is also a growing interest in non-estrogen-based therapies and alternative delivery methods, though transdermal estrogen remains a significant segment [6].

What is the Historical and Projected Financial Performance of VIVELLE-DOT?

Specific historical and projected financial data for VIVELLE-DOT as a distinct product line are not publicly disclosed by Noven Pharmaceuticals or Hisamitsu Pharmaceutical Co., Inc. due to its integration into broader product portfolios. However, its financial trajectory can be inferred from market data on transdermal HRT sales.

Prior to widespread generic entry, VIVELLE-DOT was a significant revenue generator. Market research reports from the period of patent exclusivity often cited it as a leading product in the transdermal estrogen market. For instance, in the mid-2000s, sales were in the hundreds of millions of dollars annually.

Following the introduction of generic competitors, the price of estradiol transdermal patches has significantly decreased. This price erosion impacts overall market value for the drug class, even if prescription volumes remain stable or grow. The total market value for estradiol transdermal patches in the U.S. has been estimated to range from \$300 million to \$500 million annually in recent years, a figure that reflects the combined sales of branded and generic products [7].

• Pre-Generic Era (Pre-2007): VIVELLE-DOT achieved peak annual sales estimated to be between \$300 million and \$400 million.
• Post-Generic Era (2007-Present): The market value for the drug class has stabilized, with growth influenced by increased patient identification and treatment rather than significant price increases for the molecule itself. Generic competition has fragmented revenue streams.
• Projected Trajectory: The market for transdermal estradiol is expected to experience modest growth, driven by an aging female population and increasing acceptance of HRT for symptom relief. However, growth will likely be constrained by the ongoing price competition among generic manufacturers and the development of novel therapeutic alternatives [8].

What are the Regulatory Considerations and Clinical Practice Guidelines Affecting VIVELLE-DOT?

Regulatory bodies like the U.S. Food and Drug Administration (FDA) oversee the approval and marketing of HRT products. The FDA requires rigorous efficacy and safety testing. Post-marketing surveillance is also crucial.

Clinical practice guidelines, such as those from the North American Menopause Society (NAMS) and the Endocrine Society, significantly influence prescribing patterns. These guidelines recommend HRT for symptomatic menopausal women, with a preference for transdermal routes for estrogen when indicated, due to a potentially more favorable safety profile regarding thrombotic events compared to oral estrogen [5, 9].

Key considerations in current guidelines include:

• Lowest effective dose and shortest duration: HRT should be used at the lowest effective dose and for the shortest duration necessary to manage symptoms.
• Individualized risk assessment: Patients should undergo assessment of cardiovascular, venous thromboembolic, and malignancy risks.
• Type of HRT: For women without a uterus, unopposed estrogen is used. For women with a uterus, estrogen is combined with a progestogen to protect the endometrium. Transdermal estrogen can be used with or without a progestogen depending on the patient's uterine status.
• Contraindications: Specific medical conditions contraindicate HRT use.

These guidelines directly impact the demand for VIVELLE-DOT and its generic equivalents, guiding physicians on appropriate patient selection and treatment duration.

What is the Competitive Landscape for Transdermal Estrogen Patches?

The competitive landscape is characterized by the presence of multiple generic manufacturers offering estradiol transdermal patches with equivalent pharmacokinetics and pharmacodynamics to VIVELLE-DOT. Key competitors include:

• Noven Pharmaceuticals (Hisamitsu): Originator of VIVELLE-DOT.
• Teva Pharmaceuticals: A major generic pharmaceutical company with an estradiol transdermal patch offering.
• Viatris (formerly Mylan): Another significant player in the generic drug market, providing estradiol patches.
• Amneal Pharmaceuticals: Offers a portfolio of generics, including estradiol transdermal systems.
• Other smaller generic manufacturers: Contribute to market competition.

The competition primarily centers on price and supply chain reliability. The availability of multiple bioequivalent generics has driven down the average selling price per patch. Pharmaceutical companies that can offer cost-effective manufacturing and broad distribution networks are best positioned.

What are the Future Outlook and Potential Challenges for VIVELLE-DOT and its Equivalents?

The future outlook for VIVELLE-DOT and its generic equivalents is one of continued, albeit modest, demand driven by the aging demographic and persistent menopausal symptoms. The transdermal route is expected to remain a preferred option for many women due to perceived safety advantages.

Potential Challenges:

• Intensifying Price Competition: As more generic manufacturers compete, further price erosion is likely, impacting profitability for all players.
• Development of Novel Therapies: Research into new pharmacological approaches to menopausal symptom management, including non-hormonal options and improved drug delivery systems, could shift treatment paradigms.
• Evolving Safety Data: New studies or re-evaluation of existing data on HRT safety could influence clinical guidelines and patient acceptance, potentially impacting demand.
• Regulatory Scrutiny: Ongoing regulatory oversight of HRT products and manufacturing standards requires continuous compliance and investment.
• Reimbursement Landscape: Changes in insurance formulary placement and reimbursement policies could affect market access and patient affordability.

Despite these challenges, the established efficacy and favorable safety profile (when appropriately prescribed) of transdermal estradiol suggest that VIVELLE-DOT and its generic equivalents will remain a relevant treatment option for menopausal symptom management.

Key Takeaways

• VIVELLE-DOT's primary patents have expired, leading to a highly competitive generic market for estradiol transdermal patches.
• The HRT market is experiencing renewed growth driven by an aging population and improved understanding of treatment benefits.
• Transdermal estradiol delivery is favored by some clinical guidelines due to a potentially better safety profile than oral estrogen.
• Market value for estradiol transdermal patches is in the hundreds of millions of dollars annually, driven by prescription volume rather than significant price appreciation for individual generics.
• Future market growth will be influenced by ongoing price competition, the development of alternative therapies, and evolving clinical guidelines.

Frequently Asked Questions

1. What is the primary difference between VIVELLE-DOT and its generic equivalents?

The primary difference lies in branding and manufacturer. Generic equivalents are bioequivalent, meaning they have the same active ingredient (estradiol), dosage form, strength, and route of administration, and are expected to have the same clinical effect and safety profile as VIVELLE-DOT.

2. Are there any ongoing clinical trials or research that could impact the VIVELLE-DOT market?

While VIVELLE-DOT itself is an established product, ongoing research in menopausal health explores new therapeutic targets, non-hormonal treatments, and alternative delivery methods. Advances in these areas could indirectly influence the market for existing transdermal estradiol products.

3. How do insurance companies typically cover VIVELLE-DOT and its generic alternatives?

Insurance coverage varies. Many plans cover generic estradiol transdermal patches due to their lower cost. Coverage for the branded VIVELLE-DOT may depend on formulary tiers, prior authorization requirements, and whether a generic is deemed therapeutically equivalent by the payer.

4. What is the typical duration of treatment with VIVELLE-DOT or its generic alternatives?

Treatment duration is individualized based on symptom severity, patient response, and risk assessment. Clinical guidelines generally recommend using HRT at the lowest effective dose for the shortest duration necessary to manage menopausal symptoms.

5. Can VIVELLE-DOT be used for purposes other than menopausal symptom management?

VIVELLE-DOT is specifically indicated for the treatment of moderate to severe menopausal symptoms. Its use for other conditions would require specific FDA approval and prescription by a healthcare provider.

Citations

[1] Noven Pharmaceuticals. (n.d.). VIVELLE-DOT® (estradiol transdermal system) Prescribing Information. [2] U.S. Patent and Trademark Office. (n.d.). Patent Database Search. (Specific patent numbers can be searched and verified). [3] Hisamitsu Pharmaceutical Co., Inc. (2023). Annual Report. [4] Generic Pharmaceutical Association. (n.d.). Generic Drug Approvals Database. [5] North American Menopause Society. (2022). The 2022 Hormone Therapy Position Statement of The North American Menopause Society. Menopause, 29(7), 767-794. [6] Global Market Insights. (2023). Hormone Replacement Therapy Market Size, Share & Trends Analysis Report. [7] Grand View Research. (2023). Hormone Replacement Therapy Market Size, Share & Trends Analysis Report. [8] Allied Market Research. (2022). Hormone Replacement Therapy Market by Type, Application, and End User: Global Opportunity Analysis and Industry Forecast, 2021–2030. [9] The Endocrine Society. (n.d.). Clinical Practice Guidelines. (Specific guidelines on menopause management can be referenced).