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-nine 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:	3
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	4
Patent Applications:	4,071
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

Expired US Patents for VIVELLE-DOT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-006	Jan 8, 1999
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-008	Jan 8, 1999
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-007	Jan 8, 1999
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-005	Jan 8, 1999

International Patents for VIVELLE-DOT

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1006155
Norway	962833
Australia	3284789
European Patent Office	0728477

Supplementary Protection Certificates for VIVELLE-DOT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0770388	PA2009004,C0770388	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
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804

VIVELLE-DOT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vivelle-Dot

Introduction

Vivelle-Dot, an estradiol transdermal system, is a significant player in the hormone therapy market, particularly for the treatment of menopausal symptoms. This article delves into the market dynamics and financial trajectory of Vivelle-Dot, highlighting its indications, market performance, and the impact of various factors on its success.

Indications and Usage

Vivelle-Dot is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause, moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, hypoestrogenism due to hypogonadism, castration, or primary ovarian failure, and the prevention of postmenopausal osteoporosis[4].

Market Performance Pre-WHI Studies

Before the Women’s Health Initiative (WHI) studies in 2002, the hormone therapy market was robust. Vivelle-Dot, developed and marketed by Novogyne Pharmaceuticals (a joint venture between Noven Pharmaceuticals and Novartis), was a leading product in this segment. The drug's innovative transdermal delivery system, using the DOT Matrix® technology, contributed to its popularity and market share[3].

Impact of WHI Studies

The publication of the WHI studies in 2002 significantly impacted the hormone therapy market. These studies highlighted increased risks of invasive breast cancer, myocardial infarction, and other health issues associated with estrogen therapy. Despite these challenges, Vivelle-Dot managed to maintain and even grow its market share. Novogyne successfully promoted the product, and by 2007, total prescriptions for Vivelle-Dot had increased by 43% compared to 2002[3].

Financial Performance

The financial performance of Vivelle-Dot is closely tied to the overall success of its parent companies. Here are some key financial highlights:

Novogyne Pharmaceuticals

In 2007, Novogyne reported net revenues of $148 million and net income of $79.8 million, marking the fourth consecutive year of double-digit percentage growth in net income. This success was largely driven by increased sales of Vivelle-Dot[3].

Noven Pharmaceuticals

Noven Pharmaceuticals, through its equity interest in Novogyne, benefited significantly from the success of Vivelle-Dot. In 2007, Noven recognized $35.9 million in earnings from its equity interest in Novogyne, a 25% increase over 2006[3].

Novartis

As a partner in the Novogyne joint venture, Novartis also benefited from the financial performance of Vivelle-Dot. While specific financial figures for Vivelle-Dot are not isolated in Novartis's broader financial reports, the drug's success contributed to the overall revenue and profitability of Novartis's pharmaceutical division[2].

Market Share and Competition

Vivelle-Dot has maintained a strong market position despite the decline in the overall hormone therapy market following the WHI studies. It remains one of the most prescribed transdermal estrogen products in the United States. The drug's market share has been sustained through effective promotion and sales strategies by Novogyne and its partners[3].

Generic Competition

The launch of generic versions of Vivelle-Dot, such as the one by Mylan in 2014, has introduced competition into the market. Mylan's generic version of Vivelle-Dot offers an alternative to the branded product, potentially impacting market share and pricing dynamics[1].

Dosage and Administration

The flexibility in dosage and administration of Vivelle-Dot has been a key factor in its market success. The drug is available in various strengths (0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day) and can be applied to the skin twice weekly, making it a convenient option for patients[4].

Regulatory and Safety Considerations

Vivelle-Dot, like other estrogen therapies, comes with certain risks and limitations. The drug carries a boxed warning regarding the increased risk of endometrial cancer, stroke, and deep vein thrombosis. It is recommended to prescribe estrogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman[4].

Future Outlook

The future outlook for Vivelle-Dot is influenced by several factors, including ongoing research, regulatory changes, and market competition. Here are some key considerations:

Ongoing Research and Development

Continued research into the safety and efficacy of estrogen therapies will be crucial. Noven Pharmaceuticals and its partners are committed to expanding and diversifying their transdermal product offerings, which could include new indications or improved delivery systems for Vivelle-Dot[3].

Regulatory Changes

Changes in regulatory environments can impact the market dynamics of Vivelle-Dot. For instance, updates in safety guidelines or new clinical trial data could affect prescribing practices and patient safety[4].

Market Competition

The introduction of generic versions and other competing products will continue to shape the market. Effective marketing and sales strategies will be essential for maintaining Vivelle-Dot's market share in a competitive landscape[1].

Key Takeaways

• Indications and Usage: Vivelle-Dot is used for treating menopausal symptoms, vulvar and vaginal atrophy, hypoestrogenism, and preventing postmenopausal osteoporosis.
• Market Performance: Despite the WHI studies, Vivelle-Dot has maintained and grown its market share.
• Financial Performance: The drug has contributed significantly to the revenues and profits of Novogyne, Noven Pharmaceuticals, and Novartis.
• Market Share and Competition: Vivelle-Dot remains a leading product in the transdermal estrogen market but faces competition from generic versions.
• Regulatory and Safety Considerations: The drug carries significant safety risks and is subject to regulatory guidelines.

FAQs

What are the primary indications for Vivelle-Dot?

Vivelle-Dot is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause, moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, hypoestrogenism, and the prevention of postmenopausal osteoporosis[4].

How has the WHI study impacted the market for Vivelle-Dot?

The WHI study led to a decline in the overall hormone therapy market, but Vivelle-Dot managed to maintain and even grow its market share through effective promotion and sales strategies[3].

What is the financial impact of Vivelle-Dot on its parent companies?

Vivelle-Dot has significantly contributed to the revenues and profits of Novogyne, Noven Pharmaceuticals, and Novartis, with Novogyne reporting net revenues of $148 million and net income of $79.8 million in 2007[3].

What are the safety risks associated with Vivelle-Dot?

Vivelle-Dot carries risks including increased chances of endometrial cancer, stroke, and deep vein thrombosis. It is recommended to prescribe at the lowest effective doses and for the shortest duration consistent with treatment goals and risks[4].

How does the introduction of generic versions affect Vivelle-Dot?

The launch of generic versions, such as Mylan's generic version in 2014, introduces competition and could impact market share and pricing dynamics for Vivelle-Dot[1].

Sources

1. Mylan Launches First Generic Version of Vivelle-DOT - Mylan Investor Relations
2. Novartis 20-F 2014 - Novartis
3. Noven Pharmaceuticals 2007 Annual Report - AnnualReports.com
4. Vivelle-Dot: Package Insert / Prescribing Information - Drugs.com
5. Vivelle-Dot® (estradiol transdermal system) - Novartis