VIVELLE Drug Patent Profile

When do Vivelle patents expire, and what generic alternatives are available?

Vivelle is a drug marketed by Sandoz and is included in two NDAs.

The generic ingredient in VIVELLE 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

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

Summary for VIVELLE

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	4
Patent Applications:	6,208
Drug Prices:	Drug price information for VIVELLE
Drug Sales Revenues:	Drug sales revenues for VIVELLE
DailyMed Link:	VIVELLE at DailyMed

See drug prices for VIVELLE

Recent Clinical Trials for VIVELLE

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 clinical trials

US Patents and Regulatory Information for VIVELLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-005	Aug 16, 2000		DISCN	No	No
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-005	Jan 8, 1999	AB1	RX	Yes	No
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-003	Oct 28, 1994		DISCN	No	No
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-006	Jan 8, 1999	AB1	RX	Yes	No
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-001	Oct 28, 1994		DISCN	No	No
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-002	Oct 28, 1994		DISCN	No	No

Expired US Patents for VIVELLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-002	Oct 28, 1994
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-004	Oct 28, 1994
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-003	Oct 28, 1994
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-001	Oct 28, 1994
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-002	Oct 28, 1994
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-005	Aug 16, 2000

International Patents for VIVELLE

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1006155
Norway	962833
Australia	3284789
European Patent Office	0728477
Denmark	0379044
Japan	2724043

Supplementary Protection Certificates for VIVELLE

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
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
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211

VIVELLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Vivelle-Dot

Introduction

Vivelle-Dot, a transdermal estrogen patch, has been a significant player in the hormone therapy market, particularly for treating menopausal symptoms. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Context

The transdermal patch market, including Vivelle-Dot, has seen continuous growth due to the advantages of transdermal drug delivery, such as painless and non-invasive administration, ease of use, and prolonged drug activation within the body[4].

Product Overview

Vivelle-Dot is an estradiol transdermal system used to treat symptoms of menopause, including atrophic vaginitis, atrophic urethritis, and hypoestrogenism. It is available in various doses, such as 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day[1][5].

Market Performance

Despite the decline in the overall hormone therapy market following the Women's Health Initiative (WHI) studies in 2002, Vivelle-Dot has maintained its market share. Novogyne, the joint venture responsible for marketing and selling Vivelle-Dot, reported a 43% increase in total prescriptions for Vivelle-Dot between 2002 and 2007, despite the market downturn[3].

Financial Performance

In 2007, Novogyne, the entity responsible for Vivelle-Dot, reported net revenues of $148 million and net income of $79.8 million. This represented a 12% increase in net revenues and a 22% increase in net income compared to the previous year. Novogyne also distributed $28.8 million in cash to Noven Pharmaceuticals in 2007[3].

Competitive Landscape

The generic version of Vivelle-Dot, launched by Mylan in 2014, marked a significant shift in the competitive landscape. Mylan's generic version offered patients a more affordable alternative, potentially impacting the market share of the branded product. However, the branded version has continued to maintain its position due to its established reputation and marketing efforts[1].

Pricing and Accessibility

The cost of Vivelle-Dot can vary, but on average, a supply of 8 films costs around $171, depending on the pharmacy and any available discounts or coupons. The availability of generic versions has also helped in reducing costs for patients[2].

Clinical and Regulatory Aspects

Vivelle-Dot has undergone extensive clinical trials to establish its efficacy and safety. For instance, a 12-week placebo-controlled study demonstrated the efficacy of the 0.0375 mg dose in reducing vasomotor symptoms in menopausal women[5].

Risks and Side Effects

The use of Vivelle-Dot is associated with certain risks, including an increased risk of endometrial cancer, stroke, and deep vein thrombosis. It is also noted that estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia, as highlighted by the WHI studies[1].

Future Prospects

The global transdermal patch market, including products like Vivelle-Dot, is projected to continue growing, driven by the advantages of transdermal drug delivery. The market is expected to exceed $15 billion, with over 100 patches currently in clinical trials[4].

Regional Trends

The market for transdermal patches, including Vivelle-Dot, varies by region. The US, Europe, and Asia-Pacific regions are key markets, each with their own trends and regulatory environments. Effective marketing and distribution strategies are crucial for maintaining market share in these regions[4].

Conclusion

Vivelle-Dot has navigated the challenges in the hormone therapy market successfully, maintaining its market share and financial performance despite significant market changes. The introduction of generic versions and ongoing clinical trials will continue to shape its market dynamics.

Key Takeaways

• Market Resilience: Vivelle-Dot has shown resilience in the face of declining hormone therapy market trends.
• Financial Performance: The product has contributed significantly to the financial health of its marketing entities.
• Competitive Landscape: The launch of generic versions has introduced new competition but has not significantly eroded the branded product's market share.
• Clinical Efficacy: Extensive clinical trials have established the efficacy and safety of Vivelle-Dot.
• Future Growth: The global transdermal patch market is expected to continue growing, benefiting products like Vivelle-Dot.

FAQs

Q: What is Vivelle-Dot used for? A: Vivelle-Dot is used to treat symptoms of menopause, including atrophic vaginitis, atrophic urethritis, and hypoestrogenism.

Q: How has Vivelle-Dot performed in the market despite the WHI studies? A: Despite the decline in the hormone therapy market following the WHI studies, Vivelle-Dot has seen a 43% increase in total prescriptions between 2002 and 2007.

Q: What are the risks associated with using Vivelle-Dot? A: The use of Vivelle-Dot is associated with an increased risk of endometrial cancer, stroke, and deep vein thrombosis.

Q: Is there a generic version of Vivelle-Dot available? A: Yes, Mylan launched the first generic version of Vivelle-Dot in 2014.

Q: What is the projected growth of the transdermal patch market? A: The global transdermal patch market is expected to exceed $15 billion, with over 100 patches currently in clinical trials.

Sources

1. Mylan Launches First Generic Version of Vivelle-DOT - Mylan Investor Relations
2. Vivelle-Dot Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com
3. Noven Pharmaceuticals 2007 Annual Report - AnnualReports.com
4. Global Transdermal Patch Market, Dosage, Price & Clinical Trials - BusinessWire
5. Vivelle-Dot - FDA Label - FDA AccessData