VAGIFEM Drug Patent Profile

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

Vagifem is a drug marketed by Novo Nordisk Inc and is included in one NDA.

The generic ingredient in VAGIFEM 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 Vagifem

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

Summary for VAGIFEM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	14
Patent Applications:	4,184
Drug Prices:	Drug price information for VAGIFEM
Drug Sales Revenues:	Drug sales revenues for VAGIFEM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VAGIFEM
What excipients (inactive ingredients) are in VAGIFEM?	VAGIFEM excipients list
DailyMed Link:	VAGIFEM at DailyMed

See drug prices for VAGIFEM

See drug sales revenues for VAGIFEM

Recent Clinical Trials for VAGIFEM

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

Sponsor	Phase
Breast Cancer Research Foundation	Phase 2
University of Washington	Phase 2
Koru Health Groups	N/A

See all VAGIFEM clinical trials

Pharmacology for VAGIFEM

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Paragraph IV (Patent) Challenges for VAGIFEM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VAGIFEM	Vaginal Tablets	estradiol	10 mcg	020908	1	2013-01-02

US Patents and Regulatory Information for VAGIFEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-002	Nov 25, 2009	AB	RX	Yes	Yes
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-001	Mar 26, 1999		DISCN	Yes	No

Expired US Patents for VAGIFEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-002	Nov 25, 2009
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-002	Nov 25, 2009

International Patents for VAGIFEM

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1343508
Germany	20120246
Spain	2376649
Germany	10179223
Portugal	1343508
European Patent Office	1343508	UTILISATION D'UN OESTROGENE DANS LA FABRICATION D'UNE COMPOSITION CONTENANT DE L'OESTROGENE POUR LE TRAITEMENT DE LA VAGINITE ATROPHIQUE (USE OF AN OESTROGEN IN THE MANUFACTURE OF A COMPOSITION CONTAINING OESTROGEN FOR THE TREATMENT OF ATROPHIC VAGINITIS)

Supplementary Protection Certificates for VAGIFEM

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

VAGIFEM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vagifem

Overview of Vagifem

Vagifem, developed by Novo Nordisk, is an intravaginal estradiol tablet used to treat postmenopausal vaginal atrophy (PVA). It was first approved in the US in 1999 and in the 5EU (France, Germany, Italy, Spain, and the UK) in 1988[4].

Market Segmentation and Competitive Landscape

The global PVA market, which includes Vagifem, is segmented based on therapy type and drug forms. The therapy types include estrogen-based drugs, such as Vagifem, Premarin, Estrace, Estring, and Femring, and non-estrogen-based drugs like BZA/CE, Osphena, and Vaginorm. In terms of drug forms, the market includes vaginal gels, creams, tablets, rings, and patches[1].

Key Market Drivers

Several factors drive the growth of the PVA market, including:

• Favorable Healthcare Reforms: Positive healthcare reforms, especially in emerging economies, have increased access to treatments for PVA.
• High Unmet Medical Needs: The rising prevalence of postmenopausal vaginal atrophy and the need for effective treatments contribute to market growth.
• Shift to Non-Estrogenic Therapies: There is a gradual shift from systemic estrogen treatments to non-estrogenic therapies, which is driving the market towards more diverse treatment options[1].

Challenges in the Market

Despite the growth drivers, the market faces several challenges:

• Low Diagnosis Rates: Many cases of PVA remain undiagnosed, which restricts the market growth.
• Safety Concerns: Existing treatments, particularly estrogen-based therapies, are associated with risks such as breast cancer, endometrial cancer, and stroke. This has led to a preference for lower-dose formulations and non-estrogenic alternatives[1][4].

Product Evolution and Safety Profile

Vagifem has undergone significant changes to address safety concerns. Initially approved as a 25mcg tablet, Novo Nordisk discontinued this dosage in 2010 and introduced a lower 10mcg formulation. This change was in line with medical recommendations to use the lowest effective estrogen dose for the shortest duration[4].

Financial Performance of Vagifem

While specific financial data for Vagifem alone is not readily available, the overall performance of Novo Nordisk's women's health segment can provide insights:

• Sales Growth: Novo Nordisk's financial reports indicate strong sales growth across various therapeutic areas, including women's health. For instance, the company's overall sales grew by 31% in 2023, with significant contributions from its core therapy areas[2][5].
• Market Share: The company's focus on expanding its product portfolio and improving patient access has helped in maintaining a strong market position. Novo Nordisk's commitment to innovation and external partnerships has also contributed to its financial success[2][3].

Regional Market Analysis

The sales forecast and market analysis for Vagifem have been detailed for key regions:

• Top Seven Countries: Sales forecasts for Vagifem have been provided for the US, France, Germany, Italy, Spain, the UK, and Japan. These forecasts help in understanding the market potential and competitive landscape in these regions[4].

Future Outlook

The future outlook for Vagifem and the broader PVA market is promising due to several factors:

• Novel Drugs and Therapies: The advent of novel drugs with improved safety profiles is expected to tap into the unmet needs of the market, providing lucrative growth opportunities.
• Increased Diagnosis and Treatment: Efforts to improve diagnosis rates and patient compliance are likely to expand the market.
• Diversification of Treatment Options: The shift towards non-estrogenic therapies and the development of new drug forms will continue to drive market growth[1].

Key Takeaways

• Market Growth Drivers: Favorable healthcare reforms, high unmet medical needs, and a shift to non-estrogenic therapies drive the PVA market.
• Challenges: Low diagnosis rates and safety concerns associated with existing treatments are significant challenges.
• Product Evolution: Vagifem has evolved to include lower-dose formulations to address safety concerns.
• Financial Performance: Strong sales growth and market share expansion are indicative of Novo Nordisk's overall financial health.
• Future Outlook: The market is expected to grow with the introduction of novel drugs and improved diagnosis and treatment rates.

FAQs

What is Vagifem used for?

Vagifem is used to treat postmenopausal vaginal atrophy (PVA), a condition characterized by vaginal dryness, itching, and pain during intercourse.

When was Vagifem first approved?

Vagifem was first approved in the US in 1999 and in the 5EU in 1988[4].

What are the key drivers of the PVA market?

The key drivers include favorable healthcare reforms, high unmet medical needs, and a gradual shift from systemic estrogen treatments to non-estrogenic therapies[1].

What are the challenges faced by the PVA market?

The market faces challenges such as low diagnosis rates and safety concerns associated with existing treatments[1][4].

How has Vagifem evolved over time?

Vagifem has evolved from a 25mcg tablet to a lower 10mcg formulation to address safety concerns and align with medical recommendations for using the lowest effective estrogen dose for the shortest duration[4].

What is the future outlook for the PVA market?

The future outlook is promising with the advent of novel drugs, increased diagnosis and treatment rates, and diversification of treatment options[1].