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Last Updated: December 21, 2024

VAGIFEM Drug Patent Profile


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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 22nd, 1997.

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Drug patent expirations by year for VAGIFEM
Drug Prices for VAGIFEM

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Drug Sales Revenue Trends for VAGIFEM

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Recent Clinical Trials for VAGIFEM

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SponsorPhase
Breast Cancer Research FoundationPhase 2
University of WashingtonPhase 2
Koru Health GroupsN/A

See all VAGIFEM clinical trials

Pharmacology for VAGIFEM
Drug ClassEstrogen
Mechanism of ActionEstrogen 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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novo Nordisk Inc VAGIFEM estradiol TABLET;VAGINAL 020908-001 Mar 26, 1999 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VAGIFEM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0334429 97C0002 Belgium ⤷  Subscribe PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1453521 CA 2016 00016 Denmark ⤷  Subscribe PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
2782584 132021000000197 Italy ⤷  Subscribe PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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].

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