METROGEL-VAGINAL Drug Patent Profile

Which patents cover Metrogel-vaginal, and when can generic versions of Metrogel-vaginal launch?

Metrogel-vaginal is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in METROGEL-VAGINAL is metronidazole. There are eighteen drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Metrogel-vaginal

A generic version of METROGEL-VAGINAL was approved as metronidazole by TEVA PHARMS USA on November 6^th, 1984.

Summary for METROGEL-VAGINAL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	172
Clinical Trials:	5
Patent Applications:	3,769
DailyMed Link:	METROGEL-VAGINAL at DailyMed

Recent Clinical Trials for METROGEL-VAGINAL

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

Sponsor	Phase
New York Medical College	Phase 4
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2
Parexel	Phase 2

See all METROGEL-VAGINAL clinical trials

Paragraph IV (Patent) Challenges for METROGEL-VAGINAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
METROGEL-VAGINAL	Vaginal Gel	metronidazole	0.75%	020208	1	2004-09-02

US Patents and Regulatory Information for METROGEL-VAGINAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	AB	RX	Yes	Yes

Expired US Patents for METROGEL-VAGINAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	4,837,378
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	5,840,744
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	5,536,743

International Patents for METROGEL-VAGINAL

See the table below for patents covering METROGEL-VAGINAL around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	68914365
Australia	5829490
China	1054507

Supplementary Protection Certificates for METROGEL-VAGINAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209

METROGEL-VAGINAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Metrogel-Vaginal

Introduction to Metrogel-Vaginal

Metrogel-Vaginal, a metronidazole vaginal gel, is a widely used treatment for bacterial vaginosis (BV), a common vaginal infection. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The bacterial vaginosis market, within which Metrogel-Vaginal operates, is projected to experience significant growth. As of 2024, the bacterial vaginosis market is valued at USD 3.48 billion and is expected to reach USD 6.26 billion by 2031, growing at a CAGR of 8.7%[1].

Specific Market for Metrogel-Vaginal

Metrogel-Vaginal itself holds a substantial market share within the BV treatment segment. According to IQVIA data, the U.S. annual sales for metronidazole gel, which includes Metrogel-Vaginal, totaled approximately $62 million for the 12 months ended June 2021[2].

Competitive Landscape

The market for Metrogel-Vaginal is competitive, with several major players involved. Companies like Bausch Health, Perrigo, and Solaris Pharma have been active in this space. For instance, Solaris Pharma received FDA approval for a generic version of Metrogel-Vaginal in 2021, which was launched immediately[2].

Perrigo also acquired full ownership of the ANDA for Metrogel-Vaginal and launched the product after receiving FDA approval in 2019. The annual market sales for Metrogel-Vaginal were approximately $100 million as of May 2019[5].

Drivers of Market Growth

Several factors are driving the growth of the Metrogel-Vaginal market:

• Rising Prevalence of BV: The increasing incidence of bacterial vaginosis, particularly among women of reproductive age, is a significant driver. BV affects about 30% of women aged 14-49 in the United States, with higher rates among non-white women[4].
• Enhanced Public Health Campaigns: Increased awareness about women's reproductive health through public health campaigns is boosting the demand for effective treatments like Metrogel-Vaginal[1].

Challenges and Limitations

Despite the growth, there are challenges that could impact the market:

• Antibiotic Resistance: The growing resistance to standard antibiotics, including metronidazole, can reduce treatment efficacy and limit the use of these medications[1].
• Adverse Reactions: Adverse reactions associated with current medications can also limit their use and affect market growth[1].
• Economic Burden: The treatment of BV poses a significant economic burden, which can affect market dynamics and patient adherence to treatment[4].

Emerging Trends and Therapies

The bacterial vaginosis market is evolving with the introduction of novel therapies. Emerging drugs like LACTIN-V, STMC-105, and pHyph are expected to enter the market, potentially changing the treatment landscape and impacting the demand for traditional treatments like Metrogel-Vaginal[4].

Financial Performance

The financial performance of Metrogel-Vaginal is robust, given its established presence in the market. Here are some key financial metrics:

• Annual Sales: As mentioned, the annual sales for metronidazole gel, including Metrogel-Vaginal, were around $62 million as of June 2021[2].
• Market Share: The product holds a significant share in the BV treatment market, although exact market share figures are not provided in the sources.

Generic Competition

The approval and launch of generic versions of Metrogel-Vaginal by companies like Solaris Pharma and Perrigo can impact the financial trajectory. Generic competition can reduce the market share and revenue of the branded product but also ensures continued availability and affordability of the treatment[2][5].

Regulatory Environment

Regulatory approvals play a crucial role in the market dynamics of Metrogel-Vaginal. FDA approvals for generic versions and any changes in regulatory policies can affect the market share and financial performance of the drug[2][5].

Consumer and Healthcare Provider Awareness

Greater awareness among women and healthcare providers about bacterial vaginosis and its treatments is essential for market growth. Initiatives by organizations such as the Women's Health Organization and the European Institute of Women's Health (EIWH) are helping to increase this awareness[4].

Key Takeaways

• Market Growth: The bacterial vaginosis market, including Metrogel-Vaginal, is expected to grow significantly, driven by rising prevalence and public health campaigns.
• Challenges: Antibiotic resistance and adverse reactions are key challenges.
• Emerging Trends: Novel therapies are expected to impact the market.
• Financial Performance: Metrogel-Vaginal has robust annual sales, but faces generic competition.
• Regulatory Environment: FDA approvals are crucial for market dynamics.

FAQs

1. What is the current market size of the bacterial vaginosis market?

   • The bacterial vaginosis market is valued at USD 3.48 billion in 2024[1].

2. What is the projected growth rate of the bacterial vaginosis market?

   • The market is expected to grow at a CAGR of 8.7% from 2024 to 2031[1].

3. What are the major drivers of the Metrogel-Vaginal market?

   • The global rise in bacterial vaginosis cases and enhanced public health campaigns are major drivers[1].

4. What are the challenges facing the Metrogel-Vaginal market?

   • Growing antibiotic resistance and adverse reactions associated with current medications are significant challenges[1].

5. Who are the major players in the Metrogel-Vaginal market?

   • Major players include Bausch Health, Perrigo, and Solaris Pharma[2][5].

Cited Sources

1. Coherent Market Insights - Bacterial Vaginosis Market - Report, Trends, Share & Insights
2. BioSpace - Solaris Pharma Receives FDA Approval for Generic Metrogel-Vaginal
3. BioSpace - Metronidazole Market Size, Growth, Trends, Report 2022-2030
4. GlobeNewswire - Bacterial Vaginosis Market to Register Incremental Growth During the Study Period (2020–2034) | DelveInsight
5. PR Newswire - Perrigo Announces FDA Final Approval and Launch Of The AB-Rated Generic Version Of Metrogel-Vaginal Gel