TERCONAZOLE - Generic Drug Details

What are the generic sources for terconazole and what is the scope of patent protection?

Terconazole is the generic ingredient in three branded drugs marketed by Janssen Pharms, Fougera Pharms, Fougera Pharms Inc, Taro, and Padagis Israel, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for terconazole. Eight suppliers are listed for this compound.

Summary for TERCONAZOLE

US Patents:	0
Tradenames:	3
Applicants:	5
NDAs:	10
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	8
Patent Applications:	5,550
Drug Prices:	Drug price trends for TERCONAZOLE
What excipients (inactive ingredients) are in TERCONAZOLE?	TERCONAZOLE excipients list
DailyMed Link:	TERCONAZOLE at DailyMed

See drug prices for TERCONAZOLE

Recent Clinical Trials for TERCONAZOLE

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

Sponsor	Phase
Hatem AbuHashim	N/A
Assiut University	Phase 3
Curatek Pharmaceuticals, LLC	Phase 3

See all TERCONAZOLE clinical trials

Pharmacology for TERCONAZOLE

Drug Class

Azole Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for TERCONAZOLE

G01AG	Triazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for TERCONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fougera Pharms Inc	TERCONAZOLE	terconazole	CREAM;VAGINAL	021735-001	Oct 1, 2004	BX	RX	Yes	Yes
Taro	TERCONAZOLE	terconazole	CREAM;VAGINAL	076043-001	Jan 19, 2005	AB	RX	No	Yes
Janssen Pharms	TERAZOL 3	terconazole	CREAM;VAGINAL	019964-001	Feb 21, 1991		DISCN	Yes	No

Expired US Patents for TERCONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	TERAZOL 3	terconazole	CREAM;VAGINAL	019964-001	Feb 21, 1991
Janssen Pharms	TERAZOL 3	terconazole	SUPPOSITORY;VAGINAL	019641-001	May 24, 1988
Janssen Pharms	TERAZOL 7	terconazole	CREAM;VAGINAL	019579-001	Dec 31, 1987

TERCONAZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Terconazole

Market Overview

The global market for vulvovaginal candidiasis (VVC) treatment, which includes terconazole, is experiencing significant growth driven by several key factors.

Global Market Size and Growth

The global VVC treatment market was valued at USD 986.5 million in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 4.39% from 2022 to 2030, reaching USD 1.64 billion by 2030[1].

Drug Class and Market Share

Terconazole is one of the prominent drugs in the VVC treatment market, categorized under the drug class segment. The market is segmented into various drug classes, including clotrimazole, nystatin, fluconazole, ketoconazole, terbinafine, terconazole, and others. Fluconazole dominated the market in 2021 with a share of 45.74%, but terconazole remains a significant player due to its efficacy and specific use cases[1][4].

Route of Administration

Terconazole is administered through topical routes, including vaginal creams and suppositories. The topical segment, while not as dominant as the oral segment, is expected to grow at a steady CAGR during the forecast period. The convenience and efficacy of topical administration contribute to its market presence[1][4].

Distribution Channels

The distribution of terconazole and other VVC treatments is primarily through hospital pharmacies, retail pharmacies, and online pharmacies. The retail pharmacy segment is a major channel, given the ease of access and the common nature of VVC infections[1][4].

Regional Outlook

The global VVC treatment market is geographically segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America dominated the market in 2021, accounting for more than 37.50% of the overall revenue, due to high disease prevalence, increased patient awareness, and significant healthcare expenditure. However, the Asia Pacific region is expected to witness the fastest growth rate, driven by rising disease burden and increasing testing rates[1].

Competitive Landscape

The market for VVC treatments, including terconazole, is competitive with several key players such as Pfizer Inc., Merck & Co. Inc., Astellas Pharma Inc., and Mycovia Pharmaceuticals, Inc. These companies are involved in the development, marketing, and distribution of various antifungal medications[3][4].

Financial Trajectory

Revenue Contribution

Terconazole, as part of the broader VVC treatment market, contributes significantly to the overall revenue. While the exact revenue share of terconazole is not specified, it is part of the drug class segment that drives market growth. The total market value for VVC treatments is projected to reach USD 1.64 billion by 2030, indicating a robust financial trajectory[1].

Growth Drivers

Several factors drive the financial growth of terconazole and the VVC treatment market:

• Rising Disease Burden: VVC affects around 138 million women annually worldwide, with nearly 75% of women experiencing the infection at least once in their lifetime[1].
• New Approvals and Launches: Recent approvals of therapies, such as BREXAFEMME and VIVJOA, contribute to market growth[1].
• Increased Awareness and Healthcare Expenditure: Higher patient awareness and increased healthcare spending in regions like North America further boost the market[1].

Regional Financial Performance

North America, being the dominant region, contributes substantially to the revenue. However, the Asia Pacific region's rapid growth due to increasing disease burden and healthcare benefits provided by governments is expected to significantly impact the financial trajectory of terconazole and other VVC treatments[1].

Key Takeaways

• The global VVC treatment market, including terconazole, is expected to grow at a CAGR of 4.39% from 2022 to 2030.
• Terconazole is administered topically and is part of a competitive market with several key players.
• North America dominates the market, but the Asia Pacific region is expected to show the fastest growth.
• Rising disease burden, new drug approvals, and increased healthcare expenditure are key growth drivers.

FAQs

1. What is the current market size of the VVC treatment market? The global VVC treatment market was valued at USD 986.5 million in 2021[1].

2. What is the projected growth rate of the VVC treatment market? The market is expected to grow at a CAGR of 4.39% from 2022 to 2030[1].

3. Which region dominates the VVC treatment market? North America dominated the market in 2021, accounting for more than 37.50% of the overall revenue[1].

4. What are the primary distribution channels for VVC treatments like terconazole? The primary distribution channels are hospital pharmacies, retail pharmacies, and online pharmacies[1][4].

5. Which companies are key players in the VVC treatment market? Key players include Pfizer Inc., Merck & Co. Inc., Astellas Pharma Inc., and Mycovia Pharmaceuticals, Inc.[3][4].

Sources

1. Grand View Research: Vulvovaginal Candidiasis Treatment Market Size Report, 2030
2. FDA: TERAZOL® 7 (terconazole) Vaginal Cream 0.4% - accessdata.fda.gov
3. Research and Markets: Yeast Infection Treatment Global Market Size & Competitors
4. Allied Market Research: Drugs for Vulvovaginal Candidiasis Market Share Report, 2033