TERAZOL 7 Drug Patent Profile

When do Terazol 7 patents expire, and when can generic versions of Terazol 7 launch?

Terazol 7 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in TERAZOL 7 is terconazole. There are six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the terconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Terazol 7

A generic version of TERAZOL 7 was approved as terconazole by TARO on April 6^th, 2004.

Summary for TERAZOL 7

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	59
Patent Applications:	5,382
DailyMed Link:	TERAZOL 7 at DailyMed

US Patents and Regulatory Information for TERAZOL 7

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	TERAZOL 7	terconazole	CREAM;VAGINAL	019579-001	Dec 31, 1987		DISCN	Yes	No

Expired US Patents for TERAZOL 7

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	TERAZOL 7	terconazole	CREAM;VAGINAL	019579-001	Dec 31, 1987	4,358,449

International Patents for TERAZOL 7

See the table below for patents covering TERAZOL 7 around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	63398
Spain	465981
Australia	521329
Greece	62553	NOVEL 1-(1,3-DIOXALAN-2-YLMETHYL)-1H-IMIDAZOLES AND 1H-1,2,4-TRIAZOLES

TERAZOL 7 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TERAZOL 7

Introduction

TERAZOL 7, a vaginal cream containing the antifungal agent terconazole, is used for the local treatment of vulvovaginal candidiasis (moniliasis). Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Indicators

Discontinuation of Brand Name

The Terazol 7 brand name has been discontinued in the U.S., but generic versions of this product may still be available, approved by the FDA[1].

Generic Competition

The discontinuation of the brand name has opened the market to generic competitors. Generic versions of terconazole are subject to intense competition from other generic drug manufacturers and brand-name pharmaceutical companies[3].

Usage and Indications

Clinical Use

TERAZOL 7 is indicated for the local treatment of vulvovaginal candidiasis. The diagnosis should be confirmed by microscopic examination of a KOH smear and/or by culture[4].

Patient Base

The drug is used by women suffering from vulvovaginal candidiasis, a common fungal infection. The patient base includes both pregnant and non-pregnant women, although its use in pregnant women is limited to the second and third trimesters[4].

Financial Trajectory

Revenue Impact of Generic Competition

The transition from a brand-name drug to generic equivalents typically results in a significant reduction in revenue for the original manufacturer. Generic versions are often priced lower, which can lead to increased market share for generic manufacturers but reduced profits for the original brand[3].

Sales Performance

Historically, the sales performance of TERAZOL 7 would have been influenced by its market position as a brand-name drug. However, with the brand name discontinued, sales are now driven by generic versions. The financial performance of these generics is tied to the competitive landscape and pricing strategies of generic manufacturers.

Impact on Pharmaceutical Companies

Companies like Perrigo, which specialize in generic and over-the-counter (OTC) products, benefit from the availability of generic versions of drugs like terconazole. These companies can capitalize on the lower production costs and higher profit margins associated with generic products[3].

Market Trends

Extended Topical Market

The market for topical dosage forms, including creams and suppositories, is significant. Companies expanding their portfolio in this area, such as Perrigo, have seen substantial growth. The acquisition of Paddock Laboratories by Perrigo, for example, expanded their capabilities in this niche[3].

Consumer Preferences

Consumers often prefer generic or store-brand products due to their lower cost without a significant compromise in quality. This trend benefits retailers and generic manufacturers, as they can offer high-quality products at lower prices, increasing consumer satisfaction and loyalty[3].

Regulatory Environment

FDA Approval

Generic versions of terconazole must be approved by the FDA, ensuring they meet the same standards of safety and efficacy as the original brand-name product. This regulatory oversight maintains consumer trust and ensures the quality of generic alternatives[1].

Clinical Trials and Safety Data

Extensive clinical trials have been conducted to evaluate the safety and efficacy of terconazole. These trials have provided valuable data on adverse reactions and the therapeutic regimen, which are crucial for regulatory approval and clinical use[4].

Adverse Reactions and Safety Profile

Common Adverse Reactions

The most common adverse reactions associated with TERAZOL 7 include headache, body pain, vulvovaginal burning, itching, and irritation. These reactions are generally mild and temporary[1][2].

Photosensitivity Reactions

While photosensitivity reactions have been observed in some studies, they have not been reported in clinical trials involving vaginal administration of terconazole[4].

Dosage and Administration

Therapeutic Regimen

TERAZOL 7 is administered intravaginally once daily at bedtime for seven consecutive days. The dosage form includes a 0.4% vaginal cream, with each applicator containing 20 mg of terconazole[1][2].

Stability and Storage

The drug should be stored at controlled room temperature (15-30°C) to maintain its efficacy and stability[4].

Key Takeaways

• Market Transition: The discontinuation of the Terazol 7 brand name has shifted the market towards generic versions.
• Generic Competition: Intense competition from generic manufacturers affects pricing and market share.
• Financial Impact: Revenue for the original manufacturer decreases with the introduction of generics, while generic manufacturers can benefit from lower production costs.
• Consumer Preferences: Consumers prefer lower-cost generic or store-brand products without compromising quality.
• Regulatory Oversight: FDA approval ensures the safety and efficacy of generic versions.
• Safety Profile: Common adverse reactions are generally mild and temporary.

FAQs

1. What is TERAZOL 7 used for?

TERAZOL 7 is used for the local treatment of vulvovaginal candidiasis (moniliasis), a fungal infection.

2. Why was the Terazol 7 brand name discontinued?

The Terazol 7 brand name was discontinued, but generic versions of the drug may still be available, approved by the FDA.

3. How is TERAZOL 7 administered?

TERAZOL 7 is administered intravaginally once daily at bedtime for seven consecutive days using a 0.4% vaginal cream.

4. What are the common adverse reactions associated with TERAZOL 7?

Common adverse reactions include headache, body pain, vulvovaginal burning, itching, and irritation.

5. Can TERAZOL 7 be used during pregnancy?

TERAZOL 7 may be used in pregnant patients during the second and third trimesters, but its use should be carefully considered and monitored.

Cited Sources:

1. Drugs.com: Terazol 7: Package Insert / Prescribing Information.
2. FDA: TERAZOL® 7 (terconazole) Vaginal Cream 0.4% - accessdata.fda.gov.
3. Perrigo Annual Report 2012: AnnualReports.com.
4. PRODUCT MONOGRAPH TERAZOL 7: pdf.hres.ca.