TOTECT Drug Patent Profile

Which patents cover Totect, and when can generic versions of Totect launch?

Totect is a drug marketed by Clinigen and is included in one NDA.

The generic ingredient in TOTECT is dexrazoxane hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Totect

A generic version of TOTECT was approved as dexrazoxane hydrochloride by HIKMA on September 28^th, 2004.

Summary for TOTECT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	10
Patent Applications:	457
Drug Prices:	Drug price information for TOTECT
What excipients (inactive ingredients) are in TOTECT?	TOTECT excipients list
DailyMed Link:	TOTECT at DailyMed

See drug prices for TOTECT

Recent Clinical Trials for TOTECT

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
Children's Oncology Group	Phase 3
EsPhALL network I-BFM Study Group	Phase 3

See all TOTECT clinical trials

US Patents and Regulatory Information for TOTECT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Clinigen	TOTECT	dexrazoxane hydrochloride	INJECTABLE;INJECTION	022025-001	Sep 6, 2007		DISCN	Yes	No

Expired US Patents for TOTECT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Clinigen	TOTECT	dexrazoxane hydrochloride	INJECTABLE;INJECTION	022025-001	Sep 6, 2007

International Patents for TOTECT

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1459752
Brazil	0009473
Mexico	PA01009212	TRATAMIENTO DE LA EXTRAVASACION ACCIDENTAL DE ANTRACICLINAS. (TREATMENT OF ACCIDENTAL EXTRAVASATION OF ANTHRACYCLINES.)
European Patent Office	1162981	DEXRAZOXANE POUR LE TRAITEMENT D'EPANCHEMENT ACCIDENTEL D'ANTHRACYCLINES (DEXRAZOXANE FOR THE TREATMENT OF ACCIDENTAL EXTRAVASATION OF ANTHRACYCLINES)
Russian Federation	2252761	ЛЕЧЕНИЕ СЛУЧАЙНОЙ ТРАНССУДАЦИИ АНТРАЦИКЛИНОВ (THERAPY OF SPORADIC TRANSUDATION OF ANTHRACYCLINES)
Hong Kong	1043054
Canada	2367240	TRAITEMENT D'EPANCHEMENT ACCIDENTEL D'ANTHRACYCLINES (TREATMENT OF ACCIDENTAL EXTRAVASATION OF ANTHRACYCLINES)

TOTECT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Totect

Introduction

Totect, a cytoprotective agent developed by Clinigen Group plc and commercialized in the U.S. by Cumberland Pharmaceuticals, is a crucial drug in the oncology supportive care market. It is specifically indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy and for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration.

Market Need and Indications

Totect addresses a significant medical need by treating the toxic effects of anthracycline chemotherapy in cases of extravasation, which can cause severe tissue damage, nerve, tendon, muscle, and joint damage if not promptly managed[1][4].

Extravasation Treatment

The primary indication for Totect is the treatment of extravasation resulting from intravenous anthracycline chemotherapy. This condition can lead to serious complications, including tissue necrosis and skin ulceration, making Totect a vital emergency intervention[1][4].

Cardiomyopathy Prevention

Additionally, Totect is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m² and will continue to receive doxorubicin therapy[4].

Market Launch and Distribution

Initial Launch

The promotional launch of Totect in the U.S. was announced in September 2017 by Cumberland Pharmaceuticals and Clinigen Group plc. Cumberland managed all marketing, promotion, and distribution of the product in the U.S., while Clinigen was responsible for manufacturing, regulatory, and clinical management[1].

Distribution and Sales

Following the FDA approval of the updated labeling and product manufacturer, Cumberland initiated the distribution and sale of Totect in the United States. The product was launched during a national shortage of dexrazoxane, leading to strong initial demand[3].

Financial Performance

Revenue Growth

The launch of Totect contributed to Cumberland Pharmaceuticals' financial growth. In the fourth quarter of 2017, Cumberland reported double-digit revenue growth, partly attributed to the successful launch of Totect. The company's net revenues increased by 17% over the prior year, reaching $8.7 million[2].

Market Share and Competition

Although Totect saw strong initial demand due to a market shortage, its market share decreased as competitive products returned to the market in 2018. Following a strategic review, Cumberland concluded its distribution of Totect and transitioned the rights and responsibilities back to Clinigen[3].

Pricing and Accessibility

Cost

The cost for Totect 500 mg intravenous powder for injection is around $489 for a supply of one powder for injection, varying depending on the pharmacy[5].

Patient Assistance

While specific patient assistance programs for Totect are not detailed in the available sources, pharmaceutical companies often offer copay cards, coupons, or other forms of patient assistance to make such critical medications more accessible.

Clinical and Regulatory Aspects

FDA Approval

Totect received its initial U.S. approval in 2007 and has since undergone updates to its labeling and manufacturing processes. The FDA approved the updated labeling and product manufacturer in 2017, facilitating its relaunch in the U.S. market[4].

Clinical Trials and Safety Profile

Clinical trials have shown that Totect is effective in treating extravasation and reducing cardiomyopathy associated with doxorubicin. However, it is associated with myelosuppression, including leukopenia, neutropenia, and thrombocytopenia, which are common adverse reactions when used in conjunction with chemotherapeutic agents[4].

Strategic Partnerships and Pipeline

Partnership with Clinigen

The partnership between Cumberland Pharmaceuticals and Clinigen Group plc was crucial for the U.S. launch of Totect. Clinigen continues to commercialize its existing dexrazoxane products, Savene and Cardioxane, in Europe and other territories outside the U.S.[1].

Cumberland's Pipeline

Cumberland Pharmaceuticals has a diverse pipeline of product candidates, including those in Phase II development for conditions such as hepatorenal syndrome and cardiomyopathy associated with Duchenne Muscular Dystrophy. This pipeline indicates the company's commitment to expanding its portfolio in oncology supportive care and other therapeutic areas[3].

Key Takeaways

• Market Need: Totect addresses critical medical needs in oncology by treating extravasation and reducing cardiomyopathy associated with anthracycline chemotherapy.
• Launch and Distribution: The drug was launched in the U.S. in 2017, with Cumberland managing marketing and distribution, and Clinigen handling manufacturing and regulatory aspects.
• Financial Performance: The launch contributed to Cumberland's revenue growth, though market share decreased with the return of competitive products.
• Pricing and Accessibility: Totect is priced around $489 per dose, with potential patient assistance programs available.
• Clinical and Regulatory Aspects: FDA-approved since 2007, with updates to labeling and manufacturing processes.
• Strategic Partnerships: The partnership with Clinigen was key to the U.S. launch, and Cumberland continues to develop its pipeline in oncology supportive care.

FAQs

What is Totect used for?

Totect is used for the treatment of extravasation resulting from intravenous anthracycline chemotherapy and for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer[4].

Who are the key partners involved in the U.S. launch of Totect?

The key partners involved are Cumberland Pharmaceuticals and Clinigen Group plc. Cumberland manages marketing, promotion, and distribution in the U.S., while Clinigen handles manufacturing, regulatory, and clinical management[1].

How much does Totect cost?

The cost for Totect 500 mg intravenous powder for injection is around $489 for a supply of one powder for injection, depending on the pharmacy[5].

What are the common adverse reactions associated with Totect?

Common adverse reactions include myelosuppression, such as leukopenia, neutropenia, and thrombocytopenia, as well as febrile neutropenia[4].

Why did Cumberland transition the rights and responsibilities of Totect back to Clinigen?

Cumberland transitioned the rights and responsibilities back to Clinigen following a strategic review, as the market share of Totect decreased with the return of competitive products in 2018[3].

Sources

1. Cumberland Pharmaceuticals Launches Promotion of Totect® in the U.S. for Emergency Oncology Intervention. PR Newswire.
2. Cumberland Pharmaceutical Reports Double Digit Revenue Growth For The Fourth Consecutive Quarter. Cumberland Pharmaceuticals.
3. Developing new medicines for the future. Annual Reports.
4. Totect: Package Insert / Prescribing Information. Drugs.com.
5. Totect Prices, Coupons, Copay Cards & Patient Assistance. Drugs.com.