HECTOROL Drug Patent Profile

Which patents cover Hectorol, and what generic alternatives are available?

Hectorol is a drug marketed by Sanofi and is included in two NDAs.

The generic ingredient in HECTOROL is doxercalciferol. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the doxercalciferol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hectorol

A generic version of HECTOROL was approved as doxercalciferol by HIKMA on August 30^th, 2013.

Summary for HECTOROL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	11
Patent Applications:	1,400
Drug Prices:	Drug price information for HECTOROL
What excipients (inactive ingredients) are in HECTOROL?	HECTOROL excipients list
DailyMed Link:	HECTOROL at DailyMed

See drug prices for HECTOROL

See drug sales revenues for HECTOROL

Recent Clinical Trials for HECTOROL

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

Sponsor	Phase
Sanofi	Phase 3
Mariana Markell	Phase 4
OPKO IP Holdings II, Inc.	Phase 1

See all HECTOROL clinical trials

Pharmacology for HECTOROL

Drug Class

Vitamin D2 Analog

Paragraph IV (Patent) Challenges for HECTOROL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HECTOROL	Injection	doxercalciferol	2 mcg/mL, 1 mL in 2 mL vial	021027	1	2011-12-28
HECTOROL	Capsules	doxercalciferol	1 mcg	020862	1	2010-02-12
HECTOROL	Capsules	doxercalciferol	0.5 mcg and 2.5 mcg	020862	1	2009-03-25
HECTOROL	Injection	doxercalciferol	2 mcg/mL, 2 mL ampules	021027	1	2007-10-15

US Patents and Regulatory Information for HECTOROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-002	Apr 23, 2004	AB	RX	Yes	No
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-002	Apr 6, 2000	AP	RX	Yes	No
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-003	Jul 13, 2009	AB	RX	Yes	No
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	AB	RX	Yes	Yes

Expired US Patents for HECTOROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-002	Apr 6, 2000
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999

International Patents for HECTOROL

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

Country	Patent Number	Title	Estimated Expiration
Israel	139355	24-HYDROXYVITAMIN D, ANALOGS AND USES THEREOF
Poland	170447
Australia	2001278956
Australia	5595698

HECTOROL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for HECTOROL (Doxercalciferol)

Introduction

HECTOROL, also known as doxercalciferol, is a synthetic vitamin D2 analog used to treat secondary hyperparathyroidism in patients with chronic kidney disease (CKD). This article delves into the market dynamics and financial trajectory of HECTOROL, highlighting its clinical significance, market performance, and financial impact.

Clinical Significance of HECTOROL

HECTOROL is indicated for the treatment of secondary hyperparathyroidism in patients with CKD, both those on dialysis and those in Stage 3 or Stage 4 of the disease. It undergoes metabolic activation to form 1α,25-dihydroxyvitamin D2, a biologically active form of vitamin D2, which helps in regulating parathyroid hormone levels[1].

Market Segmentation

The global doxercalciferol market is segmented by region, company, type, and application. HECTOROL is marketed under various dosage forms, including oral capsules and intravenous injections, catering to different patient needs and preferences[4].

Market Performance

Sales and Revenue

HECTOROL has shown significant growth in sales over the years. In the third quarter of 2006, HECTOROL sales increased to $25.5 million, up from $14.1 million in the same quarter the previous year. This growth was part of Genzyme Corporation's overall strong financial performance, driven by solid revenue growth across various product lines[2].

Competitive Landscape

HECTOROL competes primarily with other vitamin D analogs, such as Zemplar (paricalcitol). A study published in Kidney International highlighted that HECTOROL and Zemplar had equally lower mortality rates among patients treated for secondary hyperparathyroidism compared to those treated with vitamin D3 therapy. This comparative data has been crucial in positioning HECTOROL in the market[2].

Financial Trajectory

Revenue Growth

The financial performance of HECTOROL is closely tied to the overall financial health of its manufacturer, Genzyme Corporation. In the third quarter of 2006, Genzyme reported a revenue of $808.6 million, a 14% increase from the same quarter the previous year. HECTOROL's sales contributed significantly to this growth, reflecting the drug's market acceptance and clinical efficacy[2].

Non-GAAP Financials

Genzyme's non-GAAP net income for the third quarter of 2006 increased by 22% to $195.9 million, with non-GAAP earnings per diluted share rising to $0.73. This growth was driven by solid revenue performance across various product lines, including HECTOROL[2].

Clinical Studies and Outcomes

Efficacy and Safety

Clinical studies, such as Study C and Study D, have evaluated the safety and effectiveness of HECTOROL Injection in patients with CKD on hemodialysis. These studies showed significant reductions in intact parathyroid hormone (iPTH) levels, indicating the drug's efficacy in managing secondary hyperparathyroidism. The studies also highlighted the drug's safety profile, although caution is advised in patients with hepatic insufficiency due to potential metabolic issues[3].

Market Drivers and Challenges

Market Drivers

• Increasing Prevalence of CKD: The growing number of patients with chronic kidney disease drives the demand for treatments like HECTOROL.
• Clinical Efficacy: The drug's proven efficacy in reducing iPTH levels and managing secondary hyperparathyroidism supports its market position.
• Regulatory Approvals: HECTOROL has received approvals in multiple regions, expanding its market reach[1][3].

Market Challenges

• Competition: The presence of other vitamin D analogs, such as Zemplar, poses a competitive challenge.
• Patient Access: Financial constraints and access to healthcare can limit the drug's adoption in some regions.
• Side Effects and Contraindications: Caution is required in patients with hepatic insufficiency, which can affect the drug's metabolism and safety profile[1][3].

Future Outlook

Market Growth Potential

The global doxercalciferol market is expected to grow, driven by the increasing prevalence of CKD and the need for effective treatments. HECTOROL's strong clinical profile and market acceptance position it for continued growth.

Strategic Initiatives

Genzyme Corporation's strategic initiatives, such as diversification of product lines and global infrastructure leverage, are expected to support the long-term growth of HECTOROL. The company's focus on late-stage programs and key milestones in the next six to twelve months will also drive future growth[2].

Key Takeaways

• Clinical Efficacy: HECTOROL is effective in managing secondary hyperparathyroidism in patients with CKD.
• Market Performance: The drug has shown significant sales growth and contributes to Genzyme's overall revenue.
• Competitive Landscape: HECTOROL competes with other vitamin D analogs but has a strong market position due to its clinical efficacy.
• Financial Trajectory: The drug's financial performance is tied to Genzyme's overall financial health, with non-GAAP figures indicating solid growth.
• Future Outlook: The market is expected to grow, driven by the increasing prevalence of CKD and the need for effective treatments.

FAQs

What is HECTOROL used for?

HECTOROL is used to treat secondary hyperparathyroidism in patients with chronic kidney disease, both those on dialysis and those in Stage 3 or Stage 4 of the disease.

What are the common dosage forms of HECTOROL?

HECTOROL is available in oral capsules and intravenous injections.

How does HECTOROL compare to other vitamin D analogs?

A study published in Kidney International showed that HECTOROL and Zemplar had equally lower mortality rates among patients treated for secondary hyperparathyroidism compared to those treated with vitamin D3 therapy.

What are the potential side effects of HECTOROL?

Patients with hepatic insufficiency should use HECTOROL with caution due to potential metabolic issues. Other side effects and contraindications should be considered based on individual patient profiles.

Who manufactures HECTOROL?

HECTOROL is marketed by Genzyme Corporation and manufactured by Catalent Pharma Solutions, Inc.[1].

Sources

1. DrugBank: Doxercalciferol: Uses, Interactions, Mechanism of Action.
2. Biospace: Genzyme Corporation Reports Strong Third-Quarter Financial Results.
3. American Kidney Fund: HECTOROL® doxercalciferol.
4. Market Growth Reports: Global Doxercalciferol Market – Industry Reports.