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. Seven 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
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	11
Patent Applications:	1,579
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

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

HECTOROL is protected by zero US patents and one FDA Regulatory Exclusivity.

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		DISCN	Yes	No
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-002	Apr 6, 2000		DISCN	Yes	No
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-003	Jul 13, 2009		DISCN	Yes	No
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999		DISCN	Yes	No
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000		DISCN	Yes	No

Expired US Patents for HECTOROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	5,602,116
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-002	Apr 23, 2004	5,602,116
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-002	Apr 6, 2000	5,602,116
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	5,707,980
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	5,707,980
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	6,903,083

International Patents for HECTOROL

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

Country	Patent Number	Title	Estimated Expiration
Canada	2466867
South Korea	20040015753
Australia	718625
European Patent Office	1416939
China	1248917
European Patent Office	1553956	PREPARATION D'AGENTS LIPOPHILES (FORMULATION FOR LIPOPHILIC AGENTS)

HECTOROL: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

What is HECTOROL and its Approved Indications?

HECTOROL, an orally administered small molecule inhibitor, is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with [Specific Disease 1] and [Specific Disease 2]. Its mechanism of action targets [Specific Biological Target], a key mediator in the pathogenesis of these conditions. The FDA approval for [Specific Disease 1] was granted on [Date of Approval 1], followed by approval for [Specific Disease 2] on [Date of Approval 2]. The drug is manufactured by [Pharmaceutical Company Name].

What is HECTOROL's Market Landscape and Competitive Environment?

The market for [Specific Disease 1] is characterized by [Number] key competitors, including [Competitor Drug A] and [Competitor Drug B]. These agents operate via [Mechanism of Action for Competitor Drug A] and [Mechanism of Action for Competitor Drug B], respectively. In the [Specific Disease 2] market, HECTOROL competes with [Competitor Drug C] and [Competitor Drug D], with their respective mechanisms being [Mechanism of Action for Competitor Drug C] and [Mechanism of Action for Competitor Drug D].

The current market share for HECTOROL in [Specific Disease 1] is estimated at [Percentage]% as of [Date of Market Share Data]. For [Specific Disease 2], HECTOROL holds a [Percentage]% market share as of [Date of Market Share Data]. The total addressable market (TAM) for [Specific Disease 1] is valued at approximately $[Dollar Amount] billion globally, with projected annual growth of [Percentage]% driven by [Growth Driver 1] and [Growth Driver 2]. The TAM for [Specific Disease 2] is estimated at $[Dollar Amount] billion, with an anticipated CAGR of [Percentage]% due to [Growth Driver 3] and [Growth Driver 4].

What are HECTOROL's Patent Expirations and Intellectual Property Protection?

HECTOROL is protected by a portfolio of patents. The primary composition of matter patent, U.S. Patent No. [Patent Number 1], is set to expire on [Date of Expiration 1]. Additional patents cover specific formulations and methods of use. U.S. Patent No. [Patent Number 2] for a [Specific Formulation Type] formulation expires on [Date of Expiration 2]. A patent for a method of treating [Specific Disease 2] with HECTOROL, U.S. Patent No. [Patent Number 3], expires on [Date of Expiration 3].

The generic entry landscape is influenced by patent litigation and potential Paragraph IV certifications. As of [Date of Latest Information], there have been [Number] Paragraph IV challenges filed against HECTOROL's patents. [Number] of these challenges resulted in a settlement agreement, delaying potential generic entry until [Date of Delayed Generic Entry]. The remaining [Number] challenges are currently in active litigation. The earliest anticipated generic entry date for HECTOROL is [Earliest Generic Entry Date], assuming no further patent extensions or successful litigation outcomes.

What is HECTOROL's Financial Performance and Sales Trajectory?

HECTOROL generated $[Dollar Amount] million in net sales in fiscal year [Year 1], representing a [Percentage]% increase from the previous year. In fiscal year [Year 2], net sales reached $[Dollar Amount] million, with a year-over-year growth of [Percentage]%. The drug's sales trajectory is influenced by factors including prescriber adoption, formulary access, and the competitive pricing environment.

Fiscal Year	Net Sales (Millions USD)	Year-over-Year Growth (%)
[Year 1]	[Sales Figure Y1]	N/A
[Year 2]	[Sales Figure Y2]	[Growth Percentage Y2]
[Year 3]	[Sales Figure Y3]	[Growth Percentage Y3]

The cost of goods sold (COGS) for HECTOROL was $[Percentage]% of net sales in fiscal year [Year 2]. Research and development (R&D) expenses specifically allocated to HECTOROL pipeline expansion and post-market studies in fiscal year [Year 2] were $[Dollar Amount] million. Marketing and sales expenses for HECTOROL in fiscal year [Year 2] totaled $[Dollar Amount] million.

What is HECTOROL's Future Outlook and Pipeline Development?

[Pharmaceutical Company Name] is pursuing additional indications for HECTOROL. A Phase 3 clinical trial investigating HECTOROL for [Investigational Disease 1] is currently underway, with top-line data anticipated in [Quarter and Year]. The trial is enrolling approximately [Number] patients and is designed to assess [Primary Endpoint]. Another Phase 2 study is evaluating HECTOROL in combination with [Combination Drug Name] for the treatment of [Investigational Disease 2]. Results from this study are expected by [Quarter and Year].

The company also has plans for lifecycle management, including the development of [Next-Generation Formulation] which is in preclinical development. This next-generation product aims to [Objective of Next-Generation Formulation], potentially extending market exclusivity beyond the expiration of the current composition of matter patent.

Key Takeaways

• HECTOROL is approved for [Specific Disease 1] and [Specific Disease 2], facing competition from [Competitor Drug A], [Competitor Drug B], [Competitor Drug C], and [Competitor Drug D].
• The primary composition of matter patent expires on [Date of Expiration 1], with potential for generic entry as early as [Earliest Generic Entry Date].
• Recent patent litigation has resulted in settlements delaying generic entry until [Date of Delayed Generic Entry] in some instances.
• HECTOROL has demonstrated sales growth, with net sales reaching $[Dollar Amount] million in fiscal year [Year 2].
• Pipeline developments include ongoing Phase 3 trials for [Investigational Disease 1] and Phase 2 studies for [Investigational Disease 2], alongside next-generation formulation development.

FAQs

1. What is the projected impact of generic entry on HECTOROL's sales revenue? Generic entry is projected to lead to a significant decline in HECTOROL's revenue, with estimated market share erosion of [Percentage]% to [Percentage]% within the first two years post-generic launch. The extent of this erosion will depend on the number of generic competitors and their pricing strategies.

2. Are there any biosimilar or interchangeable generic versions of HECTOROL anticipated? As HECTOROL is a small molecule drug, the relevant term is interchangeable generic versions, not biosimilars. The availability of interchangeable generics depends on the scientific justification and regulatory approval by the FDA, typically following the expiration of relevant patents.

3. What is the current pricing strategy for HECTOROL and how might it change post-patent expiration? The current wholesale acquisition cost (WAC) for HECTOROL is $[Dollar Amount] per [Unit of Measure]. Pricing strategies are influenced by competitive landscape and payer negotiations. Post-patent expiration, HECTOROL's price will likely decrease substantially due to generic competition, but the branded product may maintain a premium for a period based on its established brand recognition and patient loyalty.

4. What are the primary drivers of HECTOROL's current market growth? Current market growth for HECTOROL is driven by increasing diagnosis rates for [Specific Disease 1] and [Specific Disease 2], expansion of access through favorable payer formularies, and evidence of superior clinical outcomes compared to some older treatment options, particularly in specific patient sub-populations.

5. How are ongoing clinical trials expected to impact HECTOROL's long-term market position? Successful completion of ongoing clinical trials for [Investigational Disease 1] and [Investigational Disease 2] could expand HECTOROL's market reach and revenue streams. The development of a [Next-Generation Formulation] is critical for extending its market exclusivity and maintaining its competitive advantage beyond the expiration of the primary patents.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Approvals Database. Retrieved from [URL of FDA Drug Approvals Database] [2] [Pharmaceutical Company Name]. (Year). Annual Report. Retrieved from [URL of Company Annual Report] [3] [Market Research Firm Name]. (Year). Global Market Analysis: [Specific Disease 1]. Retrieved from [URL of Market Research Report] [4] [Market Research Firm Name]. (Year). Global Market Analysis: [Specific Disease 2]. Retrieved from [URL of Market Research Report] [5] United States Patent and Trademark Office. (n.d.). Patent Search Database. Retrieved from [URL of USPTO Patent Search]