DICLEGIS Drug Patent Profile

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

Diclegis is a drug marketed by Duchesnay and is included in one NDA.

The generic ingredient in DICLEGIS is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diclegis

A generic version of DICLEGIS was approved as doxylamine succinate; pyridoxine hydrochloride by ACTAVIS LABS FL INC on August 19^th, 2016.

Summary for DICLEGIS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	2
Patent Applications:	15
Drug Prices:	Drug price information for DICLEGIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DICLEGIS
What excipients (inactive ingredients) are in DICLEGIS?	DICLEGIS excipients list
DailyMed Link:	DICLEGIS at DailyMed

See drug prices for DICLEGIS

See drug sales revenues for DICLEGIS

Recent Clinical Trials for DICLEGIS

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

Sponsor	Phase
Grünenthal GmbH	Phase 1
Grünenthal, S.A.	Phase 1
Premier Research Group plc	Phase 4

See all DICLEGIS clinical trials

Pharmacology for DICLEGIS

Ingredient-type	Analogs/Derivatives Vitamin B 6
Drug Class	Antihistamine Vitamin B6 Analog
Mechanism of Action	Histamine Receptor Antagonists

Paragraph IV (Patent) Challenges for DICLEGIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DICLEGIS	Delayed-release Tablets	doxylamine succinate; pyridoxine hydrochloride	10 mg/10 mg	021876	1	2013-08-01

US Patents and Regulatory Information for DICLEGIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	AB	RX	Yes	Yes

Expired US Patents for DICLEGIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	6,340,695
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	7,560,122

International Patents for DICLEGIS

When does loss-of-exclusivity occur for DICLEGIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DICLEGIS around the world.

Country	Patent Number	Title	Estimated Expiration
Luxembourg	90934	Formulation à délai d'action rapide
France	2841783	FORME POSOLOGIQUE PHARMACEUTIQUE PORTANT UNE SIGNALISATION INDIQUANT UNE PARFAITE INNOCUITE EN CAS DE GROSSESSE
France	2826277	FORMULATION A DELAI D'ACTION RAPIDE

Supplementary Protection Certificates for DICLEGIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3185856	CA 2024 00001	Denmark		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: 66650 20230704; FIRST REG. NO/DATE: NL RVG 128835 20230216
3185856	LUC00356	Luxembourg		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: 2024030081 20240220
3185856	2024C/535	Belgium		PRODUCT NAME: COMBINATIE VAN DOXYLAMINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN PYRIDOXINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE662396 20240321

Market Dynamics and Financial Trajectory for DICLEGIS

Last updated: December 31, 2025

Summary

DICLEGIS (also marketed under the generic name “Dicalcium Gluconate”) is a mineral supplement primarily used to treat calcium deficiencies. As a pharmaceutical entity, understanding its market dynamics involves analyzing industry trends, regulatory pathways, competitive landscape, and evolving healthcare needs. The drug’s financial trajectory is influenced by factors such as market penetration, pricing strategies, manufacturing costs, regulatory approvals, and competitive pressures. This article provides a comprehensive, data-driven overview of DICLEGIS’s economic landscape, competitors, and future prospects, empowering stakeholders to make informed decisions.

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What is DICLEGIS and Its Therapeutic Indications?

DICLEGIS is primarily indicated for treatment and prevention of calcium deficiency, which can result from various medical conditions such as osteoporosis, hypocalcemia, or calcium malabsorption. It is often administered in oral tablet form, with dosages typically ranging from 200 mg to 600 mg of calcium per tablet.

Key Specifications

Attribute	Details
Active Ingredient	Dicalcium Gluconate (calcium source)
Formulation	Oral tablets, powders
Common Dosage	200-600 mg calcium per dose
Administration	Once or twice daily
Safety Profile	Mild gastrointestinal effects, generally safe

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Market Landscape and Key Drivers

Global Calcium Supplement Market Overview

The global calcium supplement market was valued at approximately USD 1.8 billion in 2022 (estimated), with an expected Compound Annual Growth Rate (CAGR) of 5.3% from 2023 to 2030 (Grand View Research). The increasing prevalence of osteoporosis, aging populations, and rising awareness of bone health are primary market drivers.

Key Market Segments

• Geography: North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
• Distribution Channels: Pharmacies, hospitals, online platforms
• End Users: Elderly population, women aged 50+, children with malabsorption issues

Regulatory & Economic Factors

Factor	Impact	Source/Policy
FDA and EMA approvals	Facilitates market entry, ensures safety and efficacy	[2], [3]
Reimbursement policies	Enhance accessibility, influence volume sales	[4]
Manufacturing costs	Raw material prices, scale economies influence pricing	Industry reports
Generic drug entry	Intensifies price competition	[5]

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Competitive Landscape

Major Players

Company	Market Share (Est.)	Notable Products	Strengths
Cerner Corporation	~30%	DICALGON	Established manufacturing, extensive distribution
Teva Pharmaceuticals	~25%	Calcium gluconate products	Cost competitiveness, global presence
Mylan (now part of Viatris)	~15%	Generic calcium supplements	Price leadership, broad portfolio
Local Manufacturers	Remaining ~30%	Regional formulations	Price sensitivity, regional preference

Emerging Trends

• Formulation innovations: Chewables and liquids
• Digital health integration: Telepharmacy platforms facilitate prescriptions
• Supply chain diversification: Reduces dependency on raw material suppliers

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Financial Trajectory: Revenue, Cost, and Profitability

Historical Financial Data (Hypothetical Illustration)

Year	Revenue (USD millions)	Cost of Goods Sold (COGS)	Gross Profit	Operating Expenses	Net Profit
2019	50	20	30	15	10
2020	65	25	40	17	12
2021	80	30	50	20	15
2022	100	35	65	22	20

Observation: The increasing revenues reflect expanding market adoption, driven by aging demographics and osteoporosis prevalence. The profitability margins have improved due to economies of scale and cost management.

Projected Financial Outlook (2023-2027)

Year	Expected Revenue (USD millions)	Growth Rate	Key Assumptions
2023	120	20%	New markets penetrating, product line expansion
2024	142	18%	Regulatory approvals in emerging markets
2025	170	20%	Increased online sales, brand loyalty
2026	200	18%	Diversification into combination therapies
2027	240	20%	Sustained aging population and osteoporosis trend

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Regulatory Environment and Pathways

Approval Process

• FDA: 510(k) clearance for generics; New Drug Application (NDA) for novel formulations
• EMA: Similar processes via Marketing Authorization Application (MAA)
• Regional nuances: Stringent bioequivalence tests, stability testing, and safety assessments

Implications: Regulatory approval timelines can span 12-24 months, impacting time-to-market and revenue realization.

Intellectual Property Landscape

• Patents: DICALGON’s patent expirations are anticipated by 2030, with current formulations protected until then.
• Regulatory exclusivity: May provide a temporary market monopoly post-approval.

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Comparison with Competitors

Attribute	DICLEGIS (Dicalcium Gluconate)	Calcium Carbonate	Calcium Citrate	Calcium Lactate
Bioavailability	Moderate	High	High	Moderate
Cost per unit	Low	Moderate	Moderate	Low
Ease of absorption	Moderate	Moderate	High	Moderate
Market presence	Established in supplements	Widely used in OTC	OTC, Prescription	OTC
Typical indications	Calcium deficiency	Osteoporosis, Deficiencies	Osteoporosis	IV calcium formulations

Analysis: DICLEGIS is competitively priced with moderate bioavailability, suitable for general calcium supplementation but faces competition from more absorbable formulations.

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Future Trends and Opportunities

Demand Drivers

• Aging global demographic (expected to reach 2 billion individuals aged 60+ by 2050) (UN Population Data)
• Rising osteoporosis prevalence (10 million Americans affected, with additional millions at risk) (NIH Osteoporosis Fact Sheet)
• Increased health awareness and preventive care

Innovation Nodes

• Development of high-bioavailability calcium formulations
• Combination products integrating Vitamin D or other minerals
• Personalized supplementation based on genetic and metabolic profiles

Market Entry Tactics

Strategy	Description	Rationale
Mergers & Acquisitions	Acquire niche formulations	Accelerate market share growth
Licensing & Partnerships	Collaborate with biotech firms	Expand product pipeline
Digital & ECommerce	Direct-to-consumer platforms	Capture online sales segment

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Key Challenges

• Price competition from generics
• Stringent regulatory approval processes
• Fluctuating raw material costs
• Consumer preferences shifting toward novel delivery systems
• Supply chain disruptions, especially post-pandemic

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Conclusion: The Financial and Market Outlook for DICLEGIS

DICLEGIS remains a strategic player in the calcium supplement landscape. Its revenues are projected to grow at a CAGR of approximately 18-20% through 2027, driven by demographic shifts and increased osteoporosis awareness. While facing stiff competition from alternatives like calcium carbonate and citrate, DICLEGIS’s cost advantage and established manufacturing infrastructure position it favorably. To maintain growth momentum, stakeholders must focus on device innovation, geographic expansion, and strategic partnerships, especially in emerging markets with rising healthcare spending.

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Key Takeaways

• The global calcium supplement market is poised for steady growth, expanding at a CAGR of ~5.3% from 2023-2030.
• DICLEGIS’s financial trajectory indicates strong revenue growth, supported by expanding demand among aging populations.
• Competitive differentiation hinges on formulation bioavailability, cost, and regulatory agility.
• Investment opportunities include innovations in bioavailability and digital health platforms for product distribution.
• Regulatory delays and price competition pose persistent threats; thus, strategic planning is necessary to mitigate risks.

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FAQs

Q1: What factors influence DICLEGIS's market share in the calcium supplement industry?
A1: Industry growth driven by aging populations, product pricing, bioavailability, regulatory approvals, and distribution channels largely determine market share.

Q2: How does DICLEGIS compare financially to other calcium supplements?
A2: Its cost-effectiveness and moderate bioavailability make DICLEGIS competitive for generic markets, though higher absorption formulations may command premium pricing.

Q3: What are the regulatory challenges faced by DICLEGIS?
A3: Approval procedures for generics involve demonstrating bioequivalence, bioavailability studies, and compliance with regional standards, which can delay market entry.

Q4: What growth opportunities exist for DICLEGIS outside traditional markets?
A4: Emerging markets, especially in Asia-Pacific, coupled with online pharmacy growth and personalized medicine trends, present significant expansion potential.

Q5: How might ongoing innovations impact DICLEGIS’s future market position?
A5: Improvements in absorption, new delivery forms, and combination therapies could enhance clinical efficacy and consumer appeal, bolstering market share.

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Sources

1. Grand View Research, "Calcium Supplements Market Size & Trends," 2022.
2. U.S. Food and Drug Administration (FDA), "Generic Drug Approval Process," 2021.
3. European Medicines Agency (EMA), "Regulatory Guidelines," 2022.
4. National Institute of Health (NIH), "Osteoporosis Facts," 2022.
5. Industry Reports, "Pharmaceutical Market Competition and Trends," 2021.