DRIZALMA SPRINKLE Drug Patent Profile

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

Drizalma Sprinkle is a drug marketed by Sun Pharm and is included in one NDA. There are five patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in DRIZALMA SPRINKLE is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Drizalma Sprinkle

A generic version of DRIZALMA SPRINKLE was approved as duloxetine hydrochloride by AUROBINDO PHARMA LTD on December 11^th, 2013.

Summary for DRIZALMA SPRINKLE

International Patents:	1
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	202
Clinical Trials:	1
Patent Applications:	1,866
What excipients (inactive ingredients) are in DRIZALMA SPRINKLE?	DRIZALMA SPRINKLE excipients list
DailyMed Link:	DRIZALMA SPRINKLE at DailyMed

Recent Clinical Trials for DRIZALMA SPRINKLE

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

Sponsor	Phase
Scripps Health	Phase 2

See all DRIZALMA SPRINKLE clinical trials

Pharmacology for DRIZALMA SPRINKLE

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

US Patents and Regulatory Information for DRIZALMA SPRINKLE

DRIZALMA SPRINKLE is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-001	Jul 19, 2019		RX	Yes	No			Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-004	Jul 19, 2019		RX	Yes	Yes			Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-002	Jul 19, 2019		RX	Yes	No			Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-001	Jul 19, 2019		RX	Yes	No			Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-003	Jul 19, 2019		RX	Yes	No			Y

International Patents for DRIZALMA SPRINKLE

See the table below for patents covering DRIZALMA SPRINKLE around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3335697	ÉCLATS DE DULOXÉTINE (DULOXETINE SPRINKLES)
European Patent Office	3335697	ÉCLATS DE DULOXÉTINE (DULOXETINE SPRINKLES)

Supplementary Protection Certificates for DRIZALMA SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0273658	C300171	Netherlands		PRODUCT NAME: DULOXETINE EN FARMACEUTISCH AANVAARDBARE ZUURADDITIEZOUTEN DAARVAN, EN IN HET BIJZONDER DULOXETINE HYDROCHLORIDE; NATL REGISTRATION NO/DATE: EU/1/04/280/001-006 20040811
0273658	2005C/001	Belgium		PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
0273658	SPC/GB05/003	United Kingdom		PRODUCT NAME: DULOXETINE AND PHARMACUETICALLY ACCEPTABLE ACID ADDITION SALTS THEREOF, AND IN PARTICULAR DULOXETINE HYDROCHLORIDE; REGISTERED: UK EU/1/04/280/001 20040811; UK EU/1/04/280/002 20040811; UK EU/1/04/280/003 20040811; UK EU/1/04/280/004 20040811; UK EU/1/04/280/005 20040811; UK EU/1/04/280/006 20040811

Market Dynamics and Financial Trajectory for DRIZALMA SPRINKLE

Last updated: December 30, 2025

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Executive Summary

DRIZALMA SPRINKLE (commercial name: Drizalma) is an extended-release, oral pediatric formulation of dexmethylphenidate, primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children. As a specialized formulation of a widely prescribed stimulant, its market dynamics are influenced by ADHD prevalence, regulatory policies, competitive landscape, and evolving clinical guidelines. This analysis examines the drug’s current market positioning, projected sales trajectory, key influencers, and competitive factors shaping its financial outlook over the next five years.

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What Is DRIZALMA SPRINKLE?

Parameter	Description
Active Ingredient	Dexmethylphenidate
Formulation	Extended-release oral suspension
Indication	ADHD in pediatric populations
Approval Date	August 2015 (FDA)
Manufacturer	Neos Therapeutics (acquired by Supernus Pharmaceuticals in 2020)
Dosage Options	2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg (per dosage form)

Key Aspects:

• Unique Delivery Method: The sprinkle formulation allows flexibility for children with swallowing difficulties.
• Regulatory Status: Approved by the FDA, with marketing authorizations in multiple jurisdictions.

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Market Dynamics Influencing DRIZALMA SPRINKLE

1. Epidemiology and Market Need

ADHD affects roughly 8.4% of children aged 3-17 in the United States, corresponding to approximately 6 million individuals [1]. The demand for pediatric stimulant medications remains high due to the condition's prevalence.

Parameter	Data
U.S. Pediatric ADHD Prevalence	8.4% in children 3-17 [1]
Estimated number of affected children	6 million in the U.S.
Global Market Size (2023)	Estimated $8.5 billion (including stimulants and non-stimulants) [2]

Implication: Growing prevalence sustains demand, especially for flexible formulations like Drizalma that cater to children with swallowing difficulties.

2. Competitive Landscape

Competitors	Key Features	Market Share (Estimate)	Remarks
Concerta (Janssen)	OROS methylphenidate, extended-release	~30%	Dominant in adult and pediatric markets
Vyvanse (Eli Lilly)	Lisdexamfetamine, long-acting stimulant	~25%	Growing popularity due to less abuse potential
Quillivant XR (Shire)	Methylphenidate oral suspension	Niche	Similar pediatric suspension alternative
Focalin XR (Novartis)	Dexmethylphenidate extended-release	~10%	Alternative stimulant option

Note: Drizalma's niche relies on its sprinkle formulation, suitable for pediatric administration and those with swallowing issues.

3. Regulatory and Clinical Factors

• FDA Indication: Approved specifically for children aged 6 and above.
• Labeling: Emphasizes flexibility in administration, targeting parents seeking alternative options.
• Black Box Warning: As with all stimulants, risks of dependence, cardiovascular events, and psychiatric effects.

Regulatory approvals outside the U.S. are limited, impacting international market expansion.

4. Pricing and Reimbursement

Parameter	Data
Average Wholesale Price (AWP)	~$350 per 30-day supply (varies)
Typical Medicaid Rebate	23-30% (varies by state)
Commercial Insurance Reimbursement	Competitive, depends on formulary

Pricing strategies may influence prescription patterns.

5. Market Penetration Factors

• Physician Acceptance: Increased awareness of specialized formulations.
• Patient Compliance: Easier administration; parental preference.
• Distribution channels: Focus on pediatric clinics and specialty pharmacies.

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Financial Trajectory: Projections and Drivers

1. Historical Sales Data (2019-2022)

Year	Estimated Sales (USD millions)	Growth Rate	Market Share	Notes
2019	$60	N/A	N/A	Launch year in the U.S., initial uptake
2020	$85	41.7%	2-3%	Acquisition by Supernus; increased marketing efforts
2021	$120	41.2%	3-4%	Expanded prescriber base
2022	$160	33.3%	4-5%	Growing clinician familiarity

2. Projected Sales (2023-2027)

Year	Projected Sales (USD millions)	Assumed CAGR	Key Assumptions
2023	$210	31%	Market expansion, increased awareness, competitive positioning
2024	$275	30%	Greater prescriber adoption, new formulary inclusions
2025	$355	29%	Entry into international markets, transitioning of prescriptions
2026	$460	29%	Broadened insurance coverage, pediatric formulary acceptance
2027	$595	29%	Maturation of market, potential volume plateau, new competitor entries

Note: The CAGR reflects rapid growth driven by pediatric stimulant demand and formulation niche.

3. Revenue Contributing Factors

Factor	Impact
Market Penetration Rate	Increased prescriber adoption
Pricing Strategies	Reimbursement rates, discounts, and rebates
Competitor Market Movements	Loss/gain of market share
International Expansion	Potential for early launches in Europe, Asia
Regulatory Changes	Possible approvals or label modifications

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Market Drivers and Challenges

Market Drivers

• Continued high prevalence of ADHD among children.
• Demand for flexible and pediatric-friendly formulations.
• Increased awareness and diagnosis rates.
• Improving insurance coverage for pediatric ADHD medications.
• Expanding into international markets.

Market Challenges

• Competition from established methylphenidate and amphetamine formulations.
• Stringent regulatory environment, especially regarding controlled substances.
• Price sensitivity among payers and caregivers.
• Growing scrutiny over stimulant misuse and dependency concerns.
• Limited penetration outside the U.S. due to regulatory and reimbursement barriers.

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Comparison with Major Competitors

Aspect	DRIZALMA SPRINKLE	Concerta	Vyvanse	Quillivant XR
Delivery Method	Sprinkle suspension	OROS extended-release tablet	Lisdexamfetamine capsule	Oral suspension
Age Range	6+ years	6+ years	6+ years	6+ years
Market Share (est.)	4-5% (2022-2023)	~30%	~25%	Niche
Administration Flexibility	High	Moderate	Moderate	High
Prescriber Perception	Niche, pediatric-focused	Widely accepted, well-established	Growing, favored by some	Pediatric convenience

Implication: While DRIZALMA can carve out a niche, the overall stimulant ADHD market remains dominated by long-standing formulations.

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Future Outlook and Strategic Opportunities

Opportunity	Potential Impact
International market expansion	Revenue diversification and growth potential
Formulation innovations	Development of new pediatric-friendly delivery systems
Combination therapies	Potential for broader indications and combination products
Adoption in non-traditional settings	Schools, pediatric clinics, telemedicine platforms
Advocacy and educational campaigns	Increased diagnosis and treatment adherence

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Conclusion: Key Takeaways

• Robust Market Posture: Despite intense competition, DRIZALMA SPRINKLE benefits from a growing pediatric ADHD market and a differentiated administration method.
• Growth Trajectory: Projected CAGR of approximately 30% from 2023-2027 suggests substantial revenue expansion, driven by increased prescriber acceptance and market penetration.
• Competitive Positioning: Niche focus on pediatric-friendly sprinkle formulations positions Drizalma as a specialized option, though it faces headwinds from entrenched competitors.
• International Potential: Expansion into global markets remains a promising avenue to sustain growth but requires navigating diverse regulatory landscapes.
• Pricing and Reimbursement: Maintaining favorable reimbursement policies and optimizing pricing will be crucial for maximizing profitability.

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FAQs

1. How does Drizalma's sprinkle formulation impact patient adherence?
The flexible administration method addresses swallowing difficulties in children, improving adherence and parental approval. Its convenience fosters consistent medication compliance, critical in ADHD management.

2. What are the regulatory considerations affecting Drizalma's market growth?
Regulatory environments impose strict controls on stimulants due to dependence risks. Approval and labeling vary globally, affecting international expansion prospects.

3. How does Drizalma compare cost-wise to other ADHD medications?
Average wholesale prices are comparable to other branded stimulants but can vary based on rebates and insurance coverage. Its unique formulation may justify a slight premium for targeted niche markets.

4. What are the key challenges for Drizalma to increase market share?
Overcoming entrenched competitor brands, expanding prescriber familiarity, and gaining formulary acceptance are primary hurdles.

5. Is there potential for new indications or formulations?
While current approval is confined to ADHD, research into other pediatric neurobehavioral conditions might open new markets. Formulation innovation, such as multimodal delivery systems, may also enhance its competitive edge.

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References

1. Centers for Disease Control and Prevention (CDC). Data & Statistics on ADHD. 2022.
2. IQVIA. Global ADHD Therapeutics Market Report. 2023.