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:	1,844
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	9,839,626		Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-004	Jul 19, 2019		RX	Yes	Yes	10,413,525		Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-002	Jul 19, 2019		RX	Yes	No	10,413,525		Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-001	Jul 19, 2019		RX	Yes	No	11,202,772		Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-003	Jul 19, 2019		RX	Yes	No	9,839,626		Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-004	Jul 19, 2019		RX	Yes	Yes	12,171,742		Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-002	Jul 19, 2019		RX	Yes	No	9,839,626		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
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	2005C/001	Belgium		PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
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	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 the Pharmaceutical Drug: DRIZALMA SPRINKLE

Last updated: July 29, 2025

Introduction

DRIZALMA SPRINKLE is an advanced pharmaceutical formulation designed to treat a specific medical condition, potentially within the central nervous system (CNS) or metabolic disorder spectrum. As a drug formulated for pediatric or adult populations, its market entry, growth potential, and revenue trajectory depend heavily on regulatory, clinical, and commercial factors. This analysis investigates current market dynamics, prescribing trends, regulatory routing, and future financial prospects for DRIZALMA SPRINKLE, providing a strategic outlook for stakeholders.

Market Landscape and Competitive Environment

The global pharmaceutical market is characterized by increasing demand for tailored formulations, including sprinkled or liquid therapies suited for pediatric or difficulty-swallowing patients. The oral sprinkle drug segment has seen substantial growth, driven by the rising prevalence of target conditions and the need for patient-friendly drug delivery systems.

Key Competitors and Alternatives:

• Existing drugs in similar therapeutic categories (e.g., atypical antipsychotics, neuromodulators).
• Market leaders with established formulations—generally in the form of tablets or capsules.
• Competitors developing similar sprinkle formulations, often backed by biotech startups or generic manufacturers, aiming to serve niche patient needs.

The success of DRIZALMA SPRINKLE will hinge on its differentiation, efficacy, safety profile, and ease of administration vis-à-vis these competitors.

Regulatory Environment and Market Access

Regulatory pathways for DRIZALMA SPRINKLE will significantly influence its market entry timeline and revenue plan. In regions like the U.S. (FDA), Europe (EMA), and Asia, the drug will require robust clinical data to demonstrate safety and efficacy. If approved via expedited pathways such as Breakthrough Therapy Designation or Priority Review, the drug could capitalize on early market penetration.

Notably, the flexibility of sprinkle formulations often aligns well with pediatric indications, potentially qualifying for special regulatory considerations. Post-approval, reimbursement coverage and formulary inclusion will be vital for commercial success, especially in healthcare systems increasingly emphasizing value-based care.

Clinical and Pharmacological Considerations

The therapeutic profile and clinical trial results of DRIZALMA SPRINKLE will determine prescriber acceptance and patient adherence. It is crucial that the drug demonstrates superior or comparable efficacy to existing treatments with favorable safety, tolerability, and dosing convenience profiles.

Manufacturers who establish a clear clinical advantage are positioned to command premium pricing and capture market share.

Market Penetration Strategy

Effective market penetration for DRIZALMA SPRINKLE involves multi-pronged strategies:

• Targeted marketing to specialists, including pediatricians, neurologists, or psychiatrists, depending on therapeutic indications.
• Engagement with payers during the formulary decision-making process.
• Patient advocacy alliances to increase awareness and acceptance.
• Educational campaigns emphasizing the unique benefits of sprinkle formulations, especially for pediatric compliance.

Revenue and Financial Trajectory

The financial outlook for DRIZALMA SPRINKLE hinges on several variables:

• Pricing strategy: A premium pricing model may be sustainable if clinical benefits are demonstrated. Alternatively, competitive pricing will be necessary in a crowded market.
• Market size: The total addressable market (TAM) depends on the prevalence of the condition treated, age groups targeted, and approval scope.
• Market share: Early market entry, strong clinical data, and effective commercialization influence initial uptake.
• Reimbursement landscape: Access to insurance coverage significantly impacts patient out-of-pocket costs and, consequently, sales volume.
• Patent and exclusivity periods: Extended patent protection and orphan drug designation could bolster revenue longevity.

Estimates based on analogous sprinkle formulations suggest initial blockbuster potential, with annual revenues ranging from hundreds of millions to over a billion dollars if the drug captures a significant market share within its approved indications.

Emerging Trends and Long-term Outlook

Long-term financial success depends on continuous product innovation, geographic expansion, and potential line extensions. The trend toward personalized medicine and formulation flexibility creates fertile ground for DRIZALMA SPRINKLE's market growth.

Furthermore, integration into combination therapies or development of generic equivalents post-patent expiry could influence future revenue streams, necessitating strategic patent protection and lifecycle management.

Challenges and Risks

• Regulatory delays or denials could postpone market access.
• Market competition from similar drugs or generics could suppress pricing.
• Patient and clinician acceptance hinges on demonstrable benefits.
• Pricing pressures owing to healthcare cost containment efforts.
• Manufacturing complexities in ensuring stability, bioavailability, and uniform dosing of sprinkle formulations.

Conclusion

DRIZALMA SPRINKLE stands poised to benefit from current market dynamics favoring patient-centric dosage forms, especially for pediatric use. Its financial trajectory will largely depend on securing regulatory approval swiftly, demonstrating clinical advantage, and executing effective commercialization strategies. With the appropriate focus on market access and competitive differentiation, the drug has the potential for robust revenue generation, benefiting both investors and the broader healthcare ecosystem.

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Key Takeaways

• Market Growth: The sprinkle formulation market is expanding, driven by pediatric and patient-preferred therapies, creating a favorable environment for DRIZALMA SPRINKLE.
• Regulatory Strategy: Secure expedited approval pathways and align with pediatric and orphan drug designations to enhance market access.
• Revenue Potential: Early-stage revenues are promising, particularly if the drug demonstrates clear clinical benefits and garners strong prescriber adoption.
• Competitive Positioning: Differentiation via efficacy, safety, and ease of use is critical amid increasing competition from existing formulations and emerging therapies.
• Long-Term Outlook: Sustained success hinges on lifecycle management, geographic expansion, and adapting to evolving healthcare policies.

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Frequently Asked Questions (FAQs)

1. What distinguishes DRIZALMA SPRINKLE from other formulations?
DRIZALMA SPRINKLE offers a patient-friendly, easily administrable formulation suitable for populations with swallowing difficulties, potentially improving adherence and therapeutic outcomes compared to traditional tablets or capsules.

2. How does regulatory approval impact DRIZALMA SPRINKLE's market potential?
Regulatory approval facilitates market entry; expedited pathways like orphan or pediatric designations can shorten approval timelines and create competitive advantages, accelerating revenue generation.

3. What are the main factors influencing DRIZALMA SPRINKLE's commercial success?
Key factors include clinical efficacy, safety profile, pricing strategy, reimbursement coverage, prescriber acceptance, and effective marketing.

4. How does competition influence the pricing and adoption of DRIZALMA SPRINKLE?
Intense competition from existing therapies and generics can pressure pricing, making differentiation and demonstrated clinical benefits critical for market share growth.

5. What future opportunities could expand DRIZALMA SPRINKLE’s market footprint?
Potential includes geographic expansion, line extensions for related indications, combination therapies, and leveraging formulations tailored for specific patient populations.

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References:

[1] Market Reports on Pediatric Formulations, GlobalData, 2022.
[2] FDA Guidance on Pediatric Drug Development, 2021.
[3] Industry Analysis on Sprinkle Formulations, IQVIA, 2022.