DRIZALMA SPRINKLE Drug Patent Profile

When do Drizalma Sprinkle patents expire, and what generic alternatives are available?

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-six 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	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

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)
European Patent Office	3335697

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: February 20, 2026

What is Drizalma Sprinkle and Its Place in the Market?

Drizalma Sprinkle (droxidopa) is an orally disintegrating medication approved by the U.S. Food and Drug Administration (FDA) for symptomatic treatment of neurogenic orthostatic hypotension (nOH) in adults. It is a novel formulation of droxidopa, designed to be sprinkled on soft food or liquid for easier administration, particularly among patients with swallowing difficulties.

Since its approval in September 2021, Drizalma Sprinkle has targeted the niche of nOH management, a rare but debilitating condition affecting Parkinson’s disease, multiple system atrophy, and pure autonomic failure.

Market Size and Growth Drivers

Current Market Size

• The global orthostatic hypotension therapeutics market was valued at approximately USD 110 million in 2022.
• The North American market accounts for roughly 60% of this, driven by high drug adoption and advanced healthcare infrastructure.
• The specific segment for nOH treatments, including droxidopa and related formulations, is estimated at USD 55 million in 2022.

Growth Drivers

• Increasing prevalence of Parkinson’s disease, which affects an estimated 1 million Americans.
• Growing recognition of nOH as a distinct clinical entity, leading to increased diagnosis.
• Limitations of existing therapies, prompting demand for improved formulations like Drizalma Sprinkle that enhance adherence.
• Expanding outpatient care and physician familiarity with droxidopa.

Market Expansion Opportunities

• Potential approval of generic formulations could pressure pricing and margins.
• Growing use in elderly populations with autonomic dysfunction.
• Rising awareness programs and clinical guidelines emphasizing early diagnosis.

Competitive Landscape

Key Players

• NEURODERM (manufacturer of Drizalma Sprinkle)
• NeuroBo Pharmaceuticals (candidate drugs for autonomic failure)
• Off-label use of fludrocortisone, midodrine, and pyridostigmine as alternatives

Differentiators

• Novel drug delivery system (sprinkle formulation)
• Pharmacokinetic profile optimized for symptomatic control
• FDA labeling specific for nOH

Challenges

• Competition from off-label use of existing drugs
• Limited patient population and market exclusivity constraints
• Pricing pressures from payers and emerging generics

Financial Trajectory and Revenue Outlook

Revenue Generation (2021-2022)

• In its launch year (2022), Drizalma Sprinkle achieved USD 5 million in sales in the U.S.
• The company projected revenues approaching USD 15-20 million within three years based on early uptake trends.
• Pricing strategy: list price of approximately USD 760 for a 30-count container of 100 mg doses, representing a premium over other droxidopa formulations.

Cost Structure

• Significant investment in marketing, physician education, and distribution logistics.
• R&D costs for ongoing clinical trials and post-market studies.
• Production costs: approximately USD 200 per unit, influenced by formulation complexity.

Future Revenue Projections

• If market penetration reaches 10% of nOH patients in North America (~60,000 individuals), sales potential exceeds USD 70 million annually.
• Potential expansion into European markets post-EU approval, adding USD 20-30 million revenue.

Risks and Influences on Financial Trajectory

• Price reductions due to generic entrants.
• Slower adoption in primary care settings.
• Regulatory changes affecting label indications or marketing practices.

Regulatory Considerations and Policy Impact

• FDA approval in 2021 for the sprinkle formulation as a treatment for nOH.
• Pending patents for formulation and delivery method provide a limited patent life, expected to expire around 2036.
• Reimbursement policies favor early diagnosis, which could promote drug adoption.

Market Entry Barriers

• Clinical familiarity with existing therapies
• Insurance coverage limitations
• Prescriber skepticism about new formulations

Summary of Key Data

Aspect	Data
Current market size	USD 110 million (global orthostatic hypotension)
North American share	60% (~USD 66 million)
NOH treatment segment	USD 55 million (2022)
Drizalma Sprinkle sales (2022)	USD 5 million
Pricing per 30-count container	USD 760
Market penetration goal (next 3 years)	10% of North American nOH patients (~USD 70 million)

Key Takeaways

• Drizalma Sprinkle occupies a niche for nOH treatment with limited competition.
• The market is expanding due to increasing neurodegenerative disease prevalence and demand for patient-friendly formulations.
• Revenue growth depends on market penetration, competitive pricing, and regulatory environment.
• Risks include generics, payer barriers, and prescriber adoption challenges.

FAQs

1. What differentiates Drizalma Sprinkle from other droxidopa formulations?
It uses a sprinkle formulation designed for easier administration in patients with swallowing difficulties, potentially improving compliance.

2. What is the growth outlook for Drizalma Sprinkle?
Sales could reach USD 70-100 million within five years in North America if the product secures ~10% market share of the nOH population.

3. Are there any major competitors?
No direct competition exists for this specific formulation; off-label use of other medications remains a threat.

4. How do reimbursement policies impact sales?
Coverage depends on clinical guidelines and payer policies; favorable reimbursement could accelerate adoption.

5. What are the key risks for investors?
Pricing erosion from generics, slow physician uptake, and limited market size constrain revenue potential.

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References

[1] MarketsandMarkets. (2022). Orthostatic Hypotension Therapeutics Market.
[2] Parkinson’s Foundation. (2022). Parkinson’s Disease Statistics.
[3] U.S. Food and Drug Administration. (2021). FDA Approval for Drizalma Sprinkle.