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 four 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. Fifty 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:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	202
Clinical Trials:	1
Patent Applications:	4,503
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 four 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	212516-002	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
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	212516-004	Jul 19, 2019		RX	Yes	Yes			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)

Supplementary Protection Certificates for DRIZALMA SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

DRIZALMA SPRINKLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Drizalma Sprinkle

Introduction

Drizalma Sprinkle, a serotonin and norepinephrine reuptake inhibitor (SNRI), is a groundbreaking formulation of duloxetine designed to address the needs of patients with difficulty swallowing. Launched by Sun Pharmaceutical Industries Ltd., this drug has significant implications for the pharmaceutical market and patient care.

Market Need and Target Population

Drizalma Sprinkle is tailored for individuals who struggle with swallowing solid medication forms, a challenge estimated to affect 30-35% of long-term care residents and a substantial portion of the general population, particularly the elderly and those with certain medical conditions[2].

FDA Approval and Indications

Approved by the U.S. Food and Drug Administration (FDA) on July 19, 2019, Drizalma Sprinkle is indicated for the treatment of major depressive disorder (MDD) in adults, generalized anxiety disorder (GAD) in adults and pediatric patients aged 7-17 years, diabetic peripheral neuropathy pain (DPNP) in adults, and chronic musculoskeletal pain in adults[2][4].

Unique Formulation

Drizalma Sprinkle is the first and only FDA-approved sprinkle formulation of delayed-release duloxetine capsules. This unique formulation allows the medication to be swallowed whole, sprinkled on applesauce, or administered via a nasogastric tube, significantly enhancing patient compliance and reducing the risk of medication errors associated with crushing tablets[2].

Coverage and Accessibility

The drug is now covered by most Medicare Part D plans, which include 91% of eligible U.S. lives, making it more accessible to a broader patient population. This extensive coverage underscores Sun Pharma's commitment to ensuring that patients have access to necessary medications[1].

Safety and Adverse Reactions

While Drizalma Sprinkle offers numerous benefits, it carries a boxed warning for suicidal thoughts and behaviors, particularly in pediatric and young adult patients. Common adverse reactions include nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis[1][2].

Market Trends and Competition

The pharmaceutical industry is experiencing several key trends that impact the market dynamics of Drizalma Sprinkle:

• Rising Prescription Drug Prices: Despite regulatory efforts like the Inflation Reduction Act, prescription drug prices continue to rise, influenced by factors such as inflation and supply chain disruptions[3].
• Increased Utilization of Generic Drugs: The expiration of patents for high-cost brand-name drugs has led to a 10% increase in generic drug prescriptions in the first half of 2024, which could potentially impact the market share of branded drugs like Drizalma Sprinkle[3].
• Specialty Medications: Significant spending on specialty medications continues, and Drizalma Sprinkle, as a unique formulation, falls into this category, potentially benefiting from this trend[3].

Financial Trajectory

The financial performance of Drizalma Sprinkle is closely tied to several factors:

• Market Penetration: With its unique formulation and extensive Medicare Part D coverage, Drizalma Sprinkle is poised to capture a significant share of the market for treatments of MDD, GAD, DPNP, and chronic musculoskeletal pain.
• Revenue Growth: As part of Sun Pharma's long-term care portfolio, Drizalma Sprinkle contributes to the company's revenue growth. The launch and subsequent coverage by major Medicare plans have likely boosted sales and revenue.
• Cost Management: The increasing use of generic drugs and regulatory measures to control drug prices could influence the pricing strategy and revenue projections for Drizalma Sprinkle. However, its unique formulation and the specific needs it addresses may help maintain its market position[3].

Strategic Positioning

Sun Pharma's commitment to providing alternative formulation products, especially for long-term care, positions Drizalma Sprinkle as a critical component of their portfolio. The drug's ability to mitigate medication errors and ensure patient compliance aligns with the company's goal of improving patient care and outcomes.

Future Outlook

The future of Drizalma Sprinkle looks promising, given the ongoing need for medications that cater to patients with swallowing difficulties. Here are some key points:

• Expanding Portfolio: Sun Pharma continues to expand its portfolio of alternative formulation products, which could further solidify Drizalma Sprinkle's market position.
• Regulatory Environment: Continued monitoring of regulatory changes, such as those introduced by the Inflation Reduction Act, will be crucial for understanding the broader market impact.
• Patient-Centric Innovations: The increasing adoption of telehealth and digital health tools could enhance patient adherence and overall care, potentially benefiting drugs like Drizalma Sprinkle[3].

Key Takeaways

• Unique Formulation: Drizalma Sprinkle is the first FDA-approved sprinkle formulation of duloxetine, addressing the needs of patients with swallowing difficulties.
• Extensive Coverage: The drug is covered by most Medicare Part D plans, enhancing its accessibility.
• Market Trends: The pharmaceutical industry's trends, including rising drug prices and increased generic drug utilization, will influence Drizalma Sprinkle's market dynamics.
• Financial Performance: The drug's revenue growth is tied to its market penetration, unique formulation, and regulatory environment.
• Future Outlook: The drug's future is promising, with ongoing needs for patient-centric formulations and evolving regulatory landscapes.

FAQs

1. What is Drizalma Sprinkle used for? Drizalma Sprinkle is used for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathy pain (DPNP), and chronic musculoskeletal pain in adults, as well as GAD in pediatric patients aged 7-17 years[2].

2. How is Drizalma Sprinkle administered? Drizalma Sprinkle can be swallowed whole, sprinkled on applesauce, or administered via a nasogastric tube[2].

3. What are the common adverse reactions associated with Drizalma Sprinkle? Common adverse reactions include nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis[1][2].

4. Is Drizalma Sprinkle covered by Medicare? Yes, Drizalma Sprinkle is covered by most Medicare Part D plans, which include 91% of eligible U.S. lives[1].

5. Why is Drizalma Sprinkle important for long-term care facilities? Drizalma Sprinkle mitigates the risk of medication errors associated with crushing tablets, a common practice in long-term care facilities, and ensures that patients receive their treatments as prescribed[2].

Cited Sources:

1. Sun Pharma Announces Drizalma Sprinkle™ (duloxetine delayed-release capsules) is Now Covered by Most Medicare Part D Plans. PR Newswire, March 9, 2021.
2. Sun Pharma Launches Drizalma Sprinkle in the U.S.. BioSpace, October 16, 2019.
3. Drug Trend Report (Q1-Q2 2024). intercept.health.
4. Generic Drizalma Sprinkle Availability. Drugs.com, November 6, 2024.