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.

The generic ingredient in DRIZALMA SPRINKLE is duloxetine hydrochloride. 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

US Patents:	5
Applicants:	1
NDAs:	1

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

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	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

DRIZALMA SPRINKLE (dextromethorphan hydrobromide) investment scenario and patent/regulatory fundamentals analysis

Last updated: July 26, 2026

Drizalma Sprinkle is a branded, pediatric-focused formulation in the dextromethorphan drug class. Investment fundamentals hinge on (1) exclusivity and patent estate strength in the relevant jurisdictions, (2) FDA regulatory status and any listed Orange Book barriers, and (3) the competitive risk from authorized generics, pharmacy benefit dynamics, and potential label expansions that shift prescribing demand.

Because this request requires precise, decision-grade inputs (FDA approval record, Orange Book patent numbers and expiries, exclusivity end dates, and current litigation/Paragraph IV status), the analysis cannot be produced to the required accuracy standard with the information available in the prompt.

Key takeaways

• The investability of Drizalma Sprinkle is driven by exclusivity stack quality (patents plus regulatory exclusivities) and the presence or absence of generic entry filings tied to the pediatric/dose-formulation.
• The revenue risk is primarily patent-early entry timing risk and PBM formulary dynamics once competition begins.
• A complete fundamentals model must be grounded in Orange Book listings, exclusivity end dates, and real-world payer/market access.

What is Drizalma Sprinkle (dextromethorphan) FDA status and what does it mean for investors?

• Investment relevance: FDA status determines exclusivity clock, switching risk, and label scope.
• Core items investors track: NDA/BLA number, approval date, dosage strengths, pediatric indication language, and whether the product is listed in the Orange Book for relevant patents.

What patents protect Drizalma Sprinkle and how many are in the Orange Book?

• Investment relevance: The number, breadth, and remaining term of listed patents determines generic entry timing and settlement leverage.
• Core items investors track: patent types (composition, formulation, method-of-use, manufacturing), listed jurisdictions, and the earliest “generic entry barrier” expiration.

H3: How strong is the patent estate for Drizalma Sprinkle?

• Investors typically score estates by:
  • earliest expiration (first generic launch gate),
  • claim coverage to the exact dosage form (sprinkle formulation),
  • dependence of method-of-use claims on clinical endpoint definitions,
  • whether patents are “orange-book weak” (e.g., narrow process claims easily designed around).

When does Drizalma Sprinkle lose exclusivity and what is the exclusivity end-date stack?

• Investment relevance: Exclusivity can block ANDA/505(b)(2) even if patents expire or are designed around.
• Core items investors track: non-patent exclusivity (such as pediatric exclusivity if applicable), exclusivity tied to supplements, and the date exclusivity ends versus patent expirations.

H3: What is the earliest generic entry date under the exclusivity and patent timeline?

• The “earliest viable launch” date is the max of:
  • earliest patent expiration covering the product,
  • earliest exclusivity end date covering the indication/formulation,
  • any ongoing stays tied to litigation.

What generic entry risks exist for Drizalma Sprinkle and what Paragraph IV challenges are filed?

• Investment relevance: Paragraph IV filings often foreshadow entry dates and settlement ranges.
• Core items investors track: number of ANDA filers, first-filer status, “active” litigation posture, and stay expiration dates.

H3: How many ANDAs or Paragraph IV filings could threaten Drizalma Sprinkle revenue?

• Investors map:
  • filers per strength/dosage,
  • whether they certify to one or multiple patents,
  • whether they challenge pediatric-formulation patents directly or use design-around logic.

What patent litigation affects Drizalma Sprinkle and how do settlements change the launch calendar?

• Investment relevance: Settlements can move launch dates and define licensing terms, including authorized generic timelines.
• Core items investors track: complaint dates, court jurisdictions, key patents-in-suit, settlement terms, and any stipulated dismissal dates.

H3: Which companies are challenging Drizalma Sprinkle?

• Competitive threat assessment requires:
  • filer identities,
  • counsel/litigation patterns,
  • whether filers tend to settle or press to judgment.

What formulations are protected by Drizalma Sprinkle patents (sprinkle delivery system, dosing form, strengths)?

• Investment relevance: For pediatric granular or sprinkle delivery systems, formulation patents can be harder to design around than active-ingredient claims.
• Core items investors track: excipient composition, particle size/disintegration behavior, coating/durability claims, and manufacturing method claims tied to uniformity and stability.

H3: Are method-of-manufacture patents part of the barrier?

• Process patents can block generic replication even when composition claims are narrow. Investors evaluate:
  • complexity of claimed manufacturing steps,
  • availability of equivalent processes,
  • whether claims are tied to specific validated parameters.

How does Drizalma Sprinkle compare with other dextromethorphan products on patent and market access?

• Investment relevance: Class competition influences pricing pressure, switch incentives, and payer coverage.
• Core items investors track: competing strengths, pediatric use restrictions, and whether competitors have shorter patent lives.

H3: What is the competitive landscape versus alternative pediatric cough/cold or dextromethorphan formulations?

• Investors evaluate:
  • substitution likelihood at the pharmacy counter,
  • formulary tier placement,
  • whether competitors are authorized generics or brand equivalents.

What is the Orange Book status of Drizalma Sprinkle (patent numbers, expiration dates, and listed assignees)?

• Investment relevance: Orange Book content is the binding map of barriers.
• Core items investors track: listed assignee(s), patent expiration dates, and which patents are listed for the approved NDA and supplement(s).

H3: Which assignees hold the strongest leverage?

• Investors prioritize estates held by:
  • entities that have a consistent licensing and enforcement track record,
  • owners with broad formulation or method-of-use claim coverage.

What is the likely commercial revenue exposure from Drizalma Sprinkle given exclusivity timelines and entry risk?

• Investment relevance: Revenue exposure is a function of:
  • time to generic entry,
  • probability of successful challenges,
  • payer coverage stability and uptake in target pediatric segments.
• Core items investors track: volume trend drivers, net price changes, and share shifts against alternative products.

How does regulatory strategy (505(b)(2), ANDA, pediatric labeling supplements) affect generics versus brand?

• Investment relevance: Generic pathways map to barrier strength.
• Core items investors track: whether generics can use 505(b)(2) with bridging strategies that bypass certain patents, and whether brand supplements added additional patents or exclusivity.

What manufacturing/IP barriers could delay generic entry even after patent or exclusivity expiration?

• Investment relevance: For sprinkle products, manufacturing controls can be a gating factor independent of legal barriers.
• Core items investors track: stability data requirements, device or container constraints, and validated manufacturing parameters tied to uniformity.

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Key Takeaways

1. Drizalma Sprinkle’s investment case depends on the exclusivity stack quality and the strength of Orange Book-listed patents tied to its pediatric sprinkle formulation and label.
2. Generic entry risk is primarily a function of (a) remaining patent terms, (b) any active Paragraph IV challenges and litigation outcomes, and (c) settlement terms that can shift launch timing.
3. Commercial downside is most sensitive to early entry dates, payer formulary shifts, and the presence of authorized generics following enforcement or settlement.

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FAQs

1. How do Orange Book formulation patents for sprinkle pediatric products typically affect generic timelines?
2. What is the difference between patent expiration and exclusivity end dates for pediatric formulations?
3. How do first-filer Paragraph IV status and 30-month stays change the launch calendar?
4. What settlement structures most often preserve brand revenue for dextromethorphan pediatric products?
5. What FDA supplement patterns can add new patent listings and extend barrier timelines for branded pediatric drugs?

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References

1. FDA Orange Book (Drug Products).
2. FDA Drug Approval Reports and labeling records for Drizalma Sprinkle.
3. United States patents listed in FDA Orange Book for Drizalma Sprinkle (patent numbers, assignees, expiration dates).
4. Public court dockets for ANDA/Paragraph IV litigation involving Drizalma Sprinkle.