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Orange Book drug · Brand (NDA)

Drizalma Sprinkle

Duloxetine Hydrochloride

RLDNDA 212516 4 strengths Sun Pharm
Approved
Jul 19, 2019
Strengths
4
Listed patents
5

What does the FDA Orange Book show for Drizalma Sprinkle?

Drizalma Sprinkle contains Duloxetine Hydrochloride and is the new drug FDA Orange Book record for NDA 212516. The application has 4 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 212516

New drug application identity from the Orange Book snapshot.

Application holder
Sun Pharmaceutical Industries Ltd

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
4

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
5

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001EQ 20MG BASECAPSULE, DELAYED REL PELLETSORALPrescriptionNone posted
RLD
002EQ 30MG BASECAPSULE, DELAYED REL PELLETSORALPrescriptionNone posted
RLD
003EQ 40MG BASECAPSULE, DELAYED REL PELLETSORALPrescriptionNone posted
RLD
004EQ 60MG BASECAPSULE, DELAYED REL PELLETSORALPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Sun Pharmaceutical Industries Ltd

The Orange Book identifies this organization as the applicant responsible for NDA 212516.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

4 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

5 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Apr 13, 2037. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

23 other ANDAs and 2 other NDAs found

16 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 212516 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-212516

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

4 approved presentations · NDA 212516
RLD
Strength
EQ 20MG BASE
Dosage form
CAPSULE, DELAYED REL PELLETS
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    7 yr 1 mo ago

  2. Today

  3. Patent 10413525 expires

    Listed drug product patent expiration.

    in 10 yr 10 mo

  4. Patent 10959982 expires

    Listed drug product patent expiration.

    in 10 yr 10 mo

  5. Patent 11202772 expires

    Listed drug product patent expiration.

    in 10 yr 10 mo

  6. Patent 12171742 expires

    Listed drug product patent expiration.

    in 10 yr 10 mo

  7. Patent 9839626 expires

    Listed drug product patent expiration.

    in 10 yr 10 mo

Patent & exclusivity timeline

Protection horizon
2026202820302032203420362038TodayPatent 10413525: 2037-04-13Patent 10413525Patent 10959982: 2037-04-13Patent 10959982Patent 11202772: 2037-04-13Patent 11202772Patent 12171742: 2037-04-13Patent 12171742Patent 9839626: 2037-04-13Patent 9839626
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

DULOXETINE HYDROCHLORIDE

Strength

EQ 20MG BASE

Dosage form

CAPSULE, DELAYED REL PELLETS

Route

ORAL

TE code

Not listed

Application

NDA 212516

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10413525in 10 yr 10 mo
Product
10959982in 10 yr 10 mo
Product
11202772in 10 yr 10 mo
Product
12171742in 10 yr 10 mo
Product
9839626in 10 yr 10 mo
Product

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Duloxetine Hydrochloride family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Drizalma Sprinkle: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 212516 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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