Orange Book drug · Brand (NDA)

Dexilant Solutab

Dexlansoprazole

DiscontinuedRLDNDA 208056 Takeda Pharms USA

Approved

Jan 26, 2016

Strengths

Listed patents

What does the FDA Orange Book show for Dexilant Solutab?

Dexilant Solutab contains Dexlansoprazole and is the new drug FDA Orange Book record for NDA 208056. The application has 1 presentation 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 208056
Application holder: Takeda Pharmaceuticals USA Inc
Product presentations: 1
Marketing categories: Discontinued
Reference roles: RLD
TE codes: None posted
Listed patents: 7
Exclusivity records: 0

Sourced from the official FDA Orange Book data file · snapshot refreshed Jul 02, 2026, 06:34 PM

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.
Product	Strength	Dosage form / route	Marketing status	TE code	Reference role
001	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASEORAL	Discontinued	None posted	RLD

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

Takeda Pharmaceuticals USA Inc

The Orange Book identifies this organization as the applicant responsible for NDA 208056.

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

1 presentation listed as on the Discontinued Drug Product List

A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.

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

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

The latest future date recorded across those files is Mar 10, 2029. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

4 other ANDAs and 1 other NDA found

4 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 208056 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet, Orally Disintegrating, Delayed Release · Oral

Dexlansoprazole

1 application

Product rows: 1
Active applications: 0
Active with AB row: 0

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-208056

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.

Product detail

NDA 208056

RLDDiscontinued

Strength: 30MG
Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route: ORAL
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Jan 26, 2016
10 yr 8 mo ago
Patent 8461187 expires
Listed drug product patent expiration.
Jan 17, 2026
6 mo ago
Patent 9238029 expires
Listed drug product patent expiration.
Jan 17, 2026
6 mo ago
Patent 9011926 expires
Listed drug product patent expiration.
Feb 24, 2026
5 mo ago
Patent 8461187*PED expires
Listed listed patent expiration.
Jul 17, 2026
9 d ago
Today
Patent 8871273 expires
Listed drug product patent expiration.
Jan 11, 2028
in 1 yr 6 mo
Patent 8871273*PED expires
Listed listed patent expiration.
Jul 11, 2028
in 2 yr
Patent 9241910 expires
Listed drug product patent expiration.
Mar 10, 2029
in 2 yr 8 mo

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

DEXLANSOPRAZOLE

Strength

30MG

Dosage form

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 208056

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8461187	Jan 17, 2026	6 mo ago	Product
9238029	Jan 17, 2026	6 mo ago	Product
9011926	Feb 24, 2026	5 mo ago	Product
8461187*PED	Jul 17, 2026	9 d ago
8871273	Jan 11, 2028	in 1 yr 6 mo	Product
8871273*PED	Jul 11, 2028	in 2 yr
9241910	Mar 10, 2029	in 2 yr 8 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 Dexlansoprazole 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.