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Orange Book drug · Brand (NDA)

Otezla

Apremilast

RLDNDA 205437 3 strengths Amgen Inc
Approved
Mar 21, 2014
Strengths
3
Listed patents
8

What does the FDA Orange Book show for Otezla?

Otezla contains Apremilast and is the new drug FDA Orange Book record for NDA 205437. The application has 3 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 205437

New drug application identity from the Orange Book snapshot.

Application holder
Amgen Inc

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

Product presentations
3

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
AB

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

Listed patents
8

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

Exclusivity records
6

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
00110MGTABLETORALPrescriptionAB
RLD
00220MGTABLETORALPrescriptionAB
RLD
00330MGTABLETORALPrescriptionAB
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

Amgen Inc

The Orange Book identifies this organization as the applicant responsible for NDA 205437.

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

3 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

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

8 listed patent expirations and 4 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Nov 29, 2034. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

13 other ANDAs and 1 other NDA found

5 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 205437 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-205437

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

3 approved presentations · NDA 205437
TE ABRLD
Strength
10MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    12 yr 6 mo ago

  2. Exclusivity ends · ODE-248

    Orphan-drug exclusivity (7 years)

    7 d ago

  3. Exclusivity ends · M-299

    New use / labeling-change exclusivity (3 years)

    6 d ago

  4. Today

  5. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 6 mo

  6. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 6 mo

  7. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    in 9 mo

  8. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 1 yr 3 mo

  9. Patent 7427638 expires

    Listed drug substance patent expiration.

    in 1 yr 7 mo

  10. Patent 7427638*PED expires

    Listed listed patent expiration.

    in 2 yr 1 mo

  11. Patent 12576034 expires

    Listed drug product patent expiration.

    in 7 yr 5 mo

  12. Patent 12576034 expires

    Listed drug product patent expiration.

    in 7 yr 5 mo

  13. Patent 12576034 expires

    Listed drug product patent expiration.

    in 7 yr 5 mo

  14. Patent 10092541 expires

    Listed method-of-use patent (U-2403) expiration.

    in 7 yr 11 mo

  15. Patent 10092541 expires

    Listed method-of-use patent (U-2659) expiration.

    in 7 yr 11 mo

  16. Patent 9872854 expires

    Listed method-of-use patent (U-2232) expiration.

    in 7 yr 11 mo

  17. Patent 9872854 expires

    Listed method-of-use patent (U-2233) expiration.

    in 7 yr 11 mo

  18. Patent 12576034*PED expires

    Listed listed patent expiration.

    in 8 yr

  19. Patent 10092541*PED expires

    Listed listed patent expiration.

    in 8 yr 6 mo

  20. Patent 9872854*PED expires

    Listed listed patent expiration.

    in 8 yr 6 mo

Patent & exclusivity timeline

Protection horizon
2026202720282029203020312032203320342035TodayExclusivity ODE-248: 2026-07-19Exclusivity ODE-248Exclusivity M-299: 2026-07-20Exclusivity M-299Exclusivity PED: 2027-01-19Exclusivity PEDExclusivity PED: 2027-01-20Exclusivity PEDExclusivity NPP: 2027-04-25Exclusivity NPPExclusivity PED: 2027-10-25Exclusivity PEDPatent 7427638: 2028-02-16Patent 7427638Patent 7427638*PED: 2028-08-16Patent 7427638*PEDPatent 12576034: 2033-11-30Patent 12576034Patent 12576034: 2033-11-30Patent 12576034Patent 12576034: 2033-11-30Patent 12576034Patent 10092541: 2034-05-29Patent 10092541Patent 10092541: 2034-05-29Patent 10092541Patent 9872854: 2034-05-29Patent 9872854Patent 9872854: 2034-05-29Patent 9872854Patent 12576034*PED: 2034-05-30Patent 12576034*PEDPatent 10092541*PED: 2034-11-29Patent 10092541*PEDPatent 9872854*PED: 2034-11-29Patent 9872854*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

APREMILAST

Strength

10MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 205437

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • ODE-248Orphan-drug exclusivity (7 years)

    7 d ago

  • M-299New use / labeling-change exclusivity (3 years)

    6 d ago

  • PEDPediatric exclusivity (adds 6 months)

    in 6 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 6 mo

  • NPPNew patient population exclusivity (3 years)

    in 9 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 1 yr 3 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7427638in 1 yr 7 mo
SubstanceProduct
7427638*PEDin 2 yr 1 mo
12576034in 7 yr 5 mo
ProductU-4291
12576034in 7 yr 5 mo
ProductU-1858
12576034in 7 yr 5 mo
ProductU-4290
10092541in 7 yr 11 mo
U-2403
10092541in 7 yr 11 mo
U-2659
9872854in 7 yr 11 mo
U-2232
9872854in 7 yr 11 mo
U-2233
12576034*PEDin 8 yr
10092541*PEDin 8 yr 6 mo
9872854*PEDin 8 yr 6 mo

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 Apremilast 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.

Otezla: 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 205437 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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