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Orange Book drug · Brand (NDA)

Lutathera

Lutetium Lu 177 Dotatate

RLDNDA 208700 Aaa USA Inc
Approved
Jan 26, 2018
Strengths
1
Listed patents
18

What does the FDA Orange Book show for Lutathera?

Lutathera contains Lutetium Lu 177 Dotatate and is the new drug FDA Orange Book record for NDA 208700. 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 208700

New drug application identity from the Orange Book snapshot.

Application holder
Advanced Accelerator Applications USA Inc

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

Product presentations
1

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
18

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

Exclusivity records
4

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
00110mCi/MLSOLUTIONINTRAVENOUSPrescriptionNone 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

Advanced Accelerator Applications USA Inc

The Orange Book identifies this organization as the applicant responsible for NDA 208700.

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 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

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

The latest future date recorded across those files is Jan 25, 2039. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 other NDAs found

0 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 208700 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Intravenous

Lutetium Lu 177 Dotatate

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

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-208700

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 208700
RLDRS
Strength
10mCi/ML
Dosage form
SOLUTION
Route
INTRAVENOUS
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    8 yr 7 mo ago

  2. Today

  3. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    in 9 mo

  4. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 1 yr 3 mo

  5. Exclusivity ends · ODE-479

    Orphan-drug exclusivity (7 years)

    in 4 yr 10 mo

  6. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 5 yr 4 mo

  7. Patent 10596276 expires

    Listed drug product patent expiration.

    in 12 yr 2 mo

  8. Patent 10596278 expires

    Listed drug product patent expiration.

    in 12 yr 2 mo

  9. Patent 11904027 expires

    Listed drug product patent expiration.

    in 12 yr 2 mo

  10. Patent 12144873 expires

    Listed method-of-use patent (U-4036) expiration.

    in 12 yr 2 mo

  11. Patent 12151003 expires

    Listed drug product patent expiration.

    in 12 yr 2 mo

  12. Patent 12161732 expires

    Listed drug product patent expiration.

    in 12 yr 2 mo

  13. Patent 12168063 expires

    Listed drug product patent expiration.

    in 12 yr 2 mo

  14. Patent 12415003 expires

    Listed method-of-use patent (U-4036) expiration.

    in 12 yr 2 mo

  15. Patent 12491272 expires

    Listed method-of-use patent (U-4036) expiration.

    in 12 yr 2 mo

  16. Patent 10596276*PED expires

    Listed listed patent expiration.

    in 12 yr 8 mo

  17. Patent 10596278*PED expires

    Listed listed patent expiration.

    in 12 yr 8 mo

  18. Patent 11904027*PED expires

    Listed listed patent expiration.

    in 12 yr 8 mo

  19. Patent 12144873*PED expires

    Listed listed patent expiration.

    in 12 yr 8 mo

  20. Patent 12151003*PED expires

    Listed listed patent expiration.

    in 12 yr 8 mo

  21. Patent 12161732*PED expires

    Listed listed patent expiration.

    in 12 yr 8 mo

  22. Patent 12168063*PED expires

    Listed listed patent expiration.

    in 12 yr 8 mo

  23. Patent 12415003*PED expires

    Listed listed patent expiration.

    in 12 yr 8 mo

  24. Patent 12491272*PED expires

    Listed listed patent expiration.

    in 12 yr 8 mo

Patent & exclusivity timeline

Protection horizon
20262028203020322034203620382040TodayExclusivity NPP: 2027-04-23Exclusivity NPPExclusivity PED: 2027-10-23Exclusivity PEDExclusivity ODE-479: 2031-04-23Exclusivity ODE-479Exclusivity PED: 2031-10-23Exclusivity PEDPatent 10596276: 2038-07-25Patent 10596276Patent 10596278: 2038-07-25Patent 10596278Patent 11904027: 2038-07-25Patent 11904027Patent 12144873: 2038-07-25Patent 12144873Patent 12151003: 2038-07-25Patent 12151003Patent 12161732: 2038-07-25Patent 12161732Patent 12168063: 2038-07-25Patent 12168063Patent 12415003: 2038-07-25Patent 12415003Patent 12491272: 2038-07-25Patent 12491272Patent 10596276*PED: 2039-01-25Patent 10596276*PEDPatent 10596278*PED: 2039-01-25Patent 10596278*PEDPatent 11904027*PED: 2039-01-25Patent 11904027*PEDPatent 12144873*PED: 2039-01-25Patent 12144873*PEDPatent 12151003*PED: 2039-01-25Patent 12151003*PEDPatent 12161732*PED: 2039-01-25Patent 12161732*PEDPatent 12168063*PED: 2039-01-25Patent 12168063*PEDPatent 12415003*PED: 2039-01-25Patent 12415003*PEDPatent 12491272*PED: 2039-01-25Patent 12491272*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

LUTETIUM LU 177 DOTATATE

Strength

10mCi/ML

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 208700

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • NPPNew patient population exclusivity (3 years)

    in 9 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 1 yr 3 mo

  • ODE-479Orphan-drug exclusivity (7 years)

    in 4 yr 10 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 5 yr 4 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10596276in 12 yr 2 mo
Product
10596278in 12 yr 2 mo
Product
11904027in 12 yr 2 mo
Product
12144873in 12 yr 2 mo
U-4036
12151003in 12 yr 2 mo
ProductU-4036
12161732in 12 yr 2 mo
ProductU-4036
12168063in 12 yr 2 mo
ProductU-4036
12415003in 12 yr 2 mo
U-4036
12491272in 12 yr 2 mo
U-4036
10596276*PEDin 12 yr 8 mo
10596278*PEDin 12 yr 8 mo
11904027*PEDin 12 yr 8 mo
12144873*PEDin 12 yr 8 mo
12151003*PEDin 12 yr 8 mo
12161732*PEDin 12 yr 8 mo
12168063*PEDin 12 yr 8 mo
12415003*PEDin 12 yr 8 mo
12491272*PEDin 12 yr 8 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.

No other applications share this active ingredient.

View full Lutetium Lu 177 Dotatate 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.

Lutathera: 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 208700 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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