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Orange Book drug · Brand (NDA)

Retevmo

Selpercatinib

RLDNDA 213246 2 strengths Eli Lilly And Co
Approved
May 08, 2020
Strengths
2
Listed patents
12
Applications
2

What does the FDA Orange Book show for Retevmo?

Retevmo contains Selpercatinib and appears in 2 FDA Orange Book applications. NDA 213246 is the lead filing, with 2 presentations shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
2; lead NDA 213246

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Eli Lilly And Co

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

Product presentations
2

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
12

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

Exclusivity records
16

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
00140MGCAPSULEORALPrescriptionNone posted
RLD
00280MGCAPSULEORALPrescriptionNone 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

Eli Lilly And Co

The Orange Book identifies this organization as the applicant responsible for NDA 213246.

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

2 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

12 listed patent expirations and 16 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Apr 10, 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 213246 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Capsule · Oral

Selpercatinib

1 application
Product rows
2
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-213246

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

2 approved presentations · NDA 213246
RLD
Strength
40MG
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    6 yr 4 mo ago

  2. Today

  3. Exclusivity ends · ODE-301

    Orphan-drug exclusivity (7 years)

    in 10 mo

  4. Exclusivity ends · ODE-302

    Orphan-drug exclusivity (7 years)

    in 10 mo

  5. Exclusivity ends · ODE-303

    Orphan-drug exclusivity (7 years)

    in 10 mo

  6. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    in 10 mo

  7. Exclusivity ends · M-311

    New use / labeling-change exclusivity (3 years)

    in 1 yr 2 mo

  8. Exclusivity ends · M-312

    New use / labeling-change exclusivity (3 years)

    in 1 yr 2 mo

  9. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 1 yr 4 mo

  10. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 1 yr 4 mo

  11. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 1 yr 4 mo

  12. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 1 yr 4 mo

  13. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 1 yr 8 mo

  14. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 1 yr 8 mo

  15. Exclusivity ends · ODE-409

    Orphan-drug exclusivity (7 years)

    in 3 yr 2 mo

  16. Exclusivity ends · ODE-412

    Orphan-drug exclusivity (7 years)

    in 3 yr 2 mo

  17. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 3 yr 8 mo

  18. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 3 yr 8 mo

  19. Exclusivity ends · ODE-484

    Orphan-drug exclusivity (7 years)

    in 4 yr 11 mo

  20. Exclusivity ends · ODE-485

    Orphan-drug exclusivity (7 years)

    in 4 yr 11 mo

  21. Exclusivity ends · ODE-487

    Orphan-drug exclusivity (7 years)

    in 4 yr 11 mo

  22. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 5 yr 5 mo

  23. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 5 yr 5 mo

  24. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 5 yr 5 mo

  25. Patent 10112942 expires

    Listed drug substance patent expiration.

    in 11 yr 4 mo

  26. Patent 10137124 expires

    Listed method-of-use patent (U-3450) expiration.

    in 11 yr 4 mo

  27. Patent 10137124 expires

    Listed method-of-use patent (U-3949) expiration.

    in 11 yr 4 mo

  28. Patent 10137124 expires

    Listed method-of-use patent (U-3950) expiration.

    in 11 yr 4 mo

  29. Patent 10137124 expires

    Listed method-of-use patent (U-3951) expiration.

    in 11 yr 4 mo

  30. Patent 10172851 expires

    Listed method-of-use patent (U-3450) expiration.

    in 11 yr 4 mo

  31. Patent 10172851 expires

    Listed method-of-use patent (U-3949) expiration.

    in 11 yr 4 mo

  32. Patent 10172851 expires

    Listed method-of-use patent (U-3950) expiration.

    in 11 yr 4 mo

  33. Patent 10172851 expires

    Listed method-of-use patent (U-3951) expiration.

    in 11 yr 4 mo

  34. Patent 10112942*PED expires

    Listed listed patent expiration.

    in 11 yr 11 mo

  35. Patent 10137124*PED expires

    Listed listed patent expiration.

    in 11 yr 11 mo

  36. Patent 10172851*PED expires

    Listed listed patent expiration.

    in 11 yr 11 mo

  37. Patent 10584124 expires

    Listed drug substance patent expiration.

    in 12 yr 5 mo

  38. Patent 10584124 expires

    Listed drug substance patent expiration.

    in 12 yr 5 mo

  39. Patent 10584124 expires

    Listed drug substance patent expiration.

    in 12 yr 5 mo

  40. Patent 10584124 expires

    Listed drug substance patent expiration.

    in 12 yr 5 mo

  41. Patent 10786489 expires

    Listed drug product patent expiration.

    in 12 yr 5 mo

  42. Patent 10786489 expires

    Listed drug product patent expiration.

    in 12 yr 5 mo

  43. Patent 10786489 expires

    Listed drug product patent expiration.

    in 12 yr 5 mo

  44. Patent 10786489 expires

    Listed drug product patent expiration.

    in 12 yr 5 mo

  45. Patent 12138250 expires

    Listed method-of-use patent (U-3949) expiration.

    in 12 yr 5 mo

  46. Patent 12138250 expires

    Listed method-of-use patent (U-3951) expiration.

    in 12 yr 5 mo

  47. Patent 12138250 expires

    Listed method-of-use patent (U-3950) expiration.

    in 12 yr 5 mo

  48. Patent 12138250 expires

    Listed method-of-use patent (U-3450) expiration.

    in 12 yr 5 mo

  49. Patent 10584124*PED expires

    Listed listed patent expiration.

    in 12 yr 11 mo

  50. Patent 10786489*PED expires

    Listed listed patent expiration.

    in 12 yr 11 mo

  51. Patent 12138250*PED expires

    Listed listed patent expiration.

    in 12 yr 11 mo

Patent & exclusivity timeline

Protection horizon
20262028203020322034203620382040TodayExclusivity ODE-301: 2027-05-08Exclusivity ODE-301Exclusivity ODE-302: 2027-05-08Exclusivity ODE-302Exclusivity ODE-303: 2027-05-08Exclusivity ODE-303Exclusivity NPP: 2027-05-29Exclusivity NPPExclusivity M-311: 2027-09-27Exclusivity M-311Exclusivity M-312: 2027-09-27Exclusivity M-312Exclusivity PED: 2027-11-08Exclusivity PEDExclusivity PED: 2027-11-08Exclusivity PEDExclusivity PED: 2027-11-08Exclusivity PEDExclusivity PED: 2027-11-29Exclusivity PEDExclusivity PED: 2028-03-27Exclusivity PEDExclusivity PED: 2028-03-27Exclusivity PEDExclusivity ODE-409: 2029-09-21Exclusivity ODE-409Exclusivity ODE-412: 2029-09-21Exclusivity ODE-412Exclusivity PED: 2030-03-21Exclusivity PEDExclusivity PED: 2030-03-21Exclusivity PEDExclusivity ODE-484: 2031-05-29Exclusivity ODE-484Exclusivity ODE-485: 2031-05-29Exclusivity ODE-485Exclusivity ODE-487: 2031-05-29Exclusivity ODE-487Exclusivity PED: 2031-11-29Exclusivity PEDExclusivity PED: 2031-11-29Exclusivity PEDExclusivity PED: 2031-11-29Exclusivity PEDPatent 10112942: 2037-10-10Patent 10112942Patent 10137124: 2037-10-10Patent 10137124Patent 10137124: 2037-10-10Patent 10137124Patent 10137124: 2037-10-10Patent 10137124Patent 10137124: 2037-10-10Patent 10137124Patent 10172851: 2037-10-10Patent 10172851Patent 10172851: 2037-10-10Patent 10172851Patent 10172851: 2037-10-10Patent 10172851Patent 10172851: 2037-10-10Patent 10172851Patent 10112942*PED: 2038-04-10Patent 10112942*PEDPatent 10137124*PED: 2038-04-10Patent 10137124*PEDPatent 10172851*PED: 2038-04-10Patent 10172851*PEDPatent 10584124: 2038-10-10Patent 10584124Patent 10584124: 2038-10-10Patent 10584124Patent 10584124: 2038-10-10Patent 10584124Patent 10584124: 2038-10-10Patent 10584124Patent 10786489: 2038-10-10Patent 10786489Patent 10786489: 2038-10-10Patent 10786489Patent 10786489: 2038-10-10Patent 10786489Patent 10786489: 2038-10-10Patent 10786489Patent 12138250: 2038-10-10Patent 12138250Patent 12138250: 2038-10-10Patent 12138250Patent 12138250: 2038-10-10Patent 12138250Patent 12138250: 2038-10-10Patent 12138250Patent 10584124*PED: 2039-04-10Patent 10584124*PEDPatent 10786489*PED: 2039-04-10Patent 10786489*PEDPatent 12138250*PED: 2039-04-10Patent 12138250*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

SELPERCATINIB

Strength

40MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 213246

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • ODE-301Orphan-drug exclusivity (7 years)

    in 10 mo

  • ODE-302Orphan-drug exclusivity (7 years)

    in 10 mo

  • ODE-303Orphan-drug exclusivity (7 years)

    in 10 mo

  • NPPNew patient population exclusivity (3 years)

    in 10 mo

  • M-311New use / labeling-change exclusivity (3 years)

    in 1 yr 2 mo

  • M-312New use / labeling-change exclusivity (3 years)

    in 1 yr 2 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 1 yr 4 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 1 yr 4 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 1 yr 4 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 1 yr 4 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 1 yr 8 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 1 yr 8 mo

  • ODE-409Orphan-drug exclusivity (7 years)

    in 3 yr 2 mo

  • ODE-412Orphan-drug exclusivity (7 years)

    in 3 yr 2 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 3 yr 8 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 3 yr 8 mo

  • ODE-484Orphan-drug exclusivity (7 years)

    in 4 yr 11 mo

  • ODE-485Orphan-drug exclusivity (7 years)

    in 4 yr 11 mo

  • ODE-487Orphan-drug exclusivity (7 years)

    in 4 yr 11 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 5 yr 5 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 5 yr 5 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 5 yr 5 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10112942in 11 yr 4 mo
SubstanceProduct
10137124in 11 yr 4 mo
U-3450
10137124in 11 yr 4 mo
U-3949
10137124in 11 yr 4 mo
U-3950
10137124in 11 yr 4 mo
U-3951
10172851in 11 yr 4 mo
U-3450
10172851in 11 yr 4 mo
U-3949
10172851in 11 yr 4 mo
U-3950
10172851in 11 yr 4 mo
U-3951
10112942*PEDin 11 yr 11 mo
10137124*PEDin 11 yr 11 mo
10172851*PEDin 11 yr 11 mo
10584124in 12 yr 5 mo
SubstanceU-3450
10584124in 12 yr 5 mo
SubstanceU-3949
10584124in 12 yr 5 mo
SubstanceU-3950
10584124in 12 yr 5 mo
SubstanceU-3951
10786489in 12 yr 5 mo
ProductU-3450
10786489in 12 yr 5 mo
ProductU-3949
10786489in 12 yr 5 mo
ProductU-3951
10786489in 12 yr 5 mo
ProductU-3950
12138250in 12 yr 5 mo
U-3949
12138250in 12 yr 5 mo
U-3951
12138250in 12 yr 5 mo
U-3950
12138250in 12 yr 5 mo
U-3450
10584124*PEDin 12 yr 11 mo
10786489*PEDin 12 yr 11 mo
12138250*PEDin 12 yr 11 mo

Other FDA applications for Retevmo

1 additional filing

The FDA has approved 2 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Retevmo, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 218160Eli Lilly And CoApr 10, 20244—Prescription

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 Selpercatinib 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.

Retevmo: 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 213246 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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