Is there a generic for Selpercatinib?

The FDA Orange Book does not currently list an approved generic (ANDA) for Selpercatinib. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Selpercatinib?

RETEVMO (NDA 218160, ELI LILLY AND CO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Selpercatinib?

The Orange Book lists 12 patents against Selpercatinib products, with the earliest listed expiry in 2037. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Selpercatinib have FDA marketing exclusivity?

Yes. The Orange Book records 124 marketing-exclusivity periods for Selpercatinib. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Selpercatinib are approved?

Selpercatinib is approved in the following dosage forms: capsule, tablet.

FDA Orange Book · active-ingredient family

Selpercatinib

Selpercatinib is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:RETEVMO · NDA 218160

Brand (NDA)

Generics (ANDA)

Listed patents

124

Exclusivity periods

Brand (NDA) products · capsule, tablet

Product	Applicant	Application	TE	Approved
RETEVMORLD×4	ELI LILLY AND CO	NDA 218160	—	Apr 10, 2024
RETEVMORLD×2	ELI LILLY AND CO	NDA 213246	—	May 08, 2020

Marketing exclusivity (124)

M-311New use / labeling-change exclusivity (3 years)
Sep 27, 2027
in 1 yr 4 mo
M-312New use / labeling-change exclusivity (3 years)
Sep 27, 2027
in 1 yr 4 mo
NPPNew patient population exclusivity (3 years)
May 29, 2027
in 11 mo
ODE-301Orphan-drug exclusivity (7 years)
May 08, 2027
in 11 mo
ODE-302Orphan-drug exclusivity (7 years)
May 08, 2027
in 11 mo
ODE-303Orphan-drug exclusivity (7 years)
May 08, 2027
in 11 mo
ODE-409Orphan-drug exclusivity (7 years)
Sep 21, 2029
in 3 yr 4 mo
ODE-412Orphan-drug exclusivity (7 years)
Sep 21, 2029
in 3 yr 4 mo
ODE-484Orphan-drug exclusivity (7 years)
May 29, 2031
in 5 yr
ODE-485Orphan-drug exclusivity (7 years)
May 29, 2031
in 5 yr
ODE-487Orphan-drug exclusivity (7 years)
May 29, 2031
in 5 yr
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Mar 27, 2028
in 1 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Mar 27, 2028
in 1 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Mar 21, 2030
in 3 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Mar 21, 2030
in 3 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2027
in 1 yr 6 mo
M-311New use / labeling-change exclusivity (3 years)
Sep 27, 2027
in 1 yr 4 mo
M-312New use / labeling-change exclusivity (3 years)
Sep 27, 2027
in 1 yr 4 mo
NPPNew patient population exclusivity (3 years)
May 29, 2027
in 11 mo
ODE-301Orphan-drug exclusivity (7 years)
May 08, 2027
in 11 mo
ODE-302Orphan-drug exclusivity (7 years)
May 08, 2027
in 11 mo
ODE-303Orphan-drug exclusivity (7 years)
May 08, 2027
in 11 mo
ODE-409Orphan-drug exclusivity (7 years)
Sep 21, 2029
in 3 yr 4 mo
ODE-412Orphan-drug exclusivity (7 years)
Sep 21, 2029
in 3 yr 4 mo
ODE-484Orphan-drug exclusivity (7 years)
May 29, 2031
in 5 yr
ODE-485Orphan-drug exclusivity (7 years)
May 29, 2031
in 5 yr
ODE-487Orphan-drug exclusivity (7 years)
May 29, 2031
in 5 yr
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Mar 27, 2028
in 1 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Mar 27, 2028
in 1 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Mar 21, 2030
in 3 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Mar 21, 2030
in 3 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2027
in 1 yr 6 mo
M-311New use / labeling-change exclusivity (3 years)
Sep 27, 2027
in 1 yr 4 mo
M-312New use / labeling-change exclusivity (3 years)
Sep 27, 2027
in 1 yr 4 mo
ODE*FDA marketing exclusivity
May 29, 2031
in 5 yr
ODE*FDA marketing exclusivity
May 29, 2031
in 5 yr
ODE*FDA marketing exclusivity
May 08, 2027
in 11 mo
ODE*FDA marketing exclusivity
May 08, 2027
in 11 mo
ODE*FDA marketing exclusivity
May 08, 2027
in 11 mo
ODE*FDA marketing exclusivity
Sep 21, 2029
in 3 yr 4 mo
ODE*FDA marketing exclusivity
Sep 21, 2029
in 3 yr 4 mo
ODE*FDA marketing exclusivity
May 29, 2031
in 5 yr
PEDPediatric exclusivity (adds 6 months)
Mar 27, 2028
in 1 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Mar 27, 2028
in 1 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Mar 21, 2030
in 3 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Mar 21, 2030
in 3 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
M-311New use / labeling-change exclusivity (3 years)
Sep 27, 2027
in 1 yr 4 mo
M-312New use / labeling-change exclusivity (3 years)
Sep 27, 2027
in 1 yr 4 mo
ODE*FDA marketing exclusivity
Sep 21, 2029
in 3 yr 4 mo
ODE*FDA marketing exclusivity
May 08, 2027
in 11 mo
ODE*FDA marketing exclusivity
May 29, 2031
in 5 yr
ODE*FDA marketing exclusivity
May 08, 2027
in 11 mo
ODE*FDA marketing exclusivity
May 08, 2027
in 11 mo
ODE*FDA marketing exclusivity
Sep 21, 2029
in 3 yr 4 mo
ODE*FDA marketing exclusivity
May 29, 2031
in 5 yr
ODE*FDA marketing exclusivity
May 29, 2031
in 5 yr
PEDPediatric exclusivity (adds 6 months)
Mar 27, 2028
in 1 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Mar 27, 2028
in 1 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Mar 21, 2030
in 3 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Mar 21, 2030
in 3 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
M-311New use / labeling-change exclusivity (3 years)
Sep 27, 2027
in 1 yr 4 mo
M-312New use / labeling-change exclusivity (3 years)
Sep 27, 2027
in 1 yr 4 mo
ODE*FDA marketing exclusivity
May 08, 2027
in 11 mo
ODE*FDA marketing exclusivity
Sep 21, 2029
in 3 yr 4 mo
ODE*FDA marketing exclusivity
May 08, 2027
in 11 mo
ODE*FDA marketing exclusivity
Sep 21, 2029
in 3 yr 4 mo
ODE*FDA marketing exclusivity
May 08, 2027
in 11 mo
ODE*FDA marketing exclusivity
May 29, 2031
in 5 yr
ODE*FDA marketing exclusivity
May 29, 2031
in 5 yr
ODE*FDA marketing exclusivity
May 29, 2031
in 5 yr
PEDPediatric exclusivity (adds 6 months)
Mar 27, 2028
in 1 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Mar 27, 2028
in 1 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Mar 21, 2030
in 3 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Mar 21, 2030
in 3 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
M-311New use / labeling-change exclusivity (3 years)
Sep 27, 2027
in 1 yr 4 mo
M-312New use / labeling-change exclusivity (3 years)
Sep 27, 2027
in 1 yr 4 mo
ODE*FDA marketing exclusivity
May 29, 2031
in 5 yr
ODE*FDA marketing exclusivity
May 29, 2031
in 5 yr
ODE*FDA marketing exclusivity
May 29, 2031
in 5 yr
ODE*FDA marketing exclusivity
Sep 21, 2029
in 3 yr 4 mo
ODE*FDA marketing exclusivity
Sep 21, 2029
in 3 yr 4 mo
ODE*FDA marketing exclusivity
May 08, 2027
in 11 mo
ODE*FDA marketing exclusivity
May 08, 2027
in 11 mo
ODE*FDA marketing exclusivity
May 08, 2027
in 11 mo
PEDPediatric exclusivity (adds 6 months)
Mar 27, 2028
in 1 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Mar 27, 2028
in 1 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Nov 29, 2031
in 5 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Mar 21, 2030
in 3 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Mar 21, 2030
in 3 yr 10 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10172851	Oct 10, 2037	in 11 yr 6 mo	U-3450
10137124	Oct 10, 2037	in 11 yr 6 mo	U-3450
10112942	Oct 10, 2037	in 11 yr 6 mo	SubstanceProduct
10112942*PED	Apr 10, 2038	in 12 yr
10137124*PED	Apr 10, 2038	in 12 yr
10172851*PED	Apr 10, 2038	in 12 yr
12138250	Oct 10, 2038	in 12 yr 6 mo	U-3949
10584124	Oct 10, 2038	in 12 yr 6 mo	SubstanceU-3450
10786489	Oct 10, 2038	in 12 yr 6 mo	ProductU-3450
12138250*PED	Apr 10, 2039	in 13 yr
10786489*PED	Apr 10, 2039	in 13 yr
10584124*PED	Apr 10, 2039	in 13 yr

Selpercatinib — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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