Is Augtyro still available?

Yes. Augtyro (NDA 218213) is listed with marketing status Prescription in the FDA Orange Book.

Does Augtyro have a generic?

The FDA Orange Book does not currently list an approved generic (ANDA) sharing Augtyro's active ingredient (Repotrectinib).

When do Augtyro's patents expire?

The FDA Orange Book lists 6 patents against Augtyro, with the last listed patent expiring Jul 24, 2036. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

Does Augtyro have FDA marketing exclusivity?

Yes. The Orange Book records 3 marketing-exclusivity periods for Augtyro. Exclusivity can delay generic approval independently of any listed patents.

What is Augtyro's FDA application number?

Augtyro is approved under NDA 218213, held by Bristol.

Orange Book product · Brand (NDA)

Augtyro

Repotrectinib

Brand (NDA)NDA 218213RLD Bristol

Approved

Nov 15, 2023

Application

Brand (NDA)

TE code

Not listed

Listed patents

Augtyro (Repotrectinib) is Bristol's brand-name drug, approved by the FDA under NDA 218213 in 2023. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. The FDA Orange Book lists 6 patents against it, the last expiring 2036. 3 marketing-exclusivity periods are recorded.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Nov 15, 2023
2 yr 8 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Nov 15, 2028
in 2 yr 5 mo
Exclusivity ends · ODE-455
Orphan-drug exclusivity (7 years)
Nov 15, 2030
in 4 yr 5 mo
Exclusivity ends · ODE-483
Orphan-drug exclusivity (7 years)
Jun 13, 2031
in 5 yr
Patent RE50634 expires
Listed drug substance patent expiration.
Jan 23, 2035
in 8 yr 8 mo
Patent 10294242 expires
Listed drug substance patent expiration.
Jul 05, 2036
in 10 yr 2 mo
Patent 12187739 expires
Listed drug product patent expiration.
Jul 05, 2036
in 10 yr 2 mo
Patent 12310968 expires
Listed method-of-use patent (U-3755) expiration.
Jul 20, 2036
in 10 yr 2 mo
Patent 11452725 expires
Listed method-of-use patent (U-3961) expiration.
Jul 24, 2036
in 10 yr 2 mo
Patent 11452725 expires
Listed method-of-use patent (U-3755) expiration.
Jul 24, 2036
in 10 yr 2 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

REPOTRECTINIB

Strength

40MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 218213

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Same application

Other strengths in NDA 218213

160MGCAPSULE

Brand + generics

Active-ingredient family

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 Repotrectinib family

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (3)

NCENew chemical entity exclusivity (5 years)
Nov 15, 2028
in 2 yr 5 mo
ODE-455Orphan-drug exclusivity (7 years)
Nov 15, 2030
in 4 yr 5 mo
ODE-483Orphan-drug exclusivity (7 years)
Jun 13, 2031
in 5 yr

Orange Book patent file

Listed patents

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
RE50634	Jan 23, 2035	in 8 yr 8 mo	SubstanceProduct
10294242	Jul 05, 2036	in 10 yr 2 mo	Substance
12187739	Jul 05, 2036	in 10 yr 2 mo	Product
12310968	Jul 20, 2036	in 10 yr 2 mo	U-3755
11452725	Jul 24, 2036	in 10 yr 2 mo	U-3961
11452725	Jul 24, 2036	in 10 yr 2 mo	U-3755

Augtyro — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Repotrectinib active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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