Is Aptensio XR still available?

Yes. Aptensio XR (NDA 205831) is listed with marketing status Prescription in the FDA Orange Book.

Does Aptensio XR have a generic?

Yes. The Orange Book lists 41 approved generic (ANDA) applications sharing Aptensio XR's active ingredient (Methylphenidate Hydrochloride). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Aptensio XR's TE code AB3 mean?

AB3 is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Aptensio XR substitutable for its reference brand with no expected difference in clinical effect.

What is Aptensio XR's FDA application number?

Aptensio XR is approved under NDA 205831, held by Rhodes Pharms.

Orange Book product · Brand (NDA)

Aptensio XR

Methylphenidate Hydrochloride

Brand (NDA)NDA 205831TE AB3RLD Rhodes Pharms

Approved

Apr 17, 2015

Application

Brand (NDA)

TE code

AB3

Listed patents

Aptensio XR (Methylphenidate Hydrochloride) is Rhodes Pharms's brand-name drug, approved by the FDA under NDA 205831 in 2015. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is AB3, so the FDA considers it substitutable for the reference brand. 41 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Apr 17, 2015
11 yr 5 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

METHYLPHENIDATE HYDROCHLORIDE

Strength

30MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

AB3

Application

NDA 205831

Product number

004

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 205831

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.

View full Methylphenidate Hydrochloride family

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Aptensio XR — 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 Methylphenidate Hydrochloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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