Orange Book product · Brand (NDA)
ADHANSIA XR
METHYLPHENIDATE HYDROCHLORIDE
At a glance
Feb 27, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 27, 2019
7 yr 5 mo ago
Today
Patent 10111839 expires
Listed method-of-use patent (U-2357) expiration.
Oct 30, 2035
in 9 yr 6 mo
Patent 10292938 expires
Listed drug product patent expiration.
Oct 30, 2035
in 9 yr 6 mo
Patent 10292939 expires
Listed drug product patent expiration.
Oct 30, 2035
in 9 yr 6 mo
Patent 10449159 expires
Listed method-of-use patent (U-2357) expiration.
Oct 30, 2035
in 9 yr 6 mo
Patent 10500162 expires
Listed method-of-use patent (U-2357) expiration.
Oct 30, 2035
in 9 yr 6 mo
Patent 10507186 expires
Listed drug product patent expiration.
Oct 30, 2035
in 9 yr 6 mo
Patent 10512612 expires
Listed drug product patent expiration.
Oct 30, 2035
in 9 yr 6 mo
Patent 10512613 expires
Listed method-of-use patent (U-2357) expiration.
Oct 30, 2035
in 9 yr 6 mo
Patent 10568841 expires
Listed drug product patent expiration.
Oct 30, 2035
in 9 yr 6 mo
Patent 10688060 expires
Listed drug product patent expiration.
Oct 30, 2035
in 9 yr 6 mo
Patent 9974752 expires
Listed drug product patent expiration.
Oct 30, 2035
in 9 yr 6 mo
Patent 10722473 expires
Listed method-of-use patent (U-2357) expiration.
Nov 19, 2038
in 12 yr 7 mo
Pharmaceutical detail
Active ingredient
METHYLPHENIDATE HYDROCHLORIDE
Strength
55MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 212038
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2018JORNAY PMBrand (NDA)
NDA 209311 · IRONSHORE PHARMS
- 2015QUILLICHEW ERBrand (NDA)
NDA 207960 · NEXTWAVE PHARMS
- 2015APTENSIO XRBrand (NDA)
NDA 205831 · RHODES PHARMS
- 2012QUILLIVANT XRBrand (NDA)
NDA 202100 · NEXTWAVE
- 2004RITALIN LABrand (NDA)
NDA 021284 · SANDOZ
- 2003METADATE CDBrand (NDA)
NDA 021259 · AYTU BIOPHARMA
- 2003METHYLINBrand (NDA)
NDA 021475 · SPECGX LLC
- 2002METHYLINBrand (NDA)
NDA 021419 · SPECGX LLC
- 2000CONCERTABrand (NDA)
NDA 021121 · JANSSEN PHARMS
- 2023METHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 214447 · ALKEM LABS LTD
- 2021METHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 207417 · ASCENT PHARMS INC
- 2020METHYLPHENIDATE HYDROCHLORIDEGeneric (ANDA)
ANDA 207414 · CHARTWELL MOLECULAR
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10111839 | Oct 30, 2035 | in 9 yr 6 mo | U-2357 |
| 10292938 | Oct 30, 2035 | in 9 yr 6 mo | Product |
| 10292939 | Oct 30, 2035 | in 9 yr 6 mo | ProductU-2357 |
| 10449159 | Oct 30, 2035 | in 9 yr 6 mo | U-2357 |
| 10500162 | Oct 30, 2035 | in 9 yr 6 mo | U-2357 |
| 10507186 | Oct 30, 2035 | in 9 yr 6 mo | Product |
| 10512612 | Oct 30, 2035 | in 9 yr 6 mo | Product |
| 10512613 | Oct 30, 2035 | in 9 yr 6 mo | U-2357 |
| 10568841 | Oct 30, 2035 | in 9 yr 6 mo | ProductU-2357 |
| 10688060 | Oct 30, 2035 | in 9 yr 6 mo | Product |
| 9974752 | Oct 30, 2035 | in 9 yr 6 mo | Product |
| 10722473 | Nov 19, 2038 | in 12 yr 7 mo | U-2357 |
