Orange Book product · Brand (NDA)
QUILLICHEW ER
METHYLPHENIDATE HYDROCHLORIDE
At a glance
Dec 04, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 04, 2015
10 yr 8 mo ago
Today
Patent 8202537 expires
Listed drug product patent expiration.
Mar 15, 2027
in 9 mo
Patent 8287903 expires
Listed drug product patent expiration.
Feb 15, 2031
in 4 yr 9 mo
Patent 10857143 expires
Listed drug product patent expiration.
Aug 14, 2033
in 7 yr 3 mo
Patent 11103494 expires
Listed drug product patent expiration.
Aug 14, 2033
in 7 yr 3 mo
Patent 11103495 expires
Listed drug product patent expiration.
Aug 14, 2033
in 7 yr 3 mo
Patent 11633389 expires
Listed drug product patent expiration.
Aug 14, 2033
in 7 yr 3 mo
Patent 8999386 expires
Listed drug product patent expiration.
Aug 14, 2033
in 7 yr 3 mo
Patent 9295642 expires
Listed drug product patent expiration.
Aug 14, 2033
in 7 yr 3 mo
Patent 9545399 expires
Listed drug product patent expiration.
Aug 14, 2033
in 7 yr 3 mo
Patent 9844544 expires
Listed drug product patent expiration.
Aug 14, 2033
in 7 yr 3 mo
Pharmaceutical detail
Active ingredient
METHYLPHENIDATE HYDROCHLORIDE
Strength
20MG
Dosage form
TABLET, EXTENDED RELEASE, CHEWABLE
Route
ORAL
TE code
Not listed
Application
NDA 207960
Product number
001
Marketing status
RX
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.
- 2019ADHANSIA XRBrand (NDA)
NDA 212038 · KNOA PHARMA
- 2018JORNAY PMBrand (NDA)
NDA 209311 · IRONSHORE 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 (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8202537 | Mar 15, 2027 | in 9 mo | Product |
| 8287903 | Feb 15, 2031 | in 4 yr 9 mo | Product |
| 10857143 | Aug 14, 2033 | in 7 yr 3 mo | ProductU-2993 |
| 11103494 | Aug 14, 2033 | in 7 yr 3 mo | Product |
| 11103495 | Aug 14, 2033 | in 7 yr 3 mo | ProductU-2993 |
| 11633389 | Aug 14, 2033 | in 7 yr 3 mo | Product |
| 8999386 | Aug 14, 2033 | in 7 yr 3 mo | Product |
| 9295642 | Aug 14, 2033 | in 7 yr 3 mo | ProductU-1827 |
| 9545399 | Aug 14, 2033 | in 7 yr 3 mo | ProductU-1827 |
| 9844544 | Aug 14, 2033 | in 7 yr 3 mo | ProductU-2203 |
