FDA Orange Book · active-ingredient family
Methylphenidate
Methylphenidate: 2 brands, 2 generics; first approved Apr 06, 2006; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
2
Listed patents
4
Next patent expiry
Jun 05, 2026
5 mo ago
Brand (NDA) products
Originator applications
- NEOS THERAPS INCNDA 20548920174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8.6MG TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB 17.3MG TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB 25.9MG TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB 34.6MG TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Discontinued - - DAYTRANARLDNOVEN PHARMS INCNDA 02151420064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/9HR (1.1MG/HR) FILM, EXTENDED RELEASE TRANSDERMAL Rx AB 15MG/9HR (1.6MG/HR) FILM, EXTENDED RELEASE TRANSDERMAL Rx AB 20MG/9HR (2.2MG/HR) FILM, EXTENDED RELEASE TRANSDERMAL Rx AB 30MG/9HR (3.3MG/HR) FILM, EXTENDED RELEASE TRANSDERMAL Rx AB
Generic (ANDA) products (2)
Abbreviated applications
- METHYLPHENIDATEMYLAN TECH VIATRISANDA 20649720224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/9HR (1.1MG/HR) FILM, EXTENDED RELEASE TRANSDERMAL Rx AB 15MG/9HR (1.6MG/HR) FILM, EXTENDED RELEASE TRANSDERMAL Rx AB 20MG/9HR (2.2MG/HR) FILM, EXTENDED RELEASE TRANSDERMAL Rx AB 30MG/9HR (3.3MG/HR) FILM, EXTENDED RELEASE TRANSDERMAL Rx AB - METHYLPHENIDATEACTAVIS ELIZABETHANDA 21092420203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 8.6MG TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB 17.3MG TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB 25.9MG TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8840924 | 5 mo ago | Product | |
| 9089496 | in 5 yr 9 mo | Product | |
| 9072680 | in 5 yr 9 mo | Product | |
| 11166947 | in 11 yr 5 mo | U-3299 |
Approval history
FDA approval span
First approval
20 yr 10 mo ago
Most recent approval
2 yr 3 mo ago
Approvals span 2006–2024 across 4 FDA applications.
Brand (NDA) 250%
Generic (ANDA) 250%
Methylphenidate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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