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METHYLPHENIDATE

ANDA

METHYLPHENIDATE | A210924 | ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: COTEMPLA XR-ODT(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Neos Therapeutics, Inc. et al v. Teva Pharmaceuticals USA, Inc. 1:2017cv01793 3 patentsANDA 210924methylphenidate	D. Del.	2017-12-13	Terminated 2019-01-02	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain7 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

SPECGX LLCMETHYLPHENIDATE BASE

DMF 131321998

CHATTEM CHEMICALS INCMETHYLPHENIDATE BASE

DMF 176682004

VERANOVA LPMETHYLPHENIDATE FREE BASE

DMF 229392009

TRIS PHARMA INCMETHYLPHENIDATE ERL (METHYLPHENIDATE ER POWDER FOR ORAL SUSPENSION)

DMF 238702010

TRIS PHARMA INCMETHYLPHENIDATE ERCT (METHYLPHENIDATE HCI ER CHEWABLE TABLETS)

DMF 259092012

NORAMCO LLCMETHYLPHENIDATE HCL USP

DMF 272082013

AMPAC FINE CHEMICALS LLCMETHYLPHENIDATE HCI

DMF 301162016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 21, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 8.6MG

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Approved: Jun 19, 2020

No patent or exclusivity listings for this strength.

#002 — 17.3MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Approved: Jun 19, 2020

#003 — 25.9MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Approved: Jun 19, 2020