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ADDERALL XR 10

NDA

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | N021303 | TAKEDA PHARMACEUTICALS USA INC

6 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Shire Development LLC et al v. Rhodes Pharmaceuticals L.P. 1:2017cv01840 2 patentsANDA 210651dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate	D. Del.	2017-12-21	Terminated 2018-04-26	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

22 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 2.5MG;2.5MG;2.5MG;2.5MG

RLDAB1

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Oct 11, 2001

No patent or exclusivity listings for this strength.

#006 — 3.75MG;3.75MG;3.75MG;3.75MG

RLDAB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 22, 2002

#002 — 5MG;5MG;5MG;5MG

RLDAB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Oct 11, 2001

#004 — 6.25MG;6.25MG;6.25MG;6.25MG

RLDAB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 22, 2002

#003 — 7.5MG;7.5MG;7.5MG;7.5MG

RLDAB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Oct 11, 2001

#005 — 1.25MG;1.25MG;1.25MG;1.25MG

RLDAB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 22, 2002