Viewing data from:

NUVIGIL

NDA

ARMODAFINIL | N021875 | NUVO PHARMACEUTICALS (IRELAND) DAC

5 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
Cephalon, Inc. et al v. Apotex Corp et al 1:2010cv01078 3 patentsANDA 20-1514armodafinil	D. Del.	2010-12-14	Terminated 2013-03-30	—

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

Medicare Part D Spending

CMS annual spending data for Nuvigil (2023)

Total Spending

$3.8M

Total Claims

2,690

Beneficiaries

448

Avg Cost/Unit

$33.75

Spending Trend

$7.0M(2019)→$5.9M(2020)→$4.8M(2021)→$4.7M(2022)→$3.8M(2023)

YoY Change:-0.5%

5yr CAGR:+6.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs3 inactive

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

CEPHALON INCARMODAFINIL DRUG SUBSTANCE

DMF 196852006

MATRIX PHARMACORP PRIVATE LTDARMODAFINIL

DMF 212002007

ACTAVIS GROUP PTC EHFARMODAFINIL (NON STERILE BULK DRUG SUBSTANCE)

DMF 229832009

LUPIN LTDARMODAFINIL

DMF 231342009

UNIMARK REMEDIES LTDARMODAFINIL

DMF 249452011

ORCHID PHARMA LTDARMODAFINIL

DMF 250312011

APITORIA PHARMA PRIVATE LTDARMODAFINIL

DMF 273022013

TAPI NL BVARMODAFINIL 7SM1029

DMF 303502016

PIRAMAL PHARMA LTDARMODAFINIL

DMF 304052016

CHROMO LABORATORIES INDIA PRIVATE LTDARMODAFINIL

DMF 407322025

SIGMA ALDRICH IRELAND LTDInactiveARMODAFINIL DRUG SUBSTANCE

DMF 181072005

NOVASEP PROCESS SASInactiveARMODAFINIL

DMF 181092005

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveARMODAFINIL

DMF 229572009

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Feb 9, 2017	SUPPL -23	View Letter (PDF)
Apr 17, 2015	SUPPL -21	View Letter (PDF)
Jul 2, 2013	SUPPL -12	View Letter (PDF)
Jan 19, 2012	SUPPL -16	View Letter (PDF)
Jan 19, 2012	SUPPL -17	View Letter (PDF)
Oct 25, 2010	SUPPL -15	View Letter (PDF)
Oct 25, 2010	SUPPL -8	View Letter (PDF)
Oct 25, 2010	SUPPL -5	View Letter (PDF)
Apr 1, 2009	SUPPL -6	View Letter (PDF)
Jul 5, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 50MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 15, 2007

No patent or exclusivity listings for this strength.

#002 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 26, 2009

#003 — 150MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 15, 2007

#004 — 250MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 15, 2007

#005 — 200MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 26, 2009