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FENTORA

NDA

FENTANYL CITRATE | N021947 | CEPHALON LLC

6 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

Today

7862832

Jun. 15, 2028

7862833

Jun. 15, 2028

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. Impax Laboratories Inc. 1:2011cv01152 4 patentsANDA 203357fentanyl buccal tablets	D. Del.	2011-11-18	Terminated 2013-07-16	—

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 Fentora (2023)

Total Spending

$1.2M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$192.96

Spending Trend

$7.6M(2019)→$3.3M(2020)→$2.1M(2021)→$1.5M(2022)→$1.2M(2023)

YoY Change:+3.8%

5yr CAGR:+16.6%

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

API Supply Chain5 active DMFs7 inactive

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

VERANOVA LPFENTANYL CITRATE (BULK)

DMF 50381983

SPECGX LLCFENTANYL CITRATE (NEW PROCESS)

DMF 101281993

CAMBREX CHARLES CITY INCFENTANYL CITRATE USP

DMF 170552003

CURIA WISCONSIN INCFENTANYL CITRATE

DMF 181782005

CHATTEM CHEMICALS INCFENTANYL CITRATE USP

DMF 230132009

DIOSYNTH BVInactiveFENTANYL CITRATE

DMF 47511983

MALLINCKRODT CHEMICAL INCInactiveFENTANYL CITRATE USP

DMF 70511987

ABBOTT PHARMACEUTICALS INCInactiveFENTANYL CITRATE

DMF 82791989

JOHNSON MATTHEY INCInactiveFENTANYL CITRATE

DMF 85131990

BOEHRINGER INGELHEIM CHEMICALS INCInactiveFENTANYL CITRATE

DMF 178262004

NV ORGANONInactiveFENTANYL CITRATE

DMF 190812006

CAMBREX CHARLES CITY INCInactiveFENTANYL CITRATE USP MICRONIZED

DMF 197242006

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

Approval Letters

26 letters from Drugs@FDA

Date	Submission	Document
Dec 31, 2025	SUPPL -46	View Letter (PDF)
Aug 29, 2024	SUPPL -45	View Letter (PDF)
Dec 19, 2023	SUPPL -43	View Letter (PDF)
Dec 9, 2022	SUPPL -42	View Letter (PDF)
Nov 25, 2022	SUPPL -38	View Letter (PDF)
Aug 18, 2022	SUPPL -40	View Letter (PDF)
Dec 20, 2021	SUPPL -37	View Letter (PDF)
Mar 5, 2021	SUPPL -34	View Letter (PDF)
Dec 28, 2020	SUPPL -30	View Letter (PDF)
Oct 9, 2019	SUPPL -29	View Letter (PDF)
Sep 11, 2017	SUPPL -27	View Letter (PDF)
Apr 14, 2017	SUPPL -19	View Letter (PDF)
Dec 20, 2016	SUPPL -25	View Letter (PDF)
Dec 20, 2016	SUPPL -24	View Letter (PDF)
Dec 30, 2014	SUPPL -22	View Letter (PDF)
Nov 12, 2013	SUPPL -17	View Letter (PDF)
Feb 25, 2013	SUPPL -8	View Letter (PDF)
Jun 7, 2012	SUPPL -15	View Letter (PDF)
Jan 3, 2012	SUPPL -13	View Letter (PDF)
Jul 21, 2011	SUPPL -9	View Letter (PDF)
Jan 25, 2011	SUPPL -11	View Letter (PDF)
Jan 25, 2010	SUPPL -10	View Letter (PDF)
Feb 14, 2008	SUPPL -6	View Letter (PDF)
May 1, 2007	SUPPL -1	View Letter (PDF)
Mar 7, 2007	SUPPL -2	View Letter (PDF)
Oct 2, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

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#001 — EQ 0.1MG BASE

RLD

2 patents0 exclusivities▴