Pharsight

1. Fentora patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6974590	CEPHALON	Sublingual buccal effervescent	Mar, 2019 (5 years ago)
US6200604	CEPHALON	Sublingual buccal effervescent	Mar, 2019 (5 years ago)
US8728441	CEPHALON	Sublingual buccal effervescent	Mar, 2019 (5 years ago)
US8753611	CEPHALON	Sublingual buccal effervescent	Mar, 2019 (5 years ago)
US8765100	CEPHALON	Transmucosal effervescent	Mar, 2019 (5 years ago)
US8092832	CEPHALON	Generally linear effervescent oral fentanyl dosage form and methods of administering	Dec, 2024 (8 months from now)
US8119158	CEPHALON	Effervescent oral fentanyl dosage form and methods of administering fentanyl	Dec, 2024 (8 months from now)
US7862832	CEPHALON	Generally linear effervescent oral fentanyl dosage form and methods of administering	Jun, 2028 (4 years from now)
US7862833	CEPHALON	Effervescent oral opiate dosage forms and methods of administering opiates	Jun, 2028 (4 years from now)

Drugs and Companies using FENTANYL CITRATE ingredient

Market Authorisation Date: 25 September, 2006

Treatment: Management of breakthrough pain in patients with cancer; Management of breakthrough pain in patients with cancer by buccal or sublingual administration of fentanyl

Dosage: TABLET;BUCCAL, SUBLINGUAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg	13 Nov, 2007	1	07 Jan, 2011	26 Mar, 2019	Extinguished Deferred

Strength	Dosage	Availability
EQ 0.8MG BASE	TABLET;BUCCAL, SUBLINGUAL	Prescription
EQ 0.1MG BASE	TABLET;BUCCAL, SUBLINGUAL	Prescription
EQ 0.6MG BASE	TABLET;BUCCAL, SUBLINGUAL	Prescription
EQ 0.2MG BASE	TABLET;BUCCAL, SUBLINGUAL	Prescription
EQ 0.4MG BASE	TABLET;BUCCAL, SUBLINGUAL	Prescription
EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;BUCCAL, SUBLINGUAL	Discontinued

FENTORA family patents

2. Gabitril patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5866590	CEPHALON	Pharmaceutical composition containing tiagabine hydrochloride and the process for its preparation	Apr, 2016 (7 years ago)
US5958951	CEPHALON	Modified form of the R(-)-N-(4,4-di(3-methylthien-2-yl)but-3-enyl)-nipecotic acid hydrochloride	Jun, 2017 (6 years ago)

Drugs and Companies using TIAGABINE HYDROCHLORIDE ingredient

Market Authorisation Date: 16 April, 1999

Treatment: NA

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
2 mg and 4 mg	01 Feb, 2005	1	04 Nov, 2011	10 Jun, 2017	Eligible
12 mg and 16 mg	24 Jan, 2014	1	13 Oct, 2017	10 Jun, 2017	Extinguished

Strength	Dosage	Availability
16MG	TABLET;ORAL	Prescription
2MG	TABLET;ORAL	Prescription
12MG	TABLET;ORAL	Prescription
4MG	TABLET;ORAL	Prescription
20MG	TABLET;ORAL	Discontinued

GABITRIL family patents

3. Nuvigil patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7132570	CEPHALON	Method for the production of crystalline forms and crystalline forms of optical enantiomers of modafinil	Dec, 2023 (4 months ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
USRE37516	CEPHALON	Acetamide derivative having defined particle size	Oct, 2014 (9 years ago)
USRE37516 (Pediatric)	CEPHALON	Acetamide derivative having defined particle size	Apr, 2015 (9 years ago)
US7297346	CEPHALON	Pharmaceutical formulations of modafinil	Nov, 2023 (4 months ago)
US7297346 (Pediatric)	CEPHALON	Pharmaceutical formulations of modafinil	May, 2024 (a month from now)
US7132570 (Pediatric)	CEPHALON	Method for the production of crystalline forms and crystalline forms of optical enantiomers of modafinil	Jun, 2024 (a month from now)

Drugs and Companies using ARMODAFINIL ingredient

Market Authorisation Date: 15 June, 2007

Treatment: Improved wakefulness in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
50 mg, 150 mg and 250 mg	24 Jul, 2009	1	01 Jun, 2012	18 Dec, 2024	Eligible
100 mg	08 Sep, 2009	1		18 Dec, 2023	Extinguished
200 mg	03 Sep, 2009	1		18 Dec, 2023	Extinguished

Strength	Dosage	Availability
250MG	TABLET;ORAL	Prescription
200MG	TABLET;ORAL	Prescription
150MG	TABLET;ORAL	Prescription
50MG	TABLET;ORAL	Prescription
100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued

NUVIGIL family patents

4. Provigil patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
USRE37516	CEPHALON	Acetamide derivative having defined particle size	Oct, 2014 (9 years ago)
USRE37516 (Pediatric)	CEPHALON	Acetamide derivative having defined particle size	Apr, 2015 (9 years ago)
US7297346	CEPHALON	Pharmaceutical formulations of modafinil	Nov, 2023 (4 months ago)
US7297346 (Pediatric)	CEPHALON	Pharmaceutical formulations of modafinil	May, 2024 (a month from now)

Drugs and Companies using MODAFINIL ingredient

Market Authorisation Date: 24 December, 1998

Treatment: Improved wakefulness in patients with excessive daytime sleepiness associated with narcolepsy

Dosage: TABLET;ORAL

Strength	Dosage	Availability
200MG	TABLET;ORAL	Prescription
100MG	TABLET;ORAL	Prescription

PROVIGIL family patents

5. Treanda patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP06718390A	2014-01-03	Accord Healthcare	Revoked
EP06718390A	2014-01-02	Gallafent, Alison	Revoked
EP06718390A	2014-01-02	Taylor Wessing LLP	Revoked
EP06718390A	2014-01-02	Bendalis GmbH	Revoked
EP06718390A	2013-12-31	Actavis Group PTC ehf	Revoked
EP06718390A	2013-12-19	LEK Pharmaceuticals d.d.	Revoked
EP06718390A	2013-12-12	Helm AG	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8895756	November, 2015	Terminated-Settled	Cephalon, Inc.	Fresenius Kabi USA, LLC
US8791270	October, 2015	Terminated-Settled	Cephalon, Inc.	Fresenius Kabi USA, LLC
US8791270	October, 2015	Terminated-Denied	Cephalon, Inc.	AGILA SPECIALTIES INC.
US8436190	December, 2014	Terminated-Settled	Cephalon, Inc.	AGILA SPECIALTIES INC.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8445524	CEPHALON	Solid forms of bendamustine hydrochloride	Mar, 2029 (4 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8609863	CEPHALON	Bendamustine pharmaceutical compositions	Jan, 2026 (1 year, 8 months from now)
US8791270	CEPHALON	Bendamustine pharmaceutical compositions	Jan, 2026 (1 year, 8 months from now)
US8895756	CEPHALON	Bendamustine pharmaceutical compositions	Jan, 2026 (1 year, 8 months from now)
US8609863 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Jul, 2026 (2 years from now)
US8791270 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Jul, 2026 (2 years from now)
US8895756 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Jul, 2026 (2 years from now)
US8883836	CEPHALON	Solid forms of bendamustine hydrochloride	Mar, 2029 (4 years from now)
US9533955	CEPHALON	Solid forms of bendamustine hydrochloride	Mar, 2029 (4 years from now)
US8669279	CEPHALON	Solid forms of bendamustine hydrochloride	Mar, 2029 (4 years from now)
US8344006	CEPHALON	Liquid formulations of bendamustine	Sep, 2029 (5 years from now)
US8445524 (Pediatric)	CEPHALON	Solid forms of bendamustine hydrochloride	Sep, 2029 (5 years from now)
US9533955 (Pediatric)	CEPHALON	Solid forms of bendamustine hydrochloride	Sep, 2029 (5 years from now)
US8669279 (Pediatric)	CEPHALON	Solid forms of bendamustine hydrochloride	Sep, 2029 (5 years from now)
US8883836 (Pediatric)	CEPHALON	Solid forms of bendamustine hydrochloride	Sep, 2029 (5 years from now)
US8344006 (Pediatric)	CEPHALON	Liquid formulations of bendamustine	Mar, 2030 (5 years from now)
US8436190	CEPHALON	Bendamustine pharmaceutical compositions	Oct, 2030 (6 years from now)
US8436190 (Pediatric)	CEPHALON	Bendamustine pharmaceutical compositions	Apr, 2031 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-580)	Oct 31, 2011
Orphan Drug Exclusivity(ODE)	Mar 20, 2015
Pediatric Exclusivity(PED)	Sep 20, 2013
ODE(ODE)	Dec 07, 2022
New Chemical Entity Exclusivity(NCE)	Mar 20, 2013

Drugs and Companies using BENDAMUSTINE HYDROCHLORIDE ingredient

NCE-1 date: 02 May, 2015

Market Authorisation Date: 01 May, 2009

Treatment: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma; For use in the treatment of patients with chronic lymphocytic leukemia (cll) and/or indolent b-cell...

Dosage: POWDER;IV (INFUSION); SOLUTION;IV (INFUSION)

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
25 mg/vial and 100 mg/vial	04 Jun, 2013	10	07 Dec, 2022	26 Oct, 2030	Eligible
90 mg/mL, 0.5 mL and 2 mL in single- dose vials	19 Jun, 2014	1		23 Sep, 2029

Strength	Dosage	Availability
100MG/VIAL	POWDER;IV (INFUSION)	Prescription
25MG/VIAL	POWDER;IV (INFUSION)	Prescription
45MG/0.5ML (90MG/ML)	SOLUTION;IV (INFUSION)	Discontinued
180MG/2ML (90MG/ML)	SOLUTION;IV (INFUSION)	Discontinued

TREANDA family patents

6. Trisenox patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6861076	CEPHALON	Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol	Nov, 2018 (5 years ago)
US6723351	CEPHALON	Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol	Nov, 2018 (5 years ago)
US6982096	CEPHALON	Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol	Nov, 2018 (5 years ago)
US6884439	CEPHALON	Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol	Nov, 2018 (5 years ago)
US6855339	CEPHALON	Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol	Nov, 2018 (5 years ago)
US8273379	CEPHALON	Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol	Nov, 2018 (5 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-167)	Jan 12, 2025

Drugs and Companies using ARSENIC TRIOXIDE ingredient

Market Authorisation Date: 13 October, 2017

Treatment: In combination with tretinoin, treating adults and pediatric patients 1 year and older with newly-diagnosed low-risk acute promyelocytic leukemia (apl) characterized by the presence of the t(15; 17) t...

Dosage: INJECTABLE;INJECTION

Pharsight

Cephalon patents expiration

1. Fentora patents expiration

FENTORA family patents

2. Gabitril patents expiration

GABITRIL family patents

3. Nuvigil patents expiration

NUVIGIL family patents

4. Provigil patents expiration

PROVIGIL family patents

5. Treanda patents expiration

TREANDA family patents

6. Trisenox patents expiration

TRISENOX family patents

Related content

Strength	Dosage	Availability
1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued
2MG/ML	INJECTABLE;INJECTION	Prescription