ABSTRAL Drug Patent Profile

When do Abstral patents expire, and what generic alternatives are available?

Abstral is a drug marketed by Sentynl Theraps Inc and is included in one NDA.

The generic ingredient in ABSTRAL is fentanyl citrate. There are thirty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Abstral

A generic version of ABSTRAL was approved as fentanyl citrate by HIKMA on July 11^th, 1984.

Summary for ABSTRAL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	7
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ABSTRAL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABSTRAL
What excipients (inactive ingredients) are in ABSTRAL?	ABSTRAL excipients list
DailyMed Link:	ABSTRAL at DailyMed

See drug prices for ABSTRAL

Recent Clinical Trials for ABSTRAL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 3
National Cancer Institute (NCI)	Phase 3
Institute of Mountain Emergency Medicine	Phase 4

See all ABSTRAL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ABSTRAL

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

N02AB	Phenylpiperidine derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for ABSTRAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ABSTRAL	Sublingual Tablets	fentanyl citrate	0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg	022510	1	2014-06-19

US Patents and Regulatory Information for ABSTRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-001	Jan 7, 2011		DISCN	Yes	No
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-004	Jan 7, 2011		DISCN	Yes	No
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-002	Jan 7, 2011		DISCN	Yes	No
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-003	Jan 7, 2011		DISCN	Yes	No

Expired US Patents for ABSTRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-003	Jan 7, 2011
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-002	Jan 7, 2011
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-001	Jan 7, 2011
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-004	Jan 7, 2011

International Patents for ABSTRAL

See the table below for patents covering ABSTRAL around the world.

Country	Patent Number	Title	Estimated Expiration
Estonia	04927	Farmatseutiline kompositsioon ja selle kasutamineravimi valmistamiseks, mis on ette n htud akuutsete h irete raviks
Hungary	230468	Gyógyszerkészítmény álmatlanság kezelésére (Pharmaceutical composition for the treatment of insomnia)
Slovakia	4012001	FENTANYL COMPOSITION FOR THE TREATMENT OF ACUTE PAIN
Poland	347126

Supplementary Protection Certificates for ABSTRAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
0383579	C960030	Netherlands		PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
2236132	92636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
0836511	SPC/GB06/022	United Kingdom		PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124