You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Dow
Express Scripts
Colorcon
Moodys
McKesson
Harvard Business School

Last Updated: February 16, 2020

DrugPatentWatch Database Preview

ABSTRAL Drug Profile


Email this page to a colleague

See Plans and Pricing

« Back to Dashboard

Which patents cover Abstral, and when can generic versions of Abstral launch?

Abstral is a drug marketed by Sentynl Theraps Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seven patent family members in twenty-eight countries.

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

US ANDA Litigation and Generic Entry Outlook for Abstral

A generic version of ABSTRAL was approved as fentanyl citrate by HOSPIRA on January 12th, 1985.

  Start Trial

Drug patent expirations by year for ABSTRAL
Drug Prices for ABSTRAL

See drug prices for ABSTRAL

Recent Clinical Trials for ABSTRAL

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

SponsorPhase
Institute of Mountain Emergency MedicinePhase 4
Azienda Sanitaria dell'Alto AdigePhase 4
Galena Biopharma, Inc.N/A

See all ABSTRAL clinical trials

Recent Litigation for ABSTRAL

Identify potential future generic entrants

District Court Litigation
Case NameDate
Orexo AB v. Actavis Elizabeth LLC2017-02-28
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13
Orexo AB v. Actavis Elizabeth LLC2014-06-26

See all ABSTRAL litigation

Pharmacology for ABSTRAL
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Paragraph IV (Patent) Challenges for ABSTRAL
Tradename Dosage Ingredient NDA Submissiondate
ABSTRAL TABLET;SUBLINGUAL fentanyl citrate 022510 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   Start Trial   Start Trial Y   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-006 Jan 7, 2011 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-002 Jan 7, 2011 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Supplementary Protection Certificates for ABSTRAL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 122015000006 Germany   Start Trial PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
1635783 C300653 Netherlands   Start Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0836511 SPC/GB06/022 United Kingdom   Start Trial PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
2236132 92636 Luxembourg   Start Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1635783 122014000024 Germany   Start Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2236132 300714 Netherlands   Start Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Merck
Dow
Mallinckrodt
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.