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Last Updated: March 28, 2024

ABSTRAL Drug Patent Profile


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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. Ten 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 11th, 1984.

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Drug patent expirations by year for ABSTRAL
Drug Prices for ABSTRAL

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Recent Clinical Trials for ABSTRAL

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

SponsorPhase
M.D. Anderson Cancer CenterPhase 3
National Cancer Institute (NCI)Phase 3
Institute of Mountain Emergency MedicinePhase 4

See all ABSTRAL clinical trials

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-002 Jan 7, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 022510-006 Jan 7, 2011 ⤷  Try a Trial ⤷  Try a Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 ⤷  Try a Trial ⤷  Try a Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-001 Jan 7, 2011 ⤷  Try a Trial ⤷  Try a Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ABSTRAL

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

Country Patent Number Title Estimated Expiration
Hong Kong 1148458 ⤷  Try a Trial
Norway 20011502 ⤷  Try a Trial
European Patent Office 2236132 Composition pharmaceutique pour le traitement de l'insomnie par la voie sub-linguale (Pharmaceutical composition for the treatment of insomnia by sublingual administration) ⤷  Try a Trial
Hong Kong 1148457 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ABSTRAL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1635783 C300653 Netherlands ⤷  Try a Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0901368 C300523 Netherlands ⤷  Try a Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0836511 SPC/GB06/022 United Kingdom ⤷  Try a Trial PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1769785 C300521 Netherlands ⤷  Try a Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.