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Last Updated: August 11, 2022

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. Eight 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 HOSPIRA on January 12th, 1985.

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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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-002 Jan 7, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-006 Jan 7, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-005 Jan 7, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

International Patents for ABSTRAL

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

Country Patent Number Title Estimated Expiration
Bulgaria 65363 See Plans and Pricing
Czech Republic 20080315 See Plans and Pricing
Japan 2004269545 FENTANYL COMPOSITION FOR TREATING ACUTE PAIN See Plans and Pricing
Estonia 05555 Farmatseutiline kompositsioon ja selle kasutamine ravimi valmistamiseks, mis on ette n htud insomnia ravimiseks See Plans and Pricing
Spain 2433930 See Plans and Pricing
Denmark 2805716 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ABSTRAL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1769785 C300521 Netherlands See Plans and Pricing PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1635783 300653 Netherlands See Plans and Pricing PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
1635783 CA 2014 00016 Denmark See Plans and Pricing PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
2236132 300714 Netherlands See Plans and Pricing PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132 CA 2015 00004 Denmark See Plans and Pricing PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
0836511 SPC/GB06/022 United Kingdom See Plans and Pricing PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Harvard Business School
Express Scripts
Baxter
Medtronic

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