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Generated: September 17, 2019

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ABSTRAL Drug Profile

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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. Fifteen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

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 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-006 Jan 7, 2011 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-002 Jan 7, 2011 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Paragraph IV (Patent) Challenges for ABSTRAL
Drugname Dosage Strength RLD Date
➤ Subscribe Sublingual Tablets 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for ABSTRAL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1769785 C300522 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
2236132 122015000006 Germany ➤ Sign Up 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 122014000024 Germany ➤ Sign Up PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2236132 484 Finland ➤ Sign Up
1635783 300653 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
2236132 CA 2015 00004 Denmark ➤ Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Farmers Insurance
US Department of Justice
Johnson and Johnson
Covington
AstraZeneca

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