Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

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

Drug patent expirations by year for ABSTRAL
Drug Prices for ABSTRAL

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Recent Clinical Trials for ABSTRAL

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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

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District Court Litigation
Case NameDate
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 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-006 Jan 7, 2011 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-002 Jan 7, 2011 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 AB RX Yes Yes   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 022510-004 Jan 7, 2011   Start Trial   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-005 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
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-005 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 CA 2015 00004 Denmark   Start Trial 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
2236132 92636 Luxembourg   Start Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
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
1769785 C300522 Netherlands   Start Trial PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Colorcon
Mallinckrodt
Dow
Moodys
Merck

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