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Medtronic
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Generated: October 17, 2018

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ABSTRAL Drug 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. There are three patents protecting this drug and one Paragraph IV challenge.

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
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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0653 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
00523 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
C/GB06/022 United Kingdom ➤ Sign Up PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Teva
Cerilliant
Daiichi Sankyo
AstraZeneca
Medtronic
Cipla
Colorcon
McKesson

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