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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Accenture
Chinese Patent Office
McKinsey
Fuji
AstraZeneca
Colorcon
McKesson
Medtronic

Generated: April 23, 2018

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.
Summary for ABSTRAL
International Patents:107
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Clinical Trials: 3
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ABSTRAL at DailyMed
Drug patent expirations by year for ABSTRAL
Pharmacology for ABSTRAL
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-006 Jan 7, 2011 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-002 Jan 7, 2011 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 Submissiondate
➤ Subscribe Sublingual Tablets 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg ➤ Subscribe 2014-06-19

Non-Orange Book US Patents for ABSTRAL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,454,996 Pharmaceutical composition for the treatment of acute disorders ➤ Try a Free Trial
8,512,747 Pharmaceutical composition for the treatment of acute disorders ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ABSTRAL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00714 Netherlands ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2014000024 Germany ➤ Try a Free Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2006 00019 Denmark ➤ Try a Free Trial PRODUCT NAME: FENTANYL HYDROCHLORID
00521 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Citi
Moodys
UBS
Healthtrust
Teva
Cipla
Medtronic
Boehringer Ingelheim

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