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ABSTRAL Drug Profile

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Abstral is a drug marketed by Sentynl Theraps Inc and is included in one NDA. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-eight 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. Eighteen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

Summary for Tradename: ABSTRAL

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Drug Prices: :see details

Pharmacology for Tradename: ABSTRAL

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sentynl Theraps Inc
ABSTRAL
fentanyl citrate
TABLET;SUBLINGUAL022510-001Jan 7, 2011RXNo6,759,059► subscribeY ► subscribe
Sentynl Theraps Inc
ABSTRAL
fentanyl citrate
TABLET;SUBLINGUAL022510-006Jan 7, 2011RXNo7,910,132► subscribeY ► subscribe
Sentynl Theraps Inc
ABSTRAL
fentanyl citrate
TABLET;SUBLINGUAL022510-003Jan 7, 2011RXNo6,759,059► subscribeY ► subscribe
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Paragraph IV activity for: ABSTRAL

Drugname Dosage Strength RLD Submissiondate
fentanyl citrateSublingual Tablets0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mgAbstral6/19/2014

Non-Orange Book Patents for Tradename: 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
8,454,996Pharmaceutical composition for the treatment of acute disorders► subscribe
8,512,747Pharmaceutical composition for the treatment of acute disorders► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ABSTRAL

Country Document Number Estimated Expiration
China1326340► subscribe
Japan3381220► subscribe
World Intellectual Property Organization (WIPO)0016750► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ABSTRAL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00004Denmark► subscribePRODUCT 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
0653Netherlands► subscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
2014 00016Denmark► subscribePRODUCT 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
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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