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Serving leading biopharmaceutical companies globally:

Medtronic
Cantor Fitzgerald
Chubb
Cipla
Harvard Business School
Merck
US Army
Fish and Richardson
Boehringer Ingelheim
QuintilesIMS

Generated: January 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 six 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. Sixteen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
Summary for ABSTRAL
International Patents:106
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 3
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 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-006 Jan 7, 2011 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-002 Jan 7, 2011 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-006 Jan 7, 2011 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-005 Jan 7, 2011 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-001 Jan 7, 2011 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-001 Jan 7, 2011 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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 6/19/2014

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 ➤ Subscribe
8,512,747 Pharmaceutical composition for the treatment of acute disorders ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for ABSTRAL

Supplementary Protection Certificates for ABSTRAL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00521 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
00523 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
2014 00016 Denmark ➤ Subscribe PRODUCT 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
2011000009 Germany ➤ Subscribe PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2015000006 Germany ➤ Subscribe 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
00653 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
4 Finland ➤ Subscribe
2015 00004 Denmark ➤ Subscribe 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
0714 Netherlands ➤ Subscribe PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
00714 Netherlands ➤ Subscribe PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
US Department of Justice
Medtronic
Queensland Health
Argus Health
Chinese Patent Office
Teva
Cerilliant

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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