ABSTRAL Drug Patent 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.
The generic ingredient in ABSTRAL is fentanyl citrate. There are thirty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Abstral
A generic version of ABSTRAL was approved as fentanyl citrate by HIKMA on July 11th, 1984.
Summary for ABSTRAL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 34 |
| Clinical Trials: | 7 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ABSTRAL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ABSTRAL |
| What excipients (inactive ingredients) are in ABSTRAL? | ABSTRAL excipients list |
| DailyMed Link: | ABSTRAL at DailyMed |
Recent Clinical Trials for ABSTRAL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Phase 3 |
| National Cancer Institute (NCI) | Phase 3 |
| Institute of Mountain Emergency Medicine | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ABSTRAL
Paragraph IV (Patent) Challenges for ABSTRAL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ABSTRAL | Sublingual Tablets | fentanyl citrate | 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg | 022510 | 1 | 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 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-004 | Jan 7, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-002 | Jan 7, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-003 | Jan 7, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-006 | Jan 7, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-005 | Jan 7, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-001 | Jan 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-001 | Jan 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-004 | Jan 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-006 | Jan 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-002 | Jan 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-004 | Jan 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ABSTRAL
See the table below for patents covering ABSTRAL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 20011502 | ⤷ Sign Up | |
| Poland | 347467 | ⤷ Sign Up | |
| Turkey | 200100812 | ⤷ Sign Up | |
| Sweden | 9803240 | ⤷ Sign Up | |
| China | 1328448 | ⤷ Sign Up | |
| Czech Republic | 20011030 | ⤷ Sign Up | |
| Spain | 2207295 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ABSTRAL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2236132 | 92636 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
| 0836511 | 122006000022 | Germany | ⤷ Sign Up | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
| 2236132 | 300714 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718 |
| 1769785 | C300522 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006 |
| 1635783 | 300653 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
| 0975367 | 122011000009 | Germany | ⤷ Sign Up | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
| 1635783 | CA 2014 00016 | Denmark | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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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