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 |
---|---|
National Cancer Institute (NCI) | Phase 3 |
M.D. Anderson Cancer Center | 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-004 | Jan 7, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-002 | Jan 7, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-003 | Jan 7, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-006 | Jan 7, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 | 022510-005 | Jan 7, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-002 | Jan 7, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-005 | Jan 7, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-001 | Jan 7, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-006 | Jan 7, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
China | 1173694 | ⤷ Try a Trial | |
Australia | 764473 | ⤷ Try a Trial | |
Czech Republic | 306387 | Farmaceutický přípravek pro léčení potíží s nespavostí ve formě pro podání pod jazyk (Sublingual pharmaceutical composition intended for the treatment of troubles with insomnia) | ⤷ Try a Trial |
China | 1328448 | ⤷ Try a Trial | |
Denmark | 1115383 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ABSTRAL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0901368 | C300523 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
2236132 | 92636 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
1635783 | CA 2014 00016 | Denmark | ⤷ Try a Trial | 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 |
2236132 | 300714 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718 |
0836511 | CA 2006 00019 | Denmark | ⤷ Try a Trial | PRODUCT NAME: FENTANYL HYDROCHLORID |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |