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 | ⤷ 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 | 022510-003 | 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 |
Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-003 | 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 |
---|---|---|---|
New Zealand | 510646 | A sublingual composition comprising fentanyl adhered to microparticles for the treatment of acute pain | ⤷ Try a Trial |
Mexico | PA01003068 | COMPOSICION FARMACEUTICA PARA EL TRATAMIENTO DE ALTERACIONES AGUDAS. (PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF ACUTE DISORDERS.) | ⤷ Try a Trial |
Australia | 6492799 | ⤷ Try a Trial | |
Poland | 347467 | ⤷ Try a Trial | |
Spain | 2289829 | ⤷ 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 |
---|---|---|---|---|
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 |
1635783 | 122014000024 | Germany | ⤷ Try a Trial | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
1635783 | C300653 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
2236132 | CA 2015 00004 | Denmark | ⤷ Try a Trial | 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 |
2236132 | 122015000006 | Germany | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |