ACTIQ Drug Patent Profile
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When do Actiq patents expire, and when can generic versions of Actiq launch?
Actiq is a drug marketed by Cephalon and is included in one NDA.
The generic ingredient in ACTIQ 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 Actiq
A generic version of ACTIQ was approved as fentanyl citrate by HIKMA on July 11th, 1984.
Summary for ACTIQ
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 39 |
Patent Applications: | 4,225 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ACTIQ |
What excipients (inactive ingredients) are in ACTIQ? | ACTIQ excipients list |
DailyMed Link: | ACTIQ at DailyMed |
Pharmacology for ACTIQ
Drug Class | Opioid Agonist |
Mechanism of Action | Full Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ACTIQ
Paragraph IV (Patent) Challenges for ACTIQ
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ACTIQ | Lozenges | fentanyl citrate | 0.6 mg | 020747 | 2004-12-20 | |
ACTIQ | Lozenges | fentanyl citrate | 0.8 mg, 1.2 mg and 1.6 mg | 020747 | 2004-11-22 | |
ACTIQ | Lozenges | fentanyl citrate | 0.2 mg | 020747 | 2004-10-29 | |
ACTIQ | Lozenges | fentanyl citrate | 0.4 mg | 020747 | 2004-10-06 |
US Patents and Regulatory Information for ACTIQ
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-001 | Nov 4, 1998 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-004 | Nov 4, 1998 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-002 | Nov 4, 1998 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-003 | Nov 4, 1998 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-006 | Nov 4, 1998 | RX | 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 ACTIQ
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-005 | Nov 4, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-002 | Nov 4, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-005 | Nov 4, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-001 | Nov 4, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-006 | Nov 4, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACTIQ
See the table below for patents covering ACTIQ around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 0745380 | ⤷ Try a Trial | |
Germany | 69023143 | ⤷ Try a Trial | |
Canada | 2178021 | PRODUIT DE REMPLACEMENT DU TABAC (TOBACCO SUBSTITUTE) | ⤷ Try a Trial |
Spain | 2089027 | ⤷ Try a Trial | |
European Patent Office | 0404205 | Compositions pour l'administration non systémique d'agents sédatifs et analgésiques. (Composition for noninvasive administration of sedatives and analgesics.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACTIQ
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0975367 | 122011000009 | 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 |
1769785 | C300521 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006 |
0836511 | CA 2006 00019 | Denmark | ⤷ Try a Trial | PRODUCT NAME: FENTANYL HYDROCHLORID |
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 |
0901368 | C300523 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |