ENABLEX Drug Patent Profile
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When do Enablex patents expire, and what generic alternatives are available?
Enablex is a drug marketed by Abbvie and is included in one NDA.
The generic ingredient in ENABLEX is darifenacin hydrobromide. There are nineteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Enablex
A generic version of ENABLEX was approved as darifenacin hydrobromide by CIPLA on September 1st, 2016.
Summary for ENABLEX
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 120 |
Clinical Trials: | 16 |
Patent Applications: | 3,294 |
Drug Prices: | Drug price information for ENABLEX |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ENABLEX |
What excipients (inactive ingredients) are in ENABLEX? | ENABLEX excipients list |
DailyMed Link: | ENABLEX at DailyMed |
Recent Clinical Trials for ENABLEX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Astellas Scientific & Medical Affairs, Inc. | |
Universidad de Valparaiso | Phase 3 |
Recalcine (GynoPharm) | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for ENABLEX
Paragraph IV (Patent) Challenges for ENABLEX
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ENABLEX | Extended-release Tablets | darifenacin hydrobromide | 7.5 mg and 15 mg | 021513 | 3 | 2008-12-22 |
US Patents and Regulatory Information for ENABLEX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | ENABLEX | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 021513-001 | Dec 22, 2004 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie | ENABLEX | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 021513-002 | Dec 22, 2004 | 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 ENABLEX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | ENABLEX | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 021513-002 | Dec 22, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ENABLEX | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 021513-002 | Dec 22, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ENABLEX | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 021513-001 | Dec 22, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ENABLEX
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
pharmaand GmbH | Emselex | darifenacin hydrobromide | EMEA/H/C/000554 Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome. |
Authorised | no | no | no | 2004-10-22 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ENABLEX
See the table below for patents covering ENABLEX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 703866 | ⤷ Try a Trial | |
New Zealand | 232958 | N-SUBSTITUTED-3-(CYANO OR CARBAMOYL-DIPHENYLMETHYL)-PYRROLE DERIVATIVES, INTERMEDIATES THEREFOR, AND MEDICAMENT COMPOSITIONS | ⤷ Try a Trial |
Colombia | 4750822 | FORMULACIONES FARMACEUTICAS TADA PARA LA ADMINISTRACION EN EL TRACTO GASTROINTESTINAL Y PROCESOS PARA ELABORAR LAS MISMAS | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ENABLEX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0850059 | CA 2005 00020 | Denmark | ⤷ Try a Trial | |
0388054 | SPC/GB05/022 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DARIFENACIN HYDROBROMIDE; REGISTERED: UK EU/1/04/294/001 20041022; UK EU/1/04/294/002 20041022; UK EU/1/04/294/003 20041022; UK EU/1/04/294/004 20041022; UK EU/1/04/294/005 20041022; UK EU/1/04/294/006 20041022; UK EU/1/04/294/007 20041022; UK EU/1/04/294/008 20041022; UK EU/1/04/294/009 20041022; UK EU/1/04/294/010 20041022; UK EU/1/04/294/011 20041022; UK EU/1/04/294/012 20041022 |
0388054 | C300191 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DARIFENACINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROBROMIDE; REGISTRATION NO/DATE: EU1/04/294/001 - 012, 20041022 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |