ENABLEX Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Enablex, and when can generic versions of Enablex launch?
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. | |
Recalcine (GynoPharm) | Phase 3 |
Universidad de Valparaiso | 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 | 021513-001 | 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 |
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 |
>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 |
---|---|---|---|
Germany | 122005000022 | ⤷ Try a Trial | |
Israel | 93694 | Pyrrolidine derivatives and pharmaceutical compositions thereof | ⤷ Try a Trial |
Egypt | 18951 | Process for preparing pyrrolidine derivatives | ⤷ Try a Trial |
Luxembourg | 91163 | ⤷ Try a Trial | |
Hungary | 211640 | ⤷ Try a Trial | |
Czech Republic | 280053 | 3-Substituovaný pyrrolidinový derivát, způsob jeho přípravy, meziprodukty tohoto způsobu, farmaceutický prostředek obsahující tento derivát (3-SUBSTITUTED PYRROLIDINE DERIVATIVE, PROCESS OF ITS PREPARATION, INTERMEDIATES OF SUCH PROCESS AND PHARMACEUTICAL COMPOSITION CONTAINING THEREOF) | ⤷ 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 |
---|---|---|---|---|
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 |
0388054 | C00388054/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: NOVARTIS INTERNATIONAL PHARMACEUTICAL LTD., BM |
0388054 | 300191 | Netherlands | ⤷ Try a Trial | 300191, 20100302, EXPIRES: 20150301 |
0850059 | CA 2005 00020 | Denmark | ⤷ Try a Trial | |
0388054 | 91161 | Luxembourg | ⤷ Try a Trial | 91161, EXPIRES: 20150302 |
0850059 | 22/2005 | Austria | ⤷ Try a Trial | PRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001- EU/1/04/294/012 20041022 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |