ENABLEX Drug Patent Profile
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When do Enablex patents expire, 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.
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Questions you can ask:
- What is the 5 year forecast for ENABLEX?
- What are the global sales for ENABLEX?
- What is Average Wholesale Price for ENABLEX?
Summary for ENABLEX
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 120 |
Clinical Trials: | 16 |
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 |
![ENABLEX drug patent expirations Drug patent expirations by year for ENABLEX](/p/graph/s/t/ENABLEX-patent-expirations.png)
![Drug Prices for ENABLEX](/p/graph/drug-price/ENABLEX.png)
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Abbvie | ENABLEX | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 021513-002 | Dec 22, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ENABLEX | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 021513-002 | Dec 22, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ENABLEX | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 021513-002 | Dec 22, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ENABLEX | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 021513-001 | Dec 22, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
South Africa | 9607745 | ⤷ Sign Up | |
Australia | 5140290 | ⤷ Sign Up | |
Israel | 93694 | Pyrrolidine derivatives and pharmaceutical compositions thereof | ⤷ Sign Up |
Czech Republic | 9800732 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ENABLEX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0850059 | 91163 | Luxembourg | ⤷ Sign Up | 91163, EXPIRES: 20191022 |
0388054 | C00388054/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: NOVARTIS INTERNATIONAL PHARMACEUTICAL LTD., BM |
0388054 | CA 2005 00019 | Denmark | ⤷ Sign Up | |
0850059 | C00850059/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: NOVARTIS AG, CH |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |