DARIFENACIN HYDROBROMIDE Drug Patent Profile
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Which patents cover Darifenacin Hydrobromide, and what generic alternatives are available?
Darifenacin Hydrobromide is a drug marketed by Alembic, Anchen Pharms, Aurobindo Pharma, Cipla, Jubilant Generics, Polygen Pharms, Torrent, and Xiromed. and is included in eight NDAs.
The generic ingredient in DARIFENACIN HYDROBROMIDE 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 Darifenacin Hydrobromide
A generic version of DARIFENACIN HYDROBROMIDE was approved as darifenacin hydrobromide by CIPLA on September 1st, 2016.
Summary for DARIFENACIN HYDROBROMIDE
Recent Clinical Trials for DARIFENACIN HYDROBROMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Toronto Rehabilitation Institute | Phase 4 |
| Ontario Neurotrauma Foundation | Phase 4 |
Pharmacology for DARIFENACIN HYDROBROMIDE
| Drug Class | Cholinergic Muscarinic Antagonist |
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for DARIFENACIN HYDROBROMIDE
Paragraph IV (Patent) Challenges for DARIFENACIN HYDROBROMIDE
| 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 DARIFENACIN HYDROBROMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 207681-001 | Dec 8, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Cipla | DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 207664-001 | Sep 1, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Anchen Pharms | DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 091190-002 | Mar 13, 2015 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Polygen Pharms | DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 211045-002 | Jan 6, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Cipla | DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 207664-002 | Sep 1, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Xiromed | DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 209571-001 | Oct 22, 2019 | DISCN | No | 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 |
EU/EMA Drug Approvals for DARIFENACIN HYDROBROMIDE
| 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 |
