DARIFENACIN Drug Patent Profile
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When do Darifenacin patents expire, and when can generic versions of Darifenacin launch?
Darifenacin is a drug marketed by Macleods Pharms Ltd, Alembic, Anchen Pharms, Aurobindo Pharma, Cipla, Jubilant Generics, Polygen Pharms, Torrent, and Xiromed. and is included in nine NDAs.
The generic ingredient in DARIFENACIN 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
A generic version of DARIFENACIN was approved as darifenacin hydrobromide by CIPLA on September 1st, 2016.
Summary for DARIFENACIN
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 43 |
| Clinical Trials: | 19 |
| Patent Applications: | 1,918 |
| Drug Prices: | Drug price information for DARIFENACIN |
| What excipients (inactive ingredients) are in DARIFENACIN? | DARIFENACIN excipients list |
| DailyMed Link: | DARIFENACIN at DailyMed |
Recent Clinical Trials for DARIFENACIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Recalcine (GynoPharm) | Phase 3 |
| Universidad de Valparaiso | Phase 3 |
| Laboratorio Elea Phoenix S.A. | Phase 1 |
Pharmacology for DARIFENACIN
| Drug Class | Cholinergic Muscarinic Antagonist |
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for DARIFENACIN
US Patents and Regulatory Information for DARIFENACIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Macleods Pharms Ltd | DARIFENACIN | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 207302-001 | Jul 28, 2017 | 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 | ||||
| Aurobindo Pharma | DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 206743-001 | Sep 19, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Alembic | DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 207681-002 | Dec 8, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Jubilant Generics | DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 205550-002 | Oct 12, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma | DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 206743-002 | Sep 19, 2016 | AB | RX | 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
| 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 |
