SILODOSIN Drug Patent Profile
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When do Silodosin patents expire, and what generic alternatives are available?
Silodosin is a drug marketed by Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Creekwood Pharms, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, MSN, Prinston Inc, Sandoz, and Zydus Pharms. and is included in twelve NDAs.
The generic ingredient in SILODOSIN is silodosin. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the silodosin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Silodosin
A generic version of SILODOSIN was approved as silodosin by SANDOZ on March 31st, 2017.
Summary for SILODOSIN
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 12 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 99 |
| Clinical Trials: | 27 |
| Patent Applications: | 478 |
| Drug Prices: | Drug price information for SILODOSIN |
| DailyMed Link: | SILODOSIN at DailyMed |
Recent Clinical Trials for SILODOSIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Benha University | N/A |
| Armed Forces Institute of Urology, Rawalpindi | Phase 1 |
| Xintian Pharmaceutical | Phase 4 |
Pharmacology for SILODOSIN
| Drug Class | alpha-Adrenergic Blocker |
| Mechanism of Action | Adrenergic alpha-Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for SILODOSIN
US Patents and Regulatory Information for SILODOSIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ajanta Pharma Ltd | SILODOSIN | silodosin | CAPSULE;ORAL | 211060-001 | Dec 3, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Msn | SILODOSIN | silodosin | CAPSULE;ORAL | 210687-002 | Dec 3, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | SILODOSIN | silodosin | CAPSULE;ORAL | 204816-002 | Dec 8, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aurobindo Pharma Ltd | SILODOSIN | silodosin | CAPSULE;ORAL | 210626-001 | Dec 10, 2018 | 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 SILODOSIN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Recordati Ireland Ltd | Urorec | silodosin | EMEA/H/C/001092 Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). |
Authorised | no | no | no | 2010-01-29 | |
| Recordati Ireland Ltd | Silodosin Recordati | silodosin | EMEA/H/C/004964 Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men. |
Authorised | yes | no | no | 2019-01-07 | |
| Recordati Ireland Ltd | Silodyx | silodosin | EMEA/H/C/001209 Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) |
Authorised | no | no | no | 2010-01-29 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
