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Silodosin Patent Expiration

Silodosin is Used for managing the signs and symptoms of benign prostatic hyperplasia (BPH). It was first introduced by Allergan Sales Llc in its drug Rapaflo on Oct 8, 2008. 13 different companies have introduced drugs containing Silodosin.


Silodosin Patents

Given below is the list of patents protecting Silodosin, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Rapaflo US5387603 1,5,7-trisubstituted indoline compounds and salts thereof Dec 01, 2018

(Expired)

 Allergan
Rapaflo US5403847 Use of α1C specific compounds to treat benign prostatic hyperlasia Nov 13, 2012

(Expired)

 Allergan
Rapaflo US5780485 Use of α1c specific compounds to treat benign prostatic hyperplasia Nov 13, 2012

(Expired)

 Allergan
Rapaflo US6015819 Use of alpha-1C specific compounds to treat benign prostatic hyperplasia Nov 13, 2012

(Expired)

 Allergan



Silodosin Generics

Several generic applications have been filed for Silodosin. The first generic version for Silodosin was by Chartwell Rx Sciences Llc and was approved on Mar 31, 2017. And the latest generic version is by Zydus Pharmaceuticals Usa Inc and was approved on Dec 8, 2022.

Given below is the list of companies who have filed for Silodosin generic.


1. AJANTA PHARMA LTD

Ajanta Pharma Ltd has filed for 2 different strengths of generic version for Silodosin. Given below are the details of the strengths of this generic introduced by Ajanta Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG capsule Prescription ORAL AB Dec 3, 2018
8MG capsule Prescription ORAL AB Dec 3, 2018


2. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Silodosin. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
8MG capsule Discontinued ORAL N/A Nov 22, 2019
4MG capsule Discontinued ORAL N/A Nov 22, 2019


3. AMNEAL PHARMS CO

Amneal Pharmaceuticals Co Gmbh has filed for 2 different strengths of generic version for Silodosin. Given below are the details of the strengths of this generic introduced by Amneal Pharms Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
8MG capsule Prescription ORAL AB Dec 3, 2018
4MG capsule Prescription ORAL AB Dec 3, 2018


4. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Silodosin. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG capsule Prescription ORAL AB Dec 10, 2018
8MG capsule Prescription ORAL AB Dec 10, 2018


5. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 2 different strengths of generic version for Silodosin. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG capsule Prescription ORAL AB Mar 31, 2017
8MG capsule Prescription ORAL AB Mar 31, 2017


6. CREEKWOOD PHARMS

Creekwood Pharmaceuticals Llc has filed for 2 different strengths of generic version for Silodosin. Given below are the details of the strengths of this generic introduced by Creekwood Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
8MG capsule Prescription ORAL AB Jan 3, 2022
4MG capsule Prescription ORAL AB Jan 3, 2022


7. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 2 different strengths of generic version for Silodosin. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG capsule Prescription ORAL AB Feb 14, 2020
8MG capsule Prescription ORAL AB Feb 14, 2020


8. LUPIN LTD

Lupin Ltd has filed for 2 different strengths of generic version for Silodosin. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG capsule Prescription ORAL AB Dec 3, 2018
8MG capsule Prescription ORAL AB Dec 3, 2018


9. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Silodosin. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG capsule Prescription ORAL AB Dec 3, 2018
8MG capsule Prescription ORAL AB Dec 3, 2018


10. MSN

Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Silodosin. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG capsule Prescription ORAL AB Dec 3, 2018
8MG capsule Prescription ORAL AB Dec 3, 2018


11. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 2 different strengths of generic version for Silodosin. Given below are the details of the strengths of this generic introduced by Prinston Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG capsule Prescription ORAL AB Jan 4, 2022
8MG capsule Prescription ORAL AB Jan 4, 2022


12. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Silodosin. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
8MG capsule Discontinued ORAL N/A Dec 8, 2022
4MG capsule Discontinued ORAL N/A Dec 8, 2022