SILODOSIN - Generic Drug Details

✉ Email this page to a colleague

What are the generic sources for silodosin and what is the scope of patent protection?

Silodosin is the generic ingredient in two branded drugs marketed by Allergan, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Creekwood Pharms, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, MSN, Prinston Inc, and Zydus Pharms, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for silodosin. Fourteen suppliers are listed for this compound.

Summary for SILODOSIN

US Patents:	0
Tradenames:	2
Applicants:	13
NDAs:	13
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	28
Patent Applications:	1,422
Drug Prices:	Drug price trends for SILODOSIN
What excipients (inactive ingredients) are in SILODOSIN?	SILODOSIN excipients list
DailyMed Link:	SILODOSIN at DailyMed

See drug prices for SILODOSIN

Recent Clinical Trials for SILODOSIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Amiri Hospital	Phase 3
Mansoura University	Phase 3
Benha University	N/A

See all SILODOSIN clinical trials

Pharmacology for SILODOSIN

Drug Class	alpha-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for SILODOSIN

G04CA	Alpha-adrenoreceptor antagonists
G04C	DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for SILODOSIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RAPAFLO	Capsules	silodosin	4 mg and 8 mg	022206	3	2012-10-09

US Patents and Regulatory Information for SILODOSIN

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	SILODOSIN	silodosin	CAPSULE;ORAL	204726-001	Mar 31, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	206541-001	Dec 3, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	206541-002	Dec 3, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ajanta Pharma Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	211060-002	Dec 3, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	SILODOSIN	silodosin	CAPSULE;ORAL	204793-002	Feb 14, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Creekwood Pharms	SILODOSIN	silodosin	CAPSULE;ORAL	213230-001	Jan 3, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	210626-001	Dec 10, 2018	AB	RX	No	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 SILODOSIN

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008	⤷ Sign Up	⤷ Sign Up
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008	⤷ Sign Up	⤷ Sign Up
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008	⤷ Sign Up	⤷ Sign Up
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008	⤷ Sign Up	⤷ Sign Up
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008	⤷ Sign Up	⤷ Sign Up
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008	⤷ Sign Up	⤷ Sign Up
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for SILODOSIN

Subscribe to access the full database, or Sign Up
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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.