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Last Updated: April 19, 2024

SILODOSIN - Generic Drug Details

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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, Creekwood Pharms, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, MSN, Prinston Inc, Sandoz, 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. Thirteen 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:	13
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	27
Patent Applications:	750
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
Benha University	N/A
Armed Forces Institute of Urology, Rawalpindi	Phase 1
Xintian Pharmaceutical	Phase 4

See all SILODOSIN clinical trials

Pharmacology for SILODOSIN

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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Creekwood Pharms	SILODOSIN	silodosin	CAPSULE;ORAL	213230-001	Jan 3, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	SILODOSIN	silodosin	CAPSULE;ORAL	204726-001	Mar 31, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Prinston Inc	SILODOSIN	silodosin	CAPSULE;ORAL	209029-002	Jan 4, 2022	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

Expired US Patents for SILODOSIN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008	⤷ Try a Trial	⤷ Try a Trial
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008	⤷ Try a Trial	⤷ Try a Trial
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for SILODOSIN

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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

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