Silodosin - Generic Drug Details

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What are the generic drug 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
Mansoura University	Phase 3
Amiri Hospital	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

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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
Aurobindo Pharma Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	210626-002	Dec 10, 2018	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
Alembic	SILODOSIN	silodosin	CAPSULE;ORAL	211731-002	Nov 22, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Co	SILODOSIN	silodosin	CAPSULE;ORAL	209745-002	Dec 3, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008	AB	RX	Yes	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

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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	⤷ 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
>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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