RAPAFLO Drug Patent Profile

Which patents cover Rapaflo, and what generic alternatives are available?

Rapaflo is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in RAPAFLO 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 Rapaflo

A generic version of RAPAFLO was approved as silodosin by CHARTWELL RX on March 31^st, 2017.

Summary for RAPAFLO

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	7
Patent Applications:	478
Drug Prices:	Drug price information for RAPAFLO
What excipients (inactive ingredients) are in RAPAFLO?	RAPAFLO excipients list
DailyMed Link:	RAPAFLO at DailyMed

See drug prices for RAPAFLO

See drug sales revenues for RAPAFLO

Recent Clinical Trials for RAPAFLO

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

Sponsor	Phase
Sir Mortimer B. Davis - Jewish General Hospital	Phase 3
Albert Einstein Healthcare Network	Phase 4
Watson Pharmaceuticals	Phase 2

See all RAPAFLO clinical trials

Pharmacology for RAPAFLO

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

Anatomical Therapeutic Chemical (ATC) Classes for RAPAFLO

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 RAPAFLO

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 RAPAFLO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008	AB	RX	Yes	Yes
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008	AB	RX	Yes	No

Expired US Patents for RAPAFLO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008
Allergan	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008

EU/EMA Drug Approvals for RAPAFLO

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

International Patents for RAPAFLO

See the table below for patents covering RAPAFLO around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0745185	DEMARREUR (STARTER)
Japan	3240567
South Africa	9502763
Germany	122010000031
Japan	H08506800
Canada	2110454	COMPOSES DE L'INDOLINE 1,5,7-TRISUBSTITUES POUR LE TRAITEMENT DE LA DYSURIE (1,5,7-TRISUBSTITUTED INDOLINE COMPOUNDS FOR THE TREATMENT OFDYSURIA)
Australia	2240495

Supplementary Protection Certificates for RAPAFLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0600675	10C0036	France		PRODUCT NAME: SILODOSIN; REGISTRATION NO/DATE IN FRANCE: EU/1/09/608/001 DU 20100129; REGISTRATION NO/DATE AT EEC: EU/1/09/608/001 DU 20100129
0600675	C300454	Netherlands		PRODUCT NAME: SILODOSIN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/607/001-014EU/1/09/608/001-014 2010290129
0600675	SPC/GB10/031	United Kingdom		PRODUCT NAME: SILODOSIN, OPTIONALLY IN A FORM OF A PHARMACEUTICAL ACCEPTABLE SALT; REGISTERED: UK EU/1/09/607/001-014 20100129; UK EU/1/09/608/001-014 20100129
0600675	1090028-0.L	Sweden		PRODUCT NAME: SILODOSIN ELLER FARMACEUTISKA GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/09/607/001-014 " EESGODKLANDKOD="EG" EESGODKDATUM="2010-01-29" SEGODKNR="EU/1/09/607/001-014 " SEGODKLANDKOD="EG" SEGODKDATUM="2010-01-29" FLAG="L" SPCNR="1090028-0" 20100129