Janssen Pharms Company Profile

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JANSSEN PHARMS has fifty-seven approved drugs.

There are twenty-three US patents protecting JANSSEN PHARMS drugs.

There are six hundred and four patent family members on JANSSEN PHARMS drugs in sixty-two countries and ninety supplementary protection certificates in seventeen countries.

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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
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-003	Jun 22, 1999		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-001	Aug 8, 2014		RX	Yes	No	7,943,788	⤷ Sign Up	Y	Y		⤷ Sign Up
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-003	Aug 8, 2014		RX	Yes	No	8,513,202	⤷ Sign Up	Y	Y		⤷ Sign Up
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-002	Aug 8, 2014		RX	Yes	No	8,222,219	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-004	Aug 8, 2014		RX	Yes	Yes	7,943,788	⤷ Sign Up	Y	Y		⤷ Sign Up
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	Sep 20, 2016		RX	Yes	No	7,943,582	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-003	Oct 29, 2003	6,544,559	⤷ Sign Up
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-005	Dec 20, 1996	5,053,407*PED	⤷ Sign Up
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-002	Aug 1, 2000	8,163,798*PED	⤷ Sign Up
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-003	Dec 24, 1996	7,498,311*PED	⤷ Sign Up
Janssen Pharms	NIZORAL	ketoconazole	TABLET;ORAL	018533-001	Approved Prior to Jan 1, 1982	4,335,125	⤷ Sign Up
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-003	Sep 20, 2016	6,723,340	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Extended-release Tablets	18 mg*, 27 mg, 36 mg and 54 mg	➤ Subscribe	2005-07-19
➤ Subscribe	Tablets	50 mg/500 mg, 50mg/1000 mg, 150mg/500 mg, and150 mg/1000 mg	➤ Subscribe	2017-03-29
➤ Subscribe	Extended-release Capsules	16 mg and 24 mg	➤ Subscribe	2006-03-11
➤ Subscribe	Tablets	25 mg, 100 mg and 200 mg	➤ Subscribe	2001-12-26
➤ Subscribe	Capsules	15 mg and 25 mg	➤ Subscribe	2005-09-07
➤ Subscribe	Tablets	10 mg, 15 mg, and 20 mg	➤ Subscribe	2015-07-01
➤ Subscribe	Tablets	4 mg, 8 mg and 12 mg	➤ Subscribe	2005-02-28
➤ Subscribe	Orally Disintegrating Tablets	3 mg and 4 mg	➤ Subscribe	2005-03-23
➤ Subscribe	Extended-release Tablets	18 mg, 27 mg, 36 mg and 54 mg	➤ Subscribe	2005-07-19
➤ Subscribe	Tablets	6.25 mg and 12.5 mg	➤ Subscribe	2005-12-08
➤ Subscribe	Extended-release Capsules	8 mg	➤ Subscribe	2006-03-02
➤ Subscribe	Tablets	100 mg and 300 mg	➤ Subscribe	2017-03-29
➤ Subscribe	Oral Solution	10 mg/mL	➤ Subscribe	2013-05-03
➤ Subscribe	Tablets	50 mg	➤ Subscribe	2005-09-08
➤ Subscribe	Transdermal System	0.15 mg/0.02 mg per 24 hours	➤ Subscribe	2007-03-22
➤ Subscribe	Oral Solution	25 mg/mL	➤ Subscribe	2009-07-30
➤ Subscribe	Orally Disintegrating Tablets	0.25 mg	➤ Subscribe	2005-04-11
➤ Subscribe	Extended-release Injectable Suspension	39 mg/0.25 mL,78 mg/0.5 mL,117 mg/0.75 mL,156 mg/mL and234 mg/1.5 mL	➤ Subscribe	2017-11-21

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261606	2008C/046	Belgium	⤷ Sign Up	PRODUCT NAME: RIVAROXABAN; AUTHORISATION NUMBER AND DATE: EU/1/08/472/001
1651658	14C0034	France	⤷ Sign Up	PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
1453521	CA 2016 00016	Denmark	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1261606	91497	Luxembourg	⤷ Sign Up	91497, EXPIRES: 20230930
1429780	132013902137451	Italy	⤷ Sign Up	PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
1651658	SPC/GB14/032	United Kingdom	⤷ Sign Up	PRODUCT NAME: CANAGLIFLOZIN; REGISTERED: UK EU/1/13/884/001 20131119; UK EU/1/13/884/002 20131119; UK EU/1/13/884/003 20131119; UK EU/1/13/884/004 20131119; UK EU/1/13/884/005 20131119; UK EU/1/13/884/006 20131119; UK EU/1/13/884/007 20131119; UK EU/1/13/884/008 20131119
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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