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Janssen Pharms Company Profile

JANSSEN PHARMS has fifty-six approved drugs.

There are nineteen US patents protecting JANSSEN PHARMS drugs. There is one tentative approval on JANSSEN PHARMS drugs.

There are five hundred and five patent family members on JANSSEN PHARMS drugs in fifty-seven countries and eighty-four 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	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-006	Aug 26, 2008	AB	RX	Yes	No		Start Trial				Start Trial
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-003	Sep 20, 2016		RX	Yes	No	8,222,219	Start Trial				Start Trial
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-004	Dec 23, 2004	AB	RX	Yes	No		Start Trial				Start Trial
Janssen Pharms	TOPAMAX	topiramate	CAPSULE;ORAL	020844-002	Oct 26, 1998	AB	RX	Yes	Yes		Start Trial				Start Trial
Janssen Pharms	ORTHO-CEPT	desogestrel; ethinyl estradiol	TABLET;ORAL-28	020301-002	Dec 14, 1992		DISCN	No	No		Start Trial				Start Trial
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-001	Aug 8, 2014		RX	Yes	No		Start Trial				Start Trial
Janssen Pharms	DURAGESIC-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-003	Aug 7, 1990	AB	RX	Yes	No		Start Trial				Start Trial
>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	021346-001	Oct 29, 2003	6,110,503*PED	Start Trial
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-001	Dec 19, 2006	5,158,952*PED	Start Trial
Janssen Pharms	LEVAQUIN	levofloxacin	INJECTABLE;INJECTION	020635-004	Dec 20, 1996	5,053,407*PED	Start Trial
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-003	Dec 20, 1996	5,053,407*PED	Start Trial
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-003	Oct 29, 2003	6,368,632*PED	Start Trial
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002	8,163,798*PED	Start Trial
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-005	Dec 24, 1996	7,018,983*PED	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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	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
➤ 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	8 mg	➤ Subscribe	2006-03-02
➤ Subscribe	Tablets	10 mg, 15 mg, and 20 mg	➤ Subscribe	2015-07-01
➤ 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	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	Tablets	100 mg and 300 mg	➤ Subscribe	2017-03-29

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	122014000050	Germany	Start Trial	PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1 /13/884/001-008 20131115
1214076	49/2008	Austria	Start Trial	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
0206283	C980016	Netherlands	Start Trial	PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606
1261606	300370	Netherlands	Start Trial
1429780	122012000070	Germany	Start Trial	PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808
1651658	PA2014008,C1651658	Lithuania	Start Trial	PRODUCT NAME: CANAGLIFOZINUM; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/004, 2013- 11-15 EU/1/13/884/005 - EU/1/13/884/008 20131115
1827461	CR 2018 00010	Denmark	Start Trial	PRODUCT NAME: CLADRIBINE; REG. NO/DATE: EU/1/17/1212 20170824
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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