Janssen Pharms Company Profile

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JANSSEN PHARMS has fifty-eight approved drugs.

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

There are six hundred and twenty-seven patent family members on JANSSEN PHARMS drugs in sixty-three countries and ninety-seven 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	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	AA	RX	Yes	Yes		See Plans and Pricing				See Plans and Pricing
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-004	Aug 8, 2014		RX	Yes	Yes	8,222,219	See Plans and Pricing				See Plans and Pricing
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-002	Mar 29, 2013		RX	Yes	Yes	7,943,582	See Plans and Pricing	Y	Y		See Plans and Pricing
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-004	Oct 11, 2018		RX	Yes	No		See Plans and Pricing				See Plans and Pricing
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-003	Oct 29, 2003		RX	Yes	No		See Plans and Pricing				See Plans and Pricing
>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	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009	5,254,556*PED	See Plans and Pricing
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-002	Dec 24, 1996	7,018,983*PED	See Plans and Pricing
Janssen Pharms	TOPAMAX SPRINKLE	topiramate	CAPSULE;ORAL	020844-003	Oct 26, 1998	4,513,006*PED	See Plans and Pricing
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009	6,077,843*PED	See Plans and Pricing
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	4,544,554	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	122015000093	Germany	See Plans and Pricing	PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1651658	164 1-2014	Slovakia	See Plans and Pricing	PRODUCT NAME: KANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/008 20131115
1261606	PA 2008 018, C 1261606	Lithuania	See Plans and Pricing	PRODUCT NAME: RIVAROXABANUM; REGISTRATION NO/DATE: EU/1/07/472/001 - EU/1/08/472/008 20080930
1608344	LUC00065	Luxembourg	See Plans and Pricing	PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
1651658	CR 2014 00024	Denmark	See Plans and Pricing	PRODUCT NAME: CANAGLIFLOZIN; REG. NO/DATE: EU/1/13/884/001-008 20131119
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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