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Janssen Pharms Company Profile

JANSSEN PHARMS has fifty-six approved drugs.

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

There are six hundred and twenty-two patent family members on JANSSEN PHARMS drugs in fifty-eight countries and eighty-two supplementary protection certificates in sixteen 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		See Pricing				See Pricing
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-002	Dec 29, 1993	AB	RX	Yes	No		See Pricing				See Pricing
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-005	Dec 20, 1996		DISCN	Yes	No		See Pricing				See Pricing
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-003	Aug 8, 2014		RX	Yes	No	8,513,202	See Pricing	Y	Y		See Pricing
Janssen Pharms	ORTHO-CEPT	desogestrel; ethinyl estradiol	TABLET;ORAL-21	020301-001	Dec 14, 1992		DISCN	No	No		See Pricing				See Pricing
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009		RX	Yes	No	6,555,544*PED	See Pricing				See 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	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992	4,616,006	See Pricing
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-001	Aug 1, 2000	6,919,373*PED	See Pricing
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-001	Dec 16, 1998	4,519,801*PED	See Pricing
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-001	Aug 1, 2000	8,629,179*PED	See Pricing
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-003	Oct 29, 2003	4,804,663*PED	See Pricing
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-004	Apr 12, 2007	5,916,598*PED	See Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	6.25 mg and 12.5 mg	➤ Subscribe	2005-12-08
➤ Subscribe	Tablets	100 mg and 300 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	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

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Country	Patent Number	Estimated Expiration
Mexico	PA02011543	See Pricing
South Africa	200603880	See Pricing
Taiwan	I262079	See Pricing
Israel	206831	See Pricing
World Intellectual Property Organization (WIPO)	2008069327	See Pricing
Japan	4852423	See Pricing
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0904081	2011/021	Ireland	See Pricing	PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
1453521	93156	Luxembourg	See Pricing	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0836511	SPC/GB06/022	United Kingdom	See Pricing	PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1453521	122015000093	Germany	See Pricing	PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1635783	122014000024	Germany	See Pricing	PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1214076	49/2008	Austria	See Pricing	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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