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Janssen Pharms Company Profile

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What is the competitive landscape for JANSSEN PHARMS, and when can generic versions of JANSSEN PHARMS drugs launch?

JANSSEN PHARMS has fifty-five approved drugs.

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

Summary for Janssen Pharms

US Patents:	28
Tradenames:	54
Ingredients:	33
NDAs:	55

Drugs and US Patents for Janssen Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	TERAZOL 3	terconazole	SUPPOSITORY;VAGINAL	019641-001	May 24, 1988		DISCN	Yes	No
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-003	Dec 20, 1996		DISCN	Yes	No
Janssen Pharms	TOPAMAX	topiramate	CAPSULE;ORAL	020844-001	Oct 26, 1998	AB	RX	Yes	No	7,125,560*PED				Y
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-003	Nov 4, 2011		RX	Yes	Yes	9,415,053		Y
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-002	Nov 4, 2011		RX	Yes	No	7,585,860			Y
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-002	Dec 16, 1998	AB	RX	Yes	No
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-003	Dec 28, 1990		DISCN	No	No

Expired US Patents for Janssen Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-001	Aug 1, 2000	4,612,008*PED
Janssen Pharms	TOPAMAX	topiramate	CAPSULE;ORAL	020844-001	Oct 26, 1998	7,018,983*PED
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-003	Dec 28, 1990	4,382,892
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-004	Apr 12, 2007	4,804,663*PED
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-001	May 18, 2015	6,077,843*PED
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-003	Dec 8, 2000	9,029,416
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-003	Jun 22, 1999	6,919,092*PED

Paragraph IV (Patent) Challenges for JANSSEN PHARMS drugs

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

International Patents for Janssen Pharms Drugs

Country	Document Number	Estimated Expiration
Argentina	064099
Taiwan	200637852
European Patent Office	2514756
China	104109155
Mexico	PA01006533
New Zealand	556631
Norway	20074356

Supplementary Protection Certificates for Janssen Pharms Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2001	Austria		PRODUCT NAME: ALMOTRIPTAN UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE; NAT. REGISTRATION NO/DATE: 1-23957, 1-23958 20010131; FIRST REGISTRATION: ES 62877 19991223
C/GB11/044	United Kingdom		PRODUCT NAME: PALIPERIDONE PALMITATE; REGISTERED: UK EU/1/11/672/001 20110304; UK EU/1/11/672/002 20110304; UK EU/1/11/672/003 20110304; UK EU/1/11/672/004 20110304; UK EU/1/11/672/005 20110304; UK EU/1/11/672/006 20110304
C/GB97/085	United Kingdom		PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606
0140011 00102	Estonia		PRODUCT NAME: KANAGLIFLOSIIN;REG NO/DATE: K(2013)8171 (LOPLIK) 15.11.2013
C/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
60030	Netherlands		PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
90027-8	Sweden		PRODUCT NAME: KANAGLIFLOZIN; REG. NO/DATE: EU/1/13/884/001 20131115

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Janssen Biotech
• Janssen Pharma
• Janssen Pharms
• Janssen Prods
• Janssen R And D
• Janssen Res And Dev
• Janssen Therap