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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-four 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	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-004	Sep 20, 2016		RX	Yes	Yes	8,513,202	Start Trial	Y	Y		Start Trial
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-004	Sep 20, 2016		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	HALDOL	haloperidol lactate	INJECTABLE;INJECTION	015923-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes		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	021346-002	Oct 29, 2003	5,770,231*PED	Start Trial
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-002	Aug 1, 2000	6,919,373*PED	Start Trial
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-002	Oct 29, 2003	6,110,921*PED	Start Trial
Janssen Pharms	TOPAMAX SPRINKLE	topiramate	CAPSULE;ORAL	020844-003	Oct 26, 1998	4,513,006*PED	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Country	Patent Number	Estimated Expiration
China	102060888	Start Trial
World Intellectual Property Organization (WIPO)	2005012321	Start Trial
Hungary	0100155	Start Trial
Eurasian Patent Organization	002926	Start Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261606	SPC/GB09/008	United Kingdom	Start Trial	SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB09/008 GRANTED TO BAYER INTELLECTUAL PROPERTY GMBH IN RESPECT OF THE PRODUCT RIVAROXABAN AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS, HYDRATES, HYDRATES OF THE SALTS AND PRODRUGS, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6352 DATED 16 FEBRUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 OCTOBER 2023.
1827461	2018C/010	Belgium	Start Trial	PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
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
0196132	94C0008	Belgium	Start Trial	PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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