JANSSEN Company Profile

What is the competitive landscape for JANSSEN

JANSSEN has seventy-nine approved drugs.

There are eighty-one US patents protecting JANSSEN drugs.

There are two thousand three hundred and thirty-eight patent family members on JANSSEN drugs in seventy-two countries and four hundred and thirty-three supplementary protection certificates in twenty countries.

Summary for JANSSEN

International Patents:	2338
US Patents:	81
Tradenames:	75
Ingredients:	51
NDAs:	79
Patent Litigation for JANSSEN:	See patent lawsuits for JANSSEN
PTAB Cases with JANSSEN as patent owner:	See PTAB cases with JANSSEN as patent owner

Drugs and US Patents for JANSSEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-002	Aug 19, 2024		RX	Yes	Yes	11,879,013
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes	10,869,844
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No	8,436,185		Y	Y
Janssen Pharms	TOPAMAX	topiramate	CAPSULE;ORAL	020844-001	Oct 26, 1998	AB	RX	Yes	No
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-006	Nov 9, 2012	AB	RX	Yes	Yes	7,700,645*PED				Y
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-004	Dec 18, 2008		RX	Yes	No	7,700,645*PED				Y
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No	9,902,714		Y

Expired US Patents for JANSSEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-003	Oct 21, 2008	5,843,946*PED
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-005	Dec 23, 2004	5,648,093*PED
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-002	Aug 1, 2000	4,612,008*PED
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-004	Dec 23, 2004	6,244,905*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-006	Nov 9, 2012	7,470,506*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-003	Oct 21, 2008	RE43802*PED
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-001	Jan 18, 2008	6,878,717*PED

Paragraph IV (Patent) Challenges for JANSSEN drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	25 mg, 100 mg and 200 mg		2001-12-26
	Capsules	15 mg and 25 mg		2005-09-07
	Tablets	10 mg, 15 mg, and 20 mg		2015-07-01
	Tablets	4 mg, 8 mg and 12 mg		2005-02-28
	Orally Disintegrating Tablets	3 mg and 4 mg		2005-03-23
	Extended-release Tablets	18 mg, 27 mg, 36 mg and 54 mg		2005-07-19
	Tablets	250 mg		2015-04-28
	Tablets	6.25 mg and 12.5 mg		2005-12-08
	Extended-release Capsules	8 mg		2006-03-02
	Tablets	100 mg and 300 mg		2017-03-29
	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
	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	500 mg		2017-08-23
	Tablets	50 mg/500 mg, 50mg/1000 mg, 150mg/500 mg, and150 mg/1000 mg		2017-03-29
	Extended-release Capsules	16 mg and 24 mg		2006-03-11
	Tablets	800 mg		2013-05-14

International Patents for JANSSEN Drugs

Country	Patent Number	Estimated Expiration
Portugal	1845961
Canada	3031705
Czech Republic	2003413
China	109908114
Nicaragua	201700035
Portugal	2805945
Argentina	121828

Supplementary Protection Certificates for JANSSEN Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	PA2015035	Lithuania		PRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
2487162	PA2016040	Lithuania		PRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
1419152	92008	Luxembourg		92008, EXPIRES: 20261128
2049506	92864	Luxembourg		PRODUCT NAME: COBICISTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001-002 20130527
3808743	PA2022515	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU EKVIVALENTISKOS JO FORMOS APSAUGOTOS PAGRINDINIU PATENTU, TOKIOS KAIP FARMACINIU POZIURIU PRIIMTINOS PRIDETINES RILPIVIRINO DRUSKOS, ISKAITANT RILPIVIRINO HIDROCHLORIDO RUGSTIES DRUSKA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
3150586	PA2020508,C3150586	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921
1651658	CA 2014 00024	Denmark		PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 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