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 sixty-four patent family members on JANSSEN drugs in seventy-two countries and four hundred and thirty-two supplementary protection certificates in twenty countries.

Summary for JANSSEN

International Patents:	2364
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	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes	8,445,507		Y	Y
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-002	May 27, 2020		RX	Yes	No	8,546,428		Y	Y
Janssen Pharms	TYLOX	acetaminophen; oxycodone hydrochloride	CAPSULE;ORAL	088790-001	Dec 12, 1984		DISCN	No	No

Expired US Patents for JANSSEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-002	Dec 16, 1998	4,519,801*PED
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-002	Dec 16, 1998	6,124,355*PED
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-003	Sep 20, 2016	8,785,403
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-003	Apr 2, 2003	4,804,663*PED

Paragraph IV (Patent) Challenges for JANSSEN drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for JANSSEN Drugs

Country	Patent Number	Estimated Expiration
Cyprus	1120393
Luxembourg	92568
Spain	2836424
Ukraine	101193

Supplementary Protection Certificates for JANSSEN Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3533792	2021046	Norway		PRODUCT NAME: APALUTAMIDE; NAT. REG. NO/DATE: 18/02193 20190123; FIRST REG. NO/DATE: 1/18/1342 20190116
1419152	C20120010 00057	Estonia		PRODUCT NAME: EDURANT - RILPIVIRIIN;REG NO/DATE: C(2011)8955 FINAL 28.11.2011
1663240	C20150041 00168	Estonia		PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA) JA TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
0605697	C300053	Netherlands		PRODUCT NAME: ALMOTRIPTAN DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH GESCHIKT ZOUT, IN HET BIJZONDER HET WATERSTOFMALAAT; REGISTRATION NO/DATE: RVG 25415 - RVG 25416 20010309

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