JANSSEN Company Profile

What is the competitive landscape for JANSSEN

JANSSEN has eighty approved drugs.

There are eighty-seven US patents protecting JANSSEN drugs.

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

Summary for JANSSEN

International Patents:	2598
US Patents:	87
Tradenames:	76
Ingredients:	52
NDAs:	80
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 Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-001	Apr 1, 2005		DISCN	Yes	No
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018	AB	RX	Yes	No	12,303,497
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes	12,303,493		Y

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	6,919,092*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	9,889,115
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-003	Jun 22, 1999	6,262,115*PED

Paragraph IV (Patent) Challenges for JANSSEN drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for JANSSEN Drugs

Country	Patent Number	Estimated Expiration
Brazil	PI0906020
Germany	60332023
Croatia	P20191224

Supplementary Protection Certificates for JANSSEN Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487162	2016C/068	Belgium		PRODUCT NAME: COBICISTAT ET DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967 20141121
1633724	S1500012	Hungary		PRODUCT NAME: OLAPARIB
0975367	122011000009	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831

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