JANSSEN Company Profile

What is the competitive landscape for JANSSEN, and what generic alternatives to JANSSEN drugs are available?

JANSSEN has seventy-eight approved drugs.

There are seventy-six US patents protecting JANSSEN drugs.

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

Summary for JANSSEN

International Patents:	2210
US Patents:	76
Tradenames:	74
Ingredients:	51
NDAs:	78
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	XARELTO	rivaroxaban	TABLET;ORAL	022406-001	Jul 1, 2011		RX	Yes	No	9,415,053*PED				Y
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes	11,446,260
Janssen Pharms	LEUSTATIN	cladribine	INJECTABLE;INJECTION	020229-001	Feb 26, 1993		DISCN	Yes	No
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-003	Feb 28, 2001		DISCN	Yes	No

Expired US Patents for JANSSEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-001	Jan 18, 2008	7,887,845*PED
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-003	Mar 26, 2012	7,887,845*PED
Janssen Pharms	XARELTO	rivaroxaban	TABLET;ORAL	022406-001	Jul 1, 2011	7,585,860
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-003	Apr 1, 2005	4,663,318

Paragraph IV (Patent) Challenges for JANSSEN drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for JANSSEN Drugs

Country	Patent Number	Estimated Expiration
Portugal	2767539
Norway	20030270
Austria	508118
European Patent Office	2322516

Supplementary Protection Certificates for JANSSEN Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	132016000024777	Italy		PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO E TENOVOFIR, IN PARTICOLARE TENOVOFIR DISOPROXIL FUMARATO(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
1527050	C 2014 034	Romania		PRODUCT NAME: BEDAQUILINA SAU O SARE DE ADITIE A UNUI ACID SAU A UNEI BAZEACCEPTABILA FARMACEUTIC A IN-3-IL)-4-(DIMETILAMINO)-2-(NAFTALEN-1-IL)-1-FENILBUTAN-2-OL; NATIONAL AUTHORISATION NUMBER: EU/1/13/901; DATE OF NATIONAL AUTHORISATION: 20140305; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/901; DATE OF FIRST AUTHORISATION IN EEA: 20140305 ACESTEIA, INCLUSIV FUMARAT DE BEDAQUILINA - FUMARAT DE BEDAQUILINA (1R,2S)-1-(6-BROMO-2-METOXIQUINOL
1663240	300781	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
1663240	122015000085	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128

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