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JANSSEN PRODS Company Profile

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

JANSSEN PRODS has seven approved drugs.

There are twenty-seven US patents protecting JANSSEN PRODS drugs.

There are nine hundred and fifty-five patent family members on JANSSEN PRODS drugs in sixty-nine countries and two hundred and twenty-two supplementary protection certificates in nineteen countries.

Summary for JANSSEN PRODS

International Patents:	955
US Patents:	27
Tradenames:	6
Ingredients:	6
NDAs:	7

Drugs and US Patents for JANSSEN PRODS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-004	Dec 18, 2008		RX	Yes	No	7,700,645*PED				Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	10,039,718		Y
Janssen Prods	YONDELIS	trabectedin	POWDER;INTRAVENOUS	207953-001	Oct 23, 2015		RX	Yes	Yes
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006		DISCN	Yes	No	8,518,987*PED				Y
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-006	Nov 9, 2012		RX	Yes	Yes	8,518,987*PED				Y
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	9,856,265		Y	Y
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-003	Oct 21, 2008		DISCN	Yes	No	7,700,645*PED				Y

Expired US Patents for JANSSEN PRODS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-002	Feb 25, 2008	6,703,403*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-004	Dec 18, 2008	7,470,506*PED
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011	6,703,403*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006	5,843,946*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-004	Dec 18, 2008	6,335,460*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-003	Oct 21, 2008	7,470,506*PED
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006	8,597,876*PED

Paragraph IV (Patent) Challenges for JANSSEN PRODS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	800 mg		2013-05-14

International Patents for JANSSEN PRODS Drugs

Country	Patent Number	Estimated Expiration
Australia	2007275860
Norway	20063851
Japan	2011225589
Denmark	2296633
Australia	1437292
Moldova, Republic of	20140011
Japan	4797067

Supplementary Protection Certificates for JANSSEN PRODS Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0513200	C00513200/01	Switzerland		PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
1663240	60/2015	Austria		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2049506	C 2015 045	Romania		PRODUCT NAME: COBICISTAT SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/830/001-002; DATE OF NATIONAL AUTHORISATION: 20130524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/830/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20130524
0513200	300148	Netherlands		300148, 20110131, EXPIRES: 20160130
1912999	2014/058	Ireland		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
3150586	301045	Netherlands		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER DARUNAVIRETHANOLAAT, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/17/1225 20170925
3150586	LUC00156	Luxembourg		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925

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