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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 thirty-three US patents protecting JANSSEN PRODS drugs.

Summary for JANSSEN PRODS

US Patents:	33
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 ethanolate	TABLET;ORAL	021976-002	Feb 25, 2008	AB	RX	Yes	No	8,597,876*PED				Y
Janssen Prods	SYMTUZA	cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	8,148,374		Y	Y
Janssen Prods	PREZISTA	darunavir ethanolate	TABLET;ORAL	021976-002	Feb 25, 2008	AB	RX	Yes	No	8,518,987*PED				Y
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011		RX	Yes	Yes	6,838,464		Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	8,597,876*PED				Y
Janssen Prods	SYMTUZA	cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	10,039,718		Y

Expired US Patents for JANSSEN PRODS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZISTA	darunavir ethanolate	TABLET;ORAL	021976-001	Jun 23, 2006	6,037,157*PED
Janssen Prods	PREZISTA	darunavir ethanolate	TABLET;ORAL	021976-002	Feb 25, 2008	5,843,946*PED
Janssen Prods	PREZISTA	darunavir ethanolate	TABLET;ORAL	021976-003	Oct 21, 2008	RE43802*PED
Janssen Prods	PREZISTA	darunavir ethanolate	TABLET;ORAL	021976-006	Nov 9, 2012	6,335,460*PED
Janssen Prods	PREZISTA	darunavir ethanolate	SUSPENSION;ORAL	202895-001	Dec 16, 2011	6,703,403*PED
Janssen Prods	PREZISTA	darunavir ethanolate	TABLET;ORAL	021976-005	Dec 18, 2008	RE43596*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	Document Number	Estimated Expiration
New Zealand	553323
Japan	5611242
European Patent Office	1278735
Austria	368461
Hong Kong	1092698
Croatia	P20161371

Supplementary Protection Certificates for JANSSEN PRODS Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0150040 00167	Estonia		PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA), TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
0170001 00217	Estonia		PRODUCT NAME: ATASANAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/15/1025 15.07.2015
0803	Netherlands		PRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123
0780	Netherlands		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2016 00012	Denmark		PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
2014036,C1912999	Lithuania		PRODUCT NAME: SIMEPREVIRAS; REGISTRATION NO/DATE: EU/1/14/924 20140514

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