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Janssen Prods Company Profile

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JANSSEN PRODS has seven approved drugs.

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

There are nine hundred and twenty-eight patent family members on JANSSEN PRODS drugs in sixty-eight countries and one hundred and ninety-nine supplementary protection certificates in eighteen countries.

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	9,856,265	Start Trial	Y	Y		Start Trial
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-005	Dec 18, 2008		RX	Yes	No	7,700,645*PED	Start Trial			Y	Start Trial
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	8,518,987	Start Trial	Y	Y		Start Trial
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011		RX	Yes	Yes	8,101,629	Start Trial	Y			Start Trial
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006		DISCN	Yes	No	8,518,987*PED	Start Trial			Y	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-006	Nov 9, 2012	RE42889*PED	Start Trial
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-002	Feb 25, 2008	6,335,460*PED	Start Trial
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006	6,335,460*PED	Start Trial
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-002	Feb 25, 2008	5,843,946*PED	Start Trial
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-005	Dec 18, 2008	6,335,460*PED	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	93382	Luxembourg	Start Trial	PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
1912999	CR 2014 00053	Denmark	Start Trial	PRODUCT NAME: SIMEPREVIR ELLER ET SALT DERAF, HERUNDER SIMEPREVIRNATRIUM; REG. NO/DATE: EU/1/14/924 20140516
2487163	300859	Netherlands	Start Trial	PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN ATAZANAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER ATAZANAVIRSULFAAT; REGISTRATION NO/DATE: EU/1/15/1025 20150715
1419152	CA 2012 00021	Denmark	Start Trial
1301519	CR 2016 00012	Denmark	Start Trial	PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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