NOVEN Company Profile

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NOVEN has eight approved drugs.

There are eleven US patents protecting NOVEN drugs. There are three tentative approvals on NOVEN drugs.

There are fifty-four patent family members on NOVEN drugs in eighteen countries and fifty-three supplementary protection certificates in fourteen countries.

International Patents:	54
US Patents:	11
Tradenames:	11
Ingredients:	7
NDAs:	8
Patent Litigation for NOVEN:	See patent lawsuits for NOVEN
PTAB Cases with NOVEN as petitioner:	See PTAB cases with NOVEN as petitioner

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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
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-001	Apr 6, 2006	AB	RX	Yes	No	9,668,981	⤷ Sign Up				⤷ Sign Up
Noven	DENTIPATCH	lidocaine	PATCH;TOPICAL	020575-002	May 21, 1996		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Noven	FENTANYL-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077775-004	Oct 16, 2009		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-004	Mar 22, 2022		RX	Yes	Yes	8,591,941	⤷ Sign Up	Y			⤷ Sign Up
Noven	FENTANYL-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077775-001	Oct 16, 2009		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
>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
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006	5,958,446	⤷ Sign Up
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-001	Oct 29, 2012	6,841,716	⤷ Sign Up
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-001	Aug 7, 1998	5,958,446	⤷ Sign Up
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-002	Oct 29, 2012	5,656,286	⤷ Sign Up
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-002	Apr 6, 2006	6,348,211	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Transdermal System	0.025 mg/day	➤ Subscribe	2015-05-08
➤ Subscribe	Transdermal System	0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/day	➤ Subscribe	2014-08-18
➤ Subscribe	Transdermal System	10 mg/9 hrs, 15 mg/9 hrs, 20 mg/9 hrs and 30 mg/9 hrs	➤ Subscribe	2011-04-13

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	9/2009	Austria	⤷ Sign Up	PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
0770388	PA2009004	Lithuania	⤷ Sign Up	PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0136011	2000C/027	Belgium	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0136011	99C0003	Belgium	⤷ Sign Up	PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
1769785	C300521	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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