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-two 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	021514-002	Apr 6, 2006	AB	RX	Yes	No	9,034,370	⤷ Try a Trial	Y			⤷ Try a Trial
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-004	Mar 22, 2022		RX	Yes	Yes	11,559,501	⤷ Try a Trial	Y			⤷ Try a Trial
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-003	Mar 22, 2022		RX	Yes	No	11,559,501	⤷ Try a Trial	Y			⤷ Try a Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-004	Oct 29, 2012	AB3	RX	Yes	Yes	9,833,419	⤷ Try a Trial	Y			⤷ Try a Trial
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-001	Mar 22, 2022		RX	Yes	No	8,591,941	⤷ Try a Trial	Y			⤷ Try a Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-005	Sep 23, 2014	AB3	RX	Yes	No	9,730,900	⤷ Try a Trial	Y			⤷ Try a Trial
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-004	Mar 22, 2022		RX	Yes	Yes	8,632,802	⤷ Try a Trial	Y			⤷ Try a 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
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-001	Apr 6, 2006	5,958,446	⤷ Try a Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-004	Oct 29, 2012	6,024,976	⤷ Try a Trial
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-001	Aug 7, 1998	5,656,286	⤷ Try a Trial
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006	6,210,705	⤷ Try a Trial
Noven	DENTIPATCH	lidocaine	FILM, EXTENDED RELEASE;BUCCAL	020575-001	May 21, 1996	5,446,070	⤷ Try a Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-002	Oct 29, 2012	5,656,286	⤷ Try a Trial
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006	5,958,446	⤷ Try a Trial
>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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Country	Patent Number	Estimated Expiration
Uruguay	31975	⤷ Try a Trial
Spain	2687344	⤷ Try a Trial
Japan	5676440	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2015100153	⤷ Try a Trial
Peru	20060491	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2022150430	⤷ Try a Trial
Hong Kong	1216503	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	07C0001	France	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0975367	122011000009	Germany	⤷ Try a Trial	PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1380301	2009C/007	Belgium	⤷ Try a Trial	PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0584952	99C0004	Belgium	⤷ Try a Trial	PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
1380301	CA 2009 00017	Denmark	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
0398460	C300221	Netherlands	⤷ Try a Trial	PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2782584	21C1058	France	⤷ Try a Trial	PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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