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Last Updated: March 28, 2024

Noven Company Profile


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Summary for Noven

Drugs and US Patents for Noven

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 DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-001 Apr 6, 2006 AB RX Yes No 9,034,370 ⤷  Try a Trial Y ⤷  Try a Trial
Noven Pharms Inc XELSTRYM dextroamphetamine SYSTEM;TRANSDERMAL 215401-003 Mar 22, 2022 RX Yes No 9,456,993 ⤷  Try a Trial Y ⤷  Try a Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-002 Apr 6, 2006 AB RX Yes No 9,668,981 ⤷  Try a Trial ⤷  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 215401-004 Mar 22, 2022 RX Yes Yes 9,456,993 ⤷  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

Expired US Patents for Noven

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc COMBIPATCH estradiol; norethindrone acetate FILM, EXTENDED RELEASE;TRANSDERMAL 020870-002 Aug 7, 1998 5,958,446 ⤷  Try a Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-004 Apr 6, 2006 6,348,211 ⤷  Try a Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-004 Apr 6, 2006 5,958,446 ⤷  Try a Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-001 Apr 6, 2006 6,210,705 ⤷  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 DENTIPATCH lidocaine FILM, EXTENDED RELEASE;BUCCAL 020575-001 May 21, 1996 5,234,957 ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for NOVEN drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ Subscribe Transdermal System 0.025 mg/day ➤ Subscribe 2015-05-08

Supplementary Protection Certificates for Noven Drugs

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
0770388 2009/012 Ireland ⤷  Try a Trial PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
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
0402407 97C0005 Belgium ⤷  Try a Trial PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
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
0770388 PA2009004,C0770388 Lithuania ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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