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Last Updated: March 28, 2024

Noven Company Profile


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What is the competitive landscape for NOVEN, and what generic alternatives to NOVEN drugs are available?

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.

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
>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
>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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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