Noven Company Profile
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What is the competitive landscape for NOVEN, and when can generic versions of NOVEN drugs launch?
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
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 |
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 | XELSTRYM | dextroamphetamine | SYSTEM;TRANSDERMAL | 215401-001 | Mar 22, 2022 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Noven Pharms Inc | XELSTRYM | dextroamphetamine | SYSTEM;TRANSDERMAL | 215401-004 | Mar 22, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Noven | MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752-001 | Oct 29, 2012 | AB3 | RX | Yes | No | 8,231,906 | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | |
Noven | DENTIPATCH | lidocaine | PATCH;TOPICAL | 020575-002 | May 21, 1996 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Noven Pharms Inc | COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870-001 | Aug 7, 1998 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Noven Therap | ESKALITH | lithium carbonate | CAPSULE;ORAL | 016860-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ 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 | |||
>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 | 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 |
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 |
International Patents for Noven Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Taiwan | 201427723 | ⤷ Try a Trial |
European Patent Office | 2310001 | ⤷ Try a Trial |
South Korea | 20110039331 | ⤷ Try a Trial |
Mexico | 2011000332 | ⤷ Try a Trial |
Taiwan | 201534310 | ⤷ Try a Trial |
Spain | 2687344 | ⤷ Try a Trial |
Peru | 20060491 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Noven Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1453521 | 132016000025143 | Italy | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
0901368 | C300523 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
0770388 | PA2009004 | 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 |
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 |
1380301 | 2009C/007 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
2782584 | 132021000000197 | Italy | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.