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-three 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 | 215401-003 | Mar 22, 2022 | RX | Yes | No | 9,456,993 | ⤷ Sign Up | Y | ⤷ 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 | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-003 | Apr 6, 2006 | AB | RX | Yes | No | 9,034,370 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-003 | Apr 6, 2006 | AB | RX | Yes | No | 8,632,802 | ⤷ Sign Up | Y | ⤷ 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 | |||
| >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 | 6,210,705 | ⤷ 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 | 203752-004 | Oct 29, 2012 | 6,024,976 | ⤷ Sign Up |
| Noven | DENTIPATCH | lidocaine | PATCH;TOPICAL | 020575-002 | May 21, 1996 | 5,234,957 | ⤷ Sign Up |
| Noven | MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752-003 | Oct 29, 2012 | 5,656,286 | ⤷ Sign Up |
| >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
Supplementary Protection Certificates for NOVEN Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2782584 | 21C1058 | France | ⤷ Sign Up | 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 |
| 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 |
| 1635783 | 300653 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
| 1453521 | CA 2016 00016 | Denmark | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| 2782584 | LUC00245 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701 |
| >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.
Here is a list of applicants with similar names.
