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-three supplementary protection certificates in fourteen countries.
Summary for Noven
| International Patents: | 54 |
| US Patents: | 11 |
| Tradenames: | 11 |
| Ingredients: | 7 |
| NDAs: | 8 |
| 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 | MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752-001 | Oct 29, 2012 | AB3 | RX | Yes | No | 9,730,900 | ⤷ Sign Up | ⤷ Sign Up | |||
| Noven Pharms Inc | XELSTRYM | dextroamphetamine | SYSTEM;TRANSDERMAL | 215401-001 | Mar 22, 2022 | RX | Yes | No | 9,474,722 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Noven Pharms Inc | XELSTRYM | dextroamphetamine | SYSTEM;TRANSDERMAL | 215401-001 | Mar 22, 2022 | RX | Yes | No | 8,632,802 | ⤷ 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 | COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870-002 | Aug 7, 1998 | 5,958,446 | ⤷ Sign Up |
| Noven Pharms Inc | COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870-002 | Aug 7, 1998 | 5,474,783 | ⤷ Sign Up |
| Noven Pharms Inc | COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870-001 | Aug 7, 1998 | 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 |
|---|---|---|---|---|
| 0334429 | 97C0002 | Belgium | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305 |
| 1453521 | C201630040 | Spain | ⤷ Sign Up | PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211 |
| 1453521 | 15C0050 | France | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129 |
| >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.
