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Novo Company Profile
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What is the competitive landscape for NOVO, and when can generic versions of NOVO drugs launch?
NOVO has eleven approved drugs.
There are fifty US patents protecting NOVO drugs.
There are four hundred and seventy-three patent family members on NOVO drugs in thirty-nine countries and one hundred and four supplementary protection certificates in sixteen countries.
Summary for Novo
| International Patents: | 473 |
| US Patents: | 50 |
| Tradenames: | 11 |
| Ingredients: | 8 |
| NDAs: | 11 |
| Patent Litigation for Novo: | See patent lawsuits for Novo |
Drugs and US Patents for Novo
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-001 | Sep 20, 2019 | RX | Yes | No | 10,086,047 | Start Trial | Y | Start Trial | |||
| Novo Nordisk | GLUCAGEN | glucagon hydrochloride | INJECTABLE;INJECTION | 020918-001 | Jun 22, 1998 | RX | Yes | Yes | Start Trial | Start Trial | |||||
| Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | RX | Yes | Yes | 9,265,893*PED | Start Trial | Y | Start Trial | |||
| Novo | SAXENDA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | 8,846,618*PED | Start Trial | Y | Start Trial | |||
| Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | RX | Yes | Yes | 9,968,659*PED | Start Trial | Y | Start Trial | |||
| Novo Nordisk Inc | VAGIFEM | estradiol | TABLET;VAGINAL | 020908-002 | Nov 25, 2009 | AB | RX | Yes | Yes | 7,018,992 | Start Trial | Start Trial | |||
| Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-001 | Dec 5, 2017 | RX | Yes | Yes | 9,486,588 | Start Trial | Y | Start 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 Novo
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | 6,458,924 | Start Trial |
| Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-002 | Jun 23, 2008 | RE37035 | Start Trial |
| Novo | SAXENDA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | 6,458,924 | Start Trial |
| Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | 6,235,004 | Start Trial |
| Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-002 | Jun 23, 2008 | 6,677,358 | Start Trial |
| Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | 6,004,297 | Start Trial |
| Novo Nordisk Inc | VAGIFEM | estradiol | TABLET;VAGINAL | 020908-002 | Nov 25, 2009 | 5,860,946 | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for NOVO drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 1 mg/500 mg and 2 mg/500 mg | ➤ Subscribe | 2009-04-09 |
| ➤ Subscribe | Injection | 18 mg/3 mL prefilled syringe | ➤ Subscribe | 2016-12-12 |
| ➤ Subscribe | Vaginal Tablets | 10 mcg | ➤ Subscribe | 2013-01-02 |
International Patents for Novo Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| United Kingdom | 0603295 | Start Trial |
| Netherlands | 300422 | Start Trial |
| Australia | 2005298944 | Start Trial |
| Russian Federation | 2008101973 | Start Trial |
| Canada | 2594764 | Start Trial |
| Hungary | E038395 | Start Trial |
| Portugal | 1351732 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Novo Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2209800 | C300698 | Netherlands | Start Trial | PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918 |
| 1863839 | CR 2018 00019 | Denmark | Start Trial | PRODUCT NAME: SEMAGLUTID; REG. NO/DATE: EU/1/17/1251 20180212 |
| 2597103 | 2017/015 | Ireland | Start Trial | PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; NAT REGISTRATION NO/DATE: EU/1/14/947 20140918; FIRST REGISTRATION NO/DATE: 65041 20140912 |
| 0944648 | SPC034/2009 | Ireland | Start Trial | SPC034/2009: 20101001, EXPIRES: 20220821 |
| 1506211 | C 2014 029 | Romania | Start Trial | PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116 |
| 1289951 | 132019000000099 | Italy | Start Trial | PRODUCT NAME: MACIMORELINA, OPZIONALMENTE NELLA FORMA DI UNA COMPOSIZIONE FARMACEUTICA, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, COMPRESA MACIMORELINA ACETATO(MACIMORELIN AETERNA ZENTARIS - MACIMORELINA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1337, 20190115 |
| 1506211 | PA2014026 | Lithuania | Start Trial | PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
| >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.
