NOVARTIS Company Profile
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What is the competitive landscape for NOVARTIS, and when can generic versions of NOVARTIS drugs launch?
NOVARTIS has one hundred and eighty-five approved drugs.
There are one hundred and three US patents protecting NOVARTIS drugs.
There are two thousand seven hundred and forty-five patent family members on NOVARTIS drugs in sixty-nine countries and five hundred and twenty supplementary protection certificates in nineteen countries.
Summary for NOVARTIS
| International Patents: | 2745 |
| US Patents: | 103 |
| Tradenames: | 154 |
| Ingredients: | 139 |
| NDAs: | 185 |
| Drug Master File Entries: | 1 |
| Patent Litigation for NOVARTIS: | See patent lawsuits for NOVARTIS |
| PTAB Cases with NOVARTIS as patent owner: | See PTAB cases with NOVARTIS as patent owner |
Drugs and US Patents for NOVARTIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | RX | Yes | No | 8,062,665*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | TAFINLAR | dabrafenib mesylate | TABLET, FOR SUSPENSION;ORAL | 217514-001 | Mar 16, 2023 | RX | Yes | Yes | 8,415,345*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | CYTADREN | aminoglutethimide | TABLET;ORAL | 018202-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Novartis | KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole; ribociclib succinate | TABLET;ORAL | 209935-001 | May 4, 2017 | RX | Yes | Yes | 9,193,732 | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-002 | Dec 21, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Novartis | RYDAPT | midostaurin | CAPSULE;ORAL | 207997-001 | Apr 28, 2017 | RX | Yes | Yes | 8,575,146 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | SERENTIL | mesoridazine besylate | TABLET;ORAL | 016774-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ 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 NOVARTIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | 7,452,874*PED | ⤷ Try a Trial |
| Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | 5,399,578*PED | ⤷ Try a Trial |
| Novartis | TYZEKA | telbivudine | SOLUTION;ORAL | 022154-001 | Apr 28, 2009 | 6,569,837 | ⤷ Try a Trial |
| Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-004 | Oct 20, 2011 | 7,332,481*PED | ⤷ Try a Trial |
| Novartis | TYZEKA | telbivudine | SOLUTION;ORAL | 022154-001 | Apr 28, 2009 | 6,444,652 | ⤷ Try a Trial |
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | 6,395,728 | ⤷ Try a Trial |
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-004 | Jun 12, 1991 | 5,753,618*PED | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for NOVARTIS drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 5 mg/160 mg | ➤ Subscribe | 2007-10-22 |
| ➤ Subscribe | Capsules | 150 mg and 200 mg | ➤ Subscribe | 2013-01-29 |
| ➤ Subscribe | Tablets | 10 mg/160 mg | ➤ Subscribe | 2007-10-01 |
| ➤ Subscribe | Injection | 4 mg/100 mg, 100 mL vial | ➤ Subscribe | 2012-01-31 |
| ➤ Subscribe | Tablets | 5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 m | ➤ Subscribe | 2009-09-14 |
| ➤ Subscribe | Nasal Spray | 0.665 mg/ Spray | ➤ Subscribe | 2009-06-29 |
| ➤ Subscribe | Tablets | 125 mg, 250 mg and 500 mg | ➤ Subscribe | 2004-12-28 |
| ➤ Subscribe | Oral Suspension | 300 mg/5 mL | ➤ Subscribe | 2006-12-26 |
| ➤ Subscribe | Tablets | 12.5 mg and 25 mg | ➤ Subscribe | 2014-02-04 |
| ➤ Subscribe | Delayed-release Tablets | 180 mg | ➤ Subscribe | 2009-06-04 |
| ➤ Subscribe | Tablets | 250 mg | ➤ Subscribe | 2011-03-14 |
| ➤ Subscribe | Capsules | 1.5 mg, 3 mg, 4.5 mg and 6 mg | ➤ Subscribe | 2004-04-21 |
| ➤ Subscribe | Tablets | 125 mg, 250 mg, and 500 mg | ➤ Subscribe | 2011-10-28 |
| ➤ Subscribe | Tablets for Oral Suspension | 2 mg, 3 mg and 5 mg | ➤ Subscribe | 2016-12-30 |
| ➤ Subscribe | Transdermal System Extended-release | 13.3 mg/24 hr | ➤ Subscribe | 2013-01-22 |
| ➤ Subscribe | Tablets | 2.5 mg, 5 mg, and 7.5 mg | ➤ Subscribe | 2014-12-10 |
| ➤ Subscribe | Tablets | 90 mg and 360 mg | ➤ Subscribe | 2015-10-19 |
| ➤ Subscribe | Tablets | 100 mg and 400 mg | ➤ Subscribe | 2007-03-12 |
| ➤ Subscribe | Tablets | 320 mg/12.5 mg and 320 mg/25 mg | ➤ Subscribe | 2007-02-07 |
| ➤ Subscribe | Tablets | 180 mg | ➤ Subscribe | 2016-04-28 |
| ➤ Subscribe | Capsules | 20 mg and 40 mg | ➤ Subscribe | 2008-06-04 |
| ➤ Subscribe | Tablets | 5 mg/320 mg | ➤ Subscribe | 2007-11-26 |
| ➤ Subscribe | Injection | 0.8 mg (base) /mL | ➤ Subscribe | 2008-06-11 |
| ➤ Subscribe | Tablets | 10 mg/320 mg | ➤ Subscribe | 2007-11-09 |
| ➤ Subscribe | Ophthalmic Solution | 0.003% | ➤ Subscribe | 2015-12-30 |
| ➤ Subscribe | Tablets | 10 mg/12.5 mg/160 mg | ➤ Subscribe | 2009-10-22 |
| ➤ Subscribe | Tablets | 150 mg, 300 mg and 600 mg | ➤ Subscribe | 2006-05-05 |
| ➤ Subscribe | Tablets | 50 mg and 75 mg | ➤ Subscribe | 2014-01-07 |
| ➤ Subscribe | Delayed-release Tablets | 360 mg | ➤ Subscribe | 2009-02-02 |
| ➤ Subscribe | Tablets | 60 mg and 120 mg | ➤ Subscribe | 2004-12-22 |
| ➤ Subscribe | Tablets | 40 mg, 80 mg,160 mg | ➤ Subscribe | 2004-12-28 |
| ➤ Subscribe | Extended-release Tablets | 100 mg | ➤ Subscribe | 2005-12-30 |
| ➤ Subscribe | Tablets | 0.25 mg, 0.5 mg, and 0.75 mg | ➤ Subscribe | 2013-09-30 |
| ➤ Subscribe | Oral Solution | 2 mg/mL | ➤ Subscribe | 2004-11-05 |
| ➤ Subscribe | Tablets | 10 mg | ➤ Subscribe | 2014-06-18 |
| ➤ Subscribe | Tablets | 2.5 mg | ➤ Subscribe | 2006-03-02 |
| ➤ Subscribe | Capsules | 0.5 mg | ➤ Subscribe | 2014-09-22 |
| ➤ Subscribe | Tablets | 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg | ➤ Subscribe | 2005-12-02 |
| ➤ Subscribe | Tablets | 180 mg | ➤ Subscribe | 2015-10-23 |
| ➤ Subscribe | Capsules | 400 mg | ➤ Subscribe | 2014-01-24 |
International Patents for NOVARTIS Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Peru | 20140162 | ⤷ Try a Trial |
| China | 1474690 | ⤷ Try a Trial |
| Slovenia | 1602370 | ⤷ Try a Trial |
| Malaysia | 196427 | ⤷ Try a Trial |
| South Korea | 20130116381 | ⤷ Try a Trial |
| Chile | 2007003552 | ⤷ Try a Trial |
| Japan | 2013213061 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NOVARTIS Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2861579 | 22C1053 | France | ⤷ Try a Trial | PRODUCT NAME: ASCIMINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TEL QUE LE CHLORHYDRATE D'ASCIMINIB; REGISTRATION NO/DATE: EU/1/22/1670 20220826 |
| 2331547 | C201730045 | Spain | ⤷ Try a Trial | PRODUCT NAME: RIBOCICLIB O UNA SAL DE ESTE FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/17/1221; DATE OF AUTHORISATION: 20170822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1221; DATE OF FIRST AUTHORISATION IN EEA: 20170822 |
| 3143995 | 122019000051 | Germany | ⤷ Try a Trial | PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/007 EU/1/09/538/008 EU/1/09/538/009 EU/1/09/538/010 20160526 |
| 2379069 | 2090022-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SIPONIMOD; REG. NO/DATE: EU/1/19/1414 20200115 |
| 1534390 | C 2010 013 | Romania | ⤷ Try a Trial | PRODUCT NAME: ELTROMBOPAG; NATIONAL AUTHORISATION NUMBER: RO EU/1/10/612/001, RO EU/1/10/612/002, RO EU/1/10/612/003, RO EU/1/10/612/004, RO EU/1/10/612/005, RO EU/1/10/612/006; DATE OF NATIONAL AUTHORISATION: 20100311; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/10/612/001, EMEA EU/1/10/612/002, EMEA EU/1/10/612/003, EMEA EU/1/10/612/004, EMEA EU/1/10/612/005, EMEA EU/1/10/612/006; DATE OF FIRST AUTHORISATION IN EEA: 20100311 |
| 0236940 | SPC/GB97/013 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LETROZOLE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: FR 341 474-2 19960724; FR 341 475-9 19960724; UK PL00001/0224 19961118 |
| 2435024 | LUC00208 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210 |
| >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.
