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 five US patents protecting NOVARTIS drugs.
There are two thousand seven hundred and forty-one 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: | 2741 |
US Patents: | 105 |
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 | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-001 | May 29, 2013 | RX | Yes | No | 9,271,941*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-002 | Aug 26, 2010 | DISCN | No | No | 8,613,949 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-003 | May 29, 2013 | RX | Yes | Yes | 10,869,869*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | VIJOICE | alpelisib | TABLET;ORAL | 215039-002 | Apr 5, 2022 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-002 | May 29, 2013 | DISCN | Yes | 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 | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-001 | Nov 25, 1998 | 5,922,682*PED | ⤷ Try a Trial |
Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | 7,858,594 | ⤷ Try a Trial |
Novartis | TRANSDERM-NITRO | nitroglycerin | FILM, EXTENDED RELEASE;TRANSDERMAL | 020144-004 | Feb 27, 1996 | 4,849,226 | ⤷ Try a Trial |
Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-002 | Nov 25, 1998 | 5,922,682*PED | ⤷ Try a Trial |
Novartis | STARLIX | nateglinide | TABLET;ORAL | 021204-001 | Dec 22, 2000 | 6,641,841 | ⤷ 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 | 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 |
➤ 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 |
International Patents for Novartis Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 2010538004 | ⤷ Try a Trial |
South Korea | 20120101148 | ⤷ Try a Trial |
New Zealand | 536272 | ⤷ Try a Trial |
Peru | 20210667 | ⤷ Try a Trial |
Hong Kong | 1068262 | ⤷ 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 |
---|---|---|---|---|
2435024 | PA2021511 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209 |
2435024 | C202130025 | Spain | ⤷ Try a Trial | PRODUCT NAME: UNA COMBINACION DE FORMOTEROL ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES I, GLICOPIRROLATO ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ) Y BUDESONIDA ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ).; NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF AUTHORISATION: 20201209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1498; DATE OF FIRST AUTHORISATION IN EEA: 20201209 |
3043773 | 301154 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: MOMETASON OF EEN ZOUT DAARVAN EN OLOPATADINE OF EEN ZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 126186 20211014; FIRST REGISTRATION: AT 140638 20210426 |
0892640 | C00892640/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ACIDUM MYCOPHENOLICUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56115 24.10.2002 |
2929031 | LUC00209 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: INCLISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1494 20201210 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
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