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-seven approved drugs.
There are one hundred and thirteen US patents protecting NOVARTIS drugs.
There are two thousand eight hundred and seventy-two patent family members on NOVARTIS drugs in sixty-nine countries and five hundred and thirty supplementary protection certificates in nineteen countries.
Summary for NOVARTIS
International Patents: | 2872 |
US Patents: | 113 |
Tradenames: | 155 |
Ingredients: | 139 |
NDAs: | 187 |
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 Pharm | TABRECTA | capmatinib hydrochloride | TABLET;ORAL | 213591-002 | May 6, 2020 | RX | Yes | Yes | 8,420,645 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Novartis Pharm | TABRECTA | capmatinib hydrochloride | TABLET;ORAL | 213591-002 | May 6, 2020 | RX | Yes | Yes | 7,767,675 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Novartis | AFINITOR | everolimus | TABLET;ORAL | 022334-002 | Mar 30, 2009 | AB | RX | Yes | No | 9,006,224 | ⤷ Subscribe | ⤷ Subscribe | |||
Novartis Pharm | TABRECTA | capmatinib hydrochloride | TABLET;ORAL | 213591-002 | May 6, 2020 | RX | Yes | Yes | 8,461,330 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-004 | Oct 20, 2011 | RX | Yes | No | 8,828,430*PED | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225-001 | Mar 18, 2019 | RX | Yes | Yes | 8,703,787 | ⤷ Subscribe | ⤷ Subscribe | ||||
Novartis | FORADIL CERTIHALER | formoterol fumarate | POWDER;INHALATION | 021592-001 | Dec 15, 2006 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
>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 | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | 6,444,652 | ⤷ Subscribe |
Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-003 | Sep 10, 1986 | 3,948,262 | ⤷ Subscribe |
Novartis | TRANSDERM-NITRO | nitroglycerin | FILM, EXTENDED RELEASE;TRANSDERMAL | 020144-005 | Feb 27, 1996 | 4,954,344 | ⤷ Subscribe |
Novartis | ZORTRESS | everolimus | TABLET;ORAL | 021560-003 | Apr 20, 2010 | 6,004,973*PED | ⤷ Subscribe |
Novartis | SEEBRI | glycopyrrolate | POWDER;INHALATION | 207923-001 | Oct 29, 2015 | 6,582,678 | ⤷ Subscribe |
Novartis Pharm | AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985-003 | Aug 29, 2012 | 8,617,598*PED | ⤷ Subscribe |
Novartis | TYZEKA | telbivudine | SOLUTION;ORAL | 022154-001 | Apr 28, 2009 | 7,795,238 | ⤷ Subscribe |
>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 | 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 |
➤ 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 |
International Patents for NOVARTIS Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Jordan | 3594 | ⤷ Subscribe |
Poland | 2284167 | ⤷ Subscribe |
Portugal | 2964202 | ⤷ Subscribe |
Norway | 20045561 | ⤷ Subscribe |
Poland | 3294283 | ⤷ Subscribe |
World Intellectual Property Organization (WIPO) | 2009082607 | ⤷ Subscribe |
Cuba | 20080006 | ⤷ Subscribe |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NOVARTIS Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2331537 | 2020C/547 | Belgium | ⤷ Subscribe | PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728 |
3143995 | 2019C/528 | Belgium | ⤷ Subscribe | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION |
1948158 | PA2016017 | Lithuania | ⤷ Subscribe | PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119 |
1948158 | 132016000051118 | Italy | ⤷ Subscribe | PRODUCT NAME: SACUBITRIL/VALSARTAN, COME SACUBITRIL VALSARTAN COMPLESSO DI SALE SODICO (TRISODIO (3-((1S,3R)-1-BIFENIL-4-ILMETIL-3-ETOSSICARBONIL-1-BUTILCARBAMMOIL)PROPIONATO-(S)-3'-METIL-2'-(PENTANOIL(2"-(TETRAZOL-5-ILATO)BIFENIL-4'-ILMETIL)AMMINO)BUTIRRATO) EMIPENTAIDRATO)(ENTRESTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1058, 20151123 |
0678503 | C300386 | Netherlands | ⤷ Subscribe | PRODUCT NAME: COMBINATIE OMVATTENDE ALISKIREN, ALS VRIJE BASE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; NATL. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: CH 58935 01-04 20081028 |
3143995 | C03143995/01 | Switzerland | ⤷ Subscribe | PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 59174 14.11.2016 |
2331547 | C20170039 00245 | Estonia | ⤷ Subscribe | PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.