Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Moodys
Express Scripts
Mallinckrodt
Colorcon
McKinsey

Last Updated: October 15, 2019

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Novartis Pharms Company Profile

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Summary for Novartis Pharms
International Patents:1901
US Patents:109
Tradenames:54
Ingredients:44
NDAs:62

Drugs and US Patents for Novartis Pharms

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 RX Yes Yes 9,149,486   See Pricing Y   See Pricing
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes 6,727,256   See Pricing Y Y   See Pricing
Novartis Pharms Corp MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-002 May 29, 2013 DISCN Yes No 8,580,304   See Pricing Y   See Pricing
Novartis Pharms Corp ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes 9,416,112   See Pricing Y Y   See Pricing
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 RX Yes No 7,160,870*PED   See Pricing Y   See Pricing
Novartis Pharms Corp SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-004 Jun 29, 2018 RX Yes No 7,473,761   See Pricing Y Y   See Pricing
>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 Pharms

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp EMADINE emedastine difumarate SOLUTION/DROPS;OPHTHALMIC 020706-001 Dec 29, 1997 4,430,343   See Pricing
Novartis Pharms Corp ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-002 Dec 31, 1992 4,753,789*PED   See Pricing
Novartis Pharms Corp PATANOL olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996 5,641,805*PED   See Pricing
Novartis Pharms Corp TOBRADEX dexamethasone; tobramycin OINTMENT;OPHTHALMIC 050616-001 Sep 28, 1988 5,149,694   See Pricing
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 6,280,959*PED   See Pricing
Novartis Pharms Corp NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 5,475,034   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for NOVARTIS PHARMS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Ophthalmic Solution 0.003% ➤ Subscribe 2015-12-30
➤ Subscribe Ophthalmic Solution 0.20% ➤ Subscribe 2008-09-08
➤ Subscribe Ophthalmic Solution 0.7% ➤ Subscribe 2015-09-10
➤ Subscribe Ophthalmic 0.50% ➤ Subscribe 2005-12-22
➤ Subscribe Ophthalmic Suspension 0.3% ➤ Subscribe 2015-12-21
➤ Subscribe Tablets 90 mg and 360 mg ➤ Subscribe 2015-10-19
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 2006-03-02
➤ Subscribe Tablets 180 mg ➤ Subscribe 2016-04-28
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe Tablets 12.5 mg and 25 mg ➤ Subscribe 2014-02-04
➤ Subscribe Oral Solution 4 mg/5 mL ➤ Subscribe 2004-12-20
➤ Subscribe Ophthalmic Solution 10.5% ➤ Subscribe 2012-02-29
➤ Subscribe Ophthalmic Solution 0.10% ➤ Subscribe 2006-07-17
➤ Subscribe Ophthalmic Solution 0.00% ➤ Subscribe 2009-02-19
➤ Subscribe Nasal Spray 0.665 mg/ Spray ➤ Subscribe 2009-06-29
➤ Subscribe Otic Suspension 0.3%/0.1% ➤ Subscribe 2012-07-31
➤ Subscribe Tablets 180 mg ➤ Subscribe 2015-10-23
➤ Subscribe Ophthalmic Emulsion 0.05% ➤ Subscribe 2014-05-01
➤ Subscribe Tablets 50 mg and 75 mg ➤ Subscribe 2014-01-07
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Tablets 250 mg ➤ Subscribe 2011-03-14

Supplementary Protection Certificates for Novartis Pharms Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1638574 C01638574/01 Switzerland   See Pricing PRODUCT NAME: MIDOSTAURIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66310 04.05.2017
1307486 C01307486/01 Switzerland   See Pricing PRODUCT NAME: PASIREOTID; REGISTRATION NO/DATE: SWISSMEDIC 61254 02.11.2012
1294378 C01294378/01 Switzerland   See Pricing FORMER OWNER: GLAXOSMITHKLINE LLC, US
1686964 C01686964/01 Switzerland   See Pricing PRODUCT NAME: PASIREOTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65148 25.02.2015
0780390 PA2004012,C0780390 Lithuania   See Pricing PRODUCT NAME: MOXIFLOXACINI HYDROCHLORIDUM (1-CIKLOPROPIL-6-FLUOR-1,4-DIHIDRO-8-METOKSI-7-((4AS, 7AS)-OKTAHIDRO-6H-PIROLO(3,4-B)PIRIDIN-6-IL)-4-OKSO-3-CHINOLINKARBOKSIRUGSTIES HIDROCHLORIDAS); REGISTRATION NO/DATE: 04/8383/3 20040309
2091918 1590054-1 Sweden   See Pricing PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/15/999 20150508
>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.

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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
AstraZeneca
Express Scripts
Dow
McKinsey

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