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:

McKinsey
Moodys
Colorcon
Baxter
Harvard Business School
McKesson

Last Updated: December 15, 2019

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Genentech Company Profile

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Summary for Genentech

Drugs and US Patents for Genentech

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes 9,255,087   Start Trial   Start Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes 8,673,893   Start Trial   Start Trial
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-002 Jan 11, 2017 DISCN Yes No 8,013,002   Start Trial   Start Trial
Genentech NUTROPIN DEPOT somatropin recombinant INJECTABLE;INJECTION 021075-002 Dec 22, 1999 DISCN No No   Start Trial   Start Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes 10,398,693   Start Trial Y   Start Trial
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-002 Oct 24, 2018 RX Yes Yes 10,392,406   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 Genentech

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genentech PROTROPIN somatrem INJECTABLE;INJECTION 019107-001 Oct 17, 1985 4,658,021   Start Trial
Genentech NUTROPIN DEPOT somatropin recombinant INJECTABLE;INJECTION 021075-001 Dec 22, 1999 5,912,015   Start Trial
Genentech NUTROPIN DEPOT somatropin recombinant INJECTABLE;INJECTION 021075-003 Dec 22, 1999 5,912,015   Start Trial
Genentech NUTROPIN DEPOT somatropin recombinant INJECTABLE;INJECTION 021075-002 Dec 22, 1999 6,051,259   Start Trial
Genentech NUTROPIN somatropin INJECTABLE;INJECTION 020168-001 Nov 17, 1993 5,096,885   Start Trial
Genentech NUTROPIN DEPOT somatropin recombinant INJECTABLE;INJECTION 021075-001 Dec 22, 1999 6,051,259   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for GENENTECH drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 267 mg, 534 mg and 801 mg ➤ Subscribe 2018-10-15

Supplementary Protection Certificates for Genentech Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1789390 C01789390/01 Switzerland   Start Trial PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: SWISSMEDIC 62497 30.05.2013
1934174 C20160012 00193 Estonia   Start Trial PRODUCT NAME: KOBIMETINIIB;REG NO/DATE: EU/1/15/1048 24.11.2015
1934174 2016/022 Ireland   Start Trial PRODUCT NAME: COBIMETINIB, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS AND SOLVATES, IN PARTICULAR COBIMETINIB HEMIFUMARATE.; REGISTRATION NO/DATE: EU/1/15/1048/001 20151120
1789390 170 12-2013 Slovakia   Start Trial PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: EU/1/13/848/001 20130712
1934174 C01934174/01 Switzerland   Start Trial PRODUCT NAME: COBIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65620 24.08.2015
1789390 CR 2013 00050 Denmark   Start Trial PRODUCT NAME: VISMODEGIB; NAT. REG. NO/DATE: EU71/13/848 20130712; FIRST REG. NO/DATE: CH 62497 20130530
>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:

Merck
Moodys
Harvard Business School
McKesson
Baxter
Mallinckrodt

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