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Last Updated: October 23, 2019

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Roche Company Profile

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What is the competitive landscape for ROCHE, and what generic and branded alternatives to ROCHE drugs are available?

ROCHE has sixty-three approved drugs.



Summary for Roche
US Patents:0
Tradenames:50
Ingredients:45
NDAs:63
Patent Litigation for Roche: See patent lawsuits for Roche

Drugs and US Patents for Roche

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche RIMIFON isoniazid INJECTABLE;INJECTION 008420-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Roche COACTIN amdinocillin INJECTABLE;INJECTION 050565-003 Dec 21, 1984 DISCN No No   Start Trial   Start Trial
Roche MENRIUM 5-2 chlordiazepoxide; estrogens, esterified TABLET;ORAL 014740-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Roche DEMADEX torsemide INJECTABLE;INJECTION 020137-002 Aug 23, 1993 DISCN Yes No   Start Trial   Start Trial
Roche QUARZAN clidinium bromide CAPSULE;ORAL 010355-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Roche Palo EVEX estrogens, esterified TABLET;ORAL 083376-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Roche KLONOPIN clonazepam TABLET;ORAL 017533-003 Approved Prior to Jan 1, 1982 AB RX Yes No   Start Trial   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 Roche

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-001 Dec 14, 2000 5,952,375*PED   Start Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997 4,642,346   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-002 Mar 11, 1994 6,294,548   Start Trial
Roche MENRIUM 10-4 chlordiazepoxide; estrogens, esterified TABLET;ORAL 014740-006 Approved Prior to Jan 1, 1982 4,316,897   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-001 Dec 29, 1993 4,886,808   Start Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-001 Dec 22, 1994 4,507,305   Start Trial
Roche KLONOPIN RAPIDLY DISINTEGRATING clonazepam TABLET, ORALLY DISINTEGRATING;ORAL 020813-002 Dec 23, 1997 4,758,598   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ROCHE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Capsules 30 mg and 45 mg ➤ Subscribe 2011-08-02
➤ Subscribe Injection 0.1 mg/mL, 1 mL single dose vial ➤ Subscribe 2007-03-08
➤ Subscribe Injection 1 mg/mL, 4 mL multi-dose vials ➤ Subscribe 2004-07-19
➤ Subscribe Tablets 2.5 mg and 150 mg ➤ Subscribe 2007-05-16
➤ Subscribe Capsule 75 mg ➤ Subscribe 2010-11-15
➤ Subscribe Oral Suspension 6 mg/mL ➤ Subscribe 2015-06-18
➤ Subscribe Injection 1 mg/mL, 1 mL vials ➤ Subscribe 2004-06-01
➤ Subscribe Injection 1 mg/mL, 3 mL Vial ➤ Subscribe 2007-08-31
➤ Subscribe For Oral Suspension 200 mg/mL ➤ Subscribe 2011-03-25
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:

Moodys
McKinsey
Mallinckrodt
Dow
Express Scripts
AstraZeneca

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