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Last Updated: December 5, 2022

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-one approved drugs.



Summary for Roche
US Patents:0
Tradenames:49
Ingredients:45
NDAs:61
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 VERSED midazolam hydrochloride SYRUP;ORAL 020942-001 Oct 15, 1998 DISCN Yes No See Plans and Pricing See Plans and Pricing
Roche NIPRIDE sodium nitroprusside INJECTABLE;INJECTION 017546-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing
Roche Palo CELLCEPT mycophenolate mofetil FOR SUSPENSION;ORAL 050759-001 Oct 1, 1998 AB RX Yes Yes See Plans and Pricing See Plans and Pricing
Roche SYNKAYVITE menadiol sodium diphosphate INJECTABLE;INJECTION 003718-006 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing
Roche MENRIUM 5-2 chlordiazepoxide; estrogens, esterified TABLET;ORAL 014740-002 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and 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 Roche

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-004 Mar 11, 1994 6,294,548 See Plans and Pricing
Roche Palo AEROBID flunisolide AEROSOL, METERED;INHALATION 018340-001 Aug 17, 1984 4,933,168 See Plans and Pricing
Roche DEMADEX torsemide INJECTABLE;INJECTION 020137-002 Aug 23, 1993 4,822,807 See Plans and Pricing
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997 4,507,305 See Plans and Pricing
Roche MENRIUM 5-2 chlordiazepoxide; estrogens, esterified TABLET;ORAL 014740-002 Approved Prior to Jan 1, 1982 4,316,897 See Plans and Pricing
>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:

Merck
Colorcon
McKinsey
Johnson and Johnson
Moodys
Harvard Business School

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