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Last Updated: March 7, 2021

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ROBINUL Drug Profile

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Which patents cover Robinul, and when can generic versions of Robinul launch?

Robinul is a drug marketed by Hikma, Robins Ah, and Casper Pharma Llc. and is included in three NDAs.

The generic ingredient in ROBINUL is glycopyrrolate. There are seventeen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

US ANDA Litigation and Generic Entry Outlook for Robinul

A generic version of ROBINUL was approved as glycopyrrolate by AM REGENT on July 23rd, 1986.

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Summary for ROBINUL
Drug patent expirations by year for ROBINUL
Drug Prices for ROBINUL

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Recent Clinical Trials for ROBINUL

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SponsorPhase
McGill University Health CenterN/A
University of OuluPhase 4
Oulu University HospitalPhase 4

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Pharmacology for ROBINUL
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Paragraph IV (Patent) Challenges for ROBINUL
Tradename Dosage Ingredient NDA Submissiondate
ROBINUL FORTE TABLET;ORAL glycopyrrolate 012827 2010-10-12
ROBINUL TABLET;ORAL glycopyrrolate 012827 2010-10-12
ROBINUL TABLET;ORAL glycopyrrolate 012827 2009-08-14
ROBINUL FORTE TABLET;ORAL glycopyrrolate 012827 2009-08-14

US Patents and Regulatory Information for ROBINUL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma ROBINUL glycopyrrolate INJECTABLE;INJECTION 017558-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Casper Pharma Llc ROBINUL FORTE glycopyrrolate TABLET;ORAL 012827-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Robins Ah ROBINUL glycopyrrolate INJECTABLE;INJECTION 014764-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Baxter
AstraZeneca
Express Scripts
McKesson

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