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Last Updated: December 21, 2024

Mylan Institutional Company Profile


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

MYLAN INSTITUTIONAL has thirty-five approved drugs.



Drugs and US Patents for Mylan Institutional

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Institutional DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride INJECTABLE;INJECTION 040498-001 Jul 12, 2005 AP RX No Yes ⤷  Subscribe ⤷  Subscribe
Mylan Institutional OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 079198-001 Feb 10, 2011 AP RX No No ⤷  Subscribe ⤷  Subscribe
Mylan Institutional MESNA mesna INJECTABLE;INTRAVENOUS 076488-001 Mar 8, 2012 DISCN No No ⤷  Subscribe ⤷  Subscribe
Mylan Institutional FOMEPIZOLE fomepizole INJECTABLE;INJECTION 078639-001 Mar 3, 2008 AP RX No Yes ⤷  Subscribe ⤷  Subscribe
>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 Mylan Institutional

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Institutional RIMSO-50 dimethyl sulfoxide SOLUTION;INTRAVESICAL 017788-001 Approved Prior to Jan 1, 1982 3,549,770 ⤷  Subscribe
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-002 Jul 12, 1996 5,466,700*PED ⤷  Subscribe
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-003 Jul 12, 1996 5,866,591*PED ⤷  Subscribe
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-001 Jul 12, 1996 5,019,583*PED ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for MYLAN INSTITUTIONAL drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe for Injection 1 mg/vial, 2 mg/vial and 5 mg/vial ➤ Subscribe 2013-12-27
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
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