Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 12, 2019

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ACETIC ACID, GLACIAL; HYDROCORTISONE - Generic Drug Details

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What are the generic sources for acetic acid, glacial; hydrocortisone and what is the scope of freedom to operate?

Acetic acid, glacial; hydrocortisone is the generic ingredient in six branded drugs marketed by Actavis Mid Atlantic, Kv Pharm, Bausch And Lomb, Taro Pharm Inds Ltd, Vintage, Wockhardt, Warner Chilcott, Hi Tech Pharma, and Bayer Pharms, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for acetic acid, glacial; hydrocortisone. Three suppliers are listed for this compound.

Summary for ACETIC ACID, GLACIAL; HYDROCORTISONE
Pharmacology for ACETIC ACID, GLACIAL; HYDROCORTISONE
Synonyms for ACETIC ACID, GLACIAL; HYDROCORTISONE
67489-69-4
ACETASOL HC
Acetic acid / hydrocortisone
Acetic acid mixture with hydrocortisone
ACETIC ACID W/ HYDROCORTISONE
Acetic acid w/hydrocortisone
C21H30O5.C2H4O2
DTXSID50217843
Hydrocortisone / Acetic acid
HYDROCORTISONE AND ACETIC ACID
Hydrocortisone and Acetid Otic
LS-178466
ORLEX HC
SCHEMBL7420

US Patents and Regulatory Information for ACETIC ACID, GLACIAL; HYDROCORTISONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Pharms NEO-CORT-DOME acetic acid, glacial; hydrocortisone; neomycin sulfate SUSPENSION/DROPS;OTIC 050238-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Bausch And Lomb HYDROCORTISONE AND ACETIC ACID acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 040097-001 Oct 31, 1994 DISCN No No   Start Trial   Start Trial   Start Trial
Warner Chilcott ORLEX HC acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 086844-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Vintage HYDROCORTISONE AND ACETIC ACID acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 040609-001 Feb 6, 2006 AT RX No No   Start Trial   Start Trial   Start Trial
Kv Pharm ACETIC ACID W/ HYDROCORTISONE acetic acid, glacial; hydrocortisone SOLUTION/DROPS;OTIC 085492-001 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:

Moodys
Baxter
Express Scripts
AstraZeneca
Colorcon
Merck

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