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Last Updated: November 2, 2024

HYDRO-RX Drug Patent Profile


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When do Hydro-rx patents expire, and what generic alternatives are available?

Hydro-rx is a drug marketed by X Gen Pharms and is included in one NDA.

The generic ingredient in HYDRO-RX is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hydro-rx

A generic version of HYDRO-RX was approved as hydrocortisone by IMPAX LABS INC on March 30th, 2007.

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Summary for HYDRO-RX
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 109
Patent Applications: 4,406
DailyMed Link:HYDRO-RX at DailyMed
Drug patent expirations by year for HYDRO-RX

US Patents and Regulatory Information for HYDRO-RX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
X Gen Pharms HYDRO-RX hydrocortisone POWDER;FOR RX COMPOUNDING 085982-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for HYDRO-RX

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch Plenadren hydrocortisone EMEA/H/C/002185
Treatment of adrenal insufficiency in adults.
Authorised no no no 2011-11-03
Diurnal Europe B.V. Alkindi hydrocortisone EMEA/H/C/004416
Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
Authorised no no no 2018-02-09
Diurnal Europe B.V. Efmody hydrocortisone EMEA/H/C/005105
Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.
Authorised no no no 2021-05-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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