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Last Updated: November 2, 2024

ALA-CORT Drug Patent Profile


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Which patents cover Ala-cort, and when can generic versions of Ala-cort launch?

Ala-cort is a drug marketed by Crown Labs and is included in two NDAs.

The generic ingredient in ALA-CORT 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 Ala-cort

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

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Drug patent expirations by year for ALA-CORT
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Pharmacology for ALA-CORT

US Patents and Regulatory Information for ALA-CORT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Crown Labs ALA-CORT hydrocortisone CREAM;TOPICAL 080706-007 Jan 5, 2016 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Crown Labs ALA-CORT hydrocortisone CREAM;TOPICAL 080706-006 Approved Prior to Jan 1, 1982 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Crown Labs ALA-CORT hydrocortisone LOTION;TOPICAL 083201-001 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 ALA-CORT

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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