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Last Updated: November 2, 2024

PENECORT Drug Patent Profile


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When do Penecort patents expire, and what generic alternatives are available?

Penecort is a drug marketed by Allergan Herbert and is included in four NDAs.

The generic ingredient in PENECORT 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 Penecort

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

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Summary for PENECORT
US Patents:0
Applicants:1
NDAs:4
Raw Ingredient (Bulk) Api Vendors: 109
Patent Applications: 4,413
DailyMed Link:PENECORT at DailyMed
Drug patent expirations by year for PENECORT

US Patents and Regulatory Information for PENECORT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Herbert PENECORT hydrocortisone CREAM;TOPICAL 088216-001 Jun 6, 1984 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Allergan Herbert PENECORT hydrocortisone SOLUTION;TOPICAL 088214-001 Jun 6, 1984 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Allergan Herbert PENECORT hydrocortisone GEL;TOPICAL 088215-001 Jun 6, 1984 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Allergan Herbert PENECORT hydrocortisone OINTMENT;TOPICAL 088217-001 Jun 6, 1984 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 PENECORT

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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