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Last Updated: October 1, 2022

ALKINDI SPRINKLE Drug Patent Profile


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When do Alkindi Sprinkle patents expire, and when can generic versions of Alkindi Sprinkle launch?

Alkindi Sprinkle is a drug marketed by Eton and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-four patent family members in twenty-four countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Alkindi Sprinkle

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

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Summary for ALKINDI SPRINKLE
International Patents:54
US Patents:3
Applicants:1
NDAs:1
Formulation / Manufacturing:see details
DailyMed Link:ALKINDI SPRINKLE at DailyMed
Drug patent expirations by year for ALKINDI SPRINKLE

US Patents and Regulatory Information for ALKINDI SPRINKLE

ALKINDI SPRINKLE is protected by three US patents.

Patents protecting ALKINDI SPRINKLE

Composition comprising hydrocortisone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADRENAL INSUFFICIENCY

Treatment of adrenal insufficiency
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADRENAL INSUFFICIENCY

Treatment of adrenal insufficiency
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADRENAL INSUFFICIENCY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eton ALKINDI SPRINKLE hydrocortisone GRANULE;ORAL 213876-001 Sep 29, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eton ALKINDI SPRINKLE hydrocortisone GRANULE;ORAL 213876-003 Sep 29, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eton ALKINDI SPRINKLE hydrocortisone GRANULE;ORAL 213876-002 Sep 29, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eton ALKINDI SPRINKLE hydrocortisone GRANULE;ORAL 213876-004 Sep 29, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 ALKINDI SPRINKLE

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

International Patents for ALKINDI SPRINKLE

See the table below for patents covering ALKINDI SPRINKLE around the world.

Country Patent Number Title Estimated Expiration
Russian Federation 2664678 Композиция, содержащая гидрокортизон (COMPOSITION COMPRISING HYDROCORTISONE) See Plans and Pricing
China 105120848 Composition comprising hydrocortisone See Plans and Pricing
World Intellectual Property Organization (WIPO) 2013072707 See Plans and Pricing
Spain 2813382 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ALKINDI SPRINKLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0809498 SPC/GB10/012 United Kingdom See Plans and Pricing PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0809498 10C0038 France See Plans and Pricing PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Johnson and Johnson
McKinsey
Colorcon
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.