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-six patent family members in twenty-five countries.
The generic ingredient in ALKINDI SPRINKLE 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 Alkindi Sprinkle
A generic version of ALKINDI SPRINKLE was approved as hydrocortisone by IMPAX LABS INC on March 30th, 2007.
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Questions you can ask:
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Summary for ALKINDI SPRINKLE
International Patents: | 56 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Patent Applications: | 4,626 |
Drug Prices: | Drug price information for ALKINDI SPRINKLE |
DailyMed Link: | ALKINDI SPRINKLE at DailyMed |


Pharmacology for ALKINDI SPRINKLE
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for ALKINDI SPRINKLE
ALKINDI SPRINKLE is protected by three US patents.
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 |
---|---|---|---|
South Korea | 20140108638 | TREATMENT OF ADRENAL INSUFFICIENCY | ⤷ Try for Free |
Spain | 2813382 | ⤷ Try for Free | |
Poland | 2780003 | ⤷ Try for Free | |
Canada | 2909060 | COMPOSITION COMPRENANT DE L'HYDROCORTISONE (COMPOSITION COMPRISING HYDROCORTISONE) | ⤷ Try for Free |
Japan | 2014533679 | 副腎機能障害の治療 | ⤷ Try for Free |
Denmark | 2780003 | ⤷ Try for Free | |
Portugal | 2780003 | ⤷ Try for Free | |
>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 | ⤷ Try for Free | PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112 |
0809498 | 10C0038 | France | ⤷ Try for Free | 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 |
Market Dynamics and Financial Trajectory for ALKINDI SPRINKLE
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