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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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: | 4,404 |
| 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.
Patents protecting ALKINDI SPRINKLE
Composition comprising hydrocortisone
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADRENAL INSUFFICIENCY
Treatment of adrenal insufficiency
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADRENAL INSUFFICIENCY
Treatment of adrenal insufficiency
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eton | ALKINDI SPRINKLE | hydrocortisone | GRANULE;ORAL | 213876-003 | Sep 29, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eton | ALKINDI SPRINKLE | hydrocortisone | GRANULE;ORAL | 213876-002 | Sep 29, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eton | ALKINDI SPRINKLE | hydrocortisone | GRANULE;ORAL | 213876-004 | Sep 29, 2020 | RX | Yes | Yes | ⤷ 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 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 |
|---|---|---|---|
| Denmark | 2978414 | ⤷ Sign Up | |
| Denmark | 2780003 | ⤷ Sign Up | |
| South Africa | 201507210 | COMPOSITION COMPRISING HYDROCORTISONE | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2013072707 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112 |
| 0809498 | 10C0038 | France | ⤷ Sign Up | 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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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.
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