Hydrocortisone butyrate - Generic Drug Details
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What are the generic drug sources for hydrocortisone butyrate and what is the scope of freedom to operate?
Hydrocortisone butyrate
is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Glenmark Pharms Ltd, Taro Pharm Inds, Bausch, Yamanouchi, Precision Dermat, Lupin Ltd, The J Molner, and Taro, and is included in fifteen NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for hydrocortisone butyrate. Six suppliers are listed for this compound.
Summary for hydrocortisone butyrate
US Patents: | 1 |
Tradenames: | 3 |
Applicants: | 9 |
NDAs: | 15 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 4 |
Patent Applications: | 6,799 |
Drug Prices: | Drug price trends for hydrocortisone butyrate |
What excipients (inactive ingredients) are in hydrocortisone butyrate? | hydrocortisone butyrate excipients list |
DailyMed Link: | hydrocortisone butyrate at DailyMed |
Recent Clinical Trials for hydrocortisone butyrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Pfizer | Phase 4 |
Peking Union Medical College Hospital | Phase 4 |
Allerderm | Phase 4 |
Pharmacology for hydrocortisone butyrate
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for hydrocortisone butyrate
Paragraph IV (Patent) Challenges for HYDROCORTISONE BUTYRATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LOCOID | Lotion | hydrocortisone butyrate | 0.10% | 022076 | 1 | 2016-08-31 |
LOCOID LIPOCREAM | Cream | hydrocortisone butyrate | 0.10% | 020769 | 1 | 2010-06-28 |
US Patents and Regulatory Information for hydrocortisone butyrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Taro Pharm Inds | HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | SOLUTION;TOPICAL | 076364-001 | Jan 14, 2004 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bausch | LOCOID | hydrocortisone butyrate | SOLUTION;TOPICAL | 019116-001 | Feb 25, 1987 | AT | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lupin Ltd | HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | LOTION;TOPICAL | 210209-001 | Aug 17, 2018 | AB | RX | No | 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 |
Expired US Patents for hydrocortisone butyrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Precision Dermat | LOCOID LIPOCREAM | hydrocortisone butyrate | CREAM;TOPICAL | 020769-001 | Sep 8, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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