HYDROCORTISONE BUTYRATE Drug Patent Profile
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When do Hydrocortisone Butyrate patents expire, and what generic alternatives are available?
Hydrocortisone Butyrate is a drug marketed by Actavis Mid Atlantic, Glenmark Pharms Ltd, Taro Pharm Inds, Lupin Ltd, The J Molner, and Taro. and is included in seven NDAs.
The generic ingredient in HYDROCORTISONE BUTYRATE is hydrocortisone butyrate. There are sixty-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Hydrocortisone Butyrate
A generic version of HYDROCORTISONE BUTYRATE was approved as hydrocortisone butyrate by TARO PHARM INDS on January 14th, 2004.
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Questions you can ask:
- What is the 5 year forecast for HYDROCORTISONE BUTYRATE?
- What are the global sales for HYDROCORTISONE BUTYRATE?
- What is Average Wholesale Price for HYDROCORTISONE BUTYRATE?
Summary for HYDROCORTISONE BUTYRATE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 4 |
| Patent Applications: | 5,712 |
| Drug Prices: | Drug price information 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Mid Atlantic | HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | CREAM;TOPICAL | 205134-001 | Dec 8, 2017 | AB2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Taro Pharm Inds | HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | SOLUTION;TOPICAL | 076364-001 | Jan 14, 2004 | AT | RX | No | No | ⤷ 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 | |||
| Glenmark Pharms Ltd | HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | CREAM;TOPICAL | 202145-001 | Sep 27, 2013 | AB2 | RX | 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 |
