DOXYCHEL Drug Patent Profile
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When do Doxychel patents expire, and what generic alternatives are available?
Doxychel is a drug marketed by Rachelle and is included in two NDAs.
The generic ingredient in DOXYCHEL is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Doxychel
A generic version of DOXYCHEL was approved as doxycycline hyclate by CARIBE HOLDINGS on November 8th, 1982.
Summary for DOXYCHEL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 64 |
Clinical Trials: | 1 |
Patent Applications: | 5,162 |
Formulation / Manufacturing: | see details |
DailyMed Link: | DOXYCHEL at DailyMed |
Recent Clinical Trials for DOXYCHEL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Washington | Phase 3 |
National Institute of Allergy and Infectious Diseases (NIAID) | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for DOXYCHEL
US Patents and Regulatory Information for DOXYCHEL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rachelle | DOXYCHEL | doxycycline | FOR SUSPENSION;ORAL | 061720-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Rachelle | DOXYCHEL HYCLATE | doxycycline hyclate | INJECTABLE;INJECTION | 061953-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 DOXYCHEL
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Pfizer Limited | Doxirobe | Doxycycline | EMEA/V/C/000044 Treatment of periodontal disease in dogs.Periodontal pocket probing depths >=4 mm are evidence of disease that may be responsive to treatment with the Doxirobe Gel. Use of this product as directed should result in attachment level gains, periodontal pocket depth reductions, local antimicrobial effect and improved gingival health. Noticeable improvements in these parameters should be evident within 2-4 weeks following treatment. The response in individual dogs is dependent on the severity of the condition and rigor of adjunctive therapy. |
Withdrawn | no | no | no | 1999-09-16 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |