MONODOX Drug Patent Profile
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When do Monodox patents expire, and what generic alternatives are available?
Monodox is a drug marketed by Chartwell Rx and is included in one NDA.
The generic ingredient in MONODOX is doxycycline. There are twenty-eight drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the doxycycline profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Monodox
A generic version of MONODOX was approved as doxycycline by SUN PHARM INDS LTD on November 22nd, 2000.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for MONODOX?
- What are the global sales for MONODOX?
- What is Average Wholesale Price for MONODOX?
Summary for MONODOX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 123 |
| Clinical Trials: | 7 |
| Patent Applications: | 5,162 |
| Drug Prices: | Drug price information for MONODOX |
| What excipients (inactive ingredients) are in MONODOX? | MONODOX excipients list |
| DailyMed Link: | MONODOX at DailyMed |
Recent Clinical Trials for MONODOX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 3 |
| University of Washington | Phase 3 |
| Par Pharmaceutical, Inc. | Phase 1 |
Pharmacology for MONODOX
| Drug Class | Tetracycline-class Drug |
US Patents and Regulatory Information for MONODOX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chartwell Rx | MONODOX | doxycycline | CAPSULE;ORAL | 050641-002 | Feb 10, 1992 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | MONODOX | doxycycline | CAPSULE;ORAL | 050641-004 | Feb 17, 2022 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | MONODOX | doxycycline | CAPSULE;ORAL | 050641-003 | Oct 18, 2006 | AB | RX | Yes | 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 |
EU/EMA Drug Approvals for MONODOX
| 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 |
