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Last Updated: March 18, 2024

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-two 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.

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Drug patent expirations by year for MONODOX
Drug Prices for MONODOX

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Drug Sales Revenue Trends for MONODOX

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Recent Clinical Trials for MONODOX

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SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 3
University of WashingtonPhase 3
Par Pharmaceutical, Inc.Phase 1

See all MONODOX clinical trials

Pharmacology for MONODOX

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx MONODOX doxycycline CAPSULE;ORAL 050641-004 Feb 17, 2022 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx MONODOX doxycycline CAPSULE;ORAL 050641-003 Oct 18, 2006 AB RX Yes 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 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

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