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Last Updated: November 5, 2024

DOXYCYCLINE Drug Patent Profile


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When do Doxycycline patents expire, and when can generic versions of Doxycycline launch?

Doxycycline is a drug marketed by Alembic, Apotex, Cosette, Dr Reddys, Dr Reddys Labs Sa, Impax Labs Inc, Lupin, Lupin Ltd, Rising, Sandoz Inc, Strides Pharma, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell, Hikma, Mylan Labs Ltd, Heritage, Lannett Co Inc, Somerset Theraps Llc, Sun Pharm Industries, Pliva, Bausch, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, Par Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Zydus Lifesciences, Endo Operations, Gland Pharma Ltd, Slate Run Pharma, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Prinston Inc, Acella, Amneal, Amneal Pharms Co, Avet Lifesciences, Caribe Holdings, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Oryza, Praxgen, and Torrent. and is included in one hundred and twelve NDAs.

The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Doxycycline

A generic version of DOXYCYCLINE was approved as doxycycline hyclate by CARIBE HOLDINGS on November 8th, 1982.

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Drug patent expirations by year for DOXYCYCLINE
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Recent Clinical Trials for DOXYCYCLINE

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SponsorPhase
Chinese University of Hong KongPhase 4
Mahidol Oxford Tropical Medicine Research UnitPhase 2/Phase 3
Lao-Oxford-Mahosot Hospital Wellcome Trust Research UnitPhase 2/Phase 3

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Pharmacology for DOXYCYCLINE
Medical Subject Heading (MeSH) Categories for DOXYCYCLINE
Paragraph IV (Patent) Challenges for DOXYCYCLINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ORACEA Delayed-release Capsules doxycycline 40 mg 050805 1 2008-12-12

US Patents and Regulatory Information for DOXYCYCLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms DOXYCYCLINE doxycycline TABLET;ORAL 209582-003 Sep 28, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nostrum Labs Inc DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 209393-002 Dec 10, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Labs Ltd DOXYCYCLINE doxycycline hyclate INJECTABLE;INJECTION 091406-001 Aug 21, 2012 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms DOXYCYCLINE doxycycline CAPSULE;ORAL 205115-001 Feb 18, 2016 AB 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

EU/EMA Drug Approvals for DOXYCYCLINE

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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