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Last Updated: April 22, 2024

Doxycycline - Generic Drug Details


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What are the generic drug sources for doxycycline and what is the scope of freedom to operate?

Doxycycline is the generic ingredient in eighteen branded drugs marketed by Alembic, Cosette, Dr Reddys Labs Sa, Impax Labs Inc, Lupin Ltd, Rising, Sandoz Inc, Strides Pharma, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell Rx, Galderma Labs Lp, Rachelle, Chartwell, Pfizer, Appco, Heritage Pharms, Lannett Co Inc, Sun Pharm Industries, Pliva, Mayne Pharma, Warner Chilcott, Bausch, Teva, 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, Zhejiang Yongtai, Zydus Lifesciences, Collagenex, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, Gland Pharma Ltd, Par Sterile Products, West-ward Pharms Int, Den-mat, Actavis Elizabeth, Aurobindo Pharma Usa, Lupin, Prinston Inc, Acella, Amneal, Amneal Pharms Co, Apotex, Avet Lifesciences, Caribe Holdings, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Pharmobedient, Praxgen, and Chartwell Pharma, and is included in one hundred and twenty-four NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Doxycycline has eighteen patent family members in eight countries.

There are twenty-eight drug master file entries for doxycycline. Forty-two suppliers are listed for this compound. There are six tentative approvals for this compound.

Drug Prices for doxycycline

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Drug Sales Revenue Trends for doxycycline

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Recent Clinical Trials for doxycycline

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SponsorPhase
Hôpital Necker-Enfants MaladesPhase 3
Institut PasteurPhase 3
Centre Hospitalier Universitaire de CaenPhase 3

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Generic filers with tentative approvals for DOXYCYCLINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial40MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial40MGCAPSULE; ORAL
⤷  Try a Trial⤷  Try a Trial40MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Alembic DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 211744-001 Jun 30, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms DOXYCYCLINE doxycycline TABLET;ORAL 209582-004 Sep 28, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mutual Pharm DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 062391-001 Sep 30, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 062142-001 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

Expired US Patents for doxycycline

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

International Patents for doxycycline

Country Patent Number Title Estimated Expiration
European Patent Office 1615622 FORMULATIONS DE DOXYCYCLINES EN DOSE QUOTIDIENNE UNIQUE (ONCE DAILY FORMULATIONS OF DOXYCYCLINES) ⤷  Try a Trial
Spain 2391385 ⤷  Try a Trial
Portugal 2204168 ⤷  Try a Trial
Canada 2521885 FORMULATIONS DE TETRACYCLINES EN DOSE QUOTIDIENNE UNIQUE (ONCE DAILY FORMULATIONS OF TETRACYCLINES) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.