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Last Updated: December 7, 2022

Doxycycline - Generic Drug Details


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What are the generic drug sources for doxycycline and what is the scope of patent protection?

Doxycycline is the generic ingredient in eighteen branded drugs marketed by Alembic Pharms Ltd, Cosette, Impax Labs Inc, Lupin Ltd, Mayne Pharma Inc, Rising, Sandoz Inc, Strides Pharma, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell Rx, Galderma Labs Lp, Rachelle, Chartwell, Pfizer, Heritage Pharms, Lannett Co Inc, Mylan, Sun Pharm Industries, Pliva, Mayne Pharma Intl, Warner Chilcott, Bausch, Almirall, Teva, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Cadila, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, Par Pharm, Pvt Form, Ranbaxy, Superpharm, Zhejiang Yongtai, Collagenex, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, West-ward Pharms Int, Den-mat, Mayne Pharma, Actavis Elizabeth, Mylan Pharms Inc, Prinston Inc, Acella, Amici, Amneal, Amneal Pharms Co, Apotex, Caribe Holdings, Chartwell Molecular, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Larken Labs, Novel Labs Inc, Praxgen, and Chartwell Pharma, and is included in one hundred and twenty-one NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Doxycycline has thirty-seven patent family members in thirteen countries.

There are twenty-eight drug master file entries for doxycycline. Thirty-six suppliers are listed for this compound. There are five 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
National University Hospital, SingaporePhase 3
Hospital Queen Elizabeth, MalaysiaPhase 3
Tan Tock Seng HospitalPhase 3

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Generic filers with tentative approvals for DOXYCYCLINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing40MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing40MGCAPSULE; ORAL
See Plans and PricingSee Plans and Pricing40MGCAPSULE;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 Pharms Ltd DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 210536-001 May 14, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rising DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 209987-001 Oct 5, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alembic Pharms Ltd DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 210527-001 Jun 13, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 See Plans and Pricing See Plans and Pricing
>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

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