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Last Updated: July 2, 2022

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 Pharms Ltd, Cosette Pharms, Impax Labs Inc, Lupin Ltd, Mayne Pharma Inc, Mylan Pharms 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, Prinston Inc, Acella, Amici, Amneal Pharms Co, Apotex, Caribe Holdings, 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 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-eight 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Health Clinics LimitedPhase 3
Weill Medical College of Cornell UniversityPhase 2
University of MichiganPhase 2

See all doxycycline clinical trials

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
Heritage Pharms DOXYCYCLINE HYCLATE doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 200856-001 Apr 30, 2013 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ranbaxy DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 062479-002 Dec 23, 1983 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pvt Form DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 062631-001 Jul 24, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-005 Apr 11, 2013 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rising DOXYCYCLINE HYCLATE doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 090431-003 May 23, 2016 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amici DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 213475-001 Mar 10, 2021 DISCN 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
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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