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Last Updated: April 15, 2021

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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, Impax Labs Inc, Lupin Ltd, Mayne Pharma Inc, Mylan Pharms Inc, Par Pharm, Sandoz Inc, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell Rx, Galderma Labs Lp, Rachelle, Chartwell Life Sci, Pfizer, Heritage Pharms Inc, Lannett Co Inc, Mylan, Sun Pharm Industries, Pliva, Mayne Pharma Intl, Warner Chilcott, Medicis, Almirall, Teva, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nostrum Labs Inc, Pvt Form, Ranbaxy, Superpharm, Zhejiang Yongtai, Collagenex, Fresenius Kabi Usa, Mylan Labs Ltd, West-ward Pharms Int, Den-mat, Mayne Pharma, Actavis Elizabeth, Prinston Inc, Acella, Amneal Pharms Co, Apotex, Cadila, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Larken Labs, Novel Labs Inc, Vintage Pharms, and Chartwell Pharma, and is included in one hundred and fifteen 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

University of PennsylvaniaPhase 4
University of KarachiPhase 1/Phase 2
The Jinnah Postgraduate Medical Centre, Rafiqui، Sarwar Shaheed Rd, Karachi Cantonment, Karachi, Karachi City, Sindh 75510Phase 1/Phase 2

See all doxycycline clinical trials

Generic filers with tentative approvals for DOXYCYCLINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial40MGCAPSULE;ORAL
  Start Trial  Start Trial40MGCAPSULE; ORAL
  Start Trial  Start 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 NDA Submissiondate
ORACEA CAPSULE;ORAL doxycycline 050805 2008-12-12
ORACEA CAPSULE;ORAL doxycycline 050805 2008-12-11

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
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-005 Apr 11, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Almirall ACTICLATE doxycycline hyclate TABLET;ORAL 205931-002 Jul 25, 2014 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 209987-002 Oct 5, 2020 DISCN No No   Start Trial   Start Trial   Start Trial
Ranbaxy DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 062479-002 Dec 23, 1983 DISCN No No   Start Trial   Start Trial   Start Trial
Halsey DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 062119-002 May 24, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Pfizer VIBRA-TABS doxycycline hyclate TABLET;ORAL 050533-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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