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Last Updated: August 8, 2020

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Doxycycline hyclate - Generic Drug Details

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

Doxycycline hyclate is the generic ingredient in fifteen branded drugs marketed by Pliva, Mayne Pharma Intl, Warner Chilcott, Medicis, Almirall, Teva, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Changzhou Pharm, Chartwell Life Sci, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Mylan, Par Pharm, Pvt Form, Ranbaxy, Sun Pharm Industries, Superpharm, Watson Labs, Zhejiang Yongtai, Zydus Pharms, Collagenex, Pfizer, Fresenius Kabi Usa, Rachelle, Mylan Labs Ltd, West-ward Pharms Int, Tolmar, Mayne Pharma, Actavis Elizabeth, Heritage Pharms Inc, Impax Labs Inc, Mylan Pharms Inc, Prinston Inc, Amneal Pharms Co, Apotex, Cadila, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Lannett Co Inc, Larken Labs, Lupin Ltd, Mayne Pharma Inc, Novel Labs Inc, Oaklock Llc, Vintage Pharms, Chartwell Pharma, and Galderma Labs Lp, and is included in eighty-four NDAs. There are five patents protecting this compound and seven Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Doxycycline hyclate has two patent family members in two countries.

There are twenty-eight drug master file entries for doxycycline hyclate. Seventy-four suppliers are listed for this compound.

Drug Prices for doxycycline hyclate

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Drug Sales Revenue Trends for doxycycline hyclate

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Recent Clinical Trials for doxycycline hyclate

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

SponsorPhase
Galderma R&DPhase 4
Royal Alexandra HospitalPhase 2
University of AlbertaPhase 2

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Pharmacology for doxycycline hyclate
Paragraph IV (Patent) Challenges for DOXYCYCLINE HYCLATE
Tradename Dosage Ingredient NDA Submissiondate
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2017-09-28
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2017-09-28
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-11-05
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-11-05
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-07-01
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-07-01
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2014-05-19
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2014-05-19
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2008-12-19
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2008-12-19

US Patents and Regulatory Information for doxycycline hyclate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ajanta Pharma Ltd DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 211012-001 Sep 24, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int DOXYCYCLINE doxycycline hyclate INJECTABLE;INJECTION 062569-002 Mar 9, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 210527-002 Jun 13, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan DOXYCYCLINE HYCLATE doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 090431-002 Dec 28, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
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
Prinston Inc DOXYCYCLINE HYCLATE doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 207494-003 Feb 19, 2019 AB RX No 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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