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Last Updated: October 23, 2021

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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, Bausch, Almirall, Teva, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Changzhou Pharm, Chartwell, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Mylan, Nostrum Labs Inc, 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, Den-mat, Mayne Pharma, Actavis Elizabeth, Heritage Pharms Inc, Impax Labs Inc, Mylan Pharms Inc, Prinston Inc, Acella, 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, Oryza, Vintage Pharms, Chartwell Pharma, and Galderma Labs Lp, and is included in eighty-nine 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-three 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
University of PennsylvaniaPhase 4
Canadian Institutes of Health Research (CIHR)Phase 2/Phase 3
Jonathan Troy GrennanPhase 2/Phase 3

See all doxycycline hyclate clinical trials

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 TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-11-05
DORYX MPC 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 MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2014-05-19
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2014-05-19
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2008-12-19
DORYX MPC 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
Novel Labs Inc DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 207558-001 Sep 6, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Par Pharm DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 062442-001 Dec 22, 1983 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Heather DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 062463-001 Dec 7, 1983 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Emcure Pharms Ltd DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 209969-001 Nov 9, 2018 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-007 May 20, 2016 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Hikma Intl Pharms DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 062396-002 Nov 7, 1984 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
McKinsey
Express Scripts
Johnson and Johnson
McKesson

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