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Last Updated: March 19, 2024

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, Warner Chilcott, Bausch, Chartwell Rx, Teva, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Changzhou Pharm, Chartwell, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, Par Pharm, Pvt Form, Ranbaxy, Strides Pharma, Sun Pharm Industries, Superpharm, Watson Labs, Zhejiang Yongtai, Zydus Lifesciences, Collagenex, Pfizer, Fresenius Kabi Usa, Rachelle, Hikma, Mylan Labs Ltd, Zydus Pharms, Gland Pharma Ltd, Par Sterile Products, West-ward Pharms Int, Den-mat, Actavis Elizabeth, Aurobindo Pharma Usa, Heritage Pharms, Impax Labs Inc, Lupin, Prinston Inc, Rising, Acella, Amneal, Amneal Pharms Co, Apotex, Avet Lifesciences, Caribe Holdings, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Larken Labs, Lupin Ltd, Mylan, Novel Labs Inc, Pharmobedient, Praxgen, Chartwell Pharma, and Galderma Labs Lp, and is included in ninety-six NDAs. There are four 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 fifteen drug master file entries for doxycycline hyclate. Seventy-two 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
Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou, ChinaPhase 1/Phase 2
The Jinnah Postgraduate Medical Centre, Rafiqui، Sarwar Shaheed Rd, Karachi Cantonment, Karachi, Karachi City, Sindh 75510Phase 1/Phase 2
University of KarachiPhase 1/Phase 2

See all doxycycline hyclate clinical trials

Pharmacology for doxycycline hyclate
Paragraph IV (Patent) Challenges for DOXYCYCLINE HYCLATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DORYX MPC Delayed-release Tablets doxycycline hyclate 60 mg and 120 mg 050795 1 2017-09-28
DORYX MPC Delayed-release Tablets doxycycline hyclate 50 mg 050795 1 2015-11-05
DORYX MPC Delayed-release Tablets doxycycline hyclate 80 mg 050795 1 2015-07-01
DORYX MPC Delayed-release Tablets doxycycline hyclate 200 mg 050795 1 2014-05-19
DORYX MPC Delayed-release Tablets doxycycline hyclate 150 mg 050795 1 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
Rachelle DOXYCHEL HYCLATE doxycycline hyclate INJECTABLE;INJECTION 061953-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Elizabeth DOXYCYCLINE HYCLATE doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 090134-004 May 22, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Prinston Inc DOXYCYCLINE HYCLATE doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 207494-003 Feb 19, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic DOXYCYCLINE HYCLATE doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 213075-004 Jan 3, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms DOXYCYCLINE HYCLATE doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 206772-002 Dec 21, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin DOXYCYCLINE HYCLATE doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 208741-001 Aug 11, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 hyclate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-006 Dec 19, 2014 ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-003 Jun 20, 2008 ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-005 Apr 11, 2013 ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-007 May 20, 2016 ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-002 May 6, 2005 ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-001 May 6, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.