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, Endo Operations, Gland Pharma Ltd, Heritage, Kindos, Lupin Ltd, Slate Run Pharma, West-ward Pharms Int, Den-mat, Actavis Elizabeth, Aurobindo Pharma Usa, Impax Labs Inc, Lupin, Prinston Inc, Rising, Acella, Amneal, Amneal Pharms Co, Apotex, Avet Lifesciences, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Oryza, Praxgen, Torrent, Chartwell Pharma, and Galderma Labs Lp, and is included in one hundred and two 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-four suppliers are listed for this compound.

Summary for doxycycline hyclate

International Patents:	2
US Patents:	4
Tradenames:	15
Applicants:	66
NDAs:	102
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	74
Raw Ingredient (Bulk) Api Vendors:	194
Clinical Trials:	25
Drug Prices:	Drug price trends for doxycycline hyclate
Drug Sales Revenues:	Drug sales revenues for doxycycline hyclate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for doxycycline hyclate
What excipients (inactive ingredients) are in doxycycline hyclate?	doxycycline hyclate excipients list
DailyMed Link:	doxycycline hyclate at DailyMed

See drug prices for doxycycline hyclate

Drug Sales Revenue Trends for doxycycline hyclate

See drug sales revenues for doxycycline hyclate

Recent Clinical Trials for doxycycline hyclate

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

Sponsor	Phase
Chinese University of Hong Kong	Phase 4
The Jinnah Postgraduate Medical Centre, Rafiqui، Sarwar Shaheed Rd, Karachi Cantonment, Karachi, Karachi City, Sindh 75510	Phase 1/Phase 2
University of Karachi	Phase 1/Phase 2

See all doxycycline hyclate clinical trials

Pharmacology for doxycycline hyclate

Drug Class	Tetracycline-class Drug

Anatomical Therapeutic Chemical (ATC) Classes for doxycycline hyclate

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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Glossary

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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	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Pfizer	VIBRAMYCIN	doxycycline hyclate	CAPSULE;ORAL	050007-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Epic Pharma Llc	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	214207-001	Dec 16, 2020	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Prinston Inc	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	207494-002	Nov 15, 2016	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Lupin	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	208741-005	Aug 11, 2023		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Lupin	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	208741-003	Aug 11, 2023		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Ajanta Pharma Ltd	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	211012-002	Sep 24, 2018		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	DORYX MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-007	May 20, 2016	⤷ Subscribe	⤷ Subscribe
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-006	Dec 19, 2014	⤷ Subscribe	⤷ Subscribe
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-005	Apr 11, 2013	⤷ Subscribe	⤷ Subscribe
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-002	May 6, 2005	⤷ Subscribe	⤷ Subscribe
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-003	Jun 20, 2008	⤷ Subscribe	⤷ Subscribe
Mayne Pharma	DORYX MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-008	May 20, 2016	⤷ Subscribe	⤷ Subscribe
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-004	Apr 11, 2013	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for doxycycline hyclate

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Country	Patent Number	Title	Estimated Expiration
Australia	2005299253	Improved tabletting process	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2006045152		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

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