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Last Updated: October 29, 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, Den-mat, 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-five 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-two suppliers are listed for this compound.

Summary for doxycycline hyclate

International Patents:	2
US Patents:	5
Tradenames:	15
Applicants:	55
NDAs:	85
Drug Master File Entries:	28
Suppliers / Packagers:	72
Bulk Api Vendors:	81
Clinical Trials:	11
Patent Applications:	3,697
Formulation / Manufacturing:	see details
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
DailyMed Link:	doxycycline hyclate at DailyMed

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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

Sponsor	Phase
University of Pennsylvania	Phase 4
University of Iowa	Phase 2
Galderma R&D	Phase 4

See all doxycycline hyclate clinical trials

Pharmacology for doxycycline hyclate

Drug Class	Tetracycline-class Drug

Paragraph IV (Patent) Challenges for DOXYCYCLINE HYCLATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
DORYX	TABLET, DELAYED RELEASE;ORAL	doxycycline hyclate	050795	2017-09-28
DORYX MPC	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 MPC	TABLET, DELAYED RELEASE;ORAL	doxycycline hyclate	050795	2015-07-01
DORYX	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

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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
Galderma Labs Lp	PERIOSTAT	doxycycline hyclate	TABLET;ORAL	050783-001	Feb 2, 2001		DISCN	Yes	No	Start Trial	Start Trial				Start Trial
Mylan Labs Ltd	DOXYCYCLINE	doxycycline hyclate	INJECTABLE;INJECTION	091406-001	Aug 21, 2012	AP	RX	No	No	Start Trial	Start Trial				Start Trial
Teva	DOXY-LEMMON	doxycycline hyclate	CAPSULE;ORAL	062497-001	Aug 23, 1984		DISCN	No	No	Start Trial	Start Trial				Start Trial
Mayne Pharma	DORYX MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-008	May 20, 2016		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Superpharm	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	062469-002	Oct 31, 1984		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
Chartwell Pharma	LYMEPAK	doxycycline hyclate	TABLET;ORAL	209844-001	Jun 15, 2018		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

International Patents for doxycycline hyclate

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006045152	Start Trial
Australia	2005299253	Start Trial
>Country	>Patent Number	>Estimated 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.

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