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-two 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.

Summary for DOXYCYCLINE HYCLATE

International Patents:	2
US Patents:	5
Tradenames:	15
Applicants:	55
NDAs:	82
Drug Master File Entries:	28
Suppliers / Packagers:	74
Bulk Api Vendors:	137
Clinical Trials:	8
Patent Applications:	3,478
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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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 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

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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
Vintage Pharms	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	062538-001	Apr 7, 1986		DISCN	No	No	Start Trial	Start Trial				Start Trial
Mayne Pharma Inc	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	208765-001	Jun 14, 2017	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Actavis Elizabeth	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	090134-004	May 22, 2018	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Medicis	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE, DELAYED RELEASE;ORAL	065281-001	Dec 21, 2005		DISCN	No	No	Start Trial	Start Trial				Start Trial
Amneal Pharms Co	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	209372-002	Oct 6, 2017	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

International Patents for DOXYCYCLINE HYCLATE

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

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