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Last Updated: April 25, 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.

Summary for doxycycline hyclate

International Patents:	2
US Patents:	4
Tradenames:	15
Applicants:	64
NDAs:	96
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	72
Raw Ingredient (Bulk) Api Vendors:	194
Clinical Trials:	24
Patent Applications:	6,373
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
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
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
The Jinnah Postgraduate Medical Centre, Karachi, Sindh 75510, Pakistan	Phase 1/Phase 2

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	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
Superpharm	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	062469-001	Oct 31, 1984		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Heather	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	062463-001	Dec 7, 1983		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chartwell	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	062500-001	Sep 11, 1984	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Superpharm	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	062494-001	Feb 20, 1985		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mayne Pharma	DORYX MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-008	May 20, 2016		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Ajanta Pharma Ltd	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	211012-002	Sep 24, 2018		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Impax Labs Inc	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	090505-002	Dec 28, 2010		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

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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	⤷ Try a Trial	⤷ Try a Trial
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-004	Apr 11, 2013	⤷ 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	050795-006	Dec 19, 2014	⤷ 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	050795-008	May 20, 2016	⤷ 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
>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
World Intellectual Property Organization (WIPO)	2006045152		⤷ Try a Trial
Australia	2005299253	Improved tabletting process	⤷ Try a Trial
>Country	>Patent Number	>Title	>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.