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Doxycycline - Generic Drug Details

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What are the generic drug sources for doxycycline and what is the scope of patent protection?

Doxycycline is the generic ingredient in eighteen branded drugs marketed by Alembic Pharms Ltd, Cosette, Impax Labs Inc, Lupin Ltd, Mayne Pharma Inc, Mylan Pharms Inc, Par Pharm, Sandoz Inc, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell Rx, Galderma Labs Lp, Rachelle, Chartwell Life Sci, Pfizer, Heritage Pharms Inc, Lannett Co Inc, Mylan, Sun Pharm Industries, Pliva, Mayne Pharma Intl, Warner Chilcott, Medicis, Almirall, Teva, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nostrum Labs Inc, Pvt Form, Ranbaxy, Superpharm, Zhejiang Yongtai, Collagenex, Fresenius Kabi Usa, Mylan Labs Ltd, West-ward Pharms Int, Den-mat, Mayne Pharma, Actavis Elizabeth, Prinston Inc, Acella, Amneal Pharms Co, Apotex, Cadila, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Larken Labs, Novel Labs Inc, Vintage Pharms, and Chartwell Pharma, and is included in one hundred and fifteen NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Doxycycline has thirty-seven patent family members in thirteen countries.

There are twenty-eight drug master file entries for doxycycline. Thirty-eight suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for doxycycline

International Patents:	37
US Patents:	16
Tradenames:	18
Applicants:	60
NDAs:	115
Drug Master File Entries:	28
Suppliers / Packagers:	38
Bulk Api Vendors:	46
Clinical Trials:	296
Patent Applications:	7,057
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for doxycycline
Drug Sales Revenues:	Drug sales revenues for doxycycline
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for doxycycline
What excipients (inactive ingredients) are in doxycycline?	doxycycline excipients list
DailyMed Link:	doxycycline at DailyMed

See drug prices for doxycycline

See drug sales revenues for doxycycline

Recent Clinical Trials for doxycycline

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

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

See all doxycycline clinical trials

Generic filers with tentative approvals for DOXYCYCLINE

Applicant	Application No.	Strength	Dosage Form
		40MG	CAPSULE;ORAL
		40MG	CAPSULE; ORAL
		40MG	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for doxycycline

Drug Class

Tetracycline-class Drug

Medical Subject Heading (MeSH) Categories for doxycycline

Anti-Bacterial Agents

Antimalarials

Paragraph IV (Patent) Challenges for DOXYCYCLINE

Tradename	Dosage	Ingredient	NDA	Submissiondate
ORACEA	CAPSULE;ORAL	doxycycline	050805	2008-12-12
ORACEA	CAPSULE;ORAL	doxycycline	050805	2008-12-11

US Patents and Regulatory Information for doxycycline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Halsey	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	062119-002	May 24, 1985		DISCN	No	No
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-006	Dec 19, 2014	AB	RX	Yes	No			Y
Superpharm	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	062469-001	Oct 31, 1984		DISCN	No	No
Chartwell Life Sci	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	062505-001	Sep 11, 1984	AB	RX	No	No

Expired US Patents for doxycycline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006

International Patents for doxycycline

Country	Patent Number	Estimated Expiration
Japan	5586123
Canada	2521885
Spain	2534827
World Intellectual Property Organization (WIPO)	02080932