DOXYCYCLINE - Generic Drug Details

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, Cosette, Dr Reddys, Dr Reddys Labs Sa, Impax Labs Inc, Lupin, Lupin Ltd, Rising, Sandoz Inc, Strides Pharma, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell Rx, Galderma Labs Lp, Rachelle, Chartwell, Pfizer, Appco, Heritage Pharms, Lannett Co Inc, Sun Pharm Industries, Pliva, Mayne Pharma, Warner Chilcott, Bausch, Teva, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, Par Pharm, Pvt Form, Ranbaxy, Superpharm, Zhejiang Yongtai, Zydus Lifesciences, Collagenex, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, Endo Operations, Gland Pharma Ltd, West-ward Pharms Int, Den-mat, Actavis Elizabeth, Aurobindo Pharma Usa, Prinston Inc, Acella, Amneal, Amneal Pharms Co, Apotex, Avet Lifesciences, Caribe Holdings, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Pharmobedient, Praxgen, Torrent, and Chartwell Pharma, and is included in one hundred and twenty-nine NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Doxycycline has eighteen patent family members in eight countries.

There are twenty-eight drug master file entries for doxycycline. Forty-three suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for DOXYCYCLINE

International Patents:	18
US Patents:	10
Tradenames:	18
Applicants:	71
NDAs:	129
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	357
Patent Applications:	7,317
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
Kaohsiung Medical University Chung-Ho Memorial Hospital	N/A
Chiayi Christian Hospital	N/A
Taipei Veterans General Hospital, Taiwan	N/A

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

Anatomical Therapeutic Chemical (ATC) Classes for DOXYCYCLINE

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORACEA	Delayed-release Capsules	doxycycline	40 mg	050805	1	2008-12-12

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
Sun Pharm Industries	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	062676-002	Jul 10, 1986	AB	RX	No	No
Heritage Pharms	DOXYCYCLINE	doxycycline	TABLET;ORAL	091605-002	Dec 20, 2011	AB	RX	No	No
Alembic	DOXYCYCLINE	doxycycline	CAPSULE;ORAL	209165-002	Jul 28, 2017	AB	RX	No	No
West-ward Pharms Int	DOXYCYCLINE HYCLATE	doxycycline hyclate	INJECTABLE;INJECTION	062992-001	Feb 16, 1989	AP	RX	No	No
Heritage Pharms	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	200856-003	Apr 30, 2013	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
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006

EU/EMA Drug Approvals for DOXYCYCLINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Limited	Doxirobe	Doxycycline	EMEA/V/C/000044 Treatment of periodontal disease in dogs.Periodontal pocket probing depths >=4 mm are evidence of disease that may be responsive to treatment with the Doxirobe Gel. Use of this product as directed should result in attachment level gains, periodontal pocket depth reductions, local antimicrobial effect and improved gingival health. Noticeable improvements in these parameters should be evident within 2-4 weeks following treatment. The response in individual dogs is dependent on the severity of the condition and rigor of adjunctive therapy.	Withdrawn	no	no	no	1999-09-16

International Patents for DOXYCYCLINE

Country	Patent Number	Title	Estimated Expiration
Japan	5586123
Denmark	1615622
Canada	2894736	FORMULATIONS DE TETRACYCLINES EN DOSE QUOTIDIENNE UNIQUE (ONCE DAILY FORMULATIONS OF TETRACYCLINES)
Japan	5622773
Canada	2521885	FORMULATIONS DE TETRACYCLINES EN DOSE QUOTIDIENNE UNIQUE (ONCE DAILY FORMULATIONS OF TETRACYCLINES)