Doxycycline - Generic Drug Details

What are the generic drug sources for doxycycline and what is the scope of freedom to operate?

Doxycycline is the generic ingredient in eighteen branded drugs marketed by Alembic, Apotex, 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, Heritage, Lannett Co Inc, Somerset Theraps Llc, 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, Slate Run Pharma, West-ward Pharms Int, Den-mat, Actavis Elizabeth, Aurobindo Pharma Usa, Prinston Inc, Acella, Amneal, Amneal Pharms Co, Avet Lifesciences, Caribe Holdings, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Oryza, Praxgen, Torrent, and Chartwell Pharma, and is included in one hundred and thirty-three 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 five tentative approvals for this compound.

Summary for doxycycline

International Patents:	18
US Patents:	10
Tradenames:	18
Applicants:	72
NDAs:	133
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	364
Patent Applications:	6,809
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
Chinese University of Hong Kong	Phase 4
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit	Phase 2/Phase 3
Mahidol Oxford Tropical Medicine Research Unit	Phase 2/Phase 3

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
Watson Labs	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	061717-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Slate Run Pharma	DOXYCYCLINE HYCLATE	doxycycline hyclate	INJECTABLE;INJECTION	217685-002	Jun 21, 2024	AP	RX	No	No
Interpharm	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	062764-001	Sep 2, 1988		DISCN	No	No
Alembic	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	213075-003	Jan 3, 2022	AB	RX	No	No
Chartwell	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	062505-002	Jul 27, 2021	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
European Patent Office	1615622	FORMULATIONS DE DOXYCYCLINES EN DOSE QUOTIDIENNE UNIQUE (ONCE DAILY FORMULATIONS OF DOXYCYCLINES)
Denmark	2204168
Japan	5622773
Portugal	1615622
Canada	2803922	FORMULATIONS DE TETRACYCLINES EN DOSE QUOTIDIENNE UNIQUE (ONCE DAILY FORMULATIONS OF TETRACYCLINES)