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, 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, Kindos, Slate Run Pharma, West-ward Pharms Int, Den-mat, Actavis Elizabeth, Aurobindo Pharma Usa, Prinston Inc, Acella, Amneal, Amneal Pharms Co, Avet Lifesciences, 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-four 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-two 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:	134
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	364
Patent Applications:	6,734
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

Drug Sales Revenue Trends 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
Mahidol Oxford Tropical Medicine Research Unit	Phase 2/Phase 3
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit	Phase 2/Phase 3

See all doxycycline clinical trials

Generic filers with tentative approvals for DOXYCYCLINE

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

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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
Somerset Theraps Llc	DOXYCYCLINE	doxycycline	TABLET;ORAL	065377-003	Nov 7, 2006		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Sandoz Inc	DOXYCYCLINE	doxycycline	TABLET;ORAL	065353-003	Nov 27, 2006		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
West-ward Pharms Int	DOXYCYCLINE HYCLATE	doxycycline hyclate	INJECTABLE;INJECTION	062992-001	Feb 16, 1989	AP	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Strides Pharma	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	062337-002	Mar 29, 1982		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Par Pharm	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	062442-001	Dec 22, 1983		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Warner Chilcott	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	062593-001	Aug 28, 1985		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	8,394,406	⤷ Subscribe
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	10,058,564	⤷ Subscribe
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	8,470,364	⤷ Subscribe
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	8,603,506	⤷ Subscribe
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	8,394,405	⤷ Subscribe
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	7,211,267	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for doxycycline

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for doxycycline

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Country	Patent Number	Title	Estimated Expiration
Spain	2534827		⤷ Subscribe
World Intellectual Property Organization (WIPO)	2004091483		⤷ Subscribe
Denmark	2204168		⤷ Subscribe
Canada	2521885	FORMULATIONS DE TETRACYCLINES EN DOSE QUOTIDIENNE UNIQUE (ONCE DAILY FORMULATIONS OF TETRACYCLINES)	⤷ Subscribe
Japan	5586123		⤷ Subscribe
Portugal	2204168		⤷ Subscribe
>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.