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 Pharms Ltd, Cosette, Impax Labs Inc, Lupin Ltd, Mayne Pharma Inc, Rising, Sandoz Inc, Strides Pharma, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell Rx, Galderma Labs Lp, Rachelle, Chartwell, Pfizer, Heritage Pharms, Lannett Co Inc, Mylan, Sun Pharm Industries, Pliva, Mayne Pharma Intl, Warner Chilcott, Bausch, Almirall, Teva, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Cadila, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, Par Pharm, Pvt Form, Ranbaxy, Superpharm, Zhejiang Yongtai, Collagenex, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, West-ward Pharms Int, Den-mat, Mayne Pharma, Actavis Elizabeth, Mylan Pharms Inc, Prinston Inc, Acella, Amici, Amneal, Amneal Pharms Co, Apotex, Caribe Holdings, Chartwell Molecular, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Larken Labs, Novel Labs Inc, Praxgen, and Chartwell Pharma, and is included in one hundred and twenty-one 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-six 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:	67
NDAs:	121
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	345
Patent Applications:	3,690
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
National University Hospital, Singapore	Phase 3
Hospital Queen Elizabeth, Malaysia	Phase 3
Tan Tock Seng Hospital	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

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
Alembic Pharms Ltd	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	210536-001	May 14, 2020		DISCN	No	No
Rising	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	209987-001	Oct 5, 2020		DISCN	No	No
Alembic Pharms Ltd	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	210527-001	Jun 13, 2018	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

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	2006522162
Japan	5586123
Japan	2010053155	METHOD OF TREATING ACNE