doxycycline - Profile
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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 Aiping Pharm Inc, Alembic, Apotex, Cosette, Dr Reddys, Dr Reddys Labs Sa, Impax Labs Inc, Lupin, Lupin Ltd, Macleods Pharms Ltd, Prinston Inc, Rising, Sandoz Inc, Strides Pharma, Strides Pharma Intl, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell Rx, Galderma Labs Lp, Rachelle, Chartwell, Pfizer, Heritage, Lannett Co Inc, Sun Pharm Industries, Pliva, Mayne Pharma, Warner Chilcott, Bausch, Teva, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Bionpharma, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Par Pharm, Pvt Form, Ranbaxy, Superpharm, Zhejiang Yongtai, Zydus Lifesciences, Collagenex, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, Amneal, Aspiro, Avet Lifesciences, Gland, Kindos, Ph Health, Precision Dose Inc, Slate Run Pharma, Steriscience, West-ward Pharms Int, Den-mat, Actavis Elizabeth, Aurobindo Pharma Usa, Acella, Amneal Pharms Co, Chartwell Molecular, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Oryza, Pharmobedient, Praxgen, Torrent, and Chartwell Pharma, and is included in one hundred and forty-five NDAs. There are five 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 five tentative approvals for this compound.
Summary for doxycycline
| International Patents: | 18 |
| US Patents: | 5 |
| Tradenames: | 18 |
| Applicants: | 77 |
| NDAs: | 145 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for doxycycline |
Generic filers with tentative approvals for DOXYCYCLINE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 40MG | CAPSULE;ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 40MG | CAPSULE; ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 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.
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
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 | ⤷ Start Trial | ⤷ Start Trial |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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/000044Treatment 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
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2803922 | FORMULATIONS DE TETRACYCLINES EN DOSE QUOTIDIENNE UNIQUE (ONCE DAILY FORMULATIONS OF TETRACYCLINES) | ⤷ Start Trial |
| Poland | 2204168 | ⤷ Start Trial | |
| European Patent Office | 1615622 | FORMULATIONS DE DOXYCYCLINES EN DOSE QUOTIDIENNE UNIQUE (ONCE DAILY FORMULATIONS OF DOXYCYCLINES) | ⤷ Start Trial |
| European Patent Office | 2204168 | formulations de tetracyclines en dose quotidienne unique (Once daily formulations of tetracyclines) | ⤷ Start Trial |
| Canada | 2894736 | FORMULATIONS DE TETRACYCLINES EN DOSE QUOTIDIENNE UNIQUE (ONCE DAILY FORMULATIONS OF TETRACYCLINES) | ⤷ Start Trial |
| Japan | 2006522162 | ⤷ Start Trial | |
| Japan | 2012144554 | ONCE-DAILY FORMULATION OF TETRACYCLINE | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Doxycycline Investment Scenario and Fundamentals Analysis
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