DOXYCYCLINE Drug Patent Profile
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When do Doxycycline patents expire, and when can generic versions of Doxycycline launch?
Doxycycline is a drug marketed by Alembic, Cosette, Dr Reddys Labs Sa, Impax Labs Inc, Lupin Ltd, Rising, Sandoz Inc, Strides Pharma, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell, Hikma, Mylan Labs Ltd, Appco, Heritage Pharms, Lannett Co Inc, Sun Pharm Industries, Pliva, Bausch, 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, Warner Chilcott, Zhejiang Yongtai, Zydus Lifesciences, Gland Pharma Ltd, Par Sterile Products, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Lupin, 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, and Praxgen. and is included in one hundred and three NDAs.
The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Doxycycline
A generic version of DOXYCYCLINE was approved as doxycycline hyclate by CARIBE HOLDINGS on November 8th, 1982.
Summary for DOXYCYCLINE
| US Patents: | 0 |
| Applicants: | 59 |
| NDAs: | 103 |
| Finished Product Suppliers / Packagers: | 39 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Clinical Trials: | 354 |
| Patent Applications: | 2,449 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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
Recent Clinical Trials for DOXYCYCLINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ministry of Health, France | Phase 3 |
| Assistance Publique Hopitaux De Marseille | Phase 3 |
| Hôpital Necker-Enfants Malades | Phase 3 |
Pharmacology for DOXYCYCLINE
| Drug Class | Tetracycline-class Drug |
Medical Subject Heading (MeSH) Categories for DOXYCYCLINE
Anatomical Therapeutic Chemical (ATC) Classes for DOXYCYCLINE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE, DELAYED RELEASE;ORAL | 065281-002 | Dec 21, 2005 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pvt Form | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 062631-002 | Jul 24, 1986 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Appco | DOXYCYCLINE | doxycycline | TABLET;ORAL | 065377-002 | Nov 7, 2006 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin Ltd | DOXYCYCLINE | doxycycline | FOR SUSPENSION;ORAL | 201678-001 | Mar 18, 2013 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Amneal Pharms Co | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 209372-001 | Oct 6, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Acella | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 210664-001 | Mar 16, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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/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 |
