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DOXYCYCLINE Drug 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 Pharms Ltd, Cosette, Impax Labs Inc, Lupin Ltd, Mayne Pharma Inc, Mylan Pharms Inc, Par Pharm, Sandoz Inc, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell Life Sci, Mylan Labs Ltd, West-ward Pharms Int, Heritage Pharms Inc, Lannett Co Inc, Mylan, Sun Pharm Industries, Pliva, Medicis, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nostrum Labs Inc, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Actavis Elizabeth, Prinston Inc, Acella, Amneal Pharms Co, Apotex, Cadila, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Larken Labs, Novel Labs Inc, and Vintage Pharms. and is included in ninety-four NDAs.
The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-five 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: | 48 |
| NDAs: | 94 |
| Suppliers / Packagers: | 37 |
| Bulk Api Vendors: | 46 |
| Clinical Trials: | 296 |
| Patent Applications: | 4,594 |
| 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 |
|---|---|
| University of Pennsylvania | Phase 4 |
| Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou Avenue, Tianyuan District, Zhuzhou, China | Phase 1/Phase 2 |
| University of Karachi | Phase 1/Phase 2 |
Pharmacology for DOXYCYCLINE
| Drug Class | Tetracycline-class Drug |
Medical Subject Heading (MeSH) Categories for DOXYCYCLINE
Paragraph IV (Patent) Challenges for DOXYCYCLINE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ORACEA | CAPSULE;ORAL | doxycycline | 050805 | 2008-12-12 |
| ORACEA | CAPSULE;ORAL | doxycycline | 050805 | 2008-12-11 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ajanta Pharma Ltd | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 211012-001 | Sep 24, 2018 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sun Pharm Industries | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 062676-002 | Jul 10, 1986 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lannett Co Inc | DOXYCYCLINE | doxycycline | TABLET;ORAL | 065285-001 | Dec 8, 2005 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| West-ward Pharms Int | DOXYCYCLINE | doxycycline hyclate | INJECTABLE;INJECTION | 062569-001 | Mar 9, 1988 | AP | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
