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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 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 Rx, Galderma Labs Lp, Rachelle, Chartwell Life Sci, Pfizer, Heritage Pharms Inc, Lannett Co Inc, Mylan, Sun Pharm Industries, Pliva, Mayne Pharma Intl, Warner Chilcott, Medicis, Almirall, Teva, 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, Zhejiang Yongtai, Collagenex, Fresenius Kabi Usa, Mylan Labs Ltd, West-ward Pharms Int, Den-mat, Mayne Pharma, 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, Vintage Pharms, and Chartwell Pharma, and is included in one hundred and fifteen 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-eight 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: | 60 |
NDAs: | 115 |
Drug Master File Entries: | 28 |
Suppliers / Packagers: | 38 |
Bulk Api Vendors: | 46 |
Clinical Trials: | 296 |
Patent Applications: | 7,057 |
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 |
Recent Clinical Trials for doxycycline
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Pennsylvania | Phase 4 |
University of Karachi | Phase 1/Phase 2 |
The Jinnah Postgraduate Medical Centre, Rafiqui، Sarwar Shaheed Rd, Karachi Cantonment, Karachi, Karachi City, Sindh 75510 | Phase 1/Phase 2 |
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.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Halsey | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 062119-002 | May 24, 1985 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-006 | Dec 19, 2014 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
Superpharm | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 062469-001 | Oct 31, 1984 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Chartwell Life Sci | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 062505-001 | Sep 11, 1984 | AB | RX | No | No | 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 |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for doxycycline
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 5586123 | Start Trial |
Canada | 2521885 | Start Trial |
Spain | 2534827 | Start Trial |
World Intellectual Property Organization (WIPO) | 02080932 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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