doxycycline hyclate - Profile
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What are the generic sources for doxycycline hyclate and what is the scope of freedom to operate?
Doxycycline hyclate
is the generic ingredient in fifteen branded drugs marketed by Pliva, Mayne Pharma, Warner Chilcott, Bausch, Chartwell Rx, Teva, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Bionpharma, Changzhou Pharm, Chartwell, Halsey, Heather, Hikma Intl Pharms, Interpharm, Macleods Pharms Ltd, Mutual Pharm, Nesher Pharms, Par Pharm, Pvt Form, Ranbaxy, Strides Pharma, Sun Pharm Industries, Superpharm, Watson Labs, Zhejiang Yongtai, Zydus Lifesciences, Collagenex, Pfizer, Fresenius Kabi Usa, Rachelle, Hikma, Mylan Labs Ltd, Zydus Pharms, Amneal, Aspiro, Avet Lifesciences, Dr Reddys, Gland, Heritage, Kindos, Lupin, Ph Health, Precision Dose Inc, Slate Run Pharma, Steriscience, West-ward Pharms Int, Den-mat, Actavis Elizabeth, Aurobindo Pharma Usa, Impax Labs Inc, Prinston Inc, Rising, Acella, Amneal Pharms Co, Apotex, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Mylan, Novel Labs Inc, Oryza, Pharmobedient, Praxgen, Strides Pharma Intl, Torrent, Chartwell Pharma, and Galderma Labs Lp, and is included in one hundred and ten NDAs. There are four patents protecting this compound and seven Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Doxycycline hyclate has two patent family members in two countries.
Summary for doxycycline hyclate
| International Patents: | 2 |
| US Patents: | 4 |
| Tradenames: | 15 |
| Applicants: | 71 |
| NDAs: | 110 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for doxycycline hyclate |
Paragraph IV (Patent) Challenges for DOXYCYCLINE HYCLATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| DORYX MPC | Delayed-release Tablets | doxycycline hyclate | 60 mg and 120 mg | 050795 | 1 | 2017-09-28 |
| DORYX MPC | Delayed-release Tablets | doxycycline hyclate | 50 mg | 050795 | 1 | 2015-11-05 |
| DORYX MPC | Delayed-release Tablets | doxycycline hyclate | 80 mg | 050795 | 1 | 2015-07-01 |
| DORYX MPC | Delayed-release Tablets | doxycycline hyclate | 200 mg | 050795 | 1 | 2014-05-19 |
| DORYX MPC | Delayed-release Tablets | doxycycline hyclate | 150 mg | 050795 | 1 | 2008-12-19 |
US Patents and Regulatory Information for doxycycline hyclate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pliva | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE, COATED PELLETS;ORAL | 063187-001 | Jun 30, 1992 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mayne Pharma | DORYX | doxycycline hyclate | CAPSULE, DELAYED RELEASE;ORAL | 050582-002 | Aug 13, 2001 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mayne Pharma | DORYX | doxycycline hyclate | CAPSULE, DELAYED RELEASE;ORAL | 050582-001 | Jul 22, 1985 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Warner Chilcott | DORYX | doxycycline hyclate | CAPSULE, DELAYED RELEASE;ORAL | 062653-001 | Oct 30, 1985 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bausch | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE, DELAYED RELEASE;ORAL | 065281-001 | Dec 21, 2005 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bausch | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE, DELAYED RELEASE;ORAL | 065281-002 | Dec 21, 2005 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Chartwell Rx | ACTICLATE CAP | doxycycline hyclate | CAPSULE;ORAL | 208253-001 | Apr 26, 2016 | DISCN | Yes | 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 hyclate
International Patents for doxycycline hyclate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2005299253 | Improved tabletting process | ⤷ Start Trial |
| World Intellectual Property Organization (WIPO) | 2006045152 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Doxycycline Hyclate: Investment Scenario, Market Dynamics, and Financial Trajectory
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