Doxycycline hyclate - Generic Drug Details
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What are the generic drug 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, Changzhou Pharm, Chartwell, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Nesher Pharms, Nostrum Labs Inc, 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, Gland Pharma Ltd, Par Sterile Products, West-ward Pharms Int, Den-mat, Actavis Elizabeth, Aurobindo Pharma Usa, Heritage Pharms, Impax Labs Inc, Lupin, Prinston Inc, Rising, Acella, Amneal, Amneal Pharms Co, Apotex, Avet Lifesciences, Caribe Holdings, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Larken Labs, Lupin Ltd, Mylan, Novel Labs Inc, Pharmobedient, Praxgen, Chartwell Pharma, and Galderma Labs Lp, and is included in ninety-six 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.
There are fifteen drug master file entries for doxycycline hyclate. Seventy-two suppliers are listed for this compound.
Summary for doxycycline hyclate
International Patents: | 2 |
US Patents: | 4 |
Tradenames: | 15 |
Applicants: | 64 |
NDAs: | 96 |
Drug Master File Entries: | 15 |
Finished Product Suppliers / Packagers: | 72 |
Raw Ingredient (Bulk) Api Vendors: | 194 |
Clinical Trials: | 24 |
Patent Applications: | 6,373 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for doxycycline hyclate |
Drug Sales Revenues: | Drug sales revenues for doxycycline hyclate |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for doxycycline hyclate |
What excipients (inactive ingredients) are in doxycycline hyclate? | doxycycline hyclate excipients list |
DailyMed Link: | doxycycline hyclate at DailyMed |
Recent Clinical Trials for doxycycline hyclate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou, China | Phase 1/Phase 2 |
The Jinnah Postgraduate Medical Centre, Rafiqui، Sarwar Shaheed Rd, Karachi Cantonment, Karachi, Karachi City, Sindh 75510 | Phase 1/Phase 2 |
University of Karachi | Phase 1/Phase 2 |
Pharmacology for doxycycline hyclate
Drug Class | Tetracycline-class Drug |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rachelle | DOXYCHEL HYCLATE | doxycycline hyclate | INJECTABLE;INJECTION | 061953-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Actavis Elizabeth | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 090134-004 | May 22, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Prinston Inc | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 207494-003 | Feb 19, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Alembic | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 213075-004 | Jan 3, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Zydus Pharms | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 206772-002 | Dec 21, 2018 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Lupin | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 208741-001 | Aug 11, 2023 | DISCN | 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 |
Expired US Patents for doxycycline hyclate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-006 | Dec 19, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-003 | Jun 20, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-005 | Apr 11, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Mayne Pharma | DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-007 | May 20, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-002 | May 6, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-001 | May 6, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for doxycycline hyclate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2005299253 | Improved tabletting process | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2006045152 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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