DOXYCYCLINE HYCLATE Drug Patent Profile
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Which patents cover Doxycycline Hyclate, and when can generic versions of Doxycycline Hyclate launch?
Doxycycline Hyclate is a drug marketed by Pliva, Bausch, 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, Warner Chilcott, Watson Labs, Zhejiang Yongtai, Zydus Lifesciences, Endo Operations, Gland Pharma Ltd, Heritage, Lupin Ltd, Slate Run Pharma, West-ward Pharms Int, Actavis Elizabeth, Aurobindo Pharma Usa, Impax Labs Inc, Lupin, Prinston Inc, Rising, Zydus Pharms, Acella, Amneal, Amneal Pharms Co, Apotex, Avet Lifesciences, Caribe Holdings, Chartwell Molecular, Dr Reddys Labs Sa, Epic Pharma Llc, Heritage Pharma, Larken Labs, Mylan, Novel Labs Inc, Oryza, Praxgen, and Torrent. and is included in eighty-one NDAs.
The generic ingredient in DOXYCYCLINE HYCLATE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Doxycycline Hyclate
A generic version of DOXYCYCLINE HYCLATE was approved as doxycycline hyclate by CARIBE HOLDINGS on November 8th, 1982.
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Summary for DOXYCYCLINE HYCLATE
| US Patents: | 0 |
| Applicants: | 54 |
| NDAs: | 81 |
| Finished Product Suppliers / Packagers: | 65 |
| Raw Ingredient (Bulk) Api Vendors: | 194 |
| Clinical Trials: | 25 |
| Drug Prices: | Drug price information 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 |
See drug prices for DOXYCYCLINE HYCLATE
Recent Clinical Trials for DOXYCYCLINE HYCLATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chinese University of Hong Kong | Phase 4 |
| 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 |
Pharmacology for DOXYCYCLINE HYCLATE
| Drug Class | Tetracycline-class Drug |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impax Labs Inc | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 090505-001 | Dec 28, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alembic | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 211744-002 | Jun 30, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Warner Chilcott | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 062594-001 | Dec 5, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pvt Form | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 062631-002 | Jul 24, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 090431-001 | Dec 28, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
