DrugPatentWatch Database Preview
Doxycycline hyclate - Generic Drug Details
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 Intl, Warner Chilcott, Bausch, Almirall, Teva, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Changzhou Pharm, Chartwell, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Mylan, Nostrum Labs Inc, Par Pharm, Pvt Form, Ranbaxy, Sun Pharm Industries, Superpharm, Watson Labs, Zhejiang Yongtai, Zydus Pharms, Collagenex, Pfizer, Fresenius Kabi Usa, Rachelle, Mylan Labs Ltd, West-ward Pharms Int, Den-mat, Mayne Pharma, Actavis Elizabeth, Heritage Pharms Inc, Impax Labs Inc, Mylan Pharms Inc, Prinston Inc, Acella, Amneal Pharms Co, Apotex, Cadila, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Lannett Co Inc, Larken Labs, Lupin Ltd, Mayne Pharma Inc, Novel Labs Inc, Oryza, Vintage Pharms, Chartwell Pharma, and Galderma Labs Lp, and is included in eighty-nine NDAs. There are five 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 twenty-eight drug master file entries for doxycycline hyclate. Seventy-three suppliers are listed for this compound.
Summary for doxycycline hyclate
| International Patents: | 2 |
| US Patents: | 5 |
| Tradenames: | 15 |
| Applicants: | 57 |
| NDAs: | 89 |
| Drug Master File Entries: | 28 |
| Finished Product Suppliers / Packagers: | 73 |
| Raw Ingredient (Bulk) Api Vendors: | 101 |
| Clinical Trials: | 13 |
| Patent Applications: | 7,167 |
| 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 |
|---|---|
| University of Pennsylvania | Phase 4 |
| Canadian Institutes of Health Research (CIHR) | Phase 2/Phase 3 |
| Jonathan Troy Grennan | Phase 2/Phase 3 |
Pharmacology for doxycycline hyclate
| Drug Class | Tetracycline-class Drug |
Paragraph IV (Patent) Challenges for DOXYCYCLINE HYCLATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2017-09-28 |
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2017-09-28 |
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2015-11-05 |
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2015-11-05 |
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2015-07-01 |
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2015-07-01 |
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2014-05-19 |
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2014-05-19 |
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2008-12-19 |
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novel Labs Inc | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 207558-001 | Sep 6, 2017 | AB | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Par Pharm | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 062442-001 | Dec 22, 1983 | DISCN | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Heather | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 062463-001 | Dec 7, 1983 | DISCN | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Emcure Pharms Ltd | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 209969-001 | Nov 9, 2018 | AB | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Mayne Pharma | DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-007 | May 20, 2016 | DISCN | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Hikma Intl Pharms | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 062396-002 | Nov 7, 1984 | AB | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for doxycycline hyclate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2006045152 | ⤷ Try it Free |
| Australia | 2005299253 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2021 - 2022
NCE-1 Patent Challenge Dates 2021 - 2022
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2021, www.DrugPatentWatch.com.
Follow DrugPatentWatch:
