Doxycycline hyclate - Generic Drug Details
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
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, Almirall, Teva, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Cadila, 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, Collagenex, Pfizer, Fresenius Kabi Usa, Rachelle, Hikma, Mylan Labs Ltd, Zydus Pharms, Par Sterile Products, West-ward Pharms Int, Den-mat, Actavis Elizabeth, Heritage Pharms, Impax Labs Inc, Mylan Pharms Inc, Prinston Inc, Rising, Acella, Amici, Amneal, Amneal Pharms Co, Apotex, Caribe Holdings, Chartwell Molecular, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Larken Labs, Lupin Ltd, Mayne Pharma Inc, Mylan, Novel Labs Inc, Praxgen, Chartwell Pharma, and Galderma Labs Lp, and is included in ninety-four 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 fifteen drug master file entries for doxycycline hyclate. Seventy suppliers are listed for this compound.
Summary for doxycycline hyclate
International Patents: | 2 |
US Patents: | 5 |
Tradenames: | 15 |
Applicants: | 62 |
NDAs: | 94 |
Drug Master File Entries: | 15 |
Finished Product Suppliers / Packagers: | 70 |
Raw Ingredient (Bulk) Api Vendors: | 184 |
Clinical Trials: | 24 |
Patent Applications: | 6,345 |
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 |
---|---|
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 |
The Jinnah Postgraduate Medical Centre, Karachi, Sindh 75510, Pakistan | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma Intl Pharms | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 062396-002 | Nov 7, 1984 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Cadila | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 207773-001 | Oct 30, 2017 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Pfizer | VIBRAMYCIN | doxycycline hyclate | CAPSULE;ORAL | 050007-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 | See Plans and Pricing | See Plans and Pricing |
Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-002 | May 6, 2005 | See Plans and Pricing | See Plans and Pricing |
Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-004 | Apr 11, 2013 | See Plans and Pricing | See Plans and Pricing |
>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 | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2006045152 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >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.