Doxepin hydrochloride - Generic Drug Details
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What are the generic sources for doxepin hydrochloride and what is the scope of freedom to operate?
Doxepin hydrochloride
is the generic ingredient in four branded drugs marketed by Adaptis, Aiping Pharm Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Dava Pharms Inc, Endo Operations, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading, Mankind Pharma, Micro Labs, MSN, Mylan Pharms Inc, New River, Pts Consulting, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro, Velzen Pharma Pvt, Watson Labs, Watson Labs Teva, Zydus Lifesciences, Pfizer, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Amneal, Mylan, Actavis Elizabeth, Rk Pharma, Strides Pharma, and Currax, and is included in eighty-one NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Doxepin hydrochloride has sixteen patent family members in four countries.
There is one drug master file entry for doxepin hydrochloride. Fifty suppliers are listed for this compound.
Summary for doxepin hydrochloride
International Patents: | 16 |
US Patents: | 16 |
Tradenames: | 4 |
Applicants: | 39 |
NDAs: | 81 |
Drug Master File Entries: | 1 |
Finished Product Suppliers / Packagers: | 50 |
Raw Ingredient (Bulk) Api Vendors: | 90 |
Clinical Trials: | 22 |
Patent Applications: | 2,094 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for doxepin hydrochloride |
What excipients (inactive ingredients) are in doxepin hydrochloride? | doxepin hydrochloride excipients list |
DailyMed Link: | doxepin hydrochloride at DailyMed |
Recent Clinical Trials for doxepin hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Nanfang Hospital, Southern Medical University | N/A |
E2Bio Life Sciences, LLC | Phase 1/Phase 2 |
Hematology Center after Prof. R. Yeolyan | Phase 1/Phase 2 |
Pharmacology for doxepin hydrochloride
Drug Class | Tricyclic Antidepressant |
Medical Subject Heading (MeSH) Categories for doxepin hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for doxepin hydrochloride
Paragraph IV (Patent) Challenges for DOXEPIN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SILENOR | Tablets | doxepin hydrochloride | 3 mg and 6 mg | 022036 | 2 | 2010-09-16 |
US Patents and Regulatory Information for doxepin hydrochloride
Expired US Patents for doxepin hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | 6,217,909 | ⤷ Try for Free |
New River | DOXEPIN HYDROCHLORIDE | doxepin hydrochloride | CAPSULE;ORAL | 016987-006 | Approved Prior to Jan 1, 1982 | 3,420,851 | ⤷ Try for Free |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | 5,502,047 | ⤷ Try for Free |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | 6,217,909 | ⤷ Try for Free |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | 6,211,229 | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for doxepin hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2009537554 | ⤷ Try for Free | |
World Intellectual Property Organization (WIPO) | 2007136845 | ⤷ Try for Free | |
Japan | 2009537553 | ⤷ Try for Free | |
Japan | 2016041757 | 睡眠改善のための低用量ドキセピンの使用法 (METHODS OF USING LOW DOSE DOXEPIN FOR SLEEP IMPROVEMENT) | ⤷ Try for Free |
European Patent Office | 2026792 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for Doxepin Hydrochloride
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