DrugPatentWatch Database Preview
RANITIDINE HYDROCHLORIDE Drug Profile
» See Plans and Pricing
Which patents cover Ranitidine Hydrochloride, and what generic alternatives are available?
Ranitidine Hydrochloride is a drug marketed by Ajanta Pharma Ltd, Appco, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Mylan, Novitium Pharma, Sandoz, Teva, Bedford, Mylan Labs Ltd, West-ward Pharms Int, Zydus Pharms Usa Inc, Actavis Mid Atlantic, Akorn, Amneal Pharms, Anda Repository, Apotex Inc, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Taro, Torrent, Wockhardt, Amneal Pharms Ny, Ani Pharms Inc, Apotex, Boehringer Ingelheim, Contract Pharmacal, Dr Reddys Labs Inc, Glenmark Pharms Inc, Granules, Heritage Pharma, Par Pharm, Perrigo, Perrigo R And D, Strides Pharma, Sun Pharm Inds Ltd, Unique Pharm Labs, Vkt Pharma, Watson Labs, and Wockhardt Ltd. and is included in seventy-five NDAs.
The generic ingredient in RANITIDINE HYDROCHLORIDE is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Eighty-seven suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Ranitidine Hydrochloride
A generic version of RANITIDINE HYDROCHLORIDE was approved as ranitidine hydrochloride by SANDOZ on August 29th, 1997.
Summary for RANITIDINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 42 |
| NDAs: | 75 |
| Suppliers / Packagers: | 83 |
| Bulk Api Vendors: | 127 |
| Clinical Trials: | 117 |
| Patent Applications: | 2,037 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | RANITIDINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for RANITIDINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Sao Paulo General Hospital | Phase 3 |
| National Cancer Institute (NCI) | Phase 1 |
| City of Hope Medical Center | Phase 1 |
Pharmacology for RANITIDINE HYDROCHLORIDE
| Drug Class | Histamine-2 Receptor Antagonist |
| Mechanism of Action | Histamine H2 Receptor Antagonists |
US Patents and Regulatory Information for RANITIDINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Pharm | RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | TABLET;ORAL | 075180-001 | Jan 28, 1999 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Wockhardt | RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | TABLET;ORAL | 078884-001 | Jul 31, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Ani Pharms Inc | RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | TABLET;ORAL | 075296-001 | Jan 14, 2000 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Pharm Assoc | RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | SYRUP;ORAL | 077405-001 | Sep 21, 2007 | AA | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Strides Pharma | RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | TABLET;ORAL | 205512-001 | Aug 22, 2016 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
