RANITIDINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Ranitidine Hydrochloride, and what generic alternatives are available?
Ranitidine Hydrochloride is a drug marketed by Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Dr Reddys Labs Ltd, Mylan, Novitium Pharma, Sandoz, Teva, Bedford, Hikma, Mylan Labs Ltd, Zydus Pharms Usa Inc, Actavis Mid Atlantic, Amneal Pharms, Apotex Inc, Epic Pharma Llc, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Taro, Tolmar, Torrent, Wockhardt, Amneal Pharms Ny, Ani Pharms, Apotex, Boehringer Ingelheim, Contract Pharmacal, Dr Reddys Labs Inc, Glenmark Pharms Inc, Granules, Heritage Pharma Avet, Par Pharm, Perrigo, Perrigo R And D, Strides Pharma, Sun Pharm Inds Ltd, Thinq Pharm-cro Pvt, 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. Thirteen suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
DrugPatentWatch® 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.
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Summary for RANITIDINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 42 |
| NDAs: | 75 |
| Finished Product Suppliers / Packagers: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 169 |
| Clinical Trials: | 140 |
| Patent Applications: | 1,103 |
| DailyMed Link: | RANITIDINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for RANITIDINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kasr El Aini Hospital | N/A |
| Menoufia University | Phase 2/Phase 3 |
| Cairo University | N/A |
Pharmacology for RANITIDINE HYDROCHLORIDE
| Drug Class | Histamine-2 Receptor Antagonist |
| Mechanism of Action | Histamine H2 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for RANITIDINE HYDROCHLORIDE
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 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Wockhardt | RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | TABLET;ORAL | 078884-001 | Jul 31, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ani Pharms | RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | TABLET;ORAL | 075296-001 | Jan 14, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ranbaxy | RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | SYRUP;ORAL | 078448-001 | Dec 13, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Strides Pharma | RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | TABLET;ORAL | 205512-001 | Aug 22, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex Inc | RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | TABLET;ORAL | 200172-001 | May 31, 2012 | 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 |
