GEMCITABINE HYDROCHLORIDE Drug Patent Profile
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When do Gemcitabine Hydrochloride patents expire, and when can generic versions of Gemcitabine Hydrochloride launch?
Gemcitabine Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Inc, Actavis Totowa, Am Regent, Apotex, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hameln Rds Gmbh, Hikma, Hikma Intl Pharms, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Norvium Bioscience, Novast Labs, Sagent Pharms, Sagent Pharms Inc, Shilpa, Sun Pharm, Teva Pharms, and Teyro Labs. and is included in thirty NDAs.
The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Gemcitabine Hydrochloride
A generic version of GEMCITABINE HYDROCHLORIDE was approved as gemcitabine hydrochloride by HOSPIRA INC on November 15th, 2010.
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Summary for GEMCITABINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 25 |
| NDAs: | 30 |
| Finished Product Suppliers / Packagers: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 103 |
| Clinical Trials: | 2,804 |
| Patent Applications: | 8,044 |
| DailyMed Link: | GEMCITABINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for GEMCITABINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lee Ocuin, MD | Phase 2 |
| Merck Sharp & Dohme LLC | Phase 2 |
| Medizinische Hochschule Hannover, Germany, Prof. Dr. Arndt Vogel | Phase 2 |
Pharmacology for GEMCITABINE HYDROCHLORIDE
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for GEMCITABINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for GEMCITABINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| GEMZAR | For Injection | gemcitabine hydrochloride | 1g/vial | 020509 | 1 | 2005-11-14 |
| GEMZAR | For Injection | gemcitabine hydrochloride | 200 mg/vial | 020509 | 1 | 2005-11-01 |
US Patents and Regulatory Information for GEMCITABINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | SOLUTION;INTRAVENOUS | 209604-001 | Aug 3, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Meitheal | GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 212129-002 | Dec 11, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma Intl Pharms | GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 206617-001 | Jun 25, 2021 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Norvium Bioscience | GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 200145-001 | Jul 25, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Shilpa | GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 210991-003 | Oct 4, 2019 | AP | RX | 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 |
