Norethindrone - Generic Drug Details
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What are the generic drug sources for norethindrone and what is the scope of freedom to operate?
Norethindrone
is the generic ingredient in thirteen branded drugs marketed by Parke Davis, Dr Reddys Labs Sa, Aurobindo Pharma, Glenmark Generics, Lupin Ltd, Janssen Pharms, Teva Branded Pharm, Amneal Pharms, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Duramed Res, Aurobindo Pharma Ltd, and Barr, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-six drug master file entries for norethindrone. Fourteen suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for norethindrone
US Patents: | 0 |
Tradenames: | 13 |
Applicants: | 14 |
NDAs: | 25 |
Drug Master File Entries: | 26 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 85 |
Patent Applications: | 6,322 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for norethindrone |
What excipients (inactive ingredients) are in norethindrone? | norethindrone excipients list |
DailyMed Link: | norethindrone at DailyMed |
Recent Clinical Trials for norethindrone
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bio Genuine (Shanghai) Biotech Co., Ltd. | Phase 3 |
Myovant Sciences GmbH | Phase 4 |
University of Chicago | Phase 4 |
Generic filers with tentative approvals for NORETHINDRONE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 1MG;0.01MG;75MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 75MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for norethindrone
Drug Class | Progestin |
Medical Subject Heading (MeSH) Categories for norethindrone
US Patents and Regulatory Information for norethindrone
Make Better Decisions: Try a trial or see plans & pricing
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