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 Pharms Ltd, Lupin Ltd, Janssen Pharms, Teva Branded Pharm, Amneal Pharms, Naari Pte Ltd, Novast Labs, Xiromed, 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. Fifteen 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: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 85 |
Patent Applications: | 6,713 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for NORETHINDRONE |
Drug Sales Revenues: | Drug sales revenues 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 |
⤷ Sign Up | ⤷ Sign Up | 1MG;0.01MG;75MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glenmark Pharms Ltd | NORETHINDRONE ACETATE | norethindrone acetate | TABLET;ORAL | 091090-001 | Jul 21, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novast Labs | NORETHINDRONE | norethindrone | TABLET;ORAL-28 | 202014-001 | Sep 13, 2013 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Glenmark Pharms Ltd | HEATHER | norethindrone | TABLET;ORAL-28 | 090454-001 | Apr 23, 2010 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Barr | NORETHINDRONE ACETATE | norethindrone acetate | TABLET;ORAL | 075951-001 | May 25, 2001 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys Labs Sa | CAMILA | norethindrone | TABLET;ORAL-28 | 076177-001 | Oct 21, 2002 | AB1 | 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 |
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