Tamoxifen citrate - Generic Drug Details
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What are the generic sources for tamoxifen citrate and what is the scope of freedom to operate?
Tamoxifen citrate
is the generic ingredient in three branded drugs marketed by Mayne Pharma Commrcl, Astrazeneca, Actavis Labs Fl Inc, Aegis Pharms, Apotex, Dr Reddys Labs Sa, Eugia Pharma, Ivax Sub Teva Pharms, Mylan, Pharmachemie, Roxane, Teva, and Zydus Pharms, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.There are fifteen drug master file entries for tamoxifen citrate. Fourteen suppliers are listed for this compound.
Summary for tamoxifen citrate
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 13 |
| NDAs: | 14 |
| Drug Master File Entries: | 15 |
| Finished Product Suppliers / Packagers: | 14 |
| Raw Ingredient (Bulk) Api Vendors: | 93 |
| Clinical Trials: | 125 |
| Patent Applications: | 8,387 |
| Drug Prices: | Drug price trends for tamoxifen citrate |
| What excipients (inactive ingredients) are in tamoxifen citrate? | tamoxifen citrate excipients list |
| DailyMed Link: | tamoxifen citrate at DailyMed |
Recent Clinical Trials for tamoxifen citrate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sharif Medical Research Center | Phase 2 |
| Baylor College of Medicine | Early Phase 1 |
| Mogford Campbell Family Chair Fund | Phase 1/Phase 2 |
Pharmacology for tamoxifen citrate
| Drug Class | Estrogen Agonist/Antagonist |
| Mechanism of Action | Selective Estrogen Receptor Modulators |
Medical Subject Heading (MeSH) Categories for tamoxifen citrate
Anatomical Therapeutic Chemical (ATC) Classes for tamoxifen citrate
US Patents and Regulatory Information for tamoxifen citrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | TAMOXIFEN CITRATE | tamoxifen citrate | TABLET;ORAL | 090878-002 | Sep 23, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ivax Sub Teva Pharms | TAMOXIFEN CITRATE | tamoxifen citrate | TABLET;ORAL | 075740-002 | Feb 20, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | TAMOXIFEN CITRATE | tamoxifen citrate | TABLET;ORAL | 074732-002 | Feb 20, 2003 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Actavis Labs Fl Inc | TAMOXIFEN CITRATE | tamoxifen citrate | TABLET;ORAL | 070929-001 | Feb 20, 2003 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ivax Sub Teva Pharms | TAMOXIFEN CITRATE | tamoxifen citrate | TABLET;ORAL | 075740-001 | Feb 20, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys Labs Sa | TAMOXIFEN CITRATE | tamoxifen citrate | TABLET;ORAL | 075797-002 | Feb 20, 2003 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aegis Pharms | TAMOXIFEN CITRATE | tamoxifen citrate | TABLET;ORAL | 076398-002 | Mar 31, 2003 | 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 |
Expired US Patents for tamoxifen citrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mayne Pharma Commrcl | SOLTAMOX | tamoxifen citrate | SOLUTION;ORAL | 021807-001 | Oct 29, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | NOLVADEX | tamoxifen citrate | TABLET;ORAL | 017970-002 | Mar 21, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | NOLVADEX | tamoxifen citrate | TABLET;ORAL | 017970-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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