SARAFEM Drug Patent Profile
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When do Sarafem patents expire, and what generic alternatives are available?
Sarafem is a drug marketed by Eli Lilly And Co and Apil and is included in two NDAs.
The generic ingredient in SARAFEM is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Seventy suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sarafem
A generic version of SARAFEM was approved as fluoxetine hydrochloride by APNAR PHARMA LP on August 2nd, 2001.
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Summary for SARAFEM
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 174 |
| Clinical Trials: | 10 |
| Patent Applications: | 4,661 |
| Drug Prices: | Drug price information for SARAFEM |
| What excipients (inactive ingredients) are in SARAFEM? | SARAFEM excipients list |
| DailyMed Link: | SARAFEM at DailyMed |
Recent Clinical Trials for SARAFEM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bogachan Sahin | Phase 2 |
| Torrent Pharmaceuticals Limited | Phase 1 |
| Eli Lilly and Company | Phase 3 |
Pharmacology for SARAFEM
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Serotonin Uptake Inhibitors |
US Patents and Regulatory Information for SARAFEM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eli Lilly And Co | SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-007 | Jul 6, 2000 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apil | SARAFEM | fluoxetine hydrochloride | TABLET;ORAL | 021860-002 | May 19, 2006 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eli Lilly And Co | SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-008 | Jul 6, 2000 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apil | SARAFEM | fluoxetine hydrochloride | TABLET;ORAL | 021860-001 | May 19, 2006 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apil | SARAFEM | fluoxetine hydrochloride | TABLET;ORAL | 021860-003 | May 19, 2006 | DISCN | Yes | 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 SARAFEM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Eli Lilly And Co | SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-008 | Jul 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Eli Lilly And Co | SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-007 | Jul 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Eli Lilly And Co | SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-007 | Jul 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Eli Lilly And Co | SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-008 | Jul 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Eli Lilly And Co | SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-007 | Jul 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Eli Lilly And Co | SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936-008 | Jul 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SARAFEM
See the table below for patents covering SARAFEM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 113284 | ⤷ Sign Up | |
| South Africa | 8402457 | ⤷ Sign Up | |
| Canada | 2332814 | THERAPIE COMBINEE DE TRAITEMENT DE LA DEPRESSION RESISTANTE (COMBINATION THERAPY FOR TREATMENT OF REFRACTORY DEPRESSION) | ⤷ Sign Up |
| Bulgaria | 60761 | ⤷ Sign Up | |
| Switzerland | 609331 | Process for the preparation of 3-aryloxy-3-phenyl-propylamines | ⤷ Sign Up |
| Ireland | 40346 | ARYLOXYPHENYLPROPYLAMINES | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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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