Eletriptan hydrobromide - Generic Drug Details
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What are the generic drug sources for eletriptan hydrobromide and what is the scope of freedom to operate?
Eletriptan hydrobromide
is the generic ingredient in two branded drugs marketed by Annora Pharma, Aurobindo Pharma, Carlsbad, Chartwell Rx, Mylan, Regcon Holdings, Stevens J, Teva Pharms Usa, Zydus Pharms, and Upjohn, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.Eleven suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for eletriptan hydrobromide
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 10 |
| NDAs: | 10 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| Clinical Trials: | 2 |
| Patent Applications: | 721 |
| What excipients (inactive ingredients) are in eletriptan hydrobromide? | eletriptan hydrobromide excipients list |
| DailyMed Link: | eletriptan hydrobromide at DailyMed |
Recent Clinical Trials for eletriptan hydrobromide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| VectorB2B | PHASE1 |
| Technophage, SA | PHASE1 |
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Phase 1 |
Generic filers with tentative approvals for ELETRIPTAN HYDROBROMIDE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 40MG | TABLET; ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 20MG | 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 eletriptan hydrobromide
| Drug Class | Serotonin-1b and Serotonin-1d Receptor Agonist |
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for eletriptan hydrobromide
Paragraph IV (Patent) Challenges for ELETRIPTAN HYDROBROMIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| RELPAX | Tablets | eletriptan hydrobromide | 20 mg and 40 mg | 021016 | 1 | 2010-03-29 |
US Patents and Regulatory Information for eletriptan hydrobromide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | ELETRIPTAN HYDROBROMIDE | eletriptan hydrobromide | TABLET;ORAL | 205152-002 | Aug 11, 2017 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Chartwell Rx | ELETRIPTAN HYDROBROMIDE | eletriptan hydrobromide | TABLET;ORAL | 205186-002 | Aug 29, 2017 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Zydus Pharms | ELETRIPTAN HYDROBROMIDE | eletriptan hydrobromide | TABLET;ORAL | 206409-002 | Jun 16, 2017 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >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 eletriptan hydrobromide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Upjohn | RELPAX | eletriptan hydrobromide | TABLET;ORAL | 021016-001 | Dec 26, 2002 | ⤷ Start Trial | ⤷ Start Trial |
| Upjohn | RELPAX | eletriptan hydrobromide | TABLET;ORAL | 021016-002 | Dec 26, 2002 | ⤷ Start Trial | ⤷ Start Trial |
| Upjohn | RELPAX | eletriptan hydrobromide | TABLET;ORAL | 021016-002 | Dec 26, 2002 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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