ALMOTRIPTAN MALATE - Generic Drug Details
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What are the generic sources for almotriptan malate and what is the scope of patent protection?
Almotriptan malate
is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Mylan, Teva Pharms Usa, and Janssen Pharms, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for almotriptan malate. Three suppliers are listed for this compound.
Summary for ALMOTRIPTAN MALATE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 4 |
| Drug Master File Entries: | 5 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 82 |
| Clinical Trials: | 5 |
| Patent Applications: | 588 |
| Drug Prices: | Drug price trends for ALMOTRIPTAN MALATE |
| What excipients (inactive ingredients) are in ALMOTRIPTAN MALATE? | ALMOTRIPTAN MALATE excipients list |
| DailyMed Link: | ALMOTRIPTAN MALATE at DailyMed |
Recent Clinical Trials for ALMOTRIPTAN MALATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Janssen-Ortho LLC | Phase 4 |
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Phase 4 |
| Ortho-McNeil Neurologics, Inc. | Phase 4 |
Pharmacology for ALMOTRIPTAN MALATE
| 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 ALMOTRIPTAN MALATE
Paragraph IV (Patent) Challenges for ALMOTRIPTAN MALATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AXERT | Tablets | almotriptan malate | 6.25 mg and 12.5 mg | 021001 | 1 | 2005-12-08 |
US Patents and Regulatory Information for ALMOTRIPTAN MALATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | ALMOTRIPTAN MALATE | almotriptan malate | TABLET;ORAL | 205171-002 | Nov 9, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | ALMOTRIPTAN MALATE | almotriptan malate | TABLET;ORAL | 078027-002 | Jul 7, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ajanta Pharma Ltd | ALMOTRIPTAN MALATE | almotriptan malate | TABLET;ORAL | 205523-002 | Mar 3, 2016 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | ALMOTRIPTAN MALATE | almotriptan malate | TABLET;ORAL | 205171-001 | Nov 9, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ajanta Pharma Ltd | ALMOTRIPTAN MALATE | almotriptan malate | TABLET;ORAL | 205523-001 | Mar 3, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Janssen Pharms | AXERT | almotriptan malate | TABLET;ORAL | 021001-001 | May 7, 2001 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Pharms | AXERT | almotriptan malate | TABLET;ORAL | 021001-002 | May 7, 2001 | 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 ALMOTRIPTAN MALATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | AXERT | almotriptan malate | TABLET;ORAL | 021001-001 | May 7, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | AXERT | almotriptan malate | TABLET;ORAL | 021001-002 | May 7, 2001 | ⤷ 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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