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Last Updated: March 19, 2024

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
Drug Prices for almotriptan malate

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Recent Clinical Trials for almotriptan malate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Phase 4
Janssen-Ortho LLCPhase 4
Ortho-McNeil Neurologics, Inc.Phase 4

See all almotriptan malate clinical trials

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
Janssen Pharms AXERT almotriptan malate TABLET;ORAL 021001-002 May 7, 2001 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ajanta Pharma Ltd ALMOTRIPTAN MALATE almotriptan malate TABLET;ORAL 205523-002 Mar 3, 2016 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ajanta Pharma Ltd ALMOTRIPTAN MALATE almotriptan malate TABLET;ORAL 205523-001 Mar 3, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa ALMOTRIPTAN MALATE almotriptan malate TABLET;ORAL 078027-001 Jul 7, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 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 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms AXERT almotriptan malate TABLET;ORAL 021001-002 May 7, 2001 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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