Almotriptan malate - Generic Drug Details

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What are the generic sources for almotriptan malate and what is the scope of freedom to operate?

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

See drug prices for almotriptan malate

Recent Clinical Trials for almotriptan malate

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

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

See all almotriptan malate clinical trials

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

N02CC	Selective serotonin (5HT1) agonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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
>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

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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

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