Details for New Drug Application (NDA): 022430

✉ Email this page to a colleague

NDA 022430 describes LYSTEDA, which is a drug marketed by Amring Pharms and is included in one NDA. It is available from three suppliers. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LYSTEDA profile page.

The generic ingredient in LYSTEDA is tranexamic acid. There are eight drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.

Summary for 022430

Tradename:	LYSTEDA
Applicant:	Amring Pharms
Ingredient:	tranexamic acid
Patents:	8

Medical Subject Heading (MeSH) Categories for 022430

Antifibrinolytic Agents

Suppliers and Packaging for NDA: 022430

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LYSTEDA	tranexamic acid	TABLET;ORAL	022430	NDA AUTHORIZED GENERIC	AvPAK	50268-772	50268-772-13	30 BLISTER PACK in 1 BOX (50268-772-13) / 1 TABLET in 1 BLISTER PACK (50268-772-11)
LYSTEDA	tranexamic acid	TABLET;ORAL	022430	NDA AUTHORIZED GENERIC	Nordic Pharma, Inc.	69918-301	69918-301-30	30 TABLET in 1 BOTTLE (69918-301-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	650MG
Approval Date:	Nov 13, 2009	TE:	AB	RLD:	Yes
Patent:	7,947,739	Patent Expiration:	Mar 4, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,022,106	Patent Expiration:	Mar 4, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
Patent:	8,273,795	Patent Expiration:	Mar 4, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING

Expired US Patents for NDA 022430

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	8,957,113	⤷ Get Started Free
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	7,947,739	⤷ Get Started Free
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	9,060,939	⤷ Get Started Free
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	8,809,394	⤷ Get Started Free
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	8,487,005	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

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. 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.