Details for New Drug Application (NDA): 021821

✉ Email this page to a colleague

NDA 021821 describes TYGACIL, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TYGACIL profile page.

The generic ingredient in TYGACIL is tigecycline. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tigecycline profile page.

Summary for 021821

Tradename:	TYGACIL
Applicant:	Pf Prism Cv
Ingredient:	tigecycline
Patents:	6

Pharmacology for NDA: 021821

Suppliers and Packaging for NDA: 021821

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-4990	0008-4990-20	10 VIAL, SINGLE-USE in 1 CARTON (0008-4990-20) / 50 mL in 1 VIAL, SINGLE-USE (0008-4990-19)
TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-4994	0008-4994-20	10 VIAL, SINGLE-USE in 1 CARTON (0008-4994-20) / 50 mL in 1 VIAL, SINGLE-USE (0008-4994-19)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Jun 15, 2005	TE:	AP	RLD:	Yes
Patent:	10,588,975	Patent Expiration:	Mar 13, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	7,879,828	Patent Expiration:	Feb 5, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,372,995	Patent Expiration:	Oct 8, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021821

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	5,494,903	⤷ Subscribe
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	RE40183	⤷ Subscribe
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	RE40086	⤷ Subscribe
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	5,529,990	⤷ Subscribe
>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. 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.