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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Mallinckrodt
Deloitte
Boehringer Ingelheim
Cerilliant
Cipla
Fuji
Medtronic
Chubb
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Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020381

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NDA 020381 describes NIASPAN TITRATION STARTER PACK, which is a drug marketed by Abbvie and is included in one NDA. It is available from nine suppliers. There is one patent protecting this drug. Additional details are available on the NIASPAN TITRATION STARTER PACK profile page.

The generic ingredient in NIASPAN TITRATION STARTER PACK is niacin. There are fourteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the niacin profile page.

Summary for NDA: 020381

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:2
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020381

Ingredient-typeNicotinic Acids

Suppliers and Packaging for NDA: 020381

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL 020381 NDA AbbVie Inc. 0074-3074 0074-3074-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3074-30)
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL 020381 NDA AbbVie Inc. 0074-3074 0074-3074-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0074-3074-90)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength375MG
Approval Date:Jul 28, 1997TE:RLD:No
Patent:► SubscribePatent Expiration:May 27, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jul 28, 1997TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:May 27, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
Patent:► SubscribePatent Expiration:May 27, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT

Expired Orange Book Patents for NDA: 020381

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
NIASPAN TITRATION STARTER PACK
niacin
TABLET, EXTENDED RELEASE;ORAL020381-005Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN TITRATION STARTER PACK
niacin
TABLET, EXTENDED RELEASE;ORAL020381-005Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-001Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-003Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-003Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-001Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-003Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-002Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-004Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-002Jul 28, 1997► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Healthtrust
Chubb
QuintilesIMS
Cerilliant
Harvard Business School
Fuji
Express Scripts
Boehringer Ingelheim
Johnson and Johnson
Daiichi Sankyo

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