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Boehringer Ingelheim
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Mallinckrodt
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McKesson
Cipla
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Cantor Fitzgerald
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Generated: August 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-one 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 0074-3074-07 1 BLISTER PACK in 1 CARTON (0074-3074-07) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
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)

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:Mar 15, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF REDUCING THE CAPACITY OF EXTENDED RELEASE NICOTINIC ACID TO PROVOKE A FLUSHING REACTION BY PRETREATING AN INDIVIDUAL WITH A FLUSH INHIBITING AGENT PRIOR TO THE ADMINISTRATION OF THE EXTENDED RELEASE NICOTINIC ACID
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

Expired Orange Book Patents for NDA: 020381

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-002Jul 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 TITRATION STARTER PACK
niacin
TABLET, EXTENDED RELEASE;ORAL020381-005Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-004Jul 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;ORAL020381-002Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-004Jul 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
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Serving 500+ biopharmaceutical companies globally:

Dow
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Healthtrust
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Daiichi Sankyo

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