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Puma Biotech Company Profile

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What is the competitive landscape for PUMA BIOTECH, and what generic alternatives to PUMA BIOTECH drugs are available?

PUMA BIOTECH has one approved drug.

There are eight US patents protecting PUMA BIOTECH drugs.

There are ninety-three patent family members on PUMA BIOTECH drugs in twenty countries.

Summary for Puma Biotech

International Patents:	93
US Patents:	8
Tradenames:	1
Ingredients:	1
NDAs:	1

Drugs and US Patents for Puma Biotech

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	7,982,043
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	9,211,291
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	6,288,082		Y	Y

Non-Orange Book US Patents for Puma Biotech

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,022,216	Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quin- olinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
8,394,959	Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quin- olinyl)-4-(dimethylamino)-2-buteramide and crystalline forms thereof
8,173,814	Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quin- olinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof

International Patents for Puma Biotech Drugs

Country	Document Number	Estimated Expiration
Singapore	174382
South Korea	20120016085
Spain	2612273
European Patent Office	2258698

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Puma Biotech