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Last Updated: December 17, 2025

Afatinib - Generic Drug Details

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Generic filers with tentative approvals for AFATINIB

Applicant	Application No.	Strength	Dosage Form
⤷ Get Started Free	⤷ Get Started Free	40MG	TABLET;ORAL
⤷ Get Started Free	⤷ Get Started Free	30MG	TABLET;ORAL
⤷ Get Started Free	⤷ Get Started Free	20MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for afatinib

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013		RX	Yes	Yes	8,545,884*PED	⤷ Get Started Free			Y	⤷ Get Started Free
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013		RX	Yes	Yes	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013		RX	Yes	Yes	8,426,586*PED	⤷ Get Started Free			Y	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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