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Last Updated: March 18, 2026

DrugPatentWatch Alpha Signals Regulatory Exclusivity

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Regulatory Exclusivity: Competitive Generic Therapy

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Drugs with Competitive Generic Therapy Regulatory Exclusivity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Zenara	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	CAPSULE;ORAL	218853-001	Jul 16, 2025	AB	RX	No	No	⤷ Get Started Free	COMPETITIVE GENERIC THERAPY
Zenara	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	CAPSULE;ORAL	218853-002	Jul 16, 2025	AB	RX	No	No	⤷ Get Started Free	COMPETITIVE GENERIC THERAPY
Rubicon Research	TOPIRAMATE	topiramate	CAPSULE;ORAL	216683-003	May 27, 2025	AB	RX	No	No	⤷ Get Started Free	COMPETITIVE GENERIC THERAPY
Aspiro	MAGNESIUM SULFATE	magnesium sulfate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	219777-001	May 28, 2025	AP	RX	No	No	⤷ Get Started Free	COMPETITIVE GENERIC THERAPY
Aspiro	MAGNESIUM SULFATE	magnesium sulfate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	219777-004	May 28, 2025	AP	RX	No	No	⤷ Get Started Free	COMPETITIVE GENERIC THERAPY
Mylan Labs Ltd	IRON SUCROSE	iron sucrose	INJECTABLE;INTRAVENOUS	212559-002	Aug 8, 2025	AB	RX	No	No	⤷ Get Started Free	COMPETITIVE GENERIC THERAPY
Mylan Labs Ltd	IRON SUCROSE	iron sucrose	INJECTABLE;INTRAVENOUS	212559-003	Aug 8, 2025	AB	RX	No	No	⤷ Get Started Free	COMPETITIVE GENERIC THERAPY
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

Regulatory Exclusivity

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