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Last Updated: March 18, 2026

DrugPatentWatch Alpha Signals Regulatory Exclusivity

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Drug Search Regulatory Exclusivity

Regulatory Exclusivity: Patent Challenge

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Drugs with Patent Challenge Regulatory Exclusivity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Alkem Labs Ltd	TOPIRAMATE	topiramate	SOLUTION;ORAL	217795-001	Oct 31, 2024	AB	RX	No	No	⤷ Get Started Free	PATENT CHALLENGE
Baxter Hlthcare Corp	ACETAMINOPHEN	acetaminophen	SOLUTION;INTRAVENOUS	214331-002	May 21, 2025		RX	No	Yes	⤷ Get Started Free	PATENT CHALLENGE
Natco Pharma Ltd	BOSENTAN	bosentan	TABLET, FOR SUSPENSION;ORAL	213154-001	Feb 5, 2025	AB	RX	No	No	⤷ Get Started Free	PATENT CHALLENGE
Fresenius Kabi Usa	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	218271-001	Mar 11, 2025	AP2	RX	No	No	⤷ Get Started Free	PATENT CHALLENGE
Fresenius Kabi Usa	EPHEDRINE SULFATE	ephedrine sulfate	SOLUTION;INTRAVENOUS	218271-002	Mar 11, 2025	AP2	RX	No	No	⤷ Get Started Free	PATENT CHALLENGE
Teva Pharms	LIRAGLUTIDE	liraglutide	SOLUTION;SUBCUTANEOUS	214568-001	Aug 27, 2025	AP2	RX	No	No	⤷ Get Started Free	PATENT CHALLENGE
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

Regulatory Exclusivity

Search by exclusivity type:

Competitive Generic Therapy
New Chemical Entity
New Dosing Schedule
New Indication
New Product
New Patient Population
New Strength
Orphan Drug
Patent Challenge
Pediatric Exclusivity
RX to OTC Switch

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.