RIMEGEPANT SULFATE - Generic Drug Details

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What are the generic sources for rimegepant sulfate and what is the scope of freedom to operate?

Rimegepant sulfate is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rimegepant sulfate has one hundred and six patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for RIMEGEPANT SULFATE

International Patents:	106
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
What excipients (inactive ingredients) are in RIMEGEPANT SULFATE?	RIMEGEPANT SULFATE excipients list
DailyMed Link:	RIMEGEPANT SULFATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RIMEGEPANT SULFATE

Generic Entry Date for RIMEGEPANT SULFATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET, ORALLY DISINTEGRATING;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for RIMEGEPANT SULFATE

Drug Class	Calcitonin Gene-related Peptide Receptor Antagonist
Mechanism of Action	Calcitonin Gene-related Peptide Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for RIMEGEPANT SULFATE

N02CD	Calcitonin gene-related peptide (CGRP) antagonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for RIMEGEPANT SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NURTEC ODT	Orally Disintegrating Tablets	rimegepant sulfate	75 mg	212728	7	2024-02-27

US Patents and Regulatory Information for RIMEGEPANT SULFATE

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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
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for RIMEGEPANT SULFATE

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Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201491585	N-(5S,6S,9R)-5-АМИНО-6-(2,3-ДИФТОРФЕНИЛ)-6,7,8,9-ТЕТРАГИДРО-5H-ЦИКЛОГЕПТА[B]ПИРИДИН-9-ИЛ-4-(2-ОКСО-2,3-ДИГИДРО-1H-ИМИДАЗО[4,5-B]ПИРИДИН-1-ИЛ)ПИПЕРИДИН-1-КАРБОКСИЛАТНАЯ СОЛЬ	⤷ Sign Up
China	104136437	N-(5S,6S,9R)-5-AMINO-6-(2,3-DIFLUOROPHENYL)-6,7,8,9-TETRAHYDRO-5H-CYCLOHEPTA[B]PYRIDIN-9-YL-4-(2-OXO-2,3-DIHYDRO-1H-IMIDAZO[4,5-B]PYRIDIN-1-YL)PIPERIDINE-1-CARBOXYLATE,HEMISULFATE SALT	⤷ Sign Up
Lithuania	2820016		⤷ Sign Up
Japan	2023134690	ＣＧＲＰ関連障害のためのリメゲパント (RIMEGEPANT FOR CGRP RELATED DISORDERS)	⤷ Sign Up
Japan	5836279		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for RIMEGEPANT SULFATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2488512	2290503-8	Sweden	⤷ Sign Up	PRODUCT NAME: RIMEGEPANT; REG. NO/DATE: EU/1/22/1645 20220426
2488512	122022000048	Germany	⤷ Sign Up	PRODUCT NAME: RIMEGEPANT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1645 20220425
2488512	CR 2022 00036	Denmark	⤷ Sign Up	PRODUCT NAME: RIMEGEPANT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1645 20220426
2488512	CA 2022 00036	Denmark	⤷ Sign Up	PRODUCT NAME: RIMEGEPANT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1645 20220426
2488512	LUC00272	Luxembourg	⤷ Sign Up	PRODUCT NAME: RIMEGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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