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TRUQAP Drug Patent Profile

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Which patents cover Truqap, and what generic alternatives are available?

Truqap is a drug marketed by Astrazeneca and is included in one NDA. There are eight patents protecting this drug.

This drug has eighty-eight patent family members in forty-three countries.

The generic ingredient in TRUQAP is capivasertib. One supplier is listed for this compound. Additional details are available on the capivasertib profile page.

DrugPatentWatch^® Generic Entry Outlook for Truqap

Truqap will be eligible for patent challenges on November 16, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 16, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TRUQAP

International Patents:	88
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	351
Drug Prices:	Drug price information for TRUQAP
What excipients (inactive ingredients) are in TRUQAP?	TRUQAP excipients list
DailyMed Link:	TRUQAP at DailyMed

Drug patent expirations by year for TRUQAP

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

Generic Entry Date for TRUQAP^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 218197 Dosage: TABLET;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.

US Patents and Regulatory Information for TRUQAP

TRUQAP is protected by eight US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRUQAP is ⤷ Sign Up.

This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TRUQAP

Crystalline forms of (s)-4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo[2,3-d] pyrimidin-4-y1) piperidine-4-carboxamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT WITH FULVESTRANT OF HR-POS. HER2-NEG. LOCALLY ADVANCED OR METASTATIC BREAST CANCER WITH PIK3CA/AKT1/PTEN-ALTERATION(S) FOLLOWING PROGRESSION ON ENDOCRINE THERAPY IN THE METASTATIC SETTING OR RECURRENCE ON OR WITHIN 12 MONTHS OF ADJUVANT THERAPY

Protein kinase B inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Protein kinase B inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT WITH FULVESTRANT OF HR-POS. HER2-NEG. LOCALLY ADVANCED OR METASTATIC BREAST CANCER WITH PIK3CA/AKT1/PTEN-ALTERATION(S) FOLLOWING PROGRESSION ON ENDOCRINE THERAPY IN THE METASTATIC SETTING OR RECURRENCE ON OR WITHIN 12 MONTHS OF ADJUVANT THERAPY

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT WITH FULVESTRANT OF HR-POS. HER2-NEG. LOCALLY ADVANCED OR METASTATIC BREAST CANCER WITH PIK3CA/AKT1/PTEN-ALTERATION(S) FOLLOWING PROGRESSION ON ENDOCRINE THERAPY IN THE METASTATIC SETTING OR RECURRENCE ON OR WITHIN 12 MONTHS OF ADJUVANT THERAPY

Substituted pyrrolo[2,3-d]pyrimidine as a protein kinase B inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT WITH FULVESTRANT OF HR-POS. HER2-NEG. LOCALLY ADVANCED OR METASTATIC BREAST CANCER WITH PIK3CA/AKT1/PTEN-ALTERATION(S) FOLLOWING PROGRESSION ON ENDOCRINE THERAPY IN THE METASTATIC SETTING OR RECURRENCE ON OR WITHIN 12 MONTHS OF ADJUVANT THERAPY

Ortho-condensed pyridine and pyrimidine derivatives (e.g., purines) as protein kinases inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT WITH FULVESTRANT OF HR-POS. HER2-NEG. LOCALLY ADVANCED OR METASTATIC BREAST CANCER WITH PIK3CA/AKT1/PTEN-ALTERATION(S) FOLLOWING PROGRESSION ON ENDOCRINE THERAPY IN THE METASTATIC SETTING OR RECURRENCE ON OR WITHIN 12 MONTHS OF ADJUVANT THERAPY

Ortho-condensed pyridine and pyrimidine derivatives (e.g., purines) as protein
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Crystalline forms of (s)-4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo[2,3-d]pyrimidin-4-yl) piperidine-4-carboxamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting TRUQAP

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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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
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-002	Nov 16, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-002	Nov 16, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No	⤷ 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 TRUQAP

See the table below for patents covering TRUQAP around the world.

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1206337	-氨基- -氯苯基 -羥丙基 -吡咯並嘧啶- -基哌啶- -甲酰胺的晶型 (CRYSTALLINE FORMS OF (S)-4-AMINON-(1-(4-CHLOROPHENYL)-3- HYDROXYPROPYL)-1-(7H -PYRROLO[2, 3-D]PYRIMIDI N-4-YL) PIPERIDINE-4- CARBOXAMIDE (S)-4--N-(1-(4-)-3-)-1-(7H-[23-D]-4-) -4-)	⤷ Sign Up
Hong Kong	1110503	ORTHO-CONDENSED PYRIDINE AND PYRIMIDINE DERIVATIVES (E.G.PURINES) AS PROTEIN KINASES INHIBITORS	⤷ Sign Up
Denmark	2272517		⤷ Sign Up
Chile	2008003023		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006046024		⤷ Sign Up
China	101861321		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TRUQAP

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2201012	C02201012/01	Switzerland	⤷ Sign Up	PRODUCT NAME: CAPIVASERTIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69300 19.03.2024
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description