Product profile · United States

TIVICAY PD

· Patent Litigation & Settlement History ↓

IngredientDOLUTEGRAVIR SODIUM

Application typeNDA

Application213983

Product001

Dosage formTABLET, FOR SUSPENSION

RouteORAL

StrengthEQ 5MG BASE

Approval date2020-06-12

Marketing statusPrescription

Status event—

ApplicantVIIV HLTHCARE

Product source

Current GenericRadar decision

Year2028

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typePATENT

Anchor date2028-04-05

Patent anchor2028-04-05

Exclusivity anchor—

Protection date2030-06-08

First Final ANDA—

Status event—

Exact-product fact recovery: NDA213983/001 TIVICAY PD 5mg tablets for oral suspension, approved 2020-06-12. FDA Orange Book 2026-10-15 lists NPP through 2029-08-25 and PED through 2030-02-25. FDA 2026-08-25 label adds term neonates from birth to less than 4 weeks, at least 2kg; previously approved older patients remain outside that population-specific exclusivity. Both facts are partial scope and do not replace the US8129385*PED patent anchor 2028-04-05. US9242986*PED through 2030-06-08 remains the latest patent tail. Final decision stays 2028 DEEP_REVIEW.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
8129385	2028-04-05	DS/DP —	Y	N	TRUE_DS	—	—	—
8129385	2028-04-05	— —	Y	N	TRUE_DS	—	2028-04-05	—
9242986	2030-06-08	DS/DP —	N	N	DP	—	—	—
9242986	2030-06-08	— —	N	N	DP	—	2030-06-08	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NPP	2026-08-25	2029-08-25	Exact-product fact recovery: NDA213983/001 TIVICAY PD 5mg tablets for oral suspension, approved 2020-06-12. FDA Orange Book 2026-10-15 lists NPP through 2029-08-25 and PED through 2030-02-25. FDA 2026-08-25 label adds term neonates from birth to less than 4 weeks, at least 2kg; previously approved older patients remain outside that population-specific exclusivity. Both facts are partial scope and do not replace the US8129385PED patent anchor 2028-04-05. US9242986PED through 2030-06-08 remains the latest patent tail. Final decision stays 2028 DEEP_REVIEW.	N	N	—	—	Source
NPP	—	2029-08-25		—	—	—	—	Source
PED	2029-08-25	2030-02-25	Exact-product fact recovery: NDA213983/001 TIVICAY PD 5mg tablets for oral suspension, approved 2020-06-12. FDA Orange Book 2026-10-15 lists NPP through 2029-08-25 and PED through 2030-02-25. FDA 2026-08-25 label adds term neonates from birth to less than 4 weeks, at least 2kg; previously approved older patients remain outside that population-specific exclusivity. Both facts are partial scope and do not replace the US8129385PED patent anchor 2028-04-05. US9242986PED through 2030-06-08 remains the latest patent tail. Final decision stays 2028 DEEP_REVIEW.	N	N	—	—	Source
PED	—	2030-02-25		—	—	—	—	Source

2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
No generic approval facts are linked to this product.

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / product	Applicant	Event / status	First marketed	Product mapping	Source	Last verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 0 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last verified
No final-approval records are linked to this product.

Decision evidence (2)

Type	Date	Role	Basis	Source
REGULATORY_EXCLUSIVITY	—	FTO_TAIL	Exact-product fact recovery: NDA213983/001 TIVICAY PD 5mg tablets for oral suspension, approved 2020-06-12. FDA Orange Book 2026-10-15 lists NPP through 2029-08-25 and PED through 2030-02-25. FDA 2026-08-25 label adds term neonates from birth to less than 4 weeks, at least 2kg; previously approved older patients remain outside that population-specific exclusivity. Both facts are partial scope and do not replace the US8129385PED patent anchor 2028-04-05. US9242986PED through 2030-06-08 remains the latest patent tail. Final decision stays 2028 DEEP_REVIEW.	Source
REGULATORY_EXCLUSIVITY	—	FTO_TAIL	Exact-product fact recovery: NDA213983/001 TIVICAY PD 5mg tablets for oral suspension, approved 2020-06-12. FDA Orange Book 2026-10-15 lists NPP through 2029-08-25 and PED through 2030-02-25. FDA 2026-08-25 label adds term neonates from birth to less than 4 weeks, at least 2kg; previously approved older patients remain outside that population-specific exclusivity. Both facts are partial scope and do not replace the US8129385PED patent anchor 2028-04-05. US9242986PED through 2030-06-08 remains the latest patent tail. Final decision stays 2028 DEEP_REVIEW.	Source

Decision history

Current	Year	Status	Review	Anchor	Judged
Y	2028	DEEP_REVIEW	FINAL	2028-04-05	2026-10-16 13:34:59
N	2028	DEEP_REVIEW	FINAL	2028-04-05	2026-10-15 22:07:44

Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.