Product profile · United States

Skytrofa

· Patent Litigation & Settlement History ↓

Ingredientlonapegsomatropin-tcgd

Application typeBLA

Application761177

Product004

Dosage formFor Injection

RouteSubcutaneous

Strength5.2MG

Approval date2021-08-25

Marketing statusPrescription

Status event—

ApplicantASCENDIS PHARMA ENCOCRINOLOGY DIV A/S

Product source

Current GenericRadar decision

Year2036

SelectionDEEP_REVIEW

ReviewFINAL_CHECKING

Anchor typeDS_EQUIVALENT

Anchor date2036-11-01

Patent anchor2036-11-01

Exclusivity anchor2033-08-25

Protection date—

First Final ANDA—

Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2036. Anchor type: DS_EQUIVALENT. Patent anchor: 2036-11-01. Exclusivity anchor: 2033-08-25. Anchor date: 2036-11-01. Patent tail: yes. Exclusivity tail: not established. Review status: FINAL_CHECKING. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
US11957880	—	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US12746335	—	— —	N	N	PENDING {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"PENDING","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
USD907765	—	— —	N	N	DESIGN {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DESIGN","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US8450097	2024-10-01	— —	N	N	MATERIAL_TYPE_CANDIDATE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"MATERIAL_TYPE_CANDIDATE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US9238686	2026-02-17	— —	Y	N	TRUE_DS {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"TRUE_DS","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US7879588	2027-02-18	— —	N	N	MATERIAL_TYPE_CANDIDATE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"MATERIAL_TYPE_CANDIDATE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US8377917	2028-08-27	— —	Y	N	TRUE_DS {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"TRUE_DS","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US10098930	2029-04-29	— —	Y	N	TRUE_DS {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"TRUE_DS","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US10960053	2029-04-29	— —	N	N	U {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"U","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US12274737	2029-10-05	— —	N	N	U {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"U","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US10682395	2030-12-15	— —	N	Y	DS_EQUIVALENT {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DS_EQUIVALENT","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US9511122	2030-12-15	— —	N	N	DP {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DP","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US9919033	2030-12-15	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US12226457	2031-02-07	— —	N	N	DP {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DP","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US9272048	2031-05-30	— —	Y	N	TRUE_DS {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"TRUE_DS","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US10799563	2035-11-17	— —	Y	N	TRUE_DS {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"TRUE_DS","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US12016903	2035-11-20	— —	N	N	U {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"U","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US12133883	2036-11-01	— —	N	Y	DS_EQUIVALENT {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DS_EQUIVALENT","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US11738147	2036-12-29	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US11969581	2036-12-29	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US12226616	2036-12-29	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US12383676	2036-12-29	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US12290663	2037-03-17	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US11179524	2037-05-02	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US12005241	2037-08-14	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US10835677	2037-10-11	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US12251541	2038-05-23	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US12514983	2038-10-01	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US11684724	2038-10-09	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US11351305	2038-12-12	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US11607496	2039-03-10	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US11406760	2039-06-29	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US11524115	2040-02-19	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US11517673	2040-04-04	— —	N	N	DEVICE {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DEVICE","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
USD1090824	2040-08-26	— —	N	N	DESIGN {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"DESIGN","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—
US12303553	2040-12-31	— —	N	N	U {"batch":"BLA-05-05","reference_date_only":true,"official_current_term_verified":false,"pending_reason":"OFFICIAL_TERM_PTE_TD_CHECK","scope_review_classification":"U","source_report":"BLA_05_05_50_JUDGMENT_20261021.html"}	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
ODE	2025-07-25	—		—	—	—	—	Source
ODE	2021-08-25	—		—	—	—	—	Source
RPE	2021-08-25	2033-08-25	Full-product 12-year operational assumption; not FDA determination	Y	Y	—	—	Source

2026-10-10 · PENDING_EXCLUSIVITY_CONFIRMATION · 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 (39)

Type	Date	Role	Basis	Source
PATENT	—	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	—	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	—	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2024-10-01	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2026-02-17	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2027-02-18	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2028-08-27	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2029-04-29	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2029-04-29	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2029-10-05	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2030-12-15	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2030-12-15	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2030-12-15	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2031-02-07	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2031-05-30	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2035-11-17	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2035-11-20	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2036-11-01	ANCHOR_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2036-12-29	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2036-12-29	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2036-12-29	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2036-12-29	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2037-03-17	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2037-05-02	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2037-08-14	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2037-10-11	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2038-05-23	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2038-10-01	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2038-10-09	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2038-12-12	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2039-03-10	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2039-06-29	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2040-02-19	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2040-04-04	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2040-08-26	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
PATENT	2040-12-31	OTHER_RIGHT_REFERENCE	Product scope reviewed; reference date only; current official term verification pending	Source
REGULATORY_EXCLUSIVITY	—	SCOPE_HISTORY	Indication-specific history; full coverage not asserted	Source
REGULATORY_EXCLUSIVITY	—	SCOPE_HISTORY	Indication-specific history; full coverage not asserted	Source
REGULATORY_EXCLUSIVITY	2033-08-25	SCOPE_HISTORY	First approval + 12 years; operational assumption, not FDA determination	Source

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.