AVEED
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Rights after the canonical full-scope anchor require DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 7718640 | 2027-03-14 | DP — | N | N | FORMULATION | — | — | — |
| 7718640 | 2027-03-14 | DP — | N | N | FORMULATION Testosterone undecanoate 250 mg/mL intramuscular injection in specified castor-oil/benzyl-benzoate vehicle proportions. | — | — | — |
| 8338395 | 2027-05-08 | U U-1500 | N | N | FORMULATION_USE | — | — | — |
| 8338395 | 2027-05-08 | U U-1500 | N | N | FORMULATION_USE Testosterone replacement method constrained by castor-oil/co-solvent vehicle and injection schedule; no automatic molecule/DS equivalence. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2014-03-05 | 2017-03-05 | New 750 mg/3 mL long-acting injectable testosterone-undecanoate product for all approved adult-male primary and hypogonadotropic hypogonadism uses. | Y | Y | 2017-03-05 | Source |
2026-10-11 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 207583 / 001 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | HIKMA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
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 (4)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2027-03-14 | FTO_TAIL | Testosterone undecanoate 250 mg/mL intramuscular injection in specified castor-oil/benzyl-benzoate vehicle proportions. | Source |
| PATENT | 2027-05-08 | FTO_TAIL | Testosterone replacement method constrained by castor-oil/co-solvent vehicle and injection schedule; no automatic molecule/DS equivalence. | Source |
| REGULATORY_EXCLUSIVITY | 2017-03-05 | CANONICAL_ANCHOR | New 750 mg/3 mL long-acting injectable testosterone-undecanoate product for all approved adult-male primary and hypogonadotropic hypogonadism uses. | Source |
| REGULATORY_STATUS | 2017-03-05 | DECISION_BASIS | Rights after the canonical full-scope anchor require DEEP_REVIEW. | Source |
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.
| Event date | Party | Event | Licensed entry | Evidence | Source |
|---|---|---|---|---|---|
| 2018-07-13 | Endo Pharmaceuticals Solutions, Inc. / Bayer Intellectual Property GmbH / Bayer Pharma AG v. Custopharm Inc. | LITIGATION Brand-level record; strength scope not established
|
Not disclosed | SOURCE_CONFIRMED | Source |
| Appeal 17-1719; district court 1:14-cv-01422. Court affirmed that Custopharm had not established invalidity of claim 2 of US7718640 (formulation) or claim 18 of US8338395 (dosing method). Custopharm stipulated to infringement; ANDA 207583. This was litigation/judgment, NOT settlement. No negotiated market entry date was identified. The district court ANDA-specific approval-effective-date restriction must not be treated as a general launch date. GNR 2017 DEEP_REVIEW and whole-product exclusivity ending 2017-03-05 remain unchanged. | |||||