Product profile · United States
NOURESS
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA 2020 annual edition, as of 2019-12-31: exact NDA212535/001 in prescription list. FDA 2021 annual edition, as of 2020-12-31: same product in discontinued list. FDA listing-status transition is bounded within 2020; this is not proof of commercial launch or cessation on an exact day. Drugs@FDA API retains Prescription, so the Orange Book discontinued list is used for FDA marketing-list status. Canonical patent/exclusivity assessment is preserved as historical supporting data; it does not override this product status.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10478453 | 2039-01-15 | DP/U U-2752 | N | N | FORMULATION | — | — | — |
| 10478453 | 2039-01-15 | DP/U U-2752 | N | N | FORMULATION L-cysteine solution constrained by concentration, aluminum, cystine, pyruvate and oxygen/container properties. | — | — | — |
| 10583155 | 2039-01-15 | DP/U U-2752 | N | N | FORMULATION_USE | — | — | — |
| 10583155 | 2039-01-15 | DP/U U-2752 | N | N | FORMULATION_USE Parenteral nutrition using a solution constrained by aluminum, cystine and pyruvate limits. | — | — | — |
| 10653719 | 2039-01-15 | DP — | N | N | FORMULATION | — | — | — |
| 10653719 | 2039-01-15 | DP — | N | N | FORMULATION Cysteine 50 mg/mL solution with specified pH, aluminum and particulate limitations. | — | — | — |
| 10905713 | 2039-01-15 | DP — | N | N | FORMULATION_PROCESS | — | — | — |
| 10905713 | 2039-01-15 | DP — | N | N | FORMULATION_PROCESS Cysteine concentration, pH, aluminum, stability, single-use vial and low-oxygen preparation restrictions. | — | — | — |
| 10905714 | 2039-01-15 | DP — | N | N | FORMULATION | — | — | — |
| 10905714 | 2039-01-15 | DP — | N | N | FORMULATION Cysteine concentration, single-use vial, 12-month stability, particulate and aluminum limits. | — | — | — |
| 10912795 | 2039-01-15 | DP — | N | N | FORMULATION | — | — | — |
| 10912795 | 2039-01-15 | DP — | N | N | FORMULATION Cysteine 50 mg/mL single-use vial with pH and 150 ppb aluminum/stability limits. | — | — | — |
| 10918662 | 2039-01-15 | DP — | N | N | FORMULATION | — | — | — |
| 10918662 | 2039-01-15 | DP — | N | N | FORMULATION Cysteine 50 mg/mL single-use vial with pH and 50 ppb aluminum/stability limits. | — | — | — |
| 10933089 | 2039-01-15 | DP — | N | N | FORMULATION | — | — | — |
| 10933089 | 2039-01-15 | DP — | N | N | FORMULATION Cysteine 50 mg/mL solution with pH, aluminum and oxygen/container limitations. | — | — | — |
| 11510942 | 2039-01-15 | DP/U U-2752 | N | N | FORMULATION_USE | — | — | — |
| 11510942 | 2039-01-15 | DP/U U-2752 | N | N | FORMULATION_USE Parenteral cysteine/amino-acid admixture with concentration, aluminum/cystine and dose limitations. | — | — | — |
| 11642370 | 2039-01-15 | DP — | N | N | FORMULATION | — | — | — |
| 11642370 | 2039-01-15 | DP — | N | N | FORMULATION Cysteine solution with 12/18/24-month oxygen, aluminum, pH and particulate limits. | — | — | — |
| 11648262 | 2039-01-15 | DP — | N | N | FORMULATION | — | — | — |
| 11648262 | 2039-01-15 | DP — | N | N | FORMULATION Cysteine solution stability, pH and aluminum contribution limits at specified storage periods. | — | — | — |
| 11679125 | 2039-01-15 | DP — | N | N | FORMULATION | — | — | — |
| 11679125 | 2039-01-15 | DP — | N | N | FORMULATION Cysteine solution with six-month stability, aluminum and oxygen restrictions. | — | — | — |
| 11684636 | 2039-01-15 | DP — | N | N | FORMULATION | — | — | — |
| 11684636 | 2039-01-15 | DP — | N | N | FORMULATION Cysteine solution with vial, oxygen, aluminum and stability-period restrictions. | — | — | — |
| 11826383 | 2039-01-15 | DP — | N | N | FORMULATION | — | — | — |
| 11826383 | 2039-01-15 | DP — | N | N | FORMULATION Cysteine/aluminum ratio, pH, particulate and stability-period restrictions. | — | — | — |
| 12569514 | 2039-01-15 | DP — | N | N | FORMULATION | — | — | — |
| 12569514 | 2039-01-15 | DP — | N | N | FORMULATION Cysteine solution in 50 mL vial with pH, particulate, stability and total-parenteral-aluminum contribution limits. | — | — | — |
| 11510941 | 2039-03-02 | DP — | N | N | FORMULATION_PROCESS | — | — | — |
| 11510941 | 2039-03-02 | DP — | N | N | FORMULATION_PROCESS Cysteine solution with aluminum, cystine, oxygen, pH and stability/process restrictions. | — | — | — |
| 10493051 | 2039-03-15 | DP — | N | N | FORMULATION | — | — | — |
| 10493051 | 2039-03-15 | DP — | N | N | FORMULATION 50 mg/mL cysteine solution with specified aluminum and pH limits. | — | — | — |
| 10543186 | 2039-03-15 | U U-2722 | N | N | FORMULATION_USE | — | — | — |
| 10543186 | 2039-03-15 | U U-2722 | N | N | FORMULATION_USE Parenteral nutrition method requires a quantitatively specified cysteine solution; no unrestricted molecule protection. | — | — | — |
| 10702490 | 2039-03-15 | DP — | N | N | PROCESS_FORMULATION | — | — | — |
| 10702490 | 2039-03-15 | DP — | N | N | PROCESS_FORMULATION Cysteine product/method with acidification and inert-gas filling restrictions. | — | — | — |
| 11045438 | 2039-03-15 | DP — | N | N | FORMULATION | — | — | — |
| 11045438 | 2039-03-15 | DP — | N | N | FORMULATION Cysteine solution with concentration, pH, aluminum, particulate and vial limitations. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
2026-10-11 · CURRENT_SNAPSHOT_NO_RECORD · 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 |
|---|---|---|---|---|---|---|---|
| 214082 / 001 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | DR REDDYS LABS SA | 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 (21)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2039-01-15 | FTO_TAIL | Cysteine/aluminum ratio, pH, particulate and stability-period restrictions. | Source |
| PATENT | 2039-01-15 | FTO_TAIL | Cysteine concentration, single-use vial, 12-month stability, particulate and aluminum limits. | Source |
| PATENT | 2039-01-15 | FTO_TAIL | Parenteral nutrition using a solution constrained by aluminum, cystine and pyruvate limits. | Source |
| PATENT | 2039-01-15 | FTO_TAIL | Cysteine 50 mg/mL solution with pH, aluminum and oxygen/container limitations. | Source |
| PATENT | 2039-01-15 | FTO_TAIL | Cysteine 50 mg/mL single-use vial with pH and 150 ppb aluminum/stability limits. | Source |
| PATENT | 2039-01-15 | FTO_TAIL | Cysteine 50 mg/mL solution with specified pH, aluminum and particulate limitations. | Source |
| PATENT | 2039-01-15 | FTO_TAIL | Cysteine solution in 50 mL vial with pH, particulate, stability and total-parenteral-aluminum contribution limits. | Source |
| PATENT | 2039-01-15 | FTO_TAIL | Cysteine 50 mg/mL single-use vial with pH and 50 ppb aluminum/stability limits. | Source |
| PATENT | 2039-01-15 | FTO_TAIL | Cysteine solution with six-month stability, aluminum and oxygen restrictions. | Source |
| PATENT | 2039-01-15 | FTO_TAIL | Cysteine solution with vial, oxygen, aluminum and stability-period restrictions. | Source |
| PATENT | 2039-01-15 | FTO_TAIL | Parenteral cysteine/amino-acid admixture with concentration, aluminum/cystine and dose limitations. | Source |
| PATENT | 2039-01-15 | FTO_TAIL | L-cysteine solution constrained by concentration, aluminum, cystine, pyruvate and oxygen/container properties. | Source |
| PATENT | 2039-01-15 | FTO_TAIL | Cysteine solution stability, pH and aluminum contribution limits at specified storage periods. | Source |
| PATENT | 2039-01-15 | FTO_TAIL | Cysteine solution with 12/18/24-month oxygen, aluminum, pH and particulate limits. | Source |
| PATENT | 2039-01-15 | FTO_TAIL | Cysteine concentration, pH, aluminum, stability, single-use vial and low-oxygen preparation restrictions. | Source |
| PATENT | 2039-03-02 | FTO_TAIL | Cysteine solution with aluminum, cystine, oxygen, pH and stability/process restrictions. | Source |
| PATENT | 2039-03-15 | FTO_TAIL | Cysteine product/method with acidification and inert-gas filling restrictions. | Source |
| PATENT | 2039-03-15 | FTO_TAIL | 50 mg/mL cysteine solution with specified aluminum and pH limits. | Source |
| PATENT | 2039-03-15 | FTO_TAIL | Parenteral nutrition method requires a quantitatively specified cysteine solution; no unrestricted molecule protection. | Source |
| PATENT | 2039-03-15 | FTO_TAIL | Cysteine solution with concentration, pH, aluminum, particulate and vial limitations. | Source |
| REGULATORY_STATUS | — | TERMINAL_STATUS | FDA 2020 annual edition, as of 2019-12-31: exact NDA212535/001 in prescription list. FDA 2021 annual edition, as of 2020-12-31: same product in discontinued list. FDA listing-status transition is bounded within 2020; this is not proof of commercial launch or cessation on an exact day. Drugs@FDA API retains Prescription, so the Orange Book discontinued list is used for FDA marketing-list status. Canonical patent/exclusivity assessment is preserved as historical supporting data; it does not override this product status. | 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.