Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12161761 DP* Extended Release Multiparticulates Of Ranolazine Pat. Sub. Date(s): 002: Dec 19, 2024 Claim Types: Formulation | Jan 24, 2038 | New patent for this product |
ATORVALIQ (SUSPENSION) (ORAL) ATORVASTATIN CALCIUM
Drug Classes: HMG-CoA reductase inhibitor
NDA Applicant: CMP DEV LLC NDA No.: 213260 Prod. No.: 001 RX (20MG/5ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12168069 DP* Aqueous Suspension Suitable For Oral Administration Pat. Sub. Date(s): 001: Dec 19, 2024 Claim Types: Formulation | Jun 7, 2037 | New patent for this product |
ATTRUBY (TABLET) (ORAL) ACORAMIDIS HYDROCHLORIDE
NDA Applicant: BRIDGEBIO PHARMA NDA No.: 216540 Prod. No.: 001 RX (EQ 356MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8877795 DP* Identification of stabilizers of multimeric proteins Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Composition | May 5, 2031 | New patent for this product |
| Pat. No. 9169214 DP* Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Composition; Method of use; Formulation Use Code: U-4046: Treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) | May 5, 2031 | New patent for this product |
| Pat. No. 9642838 DS* DP* Compounds And Compositions That Bind And Stabilize Transthyretin And Their Use For Inhibiting Transthyretin Amyloidosis And Protein-protein Interactions Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Compound; Composition | May 5, 2031 | New patent for this product |
| Pat. No. 9913826 Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Method of use Use Code: U-4046: Treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) | Mar 14, 2033 | New patent for this product |
| Pat. No. 10398681 DP* Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Kit | May 5, 2031 | New patent for this product |
| Pat. No. 10513497 DS* Process for preparing AG-10, its intermediates, and salts thereof Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: New polymorph, salt or hydrate | Feb 16, 2038 | New patent for this product |
| Pat. No. 10842777 Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Method of use Use Code: U-4046: Treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) | May 5, 2031 | New patent for this product |
| Pat. No. 11058668 Methods of treating TTR amyloidosis using AG10 Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Method of use Use Code: U-4046: Treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) | Mar 22, 2039 | New patent for this product |
| Pat. No. 11260047 DP* Formulations of AG10 Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Formulation | Aug 16, 2039 | New patent for this product |
| Pat. No. 11919865 Processes for preparing AG-10, its intermediates, and salts thereof Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Method of use Use Code: U-4046: Treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) | Feb 16, 2038 | New patent for this product |
| Pat. No. 12005043 DP* Formulations of AG10 Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Formulation; Method of use Use Code: U-4046: Treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) | Aug 16, 2039 | New patent for this product |
| Pat. No. 12070449 Methods of treating TTR amyloidosis using AG10 Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Use Code: U-4046: Treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) | Mar 22, 2039 | New patent for this product |
| Exclusivity | Expiration | Change |
| Exclusivity Code: NCE - New chemical entity | Nov 22, 2029 | New exclusivity for this product |
AUVELITY (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Drug Classes: aminoketone == sigma-1 agonist == uncompetitive NMDA receptor antagonist
NDA Applicant: AXSOME NDA No.: 215430 Prod. No.: 001 RX (105MG;45MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12156914 DP* Pharmaceutical Compositions Comprising Bupropion And Cysteine Pat. Sub. Date(s): 001: Dec 19, 2024 Claim Types: Formulation | Jan 20, 2043 | New patent for this product |
BROMSITE (SOLUTION/DROPS) (OPHTHALMIC) BROMFENAC SODIUM [GENERIC AB]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: SUN PHARM NDA No.: 206911 Prod. No.: 001 RX (EQ 0.075% ACID)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. RE50218 DP* Non-steroidal Anti-inflammatory Ophthalmic Compositions Pat. Sub. Date(s): 001: Dec 26, 2024 Claim Types: Formulation; Method of use Use Code: U-1834: Treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery | Mar 5, 2029 | New patent for this product |
| Pat. No. 8778999 DP* Non-steroidal anti-inflammatory ophthalmic compositions Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-1834: Treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery | Aug 7, 2029 | This patent is no longer listed for this product |
CABENUVA KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) CABOTEGRAVIR; RILPIVIRINE
Drug Classes: human immunodeficiency virus type 1 (HIV-1) integrase strand == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: VIIV HLTHCARE NDA No.: 212888 Prod. No.: 001 RX (400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)); 002 RX (600MG/3ML (200MG/ML);900MG/3ML (300MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. RE50189 Long term treatment of HIV-infection with TMC278 Pat. Sub. Date(s): All strengths: Dec 16, 2024 Claim Types: Method of use Use Code: U-3348: Treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg | Nov 27, 2031 | New patent for this product |
CIPROFLOXACIN HYDROCHLORIDE (SOLUTION/DROPS) (OTIC) CIPROFLOXACIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: fluoroquinolone antibacterial
NDA Applicant: IDENTIRX NDA No.: 217887 Prod. No.: 001 RX (EQ 0.2% BASE)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jun 11, 2025 | New exclusivity for this product |
CRENESSITY (CAPSULE) (ORAL) CRINECERFONT
NDA Applicant: NEUROCRINE NDA No.: 218808 Prod. No.: 001 RX (25MG); 002 RX (50MG); 003 RX (100MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-503: Adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (cah) | Dec 13, 2031 | New product in Orange Book |
CRENESSITY (SOLUTION) (ORAL) CRINECERFONT
NDA Applicant: NEUROCRINE NDA No.: 218820 Prod. No.: 001 RX (50MG/ML)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-503: Adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (cah) | Dec 13, 2031 | New product in Orange Book |
CREXONT (CAPSULE, EXTENDED RELEASE) (ORAL) CARBIDOPA; LEVODOPA
Drug Classes: aromatic amino acid decarboxylation inhibitor
NDA Applicant: IMPAX NDA No.: 217186 Prod. No.: 001 RX (35MG;140MG); 002 RX (52.5MG;210MG); 003 RX (70MG;280MG); 004 RX (87.5MG;350MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12178918 DP* Muco-adhesive, Controlled Release Formulations Of Levodopa And/or Esters Of Levodopa And Uses Thereof Pat. Sub. Date(s): All strengths: Jan 8, 2025 Claim Types: Formulation | Oct 7, 2034 | New patent for this product |
| Pat. No. 12178919 DP* Muco-adhesive, Controlled Release Formulation Of Levodopa And/or Esters Of Levodopa And Uses Thereof Pat. Sub. Date(s): All strengths: Jan 8, 2025 Claim Types: Formulation; Method of use Use Code: U-219: Treatment of Parkinson's disease | Oct 7, 2034 | New patent for this product |
DEFINITY; DEFINITY RT (INJECTABLE) (INTRAVENOUS) PERFLUTREN
Drug Classes: ultrasound contrast agent
NDA Applicant: LANTHEUS MEDCL NDA No.: 021064 Prod. No.: 001 RX (13.04MG/2ML (6.52MG/ML)); 002 RX (13.04MG/2ML (6.52MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12161730 Methods For Making Ultrasound Contrast Agents Pat. Sub. Date(s): All strengths: Jan 6, 2025 Claim Types: Diagnostic or surgical method Use Code: U-665: Method of using the drug substance/drug product for ultrasound imaging | Mar 16, 2037 | New patent for this product |
DEXTENZA (INSERT) (OPHTHALMIC) DEXAMETHASONE
Drug Classes: corticosteroid
NDA Applicant: OCULAR THERAPEUTIX NDA No.: 208742 Prod. No.: 001 RX (0.4MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12144889 Methods of treating allergic conjunctivitis Pat. Sub. Date(s): 001: Dec 17, 2024 Claim Types: Method of use Use Code: U-1680: Treatment of ocular itching associated with allergic conjunctivitis | Apr 26, 2041 | New patent for this product |
| Pat. No. 12150896 Punctal Plug And Bioadhesives Pat. Sub. Date(s): 001: Dec 17, 2024 Claim Types: Method of use Use Code: U-1680: Treatment of ocular itching associated with allergic conjunctivitis Use Code: U-3455: Treatment of ocular inflammation and pain following ophthalmic surgery | Oct 7, 2036 | New patent for this product |
DUVYZAT (SUSPENSION) (ORAL) GIVINOSTAT HYDROCHLORIDE
NDA Applicant: ITALFARMACO SPA NDA No.: 217865 Prod. No.: 001 RX (EQ 8.86MG BASE/ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7329689 DS* DP* Monohydrate hydrochloride of the 4-hydroxycarbamoyl-phenyl)-carbamic acid (6-diethylaminomethyl-naphtalen-2-yl) ester Pat. Sub. Date(s): 001: Apr 19, 2024 Claim Types: New polymorph, salt or hydrate; Composition | Jan 15, 2026 | New expiration date. Was previously Jan 15, 2025 |
EMROSI (CAPSULE, EXTENDED RELEASE) (ORAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes: tetracycline class drug
NDA Applicant: JOURNEY NDA No.: 219015 Prod. No.: 001 RX (40MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NP - New product | Nov 1, 2027 | New exclusivity for this product |
EPHEDRINE SULFATE (SOLUTION) (INTRAVENOUS) EPHEDRINE SULFATE [GENERIC AP]
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == norepinephrine-releasing agent
NDA Applicant: HIKMA NDA No.: 217721 Prod. No.: 001 RX (25MG/5ML (5MG/ML))
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jun 18, 2025 | New exclusivity for this product |
EPSOLAY (CREAM) (TOPICAL) BENZOYL PEROXIDE
NDA Applicant: GALDERMA LABS LP NDA No.: 214510 Prod. No.: 001 RX (5%)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12156946 DP* Methods Of Treating Conditions Related To The S1P.SUB.1 .receptor Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Method of use | Feb 3, 2028 | New patent for this product |
INVOKAMET (TABLET) (ORAL) CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: biguanide
NDA Applicant: JANSSEN PHARMS NDA No.: 204353 Prod. No.: 001 RX (50MG;500MG); 002 RX (50MG;1GM); 003 RX (150MG;500MG); 004 RX (150MG;1GM)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7943582 DS* DP* Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate Pat. Sub. Date(s): All strengths: Sep 4, 2014 Claim Types: New polymorph, salt or hydrate; Process; Method of use Use Code: U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients Use Code: U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients Use Code: U-493: Treatment of Type 2 Diabetes Mellitus | Aug 26, 2029 *PED | New expiration date. Was previously Feb 26, 2029 |
| Pat. No. 7943788 DS* DP* Glucopyranoside compound Pat. Sub. Date(s): All strengths: Sep 4, 2014 Claim Types: Compound; Process; Composition | Jan 14, 2028 *PED | New expiration date. Was previously Jul 14, 2027 |
| Pat. No. 8222219 Glucopyranoside compound Pat. Sub. Date(s): All strengths: Sep 4, 2014 Claim Types: Method of use Use Code: U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients Use Code: U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients Use Code: U-493: Treatment of Type 2 Diabetes Mellitus | Oct 11, 2025 *PED | New expiration date. Was previously Apr 11, 2025 |
| Pat. No. 8513202 DS* DP* Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate Pat. Sub. Date(s): All strengths: Sep 4, 2014 Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Use Code: U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients Use Code: U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients Use Code: U-493: Treatment of Type 2 Diabetes Mellitus | Jun 3, 2028 *PED | New expiration date. Was previously Dec 3, 2027 |
INVOKAMET XR (TABLET, EXTENDED RELEASE) (ORAL) CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: biguanide
NDA Applicant: JANSSEN PHARMS NDA No.: 205879 Prod. No.: 001 RX (50MG;500MG); 002 RX (50MG;1GM); 003 RX (150MG;500MG); 004 RX (150MG;1GM)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7943582 DS* DP* Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate Pat. Sub. Date(s): All strengths: Oct 14, 2016 Claim Types: New polymorph, salt or hydrate; Process; Method of use Use Code: U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients Use Code: U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients Use Code: U-493: Treatment of Type 2 Diabetes Mellitus | Aug 26, 2029 *PED | New expiration date. Was previously Feb 26, 2029 |
| Pat. No. 7943788 DS* DP* Glucopyranoside compound Pat. Sub. Date(s): All strengths: Oct 14, 2016 Claim Types: Compound; Process; Composition | Jan 14, 2028 *PED | New expiration date. Was previously Jul 14, 2027 |
| Pat. No. 8222219 Glucopyranoside compound Pat. Sub. Date(s): All strengths: Oct 14, 2016 Claim Types: Method of use Use Code: U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients Use Code: U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients Use Code: U-493: Treatment of Type 2 Diabetes Mellitus | Oct 11, 2025 *PED | New expiration date. Was previously Apr 11, 2025 |
| Pat. No. 8513202 DS* DP* Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate Pat. Sub. Date(s): All strengths: Oct 14, 2016 Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Use Code: U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients Use Code: U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients Use Code: U-493: Treatment of Type 2 Diabetes Mellitus | Jun 3, 2028 *PED | New expiration date. Was previously Dec 3, 2027 |
INVOKANA (TABLET) (ORAL) CANAGLIFLOZIN
NDA Applicant: JANSSEN PHARMS NDA No.: 204042 Prod. No.: 001 RX (100MG); 002 RX (300MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7943582 DS* DP* Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate Pat. Sub. Date(s): All strengths: Apr 16, 2013 Claim Types: New polymorph, salt or hydrate; Process; Method of use Use Code: U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients Use Code: U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients Use Code: U-493: Treatment of Type 2 Diabetes Mellitus | Aug 26, 2029 *PED | New expiration date. Was previously Feb 26, 2029 |
| Pat. No. 7943788 DS* DP* Glucopyranoside compound Pat. Sub. Date(s): 001: Apr 16, 2013; 002: None Claim Types: Compound; Process; Composition | Jan 14, 2028 *PED | New expiration date. Was previously Jul 14, 2027 |
| Pat. No. 8222219 Glucopyranoside compound Pat. Sub. Date(s): All strengths: Apr 16, 2013 Claim Types: Method of use Use Code: U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients Use Code: U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients Use Code: U-493: Treatment of Type 2 Diabetes Mellitus | Oct 11, 2025 *PED | New expiration date. Was previously Apr 11, 2025 |
| Pat. No. 8513202 DS* DP* Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate Pat. Sub. Date(s): All strengths: Apr 16, 2013 Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Use Code: U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients Use Code: U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients Use Code: U-493: Treatment of Type 2 Diabetes Mellitus | Jun 3, 2028 *PED | New expiration date. Was previously Dec 3, 2027 |
| Pat. No. 10617668 DP* Pharmaceutical formulations Pat. Sub. Date(s): All strengths: May 6, 2020 Claim Types: Formulation; Method of use Use Code: U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients Use Code: U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients Use Code: U-2794: Treatment of Type 2 diabetes mellitus with 100 mg canagliflozin per day Use Code: U-2795: Treatment of Type 2 diabetes mellitus with 300 mg canagliflozin per day Use Code: U-2796: Reduction of risk of major adverse cardiovascular events in the treatment of type 2 diabetes mellitus patients with 100 mg canagliflozin per day Use Code: U-2797: Reduction of risk of major adverse cardiovascular events in the treatment of type 2 diabetes mellitus patients with 300 mg canagliflozin per day Use Code: U-2798: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of type 2 diabetes mellitus patients with 100 mg canagliflozin per day Use Code: U-2799: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of type 2 diabetes mellitus patients with 300 mg canagliflozin per day Use Code: U-493: Treatment of Type 2 Diabetes Mellitus | Nov 11, 2031 *PED | New expiration date. Was previously May 11, 2031 |
LIBERVANT (FILM) (BUCCAL) DIAZEPAM
Drug Classes: benzodiazepine
NDA Applicant: AQUESTIVE NDA No.: 218623 Prod. No.: 001 RX (5MG); 002 RX (7.5MG); 003 RX (10MG); 004 RX (12.5MG); 005 RX (15MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-501: Acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 to 5 years of age | Apr 26, 2031 | New exclusivity for this product |
LUTATHERA (SOLUTION) (INTRAVENOUS) LUTETIUM LU 177 DOTATATE
NDA Applicant: AAA USA INC NDA No.: 208700 Prod. No.: 001 RX (10mCi/ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12161732 DP* Stable, Concentrated Radionuclide Complex Solutions Pat. Sub. Date(s): 001: Dec 10, 2024 Claim Types: Process; Product-by-process; Method of use Use Code: U-4036: Treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (gep-nets), including foregut, midgut, and hindgut neuroendocrine tumors | Jan 25, 2039 *PED | New expiration date. Was previously Jul 25, 2038 |
| Pat. No. 12168063 DP* Stable, Concentrated Radionuclide Complex Solutions Pat. Sub. Date(s): 001: Dec 17, 2024 Claim Types: Product-by-process; Process Use Code: U-4036: Treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (gep-nets), including foregut, midgut, and hindgut neuroendocrine tumors | Jul 25, 2038 | New patent for this product |
METHOHEXITAL SODIUM (INJECTABLE) (INJECTION) METHOHEXITAL SODIUM [GENERIC AP]
Drug Classes: barbiturate
NDA Applicant: STERISCIENCE SPECLTS NDA No.: 215488 Prod. No.: 001 RX (500MG/VIAL)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jun 10, 2025 | New exclusivity for this product |
MINOCIN (INJECTABLE) (INJECTION) MINOCYCLINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: tetracycline class drug
NDA Applicant: REMPEX NDA No.: 050444 Prod. No.: 001 RX (EQ 100MG BASE/VIAL)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12161656 DP* Tetracycline Compositions Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Formulation | May 12, 2031 | New patent for this product |
MYFEMBREE (TABLET) (ORAL) ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Drug Classes: estrogen == progestin == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: SUMITOMO PHARMA NDA No.: 214846 Prod. No.: 001 RX (1MG;0.5MG;40MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7300935 DS* Thienopyrimidine compounds and use thereof Pat. Sub. Date(s): 001: Jun 21, 2021 Claim Types: Compound | Jan 28, 2026 | New expiration date. Was previously Jan 28, 2025 |
| Pat. No. 8058280 DS* DP* Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof Pat. Sub. Date(s): 001: Jun 21, 2021 Claim Types: Compound; Composition; Process | Jan 28, 2026 | New expiration date. Was previously Jan 28, 2025; New Drug Substance/Drug Product flag |
ONTRALFY (SOLUTION) (ORAL) TIZANIDINE HYDROCHLORIDE
Drug Classes: central alpha-2 adrenergic agonist
NDA Applicant: FIDELITY BIOPHARMA NDA No.: 216190 Prod. No.: 001 RX (EQ 2MG BASE/5ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12042484 DP* Tizanidine liquid preparation and use thereof Pat. Sub. Date(s): 001: Dec 19, 2024 Claim Types: Formulation; Method of administration Use Code: U-2779: Treatment of spasticity | May 7, 2042 | New product in Orange Book |
ORGOVYX (TABLET) (ORAL) RELUGOLIX
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: SUMITOMO PHARMA NDA No.: 214621 Prod. No.: 001 RX (120MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7300935 DS* Thienopyrimidine compounds and use thereof Pat. Sub. Date(s): 001: Jan 14, 2021 Claim Types: Compound | Jan 28, 2026 | New expiration date. Was previously Jan 28, 2025 |
| Pat. No. 8058280 DS* DP* Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof Pat. Sub. Date(s): 001: Jan 14, 2021 Claim Types: Compound; Composition; Process | Jan 28, 2026 | New expiration date. Was previously Jan 28, 2025 |
PRUCALOPRIDE SUCCINATE (TABLET) (ORAL) PRUCALOPRIDE SUCCINATE [GENERIC AB]
Drug Classes: serotonin-4 (5-HT4) receptor agonist
NDA Applicant: NOVITIUM PHARMA NDA No.: 218492 Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 2MG BASE)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jun 24, 2025 | New product in Orange Book |
PYLARIFY (SOLUTION) (INTRAVENOUS) PIFLUFOLASTAT F-18
NDA Applicant: PROGENICS PHARMS INC NDA No.: 214793 Prod. No.: 001 RX (50ML (1-80mCi/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12070513 DS* DP* PSMA-binding agents and uses thereof Pat. Sub. Date(s): 001: Dec 20, 2024 Claim Types: Composition; Diagnostic or surgical method; Method of use; Kit Use Code: U-3130: Method of positron emission tomography (PET) in men with prostate cancer | Jul 31, 2029 | New patent for this product |
RALDESY (SOLUTION) (ORAL) TRAZODONE HYDROCHLORIDE
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: KAMAT NDA No.: 218637 Prod. No.: 001 RX (10MG/ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8133893 DS* DP* Trazodone and trazodone hydrochloride in purified form Pat. Sub. Date(s): 001: Dec 4, 2024 Claim Types: Formulation; Process | Mar 13, 2029 | New patent for this product |
RAPIBLYK (POWDER) (INTRAVENOUS) LANDIOLOL HYDROCHLORIDE
NDA Applicant: AOP ORPHAN NDA No.: 217202 Prod. No.: 001 RX (EQ 280MG BASE/VIAL)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Nov 22, 2029 | New exclusivity for this product |
REVUFORJ (TABLET) (ORAL) REVUMENIB CITRATE
NDA Applicant: SYNDAX NDA No.: 218944 Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 110MG BASE); 003 RX (EQ 160MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10683302 DS* DP* Inhibitors of the menin-MLL interaction Pat. Sub. Date(s): All strengths: Dec 13, 2024 Claim Types: Compound; New polymorph, salt or hydrate; Composition | Jun 8, 2037 | New patent for this product |
| Pat. No. 11479557 DP* Inhibitors of the menin-MLL interaction Pat. Sub. Date(s): All strengths: Dec 13, 2024 Claim Types: Method of use; Formulation Use Code: U-4045: Treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2a gene (KMT2A) translocation in adult and pediatric patients 1 year and older | Jun 8, 2037 | New patent for this product |
| Exclusivity | Expiration | Change |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-502: Treatment of relapsed or refractory mixed-phenotype acute leukemia with a lysine methyltransferase 2a gene (kmt2a) translocation in adult and pediatric patients 1 year and older. | Nov 15, 2031 | New exclusivity for this product |
RYBELSUS (TABLET) (ORAL) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 213051 Prod. No.: 004 RX (1.5MG); 005 RX (4MG); 006 RX (9MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11833248 DP* Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid Pat. Sub. Date(s): All strengths: Jan 7, 2025 Claim Types: Formulation; Method of use Use Code: U-2628: Method of treating Type 2 diabetes mellitus | Feb 1, 2039 | New strength or variation of this product |
SUNLENCA (SOLUTION) (SUBCUTANEOUS) LENACAPAVIR SODIUM
Drug Classes: human immunodeficiency virus type 1 (HIV-1) capsid inhibitor
NDA Applicant: GILEAD SCIENCES INC NDA No.: 215973 Prod. No.: 001 RX (EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11944611 Capsid inhibitors for the treatment of HIV Pat. Sub. Date(s): 001: Apr 23, 2024 Claim Types: Method of use Use Code: U-3507: In combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily-treatment experienced adults with multidrug resistant HIV-1 infection | Aug 28, 2041 | New expiration date. Was previously Jun 4, 2041 |
SUNLENCA (TABLET) (ORAL) LENACAPAVIR SODIUM
Drug Classes: human immunodeficiency virus type 1 (HIV-1) capsid inhibitor
NDA Applicant: GILEAD SCIENCES INC NDA No.: 215974 Prod. No.: 001 RX (EQ 300MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11944611 Capsid inhibitors for the treatment of HIV Pat. Sub. Date(s): 001: Apr 23, 2024 Claim Types: Method of use Use Code: U-3507: In combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily-treatment experienced adults with multidrug resistant HIV-1 infection | Aug 28, 2041 | New expiration date. Was previously Jun 4, 2041 |
TETRACAINE HYDROCHLORIDE (SOLUTION) (OPHTHALMIC) TETRACAINE HYDROCHLORIDE [GENERIC AB1]
Drug Classes: ester local anesthetic
NDA Applicant: SOMERSET THERAPS LLC NDA No.: 217227 Prod. No.: 001 RX (0.5%)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jun 25, 2025 | New product in Orange Book |
TROMETHAMINE (SOLUTION) (INJECTION) TROMETHAMINE [GENERIC AP]
NDA Applicant: MILLA PHARMS NDA No.: 213116 Prod. No.: 001 RX (18GM/500ML (3.6GM/100ML))
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jul 1, 2025 | New product in Orange Book |
TWYNEO (CREAM) (TOPICAL) BENZOYL PEROXIDE; TRETINOIN
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP NDA No.: 214902 Prod. No.: 001 RX (3%;0.1%)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12156946 DP* Methods Of Treating Conditions Related To The S1P.SUB.1 .receptor Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Method of use | Feb 3, 2028 | New patent for this product |
VABOMERE (POWDER) (INTRAVENOUS) MEROPENEM; VABORBACTAM
Drug Classes: penem antibacterial == beta lactamase inhibitor
NDA Applicant: REMPEX NDA No.: 209776 Prod. No.: 001 RX (1GM/VIAL;1GM/VIAL)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12171772 DS* Therapeutic Uses Of Pharmaceutical Compositions Comprising Cyclic Boronic Acid Ester Derivatives Pat. Sub. Date(s): 001: Jan 3, 2025 Claim Types: New polymorph, salt or hydrate | Aug 8, 2031 | New patent for this product |
VELSIPITY (TABLET) (ORAL) ETRASIMOD ARGININE
Drug Classes: sphingosine 1-phosphate receptor modulator
NDA Applicant: PFIZER NDA No.: 216956 Prod. No.: 001 RX (EQ 2MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12156866 Methods Of Treating Conditions Related To The S1P.SUB.1 .receptor Pat. Sub. Date(s): 001: Dec 20, 2024 Claim Types: Method of use Use Code: U-4047: A method for treating ulcerative colitis by administering a therapeutically effective amount of estrasimod arginine as claimed | Jan 6, 2036 | New patent for this product |
XYWAV (SOLUTION) (ORAL) CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: JAZZ NDA No.: 212690 Prod. No.: 001 RX (0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12138233 Methods Of Treating Idiopathic Hypersomnia Pat. Sub. Date(s): 001: Dec 11, 2024 Claim Types: Method of use Use Code: U-4044: Treatment of idiopathic hypersomnia with a mixture of sodium, potassium, magnesium, and calcium salts of GHB | Feb 22, 2041 | New patent for this product |
| Pat. No. 12139233 Electric snowmobile Pat. Sub. Date(s): None Claim Types: Typo in patent number Comments: Correct number is 12,138,233. Use Code: U-4044: Treatment of idiopathic hypersomnia with a mixture of sodium, potassium, magnesium, and calcium salts of GHB | Feb 22, 2041 | This patent is no longer listed for this product |