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CIALIS Drug Profile
Which patents cover Cialis, and when can generic versions of Cialis launch?
Cialis is a drug marketed by Lilly and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.
The generic ingredient in CIALIS is tadalafil. There are twenty-five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for CIALIS
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 8 |
| Bulk Api Vendors: | 74 |
| Clinical Trials: | 31 |
| Patent Applications: | 3,378 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CIALIS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CIALIS |
| DailyMed Link: | CIALIS at DailyMed |
Pharmacology for CIALIS
| Drug Class | Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for CIALIS
Synonyms for CIALIS
| (2R,8R)-2-(1,3-benzodioxol-5-yl)-6-methyl-3,6,17-triazatetracyclo[8.7.0.0^{3,8}.0^{11,16}]heptadeca-1(10),11,13,15-tetraene-4,7-dione |
| (2R,8R)-2-(2H-1,3-benzodioxol-5-yl)-6-methyl-3,6,17-triazatetracyclo[8.7.0.0^{3,8}.0^{11,16}]heptadeca-1(10),11(16),12,14-tetraene-4,7-dione |
| (2R,8R)-2-(2H-1,3-benzodioxol-5-yl)-6-methyl-3,6,17-triazatetracyclo[8.7.0.0;{3,8}.0;{11,16}]heptadeca-1(10),11,13,15-tetraene-4,7-dione |
| (2R,8R)-2-(2H-1,3-BENZODIOXOL-5-YL)-6-METHYL-3,6,17-TRIAZATETRACYCLO[8.7.0.0(3),?.0(1)(1),(1)?]HEPTADECA-1(10),11(16),12,14-TETRAENE-4,7-DIONE |
| (6R-trans)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione |
| (6R,12 aR)-6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione |
| (6R,12aR) 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino [1',2':1,6] pyrido[3,4-b]indole-1,4-dione |
| (6R,12aR) 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione |
| (6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-(methylenedioxy)phenyl) pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione |
| (6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione |
| (6R,12aR)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1,2,1,6]pyrido[3,4-b]indole-1,4-dione |
| (6R,12aR)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione |
| (6R,12aR)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione |
| (6R,12AR)-6-(1,3-BENZODIOXOL-5-YL)-2,3,6,7,12,12A-HEXAHYDRO-2-METHYL-PYRAZINO[1',2':1,6]PYRIDOL[3,4-B]INDOLE-1,4-DIONE |
| (6R,12aR)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione |
| (6R,12aR)-6-(Benzo[d][1,3]dioxol-5-yl)-2-methyl-2,3,12,12a-tetrahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4(6H,7H)-dione |
| (6R,12aR)-6-(benzo[d][1,3]dioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione |
| (6R,12aR)-6-Benzo[1,3]dioxol-5-yl-2-methyl-2,3,6,7,12,12a-hexahydro-pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione |
| (6R,3,6,7,12,12a-Hexahydro-2-methyl-6-[3,4-(methylenedioxy)phenyl]pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione |
| 1,3-benzodioxol-5-yl(methyl)[?]dione |
| 171596-29-5 |
| 1xoz |
| 596T295 |
| 6-BENZO[1,3]DIOXOL-5-YL-2-METHYL-2,3,6,7,12,12A-HEXAHYDRO-PYRAZINO[1',2':1,6]PYRIDO[3,4-B]INDOLE-1,4-DIONE |
| 742SXX0ICT |
| A23556 |
| AB0008473 |
| AB00639969_09 |
| AB00639969_10 |
| AB00639969-08 |
| AB1009208 |
| AB42193 |
| ABP000527 |
| AC1L380B |
| Acdirca |
| ADCIRCA |
| Adcirca (TN) |
| AK-60035 |
| AKOS015892559 |
| AN-15538 |
| ANW-54093 |
| BDBM14777 |
| C-21522 |
| CAS-171596-29-5 |
| CC-25771 |
| CC0257 |
| CCG-100973 |
| CHEBI:71940 |
| CHEMBL779 |
| Cialis (TN) |
| Cialis, GF 196960, IC 351, ICOS 351, Tadalafil |
| Cialis, Tadalafil |
| CPD000466321 |
| CS-1414 |
| CTK8B6705 |
| D02008 |
| D05MQK |
| DB00820 |
| DR002249 |
| DSSTox_CID_26786 |
| DSSTox_GSID_46786 |
| DSSTox_RID_81904 |
| DTXSID9046786 |
| FT-0080116 |
| FT-0601538 |
| FT-0674791 |
| GF 196960 |
| GF-196960 |
| GF196960 |
| GTPL7299 |
| HMS2051N17 |
| HMS2235L21 |
| HSDB 7303 |
| HY-90009A |
| IC 351 |
| IC-351 |
| Ic351 |
| ICOS 351 |
| J90025 |
| KB-60666 |
| KS-1117 |
| Lilly brand of tadalafil |
| LS-186558 |
| LS-187015 |
| LS-187770 |
| LY-450190 |
| MFCD10465563 |
| MLS000759426 |
| MLS001165782 |
| MLS001195644 |
| MLS001424132 |
| MLS006010126 |
| MolPort-002-885-864 |
| NC00223 |
| NCGC00168781-01 |
| NCGC00263909-02 |
| NSC-750236 |
| NSC-759172 |
| NSC750236 |
| NSC759172 |
| Pharmakon1600-01505639 |
| PL048252 |
| PYR280 |
| Pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R-trans)- |
| Pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)- |
| Pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)- |
| Pyrazino[1',6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12ahexahydro-2-methyl-, (6R,12aR)- |
| RTR-007551 |
| s1512 |
| SAM001246586 |
| SC-16083 |
| SCHEMBL33333 |
| SMR000466321 |
| SR-05000001940 |
| SR-05000001940-1 |
| Tadalafil |
| Tadalafil (Cialis) |
| Tadalafil (JAN/USAN/INN) |
| Tadalafil [USAN] |
| Tadalafil 1.0 mg/ml in Acetonitrile |
| Tadalafil Lilly |
| Tadalafil solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material |
| Tadalafil(Cialis) |
| Tadalafil(Cialis)/ |
| Tadanafil |
| tardenafil |
| Tardenafil|||Cialis |
| TILDENAFIL |
| Tox21_112642 |
| Tox21_112642_1 |
| UNII-742SXX0ICT |
| W-5349 |
| WOXKDUGGOYFFRN-IIBYNOLFSA-N |
| X-3024 |
| zalutia |
| Zalutia (TN) |
| ZINC3993855 |
US Patents and Regulatory Information for CIALIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-004 | Jan 7, 2008 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-002 | Nov 21, 2003 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-003 | Nov 21, 2003 | AB1 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-004 | Jan 7, 2008 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-003 | Nov 21, 2003 | AB1 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Expired US Patents for CIALIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-002 | Nov 21, 2003 | ➤ Sign Up | ➤ Sign Up |
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-003 | Nov 21, 2003 | ➤ Sign Up | ➤ Sign Up |
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-004 | Jan 7, 2008 | ➤ Sign Up | ➤ Sign Up |
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-002 | Nov 21, 2003 | ➤ Sign Up | ➤ Sign Up |
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-003 | Nov 21, 2003 | ➤ Sign Up | ➤ Sign Up |
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | ➤ Sign Up | ➤ Sign Up |
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for CIALIS
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 2.5 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Tablets | 5 mg, 10 mg and 20 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for CIALIS
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Australia | 6419196 | ➤ Sign Up |
| Japan | 2003505509 | ➤ Sign Up |
| Czech Republic | 289832 | ➤ Sign Up |
| Spain | 2208317 | ➤ Sign Up |
| Australia | 776722 | ➤ Sign Up |
| Ukraine | 72248 | ➤ Sign Up |
| Australia | 4491200 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for CIALIS
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0017 | France | ➤ Sign Up | PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112 |
| 081 | Luxembourg | ➤ Sign Up | PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125 |
| 2003001 | Lithuania | ➤ Sign Up | PRODUCT NAME: TADALAFILUM ((6R,12AR)-2,3,6,7,12,12A-HEKSAHIDRO-2-METIL-6-(3,4-METILENDIOKSIFENIL)-PIRAZINO(2',1':6,1)PIRIDO(3,4-B)INDOL-1,4-DIONAS); REGISTRATION NO/DATE: 03/8034/3, 03/8035/3 20030328 |
| 2016 00024 | Denmark | ➤ Sign Up | PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125 |
| 2003 00008 | Denmark | ➤ Sign Up | |
| 2016000039 | Germany | ➤ Sign Up | PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120 |
| C/GB03/007 | United Kingdom | ➤ Sign Up | PRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
