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ANDROGEL Drug Profile
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Which patents cover Androgel, and when can generic versions of Androgel launch?
Androgel is a drug marketed by Abbvie and is included in two NDAs. There are eleven patents protecting this drug and three Paragraph IV challenges.
This drug has one hundred and forty-eight patent family members in thirty-six countries.
The generic ingredient in ANDROGEL is testosterone. There are sixty-five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for ANDROGEL
| International Patents: | 148 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 65 |
| Clinical Trials: | 37 |
| Patent Applications: | 4,215 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ANDROGEL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ANDROGEL |
| DailyMed Link: | ANDROGEL at DailyMed |
Pharmacology for ANDROGEL
| Ingredient-type | Androstanes |
| Drug Class | Androgen |
| Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for ANDROGEL
Synonyms for ANDROGEL
| (+-)-8-iso-testosterone |
| (+-)-retrotestosterone |
| (+-)-testosterone |
| (+)-testosterone |
| (17?)-17-Hydroxyandrost-4-en-3-one |
| (17b)-17-hydroxy-androst-4-en-3-one |
| (17beta)-17-Hydroxyandrost-4-en-3-one |
| (1S,2R,10R,11S,14S,15S)-14-hydroxy-2,15-dimethyltetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadec-6-en-5-one |
| (1S,2R,10R,11S,14S,15S)-14-HYDROXY-2,15-DIMETHYLTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADEC-6-EN-5-ONE |
| (8alpha,10alpha,13alpha,14beta,17alpha)-17-hydroxyandrost-4-en-3-one |
| (8R,9S,10R,13S,14S,17S)-17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one |
| (8R,9S,10R,13S,14S,17S)-17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-3-one |
| (8R,9S,10R,13S,14S,17S)-17-Hydroxy-10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3(2H)-one |
| 003T654 |
| 1050678-68-6 |
| 13-iso-testosterone |
| 17-.beta.-Hydroxyandrost-4-en-3-one |
| 17-beta-Hydroxy-delta(sup 4)-androsten-3-one |
| 17-beta-Hydroxyandrost-4-en-3-one |
| 17-Hydroxy-(17-beta)-androst-4-en-3-one |
| 17-Hydroxy-(17beta)-androst-4-en-3-one |
| 17-Hydroxy-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-cyclopenta[a]phenanthren-3-one |
| 17-Hydroxy-4-androsten-3-one |
| 17-hydroxy-androst-4-en-3-one |
| 17-hydroxy-D4-androsten-3-one |
| 17-Hydroxyandrost-4-en-3-one, (17.beta.)- |
| 17.beta.-Hydroxy-.DELTA.4-androsten-3-one |
| 17.beta.-Testosterone |
| 17a-hydroxy-(13a)-androst-4-en-3-one |
| 17a-hydroxy-13a-androst-4-en-3-one |
| 17a-hydroxy-14b-androst-4-en-3-one |
| 17a-hydroxy-androst-4-en-3-one |
| 17b-hydroxy-(10a)-androst-4-en-3-one |
| 17b-hydroxy-(13a)-androst-4-en-3-one |
| 17b-hydroxy-(8a,10a)-androst-4-en-3-one |
| 17b-hydroxy-(8a)-androst-4-en-3-one |
| 17b-hydroxy-(9b,10a)-androst-4-en-3-one |
| 17b-hydroxy-(9b)-androst-4-en-3-one |
| 17b-hydroxy-13a-androst-4-en-3-one |
| 17b-hydroxy-4-androsten-3-one |
| 17b-hydroxy-8a-androst-4-en-3-one |
| 17b-Hydroxy-androst-4-en-3-on |
| 17b-hydroxy-androst-4-en-3-one |
| 17b-Hydroxy-D4-androsten-3-one |
| 17b-Hydroxyandrost-4-ene-3-one |
| 17b-Testosterone |
| 17beta-Hydroxy-3-oxo-4-androstene |
| 17beta-Hydroxy-4-androsten-3-one |
| 17beta-hydroxy-4-androsten-3one |
| 17beta-Hydroxy-delta(sup4)-androsten-3-one |
| 17beta-Hydroxyandrost-4-en-3-one |
| 17beta-Hydroxyandrost-4-ene-3-one |
| 17beta-testosterone |
| 1i37 |
| 3kdm |
| 3XMK78S47O |
| 4-androsten-17-ol-3-one |
| 4-Androsten-17.beta.-ol-3-one |
| 4-Androsten-17beta-ol-3-one |
| 4-Androsten-3-one-17.beta.-ol |
| 4-Androsten-3-one-17b-ol |
| 4-Androsten-3-one, 17b-hydroxy- |
| 4-androstene-17beta-ol-3-one |
| 58-22-0 |
| 7-beta-Hydroxyandrost-4-en-3-one |
| 8-iso-testosterone |
| 9b-testosterone |
| 9b,10a-testosterone |
| AA 2500 |
| AB00973630-03 |
| AC-14899 |
| AC1L1LM0 |
| AK405367 |
| AKOS015894897 |
| AN-23597 |
| Andro 100 |
| Androderm |
| Androderm (TN) |
| Androderm, Delatestryl |
| Androgel (TN) |
| Androgel 1.62% |
| Androgel 1% |
| Androlin |
| Andronaq |
| Andronate 100 |
| Andronate 200 |
| Andropatch |
| Andropository 200 |
| Androsorb |
| Androst-4-en-17b-ol-3-one |
| Androst-4-en-17beta-ol-3-one |
| Androst-4-en-3-on-17B-ol |
| Androst-4-en-3-one, 17-beta-hydroxy- |
| Androst-4-en-3-one, 17-hydroxy-, (17-beta)- |
| Androst-4-en-3-one, 17-hydroxy-, (17.beta.)- |
| Androst-4-en-3-one, 17-hydroxy-, (17b)- |
| Androst-4-en-3-one, 17-hydroxy-, (17beta)- |
| Androst-4-en-3-one, 17-hydroxy, (17.beta.)- |
| Androst-4-en-3-one, 17beta-hydroxy- |
| Androst-4-ene-17b-ol-3-one |
| Andrusol |
| Andryl 200 |
| Axiron |
| Axiron (TN) |
| B5DEE83F-632B-48A1-A0ED-A51E7F13DF2E |
| BC208298 |
| BDBM8885 |
| beta testosterone |
| BIDD:ER0555 |
| BIM-0061761.0001 |
| Bio-0678 |
| Bio-T-Gel |
| BT000432 |
| C-18145 |
| C00535 |
| CAS-58-22-0 |
| CCG-101189 |
| CCRIS 574 |
| CDB 111C |
| CHEBI:17347 |
| CHEMBL386630 |
| CMC_13449 |
| COL 1621 |
| CompleoTRT |
| component of Di-Genik (Salt/Mix) |
| component of Di-Met (Salt/Mix) |
| component of Duogen (Salt/Mix) |
| component of Intrinsa (Salt/Mix) |
| component of Mal-O-Fem (Salt/Mix) |
| component of Tostrex (Salt/Mix) |
| CP 601B |
| CPD000058344 |
| Cristerona T |
| Cristerone T |
| CS-1415 |
| D00075 |
| D06XMU |
| D4-Androsten-17b-ol-3-one |
| DB00624 |
| delta(sup 4)-Androsten-17(beta)-ol-3-one |
| delta4-androsten-17b-ol-3-one |
| delta4-Androsten-17beta-ol-3-one |
| DSSTox_CID_2371 |
| DSSTox_GSID_22371 |
| DSSTox_RID_76563 |
| DTXSID8022371 |
| EINECS 200-370-5 |
| Epitestosteron |
| Epitope ID:135865 |
| Everone 200 |
| Fortesta |
| Geno-cristaux gremy |
| GTPL2858 |
| Halotensin |
| HMS2052N11 |
| HMS2272B03 |
| HMS2272P03 |
| Homosteron |
| Homosterone |
| HSDB 3398 |
| HY-15554A |
| Intrinsa |
| LibiGel |
| LMST02020002 |
| LS-148813 |
| Lumitestosteron |
| Malerone |
| Malestrone (amps) |
| Malogen in Oil |
| Malogen, aquaspension injection |
| MCULE-1294118086 |
| Mertestate |
| MLS000563091 |
| MLS001032098 |
| MLS001306401 |
| MLS001424262 |
| MLS002174283 |
| mpp10 |
| MUMGGOZAMZWBJJ-DYKIIFRCSA-N |
| Nasobol |
| NC00439 |
| NCGC00091018-01 |
| NCGC00258243-01 |
| Neo-Hombreol F |
| Neo-testis |
| Neotestis |
| NSC 9700 |
| Oreton |
| Oreton F |
| Oreton-F |
| Orquisteron |
| Perandren |
| Percutacrine androgenique |
| PL000185 |
| Primotest |
| Primoteston |
| Q-101251 |
| rac-17b-hydroxy-(13a)androst-4-en-3-one |
| rac-17b-hydroxy-(8a)-androst-4-en-3-one |
| rac-17b-hydroxy-(9b,10a)androst-4-en-3-one |
| rac-17b-hydroxy-androst-4-en-3-one |
| RB3046 |
| Relibra |
| RP29985 |
| S00309 |
| SC-15109 |
| Scheinpharm Testone-Cyp |
| SCHEMBL8452 |
| SMR000058344 |
| SMR001261453 |
| Striant |
| Striant (TN) |
| Sustanon |
| Sustanone |
| Sustason 250 |
| Synandrol F |
| T-Cypionate |
| Teslen |
| Testamone 100 |
| Testandrone |
| Testaqua |
| Testiculosterone |
| Testim |
| Testim (TN) |
| Testobase |
| Testoderm |
| Testoderm Tts |
| Testogel |
| Testoject-50 |
| Testolin |
| Testopel Pellets |
| Testopropon |
| Testosteroid |
| Testosteron |
| Testosterona |
| Testosterona [INN-Spanish] |
| testosterone |
| Testosterone (JAN/USP) |
| Testosterone [Androgenic steroids, anabolic] |
| Testosterone [INN:BAN] |
| Testosterone [USP:INN:BAN] |
| Testosterone 1.0 mg/ml in Acetonitrile |
| Testosterone 100 microg/mL in Acetonitrile |
| Testosterone and its esters |
| Testosterone for impurity D identification, European Pharmacopoeia (EP) Reference Standard |
| Testosterone for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Testosterone hydrate |
| Testosterone solution |
| Testosterone solution, 1.0 mg/mL in 1,2-dimethoxyethane, drug standard |
| Testosterone solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material |
| Testosterone, >=98% |
| Testosterone, 1 |
| Testosterone, cell culture tested |
| Testosterone, European Pharmacopoeia (EP) Reference Standard |
| Testosterone, purum, >=99.0% (HPLC) |
| Testosterone, VETRANAL(TM), analytical standard |
| Testosterone; 4-Androsten-17?-ol-3-one; 17?-Hydroxy-4-androsten-3-one |
| Testosteronum |
| Testosteronum [INN-Latin] |
| Testostosterone |
| Testoviron |
| Testoviron Schering |
| Testoviron T |
| Testred Cypionate 200 |
| Testrin-P.A |
| Testro AQ |
| Testrone |
| Testryl |
| Tostrelle |
| Tostrex |
| Tox21_200689 |
| trans-Testosterone |
| UNII-3XMK78S47O |
| Viatrel |
| Virilon IM |
| Virormone |
| Virosterone |
| W-5033 |
| ZINC118912393 |
US Patents and Regulatory Information for ANDROGEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | ANDROGEL | testosterone | GEL;TRANSDERMAL | 021015-002 | Feb 28, 2000 | AB1 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Abbvie | ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309-003 | Sep 7, 2012 | AB2 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Abbvie | ANDROGEL | testosterone | GEL;TRANSDERMAL | 022309-003 | Sep 7, 2012 | AB2 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Paragraph IV (Patent) Challenges for ANDROGEL
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Gel | 1.62% (1.25 g and 2.5 g packets) | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Gel | 1.62% | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Gel Metered-dose Pump | 1% | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for ANDROGEL
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 2,004,092,494 | ➤ Sign Up | |
| Patent No. | Title | Estimated Patent Expiration |
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