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ADAPALENE - Generic Drug Details
What are the generic drug sources for adapalene and what is the scope of adapalene patent protection?
Adapalene
is the generic ingredient in five branded drugs marketed by Fougera Pharms, Galderma Labs Lp, Actavis Mid Atlantic, Glenmark Generics, Pliva Hrvatska Doo, Taro, Tolmar, Call Inc, Perrigo Israel, and Galderma Labs, and is included in nineteen NDAs. There are twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are twelve drug master file entries for adapalene. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for ADAPALENE
| US Patents: | 24 |
| Tradenames: | 5 |
| Applicants: | 10 |
| NDAs: | 19 |
| Drug Master File Entries: | 12 |
| Suppliers / Packagers: | 17 |
| Bulk Api Vendors: | 98 |
| Clinical Trials: | 62 |
| Patent Applications: | 3,483 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ADAPALENE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ADAPALENE |
| DailyMed Link: | ADAPALENE at DailyMed |
Pharmacology for ADAPALENE
| Ingredient-type | Retinoids |
| Drug Class | Retinoid |
Medical Subject Heading (MeSH) Categories for ADAPALENE
Synonyms for ADAPALENE
| (non-d)Adapalene-d15 |
| 106685-40-9 |
| 1L4806J2QF |
| 2-Naphthalenecarboxylic acid, 6-(4-methoxy-3-tricyclo(3.3.1.1(sup 3,7))dec-1-ylphenyl)- |
| 2-Naphthalenecarboxylic acid, 6-(4-methoxy-3-tricyclo[3.3.1.13,7]dec-1-ylphenyl)- |
| 4CA-0111 |
| 6-(3-((3r,5r,7r)-adamantan-1-yl)-4-methoxyphenyl)-2-naphthoic acid |
| 6-(3-(1-Adamantyl)-4-methoxyphenyl)-2-naphthoic acid |
| 6-(3-(Adamantan-1-yl)-4-methoxyphenyl)-2-naphthoic acid |
| 6-(3-Adamantan-1-yl-4-methoxy-phenyl)-naphthalene-2-carboxylic acid |
| 6-(3-adamantan-1-yl-4-methoxyphenyl)naphthalene-2-carboxylic acid |
| 6-(4-Methoxy-3-tricyclo[3.3.1.13,7]dec-1-ylphenyl)-2-naphthalenecarboxylic acid |
| 6-[3-(1-adamantyl)-4-methoxy-phenyl]naphthalene-2-carboxylic acid |
| 6-[3-(1-ADAMANTYL)-4-METHOXYPHENYL]-2-NAPHTHALENE CARBOXYLIC ACID |
| 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthalene-carboxylic acid |
| 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthalenecarboxylic acid |
| 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid |
| 6-[3-(1-adamantyl)-4-methoxyphenyl]naphthalene-2-carboxylic acid |
| 6-[3-(adamantan-1-yl)-4-methoxyphenyl]-2-naphthoic acid |
| 6-[3-(adamantan-1-yl)-4-methoxyphenyl]naphthalene-2-carboxylic acid |
| 6-[4-methoxy-3-(tricyclo[3.3.1.1~3,7~]dec-1-yl)phenyl]naphthalene-2-carboxylic acid |
| 6-[4-methoxy-3-(tricyclo[3.3.1.13,7]dec-1-yl)phenyl]naphthalene-2-carboxylic acid |
| 685A409 |
| A801483 |
| AB0013899 |
| AB01274764_03 |
| AB01274764_04 |
| AB01274764-01 |
| AB01274764-02 |
| AB13763 |
| AB2000023 |
| ABP000590 |
| AC-1974 |
| AC1L1SOH |
| AC1Q5USH |
| Adaferin |
| Adaferin (TN) |
| Adapalen |
| Adapalene (JAN/USAN/INN) |
| Adapalene [USAN:BAN:INN] |
| Adapalene [USAN:INN:BAN] |
| Adapalene for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Adapalene, >=98% (HPLC) |
| Adapalene, European Pharmacopoeia (EP) Reference Standard |
| Adapalene, pharmaceutical secondary standard; traceable to USP and PhEur |
| Adapalene, United States Pharmacopeia (USP) Reference Standard |
| Adapalene/ |
| Adapaleno |
| Adapaleno [INN-Spanish] |
| Adapalenum |
| Adapalenum [INN-Latin] |
| AJ-45604 |
| AK-72900 |
| AKOS005145841 |
| AKOS015895391 |
| Ambap106685-40-9 |
| AN-593 |
| AOB6389 |
| API0001385 |
| BC205779 |
| BCP9000231 |
| BDBM50048280 |
| BIDD:GT0264 |
| BR-72900 |
| BRD-K33127281-001-01-5 |
| C28H28O3 |
| CAS-106685-40-9 |
| CCG-213060 |
| CCG-221237 |
| CD 271 |
| CD-271 |
| CD271 |
| CHEBI:31174 |
| CHEMBL1265 |
| CHEMBL76401 |
| CPD000466349 |
| CS-1789 |
| CTK8E8906 |
| D01112 |
| D0JC9N |
| DB00210 |
| Differin |
| Differin (TN) |
| Differin Gel |
| Differin Gel 0.1% |
| Differin, Adapalene |
| Differin, Teva, Pimpal, Gallet, Adelene, Adeferin |
| Differine |
| DR002478 |
| DSSTox_CID_26481 |
| DSSTox_GSID_46481 |
| DSSTox_RID_81652 |
| DTXSID5046481 |
| EBD19549 |
| F2173-0588 |
| FT-0631040 |
| GTPL5429 |
| HMS3264F15 |
| HMS3654F11 |
| HY-B0091 |
| I06-0642 |
| I810 |
| KB-246947 |
| KS-000002B5 |
| KS-1196 |
| LS-172017 |
| LZCDAPDGXCYOEH-UHFFFAOYSA-N |
| MFCD03106112 |
| MLS000759463 |
| MLS006010036 |
| MolPort-003-986-211 |
| NAP030 |
| NCGC00164617-01 |
| NCGC00164617-02 |
| NCGC00164617-04 |
| NCGC00164617-05 |
| PL029988 |
| PL040836 |
| RTR-001330 |
| S-3513 |
| s1276 |
| SAM001246663 |
| SC-17327 |
| SCHEMBL2747 |
| SMR000466349 |
| SMR002529673 |
| SR-01000942194 |
| SR-01000942194-2 |
| ST2412159 |
| STL453114 |
| TL8000241 |
| Tox21_112236 |
| Tox21_112236_1 |
| TR-001330 |
| UNII-1L4806J2QF |
| ZINC3784182 |
US Patents and Regulatory Information for ADAPALENE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Mid Atlantic | ADAPALENE | adapalene | GEL;TOPICAL | 201000-001 | Oct 27, 2014 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Galderma Labs Lp | DIFFERIN | adapalene | LOTION;TOPICAL | 022502-001 | Mar 17, 2010 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | 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 |
Expired US Patents for ADAPALENE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | DIFFERIN | adapalene | SOLUTION;TOPICAL | 020338-001 | May 31, 1996 | ➤ Sign Up | ➤ Sign Up |
| Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | ➤ Sign Up | ➤ Sign Up |
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | ➤ Sign Up | ➤ Sign Up |
| Galderma Labs Lp | DIFFERIN | adapalene | SOLUTION;TOPICAL | 020338-001 | May 31, 1996 | ➤ Sign Up | ➤ Sign Up |
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | ➤ Sign Up | ➤ Sign Up |
| Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for ADAPALENE
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 5074401 | ➤ Sign Up |
| Austria | 432072 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 03075908 | ➤ Sign Up |
| Austria | 417610 | ➤ Sign Up |
| Spain | 2327508 | ➤ Sign Up |
| Denmark | 1485080 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ADAPALENE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C/GB10/005 | United Kingdom | ➤ Sign Up | PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111 |
| C0024 | France | ➤ Sign Up | PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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