Mylan Company Profile
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What is the competitive landscape for MYLAN, and when can generic versions of MYLAN drugs launch?
MYLAN has seven hundred and thirty-eight approved drugs.
There are forty-five US patents protecting MYLAN drugs. There are forty-three tentative approvals on MYLAN drugs.
There are three hundred and three patent family members on MYLAN drugs in forty-two countries and one thousand one hundred and forty-six supplementary protection certificates in eighteen countries.
Summary for Mylan
International Patents: | 303 |
US Patents: | 45 |
Tradenames: | 515 |
Ingredients: | 465 |
NDAs: | 738 |
Patent Litigation for Mylan: | See patent lawsuits for Mylan |
PTAB Cases with Mylan as petitioner: | See PTAB cases with Mylan as petitioner |
Drugs and US Patents for Mylan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 076919-001 | Nov 4, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Mylan | LITHIUM CARBONATE | lithium carbonate | CAPSULE;ORAL | 076243-002 | Feb 24, 2003 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Mylan Labs Ltd | DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE;INJECTION | 200170-002 | Oct 28, 2011 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mylan Labs Ltd | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | fluconazole | INJECTABLE;INJECTION | 076888-001 | Mar 25, 2005 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Mylan Labs Ltd | NORETHINDRONE AND ETHINYL ESTRADIOL | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 200897-001 | May 11, 2015 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Mylan Pharms Inc | AMNESTEEM | isotretinoin | CAPSULE;ORAL | 075945-002 | Nov 8, 2002 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 Mylan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan Speclt | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | 7,462,645 | ⤷ Try a Trial |
Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618-001 | Dec 24, 1987 | RE33239 | ⤷ Try a Trial |
Mylan Speciality Lp | AEROSPAN HFA | flunisolide | AEROSOL, METERED;INHALATION | 021247-001 | Jan 27, 2006 | 5,980,867 | ⤷ Try a Trial |
Mylan | DENAVIR | penciclovir | CREAM;TOPICAL | 020629-001 | Sep 24, 1996 | 5,916,893 | ⤷ Try a Trial |
Mylan Speclt | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | 8,623,922 | ⤷ Try a Trial |
Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-004 | Nov 19, 1996 | 4,801,587 | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for MYLAN drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Sublingual Tablets | 5 mg and 10 mg | ➤ Subscribe | 2010-04-29 |
➤ Subscribe | Topical Foam | 0.05% | ➤ Subscribe | 2005-06-27 |
➤ Subscribe | for Injection | 100 mcg/vial and 500 mcg/vial | ➤ Subscribe | 2015-04-14 |
➤ Subscribe | Injection | 100 mg/mL, 2.5 mL vials | ➤ Subscribe | 2007-09-24 |
➤ Subscribe | for Injection | 1 mg/vial, 2 mg/vial and 5 mg/vial | ➤ Subscribe | 2013-12-27 |
➤ Subscribe | Injection (Auto-injector) | 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | ➤ Subscribe | 2008-11-21 |
➤ Subscribe | Ophthalmic Solution | 0.05% | ➤ Subscribe | 2006-12-13 |
➤ Subscribe | Inhalation Solution | 300 mg/5 mL | ➤ Subscribe | 2009-06-29 |
➤ Subscribe | Nasal Spray | 137 mcg/50 mcg per spray | ➤ Subscribe | 2014-06-13 |
➤ Subscribe | Foam | 0.12% | ➤ Subscribe | 2007-08-10 |
➤ Subscribe | CapsulesInhalation Solution | 0.02 mg/2 mL | ➤ Subscribe | 2009-01-21 |
➤ Subscribe | Delayed-release Tablets | 20 mg | ➤ Subscribe | 2015-06-03 |
➤ Subscribe | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
➤ Subscribe | Nasal Spray | 0.125 mg base/spray | ➤ Subscribe | 2005-11-14 |
➤ Subscribe | Injection (Auto-injector) | 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | ➤ Subscribe | 2008-11-21 |
➤ Subscribe | Inhalation Solution | 0.021% and 0.042% | ➤ Subscribe | 2005-10-19 |
➤ Subscribe | Nasal Spray | 205.5 mcg/spray | ➤ Subscribe | 2011-12-15 |
➤ Subscribe | Foam | 2% | ➤ Subscribe | 2009-07-30 |
International Patents for Mylan Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 2016026214 | ⤷ Try a Trial |
European Patent Office | 1765288 | ⤷ Try a Trial |
Australia | 2009243420 | ⤷ Try a Trial |
Hungary | S1300032 | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2006046041 | ⤷ Try a Trial |
European Patent Office | 2179759 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Mylan Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0617614 | 11/2001 | Austria | ⤷ Try a Trial | PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011 |
0253412 | 63/1997 | Austria | ⤷ Try a Trial | PRODUCT NAME: CIDOFOVIR; REGISTRATION NO/DATE: K (97) 1176 19970423 |
1856135 | LUC00153 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113 |
2924034 | 2019018 | Norway | ⤷ Try a Trial | PRODUCT NAME: DORAVIRIN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV I KOMBINASJON MED LAMIVUDIN OG I KOMBINASJON MED TENOFOVIRDISOPROKSIL FUMARAT; REG. NO/DATE: EU/1/18/1333/001-2 20181213 |
3632448 | 22C1031 | France | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 31332 20191016 |
1020454 | SPC/GB10/019 | United Kingdom | ⤷ Try a Trial | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB10/019 GRANTED TO TEIJIN LIMITED IN RESPECT OF THE PRODUCT FEBUXOSTAT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6408 DATED 14/03/2012 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22/04/2023. |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.