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 Speciality Lp | FELBATOL | felbamate | TABLET;ORAL | 020189-001 | Jul 29, 1993 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mylan Institutional | CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 077998-003 | Apr 24, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Mylan Labs Ltd | LAMIVUDINE | lamivudine | TABLET;ORAL | 078545-002 | Mar 5, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Mylan | LORATADINE | loratadine | TABLET;ORAL | 075790-001 | Nov 7, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Mylan | ZOVIRAX | acyclovir | TABLET;ORAL | 020089-002 | Apr 30, 1991 | DISCN | Yes | 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 Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-002 | Nov 19, 1996 | 5,886,039 | ⤷ Try a Trial |
Mylan Spclt Viatris | DIPENTUM | olsalazine sodium | CAPSULE;ORAL | 019715-001 | Jul 31, 1990 | 4,559,330 | ⤷ Try a Trial |
Mylan Speciality Lp | ELESTRIN | estradiol | GEL, METERED;TRANSDERMAL | 021813-001 | Dec 15, 2006 | 7,198,801 | ⤷ Try a Trial |
Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-003 | Jul 12, 1996 | 5,866,591*PED | ⤷ Try a Trial |
Mylan Speciality Lp | ELESTRIN | estradiol | GEL, METERED;TRANSDERMAL | 021813-001 | Dec 15, 2006 | 7,470,433 | ⤷ 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 | Nasal Spray | 205.5 mcg/spray | ➤ Subscribe | 2011-12-15 |
➤ Subscribe | Foam | 2% | ➤ Subscribe | 2009-07-30 |
➤ 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 |
International Patents for Mylan Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Israel | 216932 | ⤷ Try a Trial |
Spain | 2450133 | ⤷ Try a Trial |
Cyprus | 1115386 | ⤷ Try a Trial |
South Africa | 200607099 | ⤷ Try a Trial |
Japan | 4828404 | ⤷ 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 |
---|---|---|---|---|
1255752 | 2008/004 | Ireland | ⤷ Try a Trial | PRODUCT NAME: SUNITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE L-MALATE SALT; AUTHORISATION NO/DATE: IRELAND EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003 20060719 |
3300601 | 2022C/528 | Belgium | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827 |
1718641 | SPC/GB12/028 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209 |
2049506 | C201530064 | Spain | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/13/830; DATE OF AUTHORISATION: 20130524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/830; DATE OF FIRST AUTHORISATION IN EEA: 20130524 |
1458369 | CA 2008 00029 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ADAPALEN, BENZOYLPEROXID |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.