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 forty-three approved drugs.
There are forty-six US patents protecting MYLAN drugs. There are forty-two 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 fifty-six supplementary protection certificates in eighteen countries.
Summary for Mylan
International Patents: | 303 |
US Patents: | 46 |
Tradenames: | 519 |
Ingredients: | 469 |
NDAs: | 743 |
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 Pharms Inc | NIZATIDINE | nizatidine | CAPSULE;ORAL | 075806-001 | Jul 5, 2002 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Mylan Institutional | CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 077998-001 | Apr 24, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Mylan Speciality Lp | FELBATOL | felbamate | TABLET;ORAL | 020189-002 | Jul 29, 1993 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mylan | AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 200465-002 | Nov 29, 2013 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Mylan | FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | CAPSULE;ORAL | 075207-003 | May 25, 2007 | DISCN | 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 Speciality Lp | DEMADEX | torsemide | TABLET;ORAL | 020136-004 | Aug 23, 1993 | RE30633 | ⤷ Try a Trial |
Mylan Speciality Lp | DUONEB | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 020950-001 | Mar 21, 2001 | 6,632,842 | ⤷ Try a Trial |
Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | 8,715,623 | ⤷ Try a Trial |
Mylan | DENAVIR | penciclovir | CREAM;TOPICAL | 020629-001 | Sep 24, 1996 | 5,840,763 | ⤷ Try a Trial |
Mylan Speciality Lp | DEMADEX | torsemide | TABLET;ORAL | 020136-003 | Aug 23, 1993 | 4,018,929 | ⤷ 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 | 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 |
➤ 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 |
International Patents for Mylan Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
South Africa | 200500331 | ⤷ Try a Trial |
South Korea | 101174740 | ⤷ Try a Trial |
Portugal | 2179759 | ⤷ Try a Trial |
South Korea | 20070069155 | ⤷ Try a Trial |
New Zealand | 541526 | ⤷ 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 |
---|---|---|---|---|
2582683 | 2019008 | Norway | ⤷ Try a Trial | PRODUCT NAME: ALLOPURINOL/LESINURAD ELLER ET FARMASOEYTISK AKSEPTERBART SALT ELLER SALTER DERAV; REG. NO/DATE: EU/1/18/1300/001-004 20180904 |
0915894 | SPC/GB05/041 | United Kingdom | ⤷ Try a Trial | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020. |
0275821 | 01C0035 | France | ⤷ Try a Trial | PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128 |
1499331 | SPC/GB13/034 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313 |
2217577 | LUC00103 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OU UN/DES SEL(S) PHARMACEUTIQUEMENT ACCEPTABLE(S) DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1300 20180827 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.