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 Technologies | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL, SUBLINGUAL | 211785-002 | Apr 17, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan | ETOPOSIDE | etoposide | CAPSULE;ORAL | 075635-001 | Sep 19, 2001 | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Mylan | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 085762-001 | Approved Prior to Jan 1, 1982 | AA | 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 | EXTINA | ketoconazole | AEROSOL, FOAM;TOPICAL | 021738-001 | Jun 12, 2007 | 7,553,835 | ⤷ Try a Trial |
| Mylan Speciality Lp | DEMADEX | torsemide | TABLET;ORAL | 020136-004 | Aug 23, 1993 | RE30633 | ⤷ Try a Trial |
| Mylan | ZOVIRAX | acyclovir | TABLET;ORAL | 020089-002 | Apr 30, 1991 | 4,199,574 | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for Mylan Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1786491 | ⤷ Try a Trial |
| Norway | 20064579 | ⤷ Try a Trial |
| Canada | 2765621 | ⤷ 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 |
|---|---|---|---|---|
| 0252504 | 96C0046 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DOXORUBICIN HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/96/011/001 19960624 |
| 1261586 | SPC/GB10/001 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF INCLUDING SAXAGLIPTIN HYDROCHLORIDE; REGISTERED: UK EU/1/09/545/001 20091001; UK EU/1/09/545/002 20091001; UK EU/1/09/545/003 20091001; UK EU/1/09/545/004 20091001; UK EU/1/09/545/005 20091001; UK EU/1/09/545/006 20091001; UK EU/1/09/545/007 20091001; UK EU/1/09/545/008 20091001; UK EU/1/09/545/009 20091001; UK EU/1/09/545/010 20091001 |
| 1174135 | SPC/GB10/011 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: THE COMBINATION OF PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY THE HYDROCHLORIDE SALT, AND GLIMEPIRIDE.; REGISTERED: UK EU/1/06/366/001 20070108; UK EU/1/06/366/002 20070108; UK EU/1/06/366/003 20070108; UK EU/1/06/366/004 20070108; UK EU/1/06/366/005 20070108; UK EU/1/06/366/006 20070108; UK EU/1/06/366/019 20070108; UK EU/1/06/366/020 20070108; UK EU/1/06/366/021 20070108; UK EU/1/06/366/022 20070108; UK EU/1/06/366/013 20070108; UK EU/1/06/366/014 20070108; UK EU/1/06/366/015 20070108; UK EU/1/06/366/016 20070108; UK EU/1/06/366/017 20070108; UK EU/1/06/366/018 20070108; UK EU/1/06/366/007 20070108; UK EU/1/06/366/008 20070108; UK EU |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
