Generic News 2.18.15

Author: APCI Staff/Wednesday, February 18, 2015/Categories: Generics and Vendor Contracting, Generic Bulletins

**GENERIC SPECIALS - DEEP DISCOUNTS **

“Weekly Generics Campaign”

LOOK for DEEP Discounts with APCI’s Weekly Generics Campaign!

Items on the Generics Campaign will run weekly

Items on the Generics Campaign this week:

Effective 2/18/15 – 2/24/15

ITEM NDC NUM DSCR TOP 250
2237915 55111025960 ZIPRASIDONE 80mg 60 * N
2400273 51672404806 CLOTRIMAZOLE/BETAMET DIPROP   1%/0.05% 45gm * N
3260874 45802013275 FENOFIBRATE NANOCRYSTALLIZED 145MG  * Y
1263508 16714067101 ONDANSETRON O/S 4MG/5ML 50 * N
93101042 00093101042 MUPIROCIN   2% 22 * N

* Special pricing on orders placed 2/18/15 – 2/24/15

Watch for these Items on Generics Campaign NEXT week:

ITEM NDC NUM DSCR TOP 250 SLOT Disc CAMPAIGN
1267152 00168009960 KETOCONAZOLE CRM 2% FOUG 60GM@ Y A 30.00% 2/24 - 3/3
1913961 51672125906 CLOBETAS PR OIN .05% TAR 45GM@ Y A 20.00% 2/24 - 3/3
1943612 00603240728 BACLOFEN TAB 20MG Q/P 500@ Y A 30.00% 2/24 - 3/3
2156743 55111025660 ZIPRASID CAP 20MG DR/R 60@ N A 30.00% 2/24 - 3/3
3412665 00378581377 VALSARTAN TAB 80 MG MYL 90@ N A 30.00% 2/24 - 3/3

* Special pricing on orders placed 2/25/15 – 3/3/15

Check out a full list of Custom Discounted Items our website weekly - updated every Monday!

https://www.apcinet.com/AboutUs/Services/VendorContracting/APCIDiscountedGenerics/tabid/535/Default.aspx


NEWS YOU CAN USE

On Thursday, February 12, Par Pharmaceutical launched the generic equivalent of Mirapex® extended release tablets (pramipexole). 

The Par item will be added to the OneStop program in the primary position with visibility in McKesson Connect tomorrow, February 13. Estimated brand sales of Mirapex ER are approximately $60MM.

Brand Items:

Item # NDC Description
1915453 00597028530 MIRAPEX ER TAB 0.75MG  30
1915651 00597011330 MIRAPEX ER TAB 1.5MG  30

There will be no ASAP or ASAP Plus for this launch.

Product Launch Information - OneStop Add
Bx Name Mirapex ER
Bx Supplier Boehringer Ingelheim
Generic Name pramipexole ER
Generic Description pramipexole dihydrochloride ER tablets
Therapeutic Class/Indication Indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease
FDA Approval Date 02/11/2015
Launch Reason FDA Approval
Launch Exclusivity No FDA exclusivity
Number of Players 1
US Brand Sales Estimated annual brand sales are approximately $60MM.

To order, please use the following item number:

Item # Supplier Name NDC Description OS ADD
2003747 PAR PHARMACEUTICAL 10370025211 Pramipexole Dihydrochloride ER Tab 0.75mg 02/13/2015
2003739 PAR PHARMACEUTICAL 10370025311 Pramipexole Dihydrochloride ER Tab 1.5mg 02/13/2015
Subject: OneStop: Launch of Generic Nexium ® Capsules


On Tuesday, February 17, Teva Pharmaceuticals launched the generic equivalent of Nexium® capsules (esomeprazole magnesium).

The Teva items will be added to the OneStop program in the A/C position with visibility in McKesson Connect today, February 17. Estimated brand sales of Nexium are approximately $6B.

Brand Items:

Item # NDC Description
1295799 00186502031 NEXIUM CAP 20MG  30
2454965 00186502054 NEXIUM CAP 20MG  90
1297985 00186504031 NEXIUM CAP 40MG  30
2454825 00186504054 NEXIUM CAP 40MG  90

In support of this exclusive, highly supply-constrained launch, McKesson will be providing an ASAP shipment of this product with deliveries expected to begin arriving on Wednesday, February 18.   Since we do not have manufacturer support, we will be unable to provide price protection.   The limited supply of inventory will be protected for our OneStop customers and orders will be limited to two (2) bottles on each of the available SKUs of this generic Nexium.

Customers who wish to return the ASAP shipment should follow the standard return policies.

Product Launch Information - OneStop Add
Bx Name Nexium
Bx Supplier Astra Zeneca
Generic Name esomeprazole magnesium delayed-release
Generic Description esomeprazole magnesium capsules - 20mg 30ct, 20mg 90ct, 40mg 30ct, 40mg 90ct
Therapeutic Class/Indication Indicated for the treatment of heartburn, gastroesophageal reflux disease (GERD), stomach ulcers, and a damaged esophagus.
FDA Approval Date 2/17/2015
Launch Reason FDA Approval
Launch Exclusivity No FDA exclusivity
Number of Players 1
US Brand Sales Estimated annual brand sales are approximately $6B.

To order, please use the following item numbers:

Item # Supplier Name NDC Description OS ADD
3419074 TEVA PHARMACEUTICALS 00093645056 ESOMEPR MAG DR CP 20MG TEV 30 02/17/2015
3419082 TEVA PHARMACEUTICALS 00093645098 ESOMEPR MAG DR CP 20MG TEV 90 02/17/2015
3419207 TEVA PHARMACEUTICALS 00093645156 ESOMEPR MAG DR CP 40MG TEV 30 02/17/2015
3419249 TEVA PHARMACEUTICALS 00093645198 ESOMEPR MAG DR CP 40MG TEV 90 02/17/2015

For questions please contact ISManagement@McKesson.com.

Generic Concerta 27mg, 36mg and 54mg

Many Questions lately regarding this item and slotting:

McKesson is trying to be more transparent on items on the program, but it’s causing some confusion.  The generics team puts items in the “AC, alternate choice” slot to have it available to customers.

Example: esomepralzole that was the generic/non-generic for Nexium. It wasn’t AB rated due to a higher salt content. We made that available for purchase to the customer on the program if they wanted to take advantage and/or started having physicians converting patients due to the cost savings. 

McKesson added the two letter coding is for all Alternate Choice items. So now instead of seeing APC1-AC, you will see 4 different codes to give more insight into why it’s non-substitutable and why it’s in an alternate choice position.  The concerta is in a APC1-MF position. The MF is for Manufacture-being that this manufacture is preferred by customers/drs/phcys. An “AC” item cannot be subbed out due to it not being AB Rated, Therapeutic Equivalence, Shape, Color, Flavor, manufacture (maybe less supply than the preferred A Slotted item etc).  It is very confusing to many, but basically the 2 letter coded products are available to purchase and get rebated, but may not be AB-Rated or Therapeutically Equivalent.

* On 12/30/10, Mallinckrodt filed an ANDA seeking FDA approval for generic 27, 36 and 54 mg tablets. Mallinckrodt submitted Paragraph IV certifications challenging the '373 and '129 patents, but Janssen did not sue Mallinckrodt for patent infringement. On 5/18/12, when Janssen submitted the '798 patent to FDA for listing in the Orange Book, Mallickrodt was the first ANDA filer to amend its ANDA to add a Paragraph IV certification challenging the '798 patent. FDA granted effective approval to Mallinckrodt's ANDA on 12/28/12. Under pre-MMA law, FDA awarded Mallinckrot 180-day exclusivity for generic 27, 36 and 54 mg tablets. No ANDA filer received 180-day exclusivity for generic 18 mg tablets. Mallinckrodt launched its generic 27 mg tablets on 12/31/12. In February 2013, Mallinckrodt submitted a supplement to its ANDA to seek FDA approval for generic 18 mg tablets. Mallinckrodt launched its generic 36 mg and 54 mg tablets on 3/25/13.

Under the terms of a settlement agreement with Janssen, Kremers Urban received a license to launch its generic version of Concerta as of 7/1/12. On 7/9/13, FDA granted effective approval to Kremers Urban's generic 18 mg and 27 mg tablets, and tentative approval to Kremers Urban's 36 mg and 54 mg tablets. Kremers Urban launched its generic 18 mg and 27 mg tablets on 7/10/13. Following the expiration of Mallinckrodt's 180-day exclusivity, FDA granted effective approval to Kremers Urban's generic 36 mg and 54 mg tablets on 9/23/13.

At one time, Actavis was in the process of developing a generic version of Concerta, but it had not yet filed an ANDA. As part of Watson's acquisition of Actavis in October 2012, Actavis divested its development stage product to Par, which later filed an ANDA. Depending on the progress of the patent infringement lawsuit, Par may have an opportunity to launch its generic tablets after the 30-month stay on FDA's authority to grant effective approval to the ANDA expires on 11/7/15.

Depending on the progress of the patent infringement lawsuit, Mylan may have an opportunity to launch its generic tablets after the 30-month stay on its ANDA expires on 10/2/16.


FFF Enterprises Influenza Vaccine Order Forms now available

Click on the image below to download a printable PDF form, or click on the file list following this article.


APCI APPROVED VENDORS:

New vendor coming soon...

Acute Care Pharmaceuticals

P: 888.909.7700
F: 858.675.9380

www.Pharma-Choice.com

We have had many requests to offer a provider for sterile compounding supplies.  Effective March 1, 2015 we will have items loaded with contract pricing available through McKesson. Rebates/Administrative fees collected in relation to this contract will be returned to the APCI Stockholders in the form of dividends.

Comments are only visible to subscribers.