Regulatory Open Forum

Hello Everyone

Can an original NDA holder introduce its own "brand generic" product in the market anytime even during 180 days exclusivity period granted to an ANDA from different sponsor.

thanks a lot
Meghana

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Meghana Bohra
Pittsburgh PA
United States
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Meghana, I think you are referring here "Authorized Generics." Yes. NDA holder can introduce its own version of its product as AG during the 180 days exclusivity period provided that the brand product is repacked, relabeled and launched under the generic name.

21 CFR section 314.3 defines "Authorized generic drug means a listed drug, as defined in this section, that has been approved under section 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trademark that differs from that of the listed drug."


-------------------------------------------
Vikram Katragadda RAC
Sr Scientist
Lawrenceville NJ
United States
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Original Message:
Sent: 09-04-2012 12:39
From: Meghana Bohra
Subject: Brand generics

Hello Everyone

Can an original NDA holder introduce its own "brand generic" product in the market anytime even during 180 days exclusivity period granted to an ANDA from different sponsor.

thanks a lot
Meghana

-------------------------------------------
Meghana Bohra
Pittsburgh PA
United States
-------------------------------------------

Thanks Vikram for the reply.
In this case, does the NDA holder go through the approval process for generic version by submitting a supplement to original NDA.


-------------------------------------------
Meghana Bohra
Pittsburgh PA
United States
-------------------------------------------






Original Message:
Sent: 09-05-2012 19:21
From: Vikram Katragadda
Subject: Brand generics


Meghana, I think you are referring here "Authorized Generics." Yes. NDA holder can introduce its own version of its product as AG during the 180 days exclusivity period provided that the brand product is repacked, relabeled and launched under the generic name.

21 CFR section 314.3 defines "Authorized generic drug means a listed drug, as defined in this section, that has been approved under section 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trademark that differs from that of the listed drug."


-------------------------------------------
Vikram Katragadda RAC
Sr Scientist
Lawrenceville NJ
United States
-------------------------------------------






Original Message:
Sent: 09-04-2012 12:39
From: Meghana Bohra
Subject: Brand generics

Hello Everyone

Can an original NDA holder introduce its own "brand generic" product in the market anytime even during 180 days exclusivity period granted to an ANDA from different sponsor.

thanks a lot
Meghana

-------------------------------------------
Meghana Bohra
Pittsburgh PA
United States
-------------------------------------------

No Meghana. NDA holder is not required to go through the approval process to launch AG as the Brand drug is already reviewed by the FDA and the only change here is that the NDA holder is authorizing it's subsidiary or third-party provider to launch the same under the generic label. No supplement is required as annual report would suffice.

Please refer annual reports under 21 CFR 314.81

-------------------------------------------
Vikram Katragadda RAC
Sr Scientist
Lawrenceville NJ
United States
-------------------------------------------






Original Message:
Sent: 09-06-2012 08:43
From: Meghana Bohra
Subject: Brand generics

Thanks Vikram for the reply.
In this case, does the NDA holder go through the approval process for generic version by submitting a supplement to original NDA.


-------------------------------------------
Meghana Bohra
Pittsburgh PA
United States
-------------------------------------------






Original Message:
Sent: 09-05-2012 19:21
From: Vikram Katragadda
Subject: Brand generics


Meghana, I think you are referring here "Authorized Generics." Yes. NDA holder can introduce its own version of its product as AG during the 180 days exclusivity period provided that the brand product is repacked, relabeled and launched under the generic name.

21 CFR section 314.3 defines "Authorized generic drug means a listed drug, as defined in this section, that has been approved under section 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trademark that differs from that of the listed drug."


-------------------------------------------
Vikram Katragadda RAC
Sr Scientist
Lawrenceville NJ
United States
-------------------------------------------






Original Message:
Sent: 09-04-2012 12:39
From: Meghana Bohra
Subject: Brand generics

Hello Everyone

Can an original NDA holder introduce its own "brand generic" product in the market anytime even during 180 days exclusivity period granted to an ANDA from different sponsor.

thanks a lot
Meghana

-------------------------------------------
Meghana Bohra
Pittsburgh PA
United States
-------------------------------------------

got it!
21 CFR 314.81 (b)(2) (ii)(b)
Thanks a lot!
-------------------------------------------
Meghana Bohra
Pittsburgh PA
United States
-------------------------------------------






Original Message:
Sent: 09-06-2012 19:56
From: Vikram Katragadda
Subject: Brand generics

No Meghana. NDA holder is not required to go through the approval process to launch AG as the Brand drug is already reviewed by the FDA and the only change here is that the NDA holder is authorizing it's subsidiary or third-party provider to launch the same under the generic label. No supplement is required as annual report would suffice.

Please refer annual reports under 21 CFR 314.81

-------------------------------------------
Vikram Katragadda RAC
Sr Scientist
Lawrenceville NJ
United States
-------------------------------------------






Original Message:
Sent: 09-06-2012 08:43
From: Meghana Bohra
Subject: Brand generics

Thanks Vikram for the reply.
In this case, does the NDA holder go through the approval process for generic version by submitting a supplement to original NDA.


-------------------------------------------
Meghana Bohra
Pittsburgh PA
United States
-------------------------------------------






Original Message:
Sent: 09-05-2012 19:21
From: Vikram Katragadda
Subject: Brand generics


Meghana, I think you are referring here "Authorized Generics." Yes. NDA holder can introduce its own version of its product as AG during the 180 days exclusivity period provided that the brand product is repacked, relabeled and launched under the generic name.

21 CFR section 314.3 defines "Authorized generic drug means a listed drug, as defined in this section, that has been approved under section 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trademark that differs from that of the listed drug."


-------------------------------------------
Vikram Katragadda RAC
Sr Scientist
Lawrenceville NJ
United States
-------------------------------------------






Original Message:
Sent: 09-04-2012 12:39
From: Meghana Bohra
Subject: Brand generics

Hello Everyone

Can an original NDA holder introduce its own "brand generic" product in the market anytime even during 180 days exclusivity period granted to an ANDA from different sponsor.

thanks a lot
Meghana

-------------------------------------------
Meghana Bohra
Pittsburgh PA
United States
-------------------------------------------